Re: Grandfathered drugs BANNED by the FDA!

[Guest guest]

, If there is any action I can take to help with the situation, please let me know. Sincerely, wrote: This is the second post from another thyroid yahoo group I joined.I found out on New Year's Eve day that my thyroid medication was no longer going to be able to be manufactured because the FDA has stopped further manufacture of ALL drugs that were grandfathered

in.These drugs HAVE to seek FDA approval before they can be made again!This DOES include Armour thyroid and thyroid. You'll have to wade through this message...because it was in response to someone else asking me about my first post alerting them to the ban.Good luck to everyone.Joan Powers from the FDA called and left me a message yesterday(Thursday Jan. 10th) and told me that Armour thyroid is NOT on theapproved drug list.From my previous FRANTIC phone call to Ms. Powers I already knewthat if they are NOT on the FDA's approved drug list? They willhave to seek FDA approval...they are NO longer going to be allowedto be manufactured.Here is Joan Power's info from the FDA:Joan PowersConsumer Safety OfficerDivision of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug AdministrationPhone: The two times I have phoned her? It has

taken her 24 hours to returnthe call.", " 01/10/2008 04:48 PMTo nwatson@...cc "McDermott, ", "Swezey, Brad"Subject Armour-ThyroidThis is the email forwarded to me last night (Thurs. Jan. 10) from at the St. Pete Times who is helping me investigateand draw attention to this situation.From what I can glean from this, Armour thyroid faced a recallbecause their last batch didn't pass the 6 month potency test? Isthat what you all read, too?When I called Armour (Forest Pharmaceuticals) about thegrandfathered in drugs being banned, I spoke with a gentleman named. (I called Armour in the hopes that they had maybealready sought approval since they are a bigger manufactuer ofdessicated thyroid OR that they might have the money $$$ to seek

aquicker approval than the smaller manufacturers.)When I spoke with Mr. at Forest Pharm., he was reallyflustered and seemed to think that I thought Armour had beenRECALLED. I kept assuring him that wasn't what I thought...that Ionly wanted to know if Armour was ALSO not going to be manufacturedanymore. He told me I did not know what I was talking about (eventhought I just gotten off the phone with Joan Powers of the FDA andI REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.) at the St. Pete Times also talked to a rep fromArmour/Forest Pharm. who also gave her the same song-and-dance.She and I were BOTH told that the reason Armour wasn't on ourpharmacy's shelves was because it was on "back order" at themanufacturing plant because of "high demand for the product."Okay...I SMELL COVER-UP THERE because of this next item I've

pastedin here from @ the SP Times...which she got from at the FDA:Naomi:This is a recalled product.Here is the web link (I've pulled the action information and put itinto the message, below).My colleagues McDermott and Brad Swezey, who cover recallissues, should be contacted if you have additional questions. Theyare copied here. At this point the posted informaton is the mostaccurate and available.Regards,http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlPRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240 mg),each tablet contains 152-mcg levothyroxine and 36-mcgliothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008; Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg), eachtablet contains 114-mcg levothyroxine and

27-mcg liothyronine,100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots: 1,000-tablet bottles: 030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;090724, Exp. Feb-09RECALLING FIRM/MANUFACTURERRecalling Firm: ForestPharmaceuticals Inc, Earth City, MO, by letter date November 9,2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH. Firminitiated recall is ongoing. REASONProduct failed disintegrationspecification at 6-months.VOLUME OF PRODUCT IN COMMERCEa) 41,745bottles totalb) 35,222/100-tablet bottles and 422/1,000-tabletbottlesDISTRIBUTIONNationwide and BelgiumI really don't give a rat's *** about their failing the 6 month'spotency, because now

they're really screwed and so are all of us:Armour can't manufacture again without a federal judge lifting thisban immediately so all of our dessicated thyroid makers can get backto work! Then the manufacturers are going to have to seek FDAapproval...which costs money.This whole thing reeks. I am in the process of trying to hoard themeds, because this next thing I'm posting is from Joan Powers andis the PROCESS we have to go through to get our drugs from aCanadian pharmacy.By the way? My doctor has already said that she will NOT gothrough this process because of the legalities of it. Basically,what Joan Powers told me I would have to do is:Have my doctor write me a new script every three months.Contact an online Canadian pharmacy and submit the script.That pharmacy will fill the script AFTER they contact my doctor foran okay.My doctor said there is NO way she will prescribe a drug that isbanned

by the FDA and okay me to have that script filled in anothercountry.Anyway, here's the email from Joan Powers from the FDA:FDA's Personal Importation PolicyþFrom: CDER DRUG INFO (DRUGINFO@...)You may not know this sender.Mark as safe|Mark as unsafeSent: Wed 1/02/08 6:40 PMTo: greenestgurl@...Thank you for your message to the Division of Drug Information inthe Center for Drug Evaluation and Research (CDER).The United States Federal Food, Drug, and Cosmetic Act (the Act)prohibits (21 USC ' 331) the interstate shipment (which includesimportation) of, among other things, unapproved new drugs. Thus, theimportation of drugs that lack FDA approval, whether for personaluse or otherwise, violates the Act. Unapproved new drugs are anydrugs, including foreign-made versions of U.S. approved drugs, thathave not been manufactured in accordance with and pursuant to an FDAapproval. Under the Act,

FDA may refuse admission to any drugthat "appears" to be unapproved, placing the burden on the importerto prove that the drug sought to be imported is, in fact, approvedby FDA. Absent evidence that the specific drug sought to be importedfrom a foreign country has been manufactured pursuant to an approvednew drug application, in the manufacturing facility permitted underthe application, such drug would appear to be an unapproved new drugsubject to FDA enforcement action. In addition, drugs from foreigncountries often fail to meet FDA's labeling and prescriptiondispensing requirements.FDA recognizes some individuals may seek treatment with anunapproved new drug in a foreign country and may wish to continuesuch treatment upon their return to the USA. Likewise, FDArecognizes some individuals suffer from conditions for which thereexists no FDA approved treatment. FDA has developed guidance whichidentifies

circumstances in which FDA may consider exercisingenforcement discretion to allow entry of such drugs. Generallyreferred to as the personal importation policy, this guidanceprovides FDA field offices the opportunity to exercise enforcementdiscretion in allowing entry of drugs when certain criteria are met.These include: (1) the drug is unapproved and intended for use for aserious condition for which effective treatment may not be availabledomestically either through commercial or clinical means; (2) thereis no known commercialization or promotion of the drug to personsresiding in the U.S. by those involved in the distribution of theproduct; (3) the product is considered not to represent anunreasonable risk; and (4) the individual seeking to import theproduct affirms in writing that it is for the patient's own use(generally not more than a three-month supply), and provides thename and address of the doctor licensed in

the U.S. responsible forhis/her treatment with the product, or provides evidence that theproduct is for the continuation of treatment begun in a foreigncountry.This FDA guidance is not, however, a license for individuals toimport unapproved (and therefore illegal) drugs for personal useinto the U.S. Even if all of the factors noted in the guidance arepresent, the drug remains illegal and FDA may determine that suchdrugs should be refused entry or seized. The guidance does notcreate any legally enforceable rights for the public; nor does itoperate to bind FDA or the public. Most importantly, this policy isnot intended to allow importation of foreign versions of drugs thatare approved in the U.S.For additional information, visit FDA's web site athttp://www.fda.gov/importeddrugs. Some informative pages includeIMPORTS, INFORMATION FOR CONSUMERS, and the

CDER home page (FDA'sCenter for Drug Evaluation and Research).For more consumer information on buying medicines from outside theU.S., visit FDA's website:http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htmIf, after reviewing the suggested information, you have unansweredquestions, please again contact the Division of Drug Information byphone (1-) or e-mail (druginfo@...). Anadditional resource for information on human drug products can befound on the Center's website http://www.fda.gov/cder. Thank youagain for your message. We hope that the above information will helpanswer your question.Joan PowersConsumer Safety OfficerDivision of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug AdministrationPhone:

This communication is consistent with 21CFR10.85(k) and constitutesan informal communication that represents our best judgment at thistime but does not constitute an advisory opinion, does notnecessarily represent the formal position of the FDA, and does notbind or otherwise obligate or commit the agency to the viewsexpressed.If you haven't already checked with your pharmacist? Do soIMMEDIATELY. My pharmacist was the one who told me about it becauseshe found out when she tried to order more thyroid from herdistributor.I have been trying to hoard the drug and have found good luckcontacting Sam's Clubs. They can buy in mega-bulk and you don'thave to go through your insurance....which means you can fill asmany times as you want.One more thing: Joan Powers told me that the FDA would be trying toget Homeland Security to tighten up on banned drugs coming fromCanada and

Mexico.We also have to keep in mind that this isn't JUST our dessicatedthyroid medication: THIS IS ALL OF THE DRUGS THAT WERE GRANDFATHEREDIN WHEN THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE THROUGHTHE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.I'd give anything if this wasn't true and if any of you have anymore insight to this and if there is anything I can do to help? Iwill.I really have contacted three senators (with NO reply from any ofthem) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-Massachusetts.) I have also tried to contact Ralph Nader and all ofthe television stations in my area.I have an attorney looking into a class action lawsuit AND animmediate lift on the ban by a federal judge.If any of you find out about a class action lawsuit already in theworks...please post it in here so I can call my attorney and let himknow.I want you all to know

that this makes me feel better that all ofyou are here and that I'm not fighting this alone now.Day day,P.S. SERIOUSLY, CHECK WITH SAM'S CLUBS OR BULK PHARMACIES IN YOURAREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO STILLHAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROMTHEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID EVEN IFTHEY HAVE IT!!!!!Fri Jan 11, 2008 9:47 am Show Message Option ---------------------------------------------------------------------View SourceUse Fixed Width FontUnwrap Lines---------------------------------------------------------------------"" <jerry_lee_lewis_rox> jerry_lee_le... Offline Send Email Forward | Delete Message #1514 of 1514 <

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[Guest guest]

and anyone else concerned, I have contact my state's (Florida's) Sen. Bill regarding this matter, but have received no information or assistance from them at this point. I have also contacted the AARP (American Association for Retired People). If they will, they do have a strong voice in matters of this sort. However, all I could do was leave a message for them. If you want to contact the ARRP, the number for their legislative hotline is 1-. I did not find this number helpful because it was just a recorded message and a conduit to talk directly with legislators, which I had already done. In addition, I contacted the AARP chapter for my state, Florida, at 1-. If you are inclined to do so, I think a volume of calls might be helpful in obtaining action from the AARP, and of course, it does not matter what your age is or whether or not you are a member of

AARP. wrote: This is the second post from another thyroid yahoo group I joined.I found out on New Year's Eve day that my thyroid medication was no longer going to be able to be manufactured because the FDA has stopped further manufacture of ALL drugs that were grandfathered in.These drugs HAVE to seek FDA approval before they can be made again!This DOES include Armour thyroid and thyroid. You'll have to wade through this

message...because it was in response to someone else asking me about my first post alerting them to the ban.Good luck to everyone.Joan Powers from the FDA called and left me a message yesterday(Thursday Jan. 10th) and told me that Armour thyroid is NOT on theapproved drug list.From my previous FRANTIC phone call to Ms. Powers I already knewthat if they are NOT on the FDA's approved drug list? They willhave to seek FDA approval...they are NO longer going to be allowedto be manufactured.Here is Joan Power's info from the FDA:Joan PowersConsumer Safety OfficerDivision of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug AdministrationPhone: The two times I have phoned her? It has taken her 24 hours to returnthe call.", " 01/10/2008 04:48 PMTo nwatson@...cc "McDermott,

", "Swezey, Brad"Subject Armour-ThyroidThis is the email forwarded to me last night (Thurs. Jan. 10) from at the St. Pete Times who is helping me investigateand draw attention to this situation.From what I can glean from this, Armour thyroid faced a recallbecause their last batch didn't pass the 6 month potency test? Isthat what you all read, too?When I called Armour (Forest Pharmaceuticals) about thegrandfathered in drugs being banned, I spoke with a gentleman named. (I called Armour in the hopes that they had maybealready sought approval since they are a bigger manufactuer ofdessicated thyroid OR that they might have the money $$$ to seek aquicker approval than the smaller manufacturers.)When I spoke with Mr. at Forest Pharm., he was reallyflustered and seemed to think that I thought

Armour had beenRECALLED. I kept assuring him that wasn't what I thought...that Ionly wanted to know if Armour was ALSO not going to be manufacturedanymore. He told me I did not know what I was talking about (eventhought I just gotten off the phone with Joan Powers of the FDA andI REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.) at the St. Pete Times also talked to a rep fromArmour/Forest Pharm. who also gave her the same song-and-dance.She and I were BOTH told that the reason Armour wasn't on ourpharmacy's shelves was because it was on "back order" at themanufacturing plant because of "high demand for the product."Okay...I SMELL COVER-UP THERE because of this next item I've pastedin here from @ the SP Times...which she got from at the FDA:Naomi:This is a recalled product.Here is the web link (I've

pulled the action information and put itinto the message, below).My colleagues McDermott and Brad Swezey, who cover recallissues, should be contacted if you have additional questions. Theyare copied here. At this point the posted informaton is the mostaccurate and available.Regards,http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlPRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240 mg),each tablet contains 152-mcg levothyroxine and 36-mcgliothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008; Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg), eachtablet contains 114-mcg levothyroxine and 27-mcg liothyronine,100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots: 1,000-tablet bottles:

030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;090724, Exp. Feb-09RECALLING FIRM/MANUFACTURERRecalling Firm: ForestPharmaceuticals Inc, Earth City, MO, by letter date November 9,2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH. Firminitiated recall is ongoing. REASONProduct failed disintegrationspecification at 6-months.VOLUME OF PRODUCT IN COMMERCEa) 41,745bottles totalb) 35,222/100-tablet bottles and 422/1,000-tabletbottlesDISTRIBUTIONNationwide and BelgiumI really don't give a rat's *** about their failing the 6 month'spotency, because now they're really screwed and so are all of us:Armour can't manufacture again without a federal judge lifting thisban immediately so all of our dessicated thyroid makers can

get backto work! Then the manufacturers are going to have to seek FDAapproval...which costs money.This whole thing reeks. I am in the process of trying to hoard themeds, because this next thing I'm posting is from Joan Powers andis the PROCESS we have to go through to get our drugs from aCanadian pharmacy.By the way? My doctor has already said that she will NOT gothrough this process because of the legalities of it. Basically,what Joan Powers told me I would have to do is:Have my doctor write me a new script every three months.Contact an online Canadian pharmacy and submit the script.That pharmacy will fill the script AFTER they contact my doctor foran okay.My doctor said there is NO way she will prescribe a drug that isbanned by the FDA and okay me to have that script filled in anothercountry.Anyway, here's the email from Joan Powers from the FDA:FDA's Personal Importation

PolicyþFrom: CDER DRUG INFO (DRUGINFO@...)You may not know this sender.Mark as safe|Mark as unsafeSent: Wed 1/02/08 6:40 PMTo: greenestgurl@...Thank you for your message to the Division of Drug Information inthe Center for Drug Evaluation and Research (CDER).The United States Federal Food, Drug, and Cosmetic Act (the Act)prohibits (21 USC ' 331) the interstate shipment (which includesimportation) of, among other things, unapproved new drugs. Thus, theimportation of drugs that lack FDA approval, whether for personaluse or otherwise, violates the Act. Unapproved new drugs are anydrugs, including foreign-made versions of U.S. approved drugs, thathave not been manufactured in accordance with and pursuant to an FDAapproval. Under the Act, FDA may refuse admission to any drugthat "appears" to be unapproved, placing the burden on the importerto prove that the drug sought to be imported is, in fact,

approvedby FDA. Absent evidence that the specific drug sought to be importedfrom a foreign country has been manufactured pursuant to an approvednew drug application, in the manufacturing facility permitted underthe application, such drug would appear to be an unapproved new drugsubject to FDA enforcement action. In addition, drugs from foreigncountries often fail to meet FDA's labeling and prescriptiondispensing requirements.FDA recognizes some individuals may seek treatment with anunapproved new drug in a foreign country and may wish to continuesuch treatment upon their return to the USA. Likewise, FDArecognizes some individuals suffer from conditions for which thereexists no FDA approved treatment. FDA has developed guidance whichidentifies circumstances in which FDA may consider exercisingenforcement discretion to allow entry of such drugs. Generallyreferred to as the personal importation policy, this

guidanceprovides FDA field offices the opportunity to exercise enforcementdiscretion in allowing entry of drugs when certain criteria are met.These include: (1) the drug is unapproved and intended for use for aserious condition for which effective treatment may not be availabledomestically either through commercial or clinical means; (2) thereis no known commercialization or promotion of the drug to personsresiding in the U.S. by those involved in the distribution of theproduct; (3) the product is considered not to represent anunreasonable risk; and (4) the individual seeking to import theproduct affirms in writing that it is for the patient's own use(generally not more than a three-month supply), and provides thename and address of the doctor licensed in the U.S. responsible forhis/her treatment with the product, or provides evidence that theproduct is for the continuation of treatment begun in a

foreigncountry.This FDA guidance is not, however, a license for individuals toimport unapproved (and therefore illegal) drugs for personal useinto the U.S. Even if all of the factors noted in the guidance arepresent, the drug remains illegal and FDA may determine that suchdrugs should be refused entry or seized. The guidance does notcreate any legally enforceable rights for the public; nor does itoperate to bind FDA or the public. Most importantly, this policy isnot intended to allow importation of foreign versions of drugs thatare approved in the U.S.For additional information, visit FDA's web site athttp://www.fda.gov/importeddrugs. Some informative pages includeIMPORTS, INFORMATION FOR CONSUMERS, and the CDER home page (FDA'sCenter for Drug Evaluation and Research).For more consumer information on buying medicines from outside theU.S.,

visit FDA's website:http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htmIf, after reviewing the suggested information, you have unansweredquestions, please again contact the Division of Drug Information byphone (1-) or e-mail (druginfo@...). Anadditional resource for information on human drug products can befound on the Center's website http://www.fda.gov/cder. Thank youagain for your message. We hope that the above information will helpanswer your question.Joan PowersConsumer Safety OfficerDivision of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug AdministrationPhone: This communication is consistent with 21CFR10.85(k) and constitutesan informal communication that represents our best judgment at

thistime but does not constitute an advisory opinion, does notnecessarily represent the formal position of the FDA, and does notbind or otherwise obligate or commit the agency to the viewsexpressed.If you haven't already checked with your pharmacist? Do soIMMEDIATELY. My pharmacist was the one who told me about it becauseshe found out when she tried to order more thyroid from herdistributor.I have been trying to hoard the drug and have found good luckcontacting Sam's Clubs. They can buy in mega-bulk and you don'thave to go through your insurance....which means you can fill asmany times as you want.One more thing: Joan Powers told me that the FDA would be trying toget Homeland Security to tighten up on banned drugs coming fromCanada and Mexico.We also have to keep in mind that this isn't JUST our dessicatedthyroid medication: THIS IS ALL OF THE DRUGS THAT WERE GRANDFATHEREDIN WHEN

THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE THROUGHTHE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.I'd give anything if this wasn't true and if any of you have anymore insight to this and if there is anything I can do to help? Iwill.I really have contacted three senators (with NO reply from any ofthem) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-Massachusetts.) I have also tried to contact Ralph Nader and all ofthe television stations in my area.I have an attorney looking into a class action lawsuit AND animmediate lift on the ban by a federal judge.If any of you find out about a class action lawsuit already in theworks...please post it in here so I can call my attorney and let himknow.I want you all to know that this makes me feel better that all ofyou are here and that I'm not fighting this alone now.Day day,P.S. SERIOUSLY, CHECK WITH SAM'S

CLUBS OR BULK PHARMACIES IN YOURAREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO STILLHAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROMTHEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID EVEN IFTHEY HAVE IT!!!!!Fri Jan 11, 2008 9:47 am Show Message Option ---------------------------------------------------------------------View SourceUse Fixed Width FontUnwrap Lines---------------------------------------------------------------------"" <jerry_lee_lewis_rox> jerry_lee_le... Offline Send Email Forward | Delete Message #1514 of 1514 < Prev | Next >

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[Guest guest]

From another thyroid yahoo group, they are telling me that they are

still getting info from Armour that Armour will indeed keep

manufacturing. I have put another call into Joan Powers at the FDA

to see if the FDA is going to allow any of the manufacturers of

dessicated thyroid continue to make it.

When I spoke with Ms. Powers on New Year's Eve day, she told me that

they would NOT be allowed to continue to make it and I would have to

get my drugs from a Canadian online pharmacy.

However, I have found that they don't communicate very well within

their own agency, so I am hoping and praying that the people from

the other yahoo group have found out something I don't know and that

Armour will continue to manufacture.

I will keep everyone updated with what I find out...as soon as I

find out.

I am also in Florida and had no luck at all with Sen. 's

office. They told me to copy off a form request from their website

and send it by snail mail and then they can help me. I don't have

time for that nonsense.

I have contacted an attorney here in Clearwater to check on the lift

of the ban by a federal judge and a class action law suit. I will

also let you all know about that.

Also, a very nice reporter at the St. Pete Times is trying to help

me get the word out about this, but her superiors are not excited

about it. Her name is at the St. sburg Times.

I'm not sure if a bunch of phone calls from people all over the

United States might help or not, but if you want to call the St.

Pete Times and leave a message for ---tell her how important

dessicated thyroid is to you? It can't hurt.

> This is the second post from another thyroid yahoo group

I joined.

>

> I found out on New Year's Eve day that my thyroid medication was

no

> longer going to be able to be manufactured because the FDA has

> stopped further manufacture of ALL drugs that were grandfathered

in.

>

> These drugs HAVE to seek FDA approval before they can be made

again!

>

> This DOES include Armour thyroid and thyroid.

>

> You'll have to wade through this message...because it was in

> response to someone else asking me about my first post alerting

them

> to the ban.

>

> Good luck to everyone.

>

> Joan Powers from the FDA called and left me a message yesterday

> (Thursday Jan. 10th) and told me that Armour thyroid is NOT on the

> approved drug list.

>

> From my previous FRANTIC phone call to Ms. Powers I already knew

> that if they are NOT on the FDA's approved drug list? They will

> have to seek FDA approval...they are NO longer going to be allowed

> to be manufactured.

>

> Here is Joan Power's info from the FDA:

>

> Joan Powers

> Consumer Safety Officer

> Division of Drug Information

> Center for Drug Evaluation and Research

> Food and Drug Administration

> Phone:

>

> The two times I have phoned her? It has taken her 24 hours to

return

> the call.

> " , " <.@>

> 01/10/2008 04:48 PM

> To nwatson@

> cc " McDermott, "

> <.McDermott@>, " Swezey, Brad "

> <Brad.Swezey@>

> Subject Armour-Thyroid

>

> This is the email forwarded to me last night (Thurs. Jan. 10) from

> at the St. Pete Times who is helping me investigate

> and draw attention to this situation.

>

> From what I can glean from this, Armour thyroid faced a recall

> because their last batch didn't pass the 6 month potency test? Is

> that what you all read, too?

>

> When I called Armour (Forest Pharmaceuticals) about the

> grandfathered in drugs being banned, I spoke with a gentleman named

> . (I called Armour in the hopes that they had maybe

> already sought approval since they are a bigger manufactuer of

> dessicated thyroid OR that they might have the money $$$ to seek a

> quicker approval than the smaller manufacturers.)

> When I spoke with Mr. at Forest Pharm., he was really

> flustered and seemed to think that I thought Armour had been

> RECALLED. I kept assuring him that wasn't what I thought...that I

> only wanted to know if Armour was ALSO not going to be manufactured

> anymore. He told me I did not know what I was talking about (even

> thought I just gotten off the phone with Joan Powers of the FDA and

> I REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.

> POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.)

> at the St. Pete Times also talked to a rep from

> Armour/Forest Pharm. who also gave her the same song-and-dance.

> She and I were BOTH told that the reason Armour wasn't on our

> pharmacy's shelves was because it was on " back order " at the

> manufacturing plant because of " high demand for the product. "

> Okay...I SMELL COVER-UP THERE because of this next item I've pasted

> in here from @ the SP Times...which she got from Chris

> at the FDA:

>

> Naomi:

>

> This is a recalled product.

>

> Here is the web link (I've pulled the action information and put it

> into the message, below).

>

> My colleagues McDermott and Brad Swezey, who cover recall

> issues, should be contacted if you have additional questions. They

> are copied here. At this point the posted informaton is the most

> accurate and available.

>

> Regards,

>

>

>

> http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.html

>

> PRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240 mg),

> each tablet contains 152-mcg levothyroxine and 36-mcg

> liothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008;

> Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg), each

> tablet contains 114-mcg levothyroxine and 27-mcg liothyronine,

> 100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)

> Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots: 1,000-

> tablet bottles: 030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-

> tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;

> 030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;

> 040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;

> 090724, Exp. Feb-09RECALLING FIRM/MANUFACTURERRecalling Firm:

Forest

> Pharmaceuticals Inc, Earth City, MO, by letter date November 9,

> 2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH. Firm

> initiated recall is ongoing. REASONProduct failed disintegration

> specification at 6-months.VOLUME OF PRODUCT IN COMMERCEa) 41,745

> bottles totalb) 35,222/100-tablet bottles and 422/1,000-tablet

> bottlesDISTRIBUTIONNationwide and Belgium

>

> I really don't give a rat's *** about their failing the 6 month's

> potency, because now they're really screwed and so are all of us:

> Armour can't manufacture again without a federal judge lifting this

> ban immediately so all of our dessicated thyroid makers can get

back

> to work! Then the manufacturers are going to have to seek FDA

> approval...which costs money.

>

> This whole thing reeks. I am in the process of trying to hoard the

> meds, because this next thing I'm posting is from Joan Powers and

> is the PROCESS we have to go through to get our drugs from a

> Canadian pharmacy.

>

> By the way? My doctor has already said that she will NOT go

> through this process because of the legalities of it. Basically,

> what Joan Powers told me I would have to do is:

> Have my doctor write me a new script every three months.

> Contact an online Canadian pharmacy and submit the script.

> That pharmacy will fill the script AFTER they contact my doctor for

> an okay.

>

> My doctor said there is NO way she will prescribe a drug that is

> banned by the FDA and okay me to have that script filled in another

> country.

>

> Anyway, here's the email from Joan Powers from the FDA:

>

> FDA's Personal Importation Policyþ

> From: CDER DRUG INFO (DRUGINFO@)

> You may not know this sender.Mark as safe|Mark as unsafe

> Sent: Wed 1/02/08 6:40 PM

> To: greenestgurl@

>

> Thank you for your message to the Division of Drug Information in

> the Center for Drug Evaluation and Research (CDER).

>

> The United States Federal Food, Drug, and Cosmetic Act (the Act)

> prohibits (21 USC ' 331) the interstate shipment (which includes

> importation) of, among other things, unapproved new drugs. Thus,

the

> importation of drugs that lack FDA approval, whether for personal

> use or otherwise, violates the Act. Unapproved new drugs are any

> drugs, including foreign-made versions of U.S. approved drugs, that

> have not been manufactured in accordance with and pursuant to an

FDA

> approval. Under the Act, FDA may refuse admission to any drug

> that " appears " to be unapproved, placing the burden on the importer

> to prove that the drug sought to be imported is, in fact, approved

> by FDA. Absent evidence that the specific drug sought to be

imported

> from a foreign country has been manufactured pursuant to an

approved

> new drug application, in the manufacturing facility permitted under

> the application, such drug would appear to be an unapproved new

drug

> subject to FDA enforcement action. In addition, drugs from foreign

> countries often fail to meet FDA's labeling and prescription

> dispensing requirements.

>

> FDA recognizes some individuals may seek treatment with an

> unapproved new drug in a foreign country and may wish to continue

> such treatment upon their return to the USA. Likewise, FDA

> recognizes some individuals suffer from conditions for which there

> exists no FDA approved treatment. FDA has developed guidance which

> identifies circumstances in which FDA may consider exercising

> enforcement discretion to allow entry of such drugs. Generally

> referred to as the personal importation policy, this guidance

> provides FDA field offices the opportunity to exercise enforcement

> discretion in allowing entry of drugs when certain criteria are

met.

> These include: (1) the drug is unapproved and intended for use for

a

> serious condition for which effective treatment may not be

available

> domestically either through commercial or clinical means; (2) there

> is no known commercialization or promotion of the drug to persons

> residing in the U.S. by those involved in the distribution of the

> product; (3) the product is considered not to represent an

> unreasonable risk; and (4) the individual seeking to import the

> product affirms in writing that it is for the patient's own use

> (generally not more than a three-month supply), and provides the

> name and address of the doctor licensed in the U.S. responsible for

> his/her treatment with the product, or provides evidence that the

> product is for the continuation of treatment begun in a foreign

> country.

>

> This FDA guidance is not, however, a license for individuals to

> import unapproved (and therefore illegal) drugs for personal use

> into the U.S. Even if all of the factors noted in the guidance are

> present, the drug remains illegal and FDA may determine that such

> drugs should be refused entry or seized. The guidance does not

> create any legally enforceable rights for the public; nor does it

> operate to bind FDA or the public. Most importantly, this policy is

> not intended to allow importation of foreign versions of drugs that

> are approved in the U.S.

>

> For additional information, visit FDA's web site at

> http://www.fda.gov/importeddrugs. Some informative pages include

> IMPORTS, INFORMATION FOR CONSUMERS, and the CDER home page (FDA's

> Center for Drug Evaluation and Research).

>

> For more consumer information on buying medicines from outside the

> U.S., visit FDA's website:

> http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htm

>

> If, after reviewing the suggested information, you have unanswered

> questions, please again contact the Division of Drug Information by

> phone (1-) or e-mail (druginfo@). An

> additional resource for information on human drug products can be

> found on the Center's website http://www.fda.gov/cder. Thank you

> again for your message. We hope that the above information will

help

> answer your question.

>

> Joan Powers

> Consumer Safety Officer

> Division of Drug Information

> Center for Drug Evaluation and Research

> Food and Drug Administration

> Phone:

>

> This communication is consistent with 21CFR10.85(k) and constitutes

> an informal communication that represents our best judgment at this

> time but does not constitute an advisory opinion, does not

> necessarily represent the formal position of the FDA, and does not

> bind or otherwise obligate or commit the agency to the views

> expressed.

>

> If you haven't already checked with your pharmacist? Do so

> IMMEDIATELY. My pharmacist was the one who told me about it because

> she found out when she tried to order more thyroid from her

> distributor.

>

> I have been trying to hoard the drug and have found good luck

> contacting Sam's Clubs. They can buy in mega-bulk and you don't

> have to go through your insurance....which means you can fill as

> many times as you want.

>

> One more thing: Joan Powers told me that the FDA would be trying to

> get Homeland Security to tighten up on banned drugs coming from

> Canada and Mexico.

>

> We also have to keep in mind that this isn't JUST our dessicated

> thyroid medication: THIS IS ALL OF THE DRUGS THAT WERE

GRANDFATHERED

> IN WHEN THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE THROUGH

> THE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.

>

> I'd give anything if this wasn't true and if any of you have any

> more insight to this and if there is anything I can do to help? I

> will.

>

> I really have contacted three senators (with NO reply from any of

> them) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-

> Massachusetts.) I have also tried to contact Ralph Nader and all of

> the television stations in my area.

> I have an attorney looking into a class action lawsuit AND an

> immediate lift on the ban by a federal judge.

> If any of you find out about a class action lawsuit already in the

> works...please post it in here so I can call my attorney and let

him

> know.

>

> I want you all to know that this makes me feel better that all of

> you are here and that I'm not fighting this alone now.

>

> Day day,

>

>

> P.S. SERIOUSLY, CHECK WITH SAM'S CLUBS OR BULK PHARMACIES IN YOUR

> AREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO STILL

> HAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROM

> THEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID EVEN IF

> THEY HAVE IT!!!!!

>

> Fri Jan 11, 2008 9:47 am

>

> Show Message Option

> ----------------------------------------------------------

> -----------

>

> View Source

> Use Fixed Width Font

> Unwrap Lines

>

> ----------------------------------------------------------

> -----------

>

> " "

> jerry_lee_le...

> Offline

> Send Email

>

> Forward | Delete Message #1514 of 1514 < Prev | Next >

>

>

>

>

>

>

> ---------------------------------

> Never miss a thing. Make Yahoo your homepage.

>

[Guest guest]

Dear , I appreciate you writing back about this. I have both telephoned and written to Senator 's office. I also wrote to Florida Senator Mel ez, and my Congressman, Tom Feeney. Feeney's office seemed at least a little interested. The staff worker there who would handle this is Murray, and he was out to lunch when I called, so I left a voice mail for him and also sent an email to his attention. In addition, I have written to Florida Attorney General Bill McCollum and candidate . One can never tell--one of these people might do something. I have checked and the local pharmacies and many online pharmacies no longer have armour thyroid in stock. They simply say it is "out of stock." I am taking your advice to try bulk pharmacies and hope to obtain some this afternoon. wrote: From another thyroid yahoo group, they are telling me that they are still getting info from Armour that Armour will indeed keep manufacturing. I have put another call into Joan Powers at the FDA to see if the FDA is going to allow any of the manufacturers of dessicated thyroid continue to make it.When I spoke with Ms. Powers on New Year's Eve day, she told me that they would NOT be allowed to continue to make it and I would have to get my drugs from a

Canadian online pharmacy.However, I have found that they don't communicate very well within their own agency, so I am hoping and praying that the people from the other yahoo group have found out something I don't know and that Armour will continue to manufacture.I will keep everyone updated with what I find out...as soon as I find out.I am also in Florida and had no luck at all with Sen. 's office. They told me to copy off a form request from their website and send it by snail mail and then they can help me. I don't have time for that nonsense.I have contacted an attorney here in Clearwater to check on the lift of the ban by a federal judge and a class action law suit. I will also let you all know about that.Also, a very nice reporter at the St. Pete Times is trying to help me get the word out about this, but her superiors are not excited about it. Her name is at the

St. sburg Times. I'm not sure if a bunch of phone calls from people all over the United States might help or not, but if you want to call the St. Pete Times and leave a message for ---tell her how important dessicated thyroid is to you? It can't hurt.> This is the second post from another thyroid yahoo group I joined.> > I found out on New Year's Eve day that my thyroid medication was no > longer going to be able to be manufactured because the FDA has > stopped further manufacture of ALL drugs that were grandfathered in.> > These drugs HAVE to seek FDA approval before they can be made again!> > This DOES

include Armour thyroid and thyroid. > > You'll have to wade through this message...because it was in > response to someone else asking me about my first post alerting them > to the ban.> > Good luck to everyone.> > Joan Powers from the FDA called and left me a message yesterday> (Thursday Jan. 10th) and told me that Armour thyroid is NOT on the> approved drug list.> > From my previous FRANTIC phone call to Ms. Powers I already knew> that if they are NOT on the FDA's approved drug list? They will> have to seek FDA approval...they are NO longer going to be allowed> to be manufactured.> > Here is Joan Power's info from the FDA:> > Joan Powers> Consumer Safety Officer> Division of Drug Information> Center for Drug Evaluation and Research> Food and Drug Administration> Phone: > > The

two times I have phoned her? It has taken her 24 hours to return> the call.> ", " <.@>> 01/10/2008 04:48 PM> To nwatson@> cc "McDermott, "> <.McDermott@>, "Swezey, Brad"> <Brad.Swezey@>> Subject Armour-Thyroid> > This is the email forwarded to me last night (Thurs. Jan. 10) from> at the St. Pete Times who is helping me investigate> and draw attention to this situation.> > From what I can glean from this, Armour thyroid faced a recall> because their last batch didn't pass the 6 month potency test? Is> that what you all read, too?> > When I called Armour (Forest Pharmaceuticals) about the> grandfathered in drugs being banned, I spoke with a gentleman named> . (I called Armour in the hopes that they had maybe> already

sought approval since they are a bigger manufactuer of> dessicated thyroid OR that they might have the money $$$ to seek a> quicker approval than the smaller manufacturers.)> When I spoke with Mr. at Forest Pharm., he was really> flustered and seemed to think that I thought Armour had been> RECALLED. I kept assuring him that wasn't what I thought...that I> only wanted to know if Armour was ALSO not going to be manufactured> anymore. He told me I did not know what I was talking about (even> thought I just gotten off the phone with Joan Powers of the FDA and> I REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.> POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.)> at the St. Pete Times also talked to a rep from> Armour/Forest Pharm. who also gave her the same song-and-dance.> She and I were BOTH told that the reason Armour wasn't on our>

pharmacy's shelves was because it was on "back order" at the> manufacturing plant because of "high demand for the product."> Okay...I SMELL COVER-UP THERE because of this next item I've pasted> in here from @ the SP Times...which she got from > at the FDA:> > Naomi:> > This is a recalled product.> > Here is the web link (I've pulled the action information and put it> into the message, below).> > My colleagues McDermott and Brad Swezey, who cover recall> issues, should be contacted if you have additional questions. They> are copied here. At this point the posted informaton is the most> accurate and available.> > Regards,> > > > http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.html> > PRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240 mg),> each tablet contains 152-mcg levothyroxine and 36-mcg> liothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008;> Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg), each> tablet contains 114-mcg levothyroxine and 27-mcg liothyronine,> 100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)> Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots: 1,000-> tablet bottles: 030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-> tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;> 030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;> 040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;> 090724, Exp. Feb-09RECALLING

FIRM/MANUFACTURERRecalling Firm: Forest> Pharmaceuticals Inc, Earth City, MO, by letter date November 9,> 2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH. Firm> initiated recall is ongoing. REASONProduct failed disintegration> specification at 6-months.VOLUME OF PRODUCT IN COMMERCEa) 41,745> bottles totalb) 35,222/100-tablet bottles and 422/1,000-tablet> bottlesDISTRIBUTIONNationwide and Belgium> > I really don't give a rat's *** about their failing the 6 month's> potency, because now they're really screwed and so are all of us:> Armour can't manufacture again without a federal judge lifting this> ban immediately so all of our dessicated thyroid makers can get back> to work! Then the manufacturers are going to have to seek FDA> approval...which costs money.> > This whole thing reeks. I am in the process of trying to hoard the> meds,

because this next thing I'm posting is from Joan Powers and> is the PROCESS we have to go through to get our drugs from a> Canadian pharmacy.> > By the way? My doctor has already said that she will NOT go> through this process because of the legalities of it. Basically,> what Joan Powers told me I would have to do is:> Have my doctor write me a new script every three months.> Contact an online Canadian pharmacy and submit the script.> That pharmacy will fill the script AFTER they contact my doctor for> an okay.> > My doctor said there is NO way she will prescribe a drug that is> banned by the FDA and okay me to have that script filled in another> country.> > Anyway, here's the email from Joan Powers from the FDA:> > FDA's Personal Importation Policyþ> From: CDER DRUG INFO (DRUGINFO@)> You may not know this sender.Mark as safe|Mark as

unsafe> Sent: Wed 1/02/08 6:40 PM> To: greenestgurl@> > Thank you for your message to the Division of Drug Information in> the Center for Drug Evaluation and Research (CDER).> > The United States Federal Food, Drug, and Cosmetic Act (the Act)> prohibits (21 USC ' 331) the interstate shipment (which includes> importation) of, among other things, unapproved new drugs. Thus, the> importation of drugs that lack FDA approval, whether for personal> use or otherwise, violates the Act. Unapproved new drugs are any> drugs, including foreign-made versions of U.S. approved drugs, that> have not been manufactured in accordance with and pursuant to an FDA> approval. Under the Act, FDA may refuse admission to any drug> that "appears" to be unapproved, placing the burden on the importer> to prove that the drug sought to be imported is, in fact, approved> by FDA.

Absent evidence that the specific drug sought to be imported> from a foreign country has been manufactured pursuant to an approved> new drug application, in the manufacturing facility permitted under> the application, such drug would appear to be an unapproved new drug> subject to FDA enforcement action. In addition, drugs from foreign> countries often fail to meet FDA's labeling and prescription> dispensing requirements.> > FDA recognizes some individuals may seek treatment with an> unapproved new drug in a foreign country and may wish to continue> such treatment upon their return to the USA. Likewise, FDA> recognizes some individuals suffer from conditions for which there> exists no FDA approved treatment. FDA has developed guidance which> identifies circumstances in which FDA may consider exercising> enforcement discretion to allow entry of such drugs.

Generally> referred to as the personal importation policy, this guidance> provides FDA field offices the opportunity to exercise enforcement> discretion in allowing entry of drugs when certain criteria are met.> These include: (1) the drug is unapproved and intended for use for a> serious condition for which effective treatment may not be available> domestically either through commercial or clinical means; (2) there> is no known commercialization or promotion of the drug to persons> residing in the U.S. by those involved in the distribution of the> product; (3) the product is considered not to represent an> unreasonable risk; and (4) the individual seeking to import the> product affirms in writing that it is for the patient's own use> (generally not more than a three-month supply), and provides the> name and address of the doctor licensed in the U.S. responsible

for> his/her treatment with the product, or provides evidence that the> product is for the continuation of treatment begun in a foreign> country.> > This FDA guidance is not, however, a license for individuals to> import unapproved (and therefore illegal) drugs for personal use> into the U.S. Even if all of the factors noted in the guidance are> present, the drug remains illegal and FDA may determine that such> drugs should be refused entry or seized. The guidance does not> create any legally enforceable rights for the public; nor does it> operate to bind FDA or the public. Most importantly, this policy is> not intended to allow importation of foreign versions of drugs that> are approved in the U.S.> > For additional information, visit FDA's web site at> http://www.fda.gov/importeddrugs. Some informative

pages include> IMPORTS, INFORMATION FOR CONSUMERS, and the CDER home page (FDA's> Center for Drug Evaluation and Research).> > For more consumer information on buying medicines from outside the> U.S., visit FDA's website:> http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htm> > If, after reviewing the suggested information, you have unanswered> questions, please again contact the Division of Drug Information by> phone (1-) or e-mail (druginfo@). An> additional resource for information on human drug products can be> found on the Center's website http://www.fda.gov/cder. Thank you> again for your message. We hope that the above information will help> answer your question.> > Joan Powers> Consumer

Safety Officer> Division of Drug Information> Center for Drug Evaluation and Research> Food and Drug Administration> Phone: > > This communication is consistent with 21CFR10.85(k) and constitutes> an informal communication that represents our best judgment at this> time but does not constitute an advisory opinion, does not> necessarily represent the formal position of the FDA, and does not> bind or otherwise obligate or commit the agency to the views> expressed.> > If you haven't already checked with your pharmacist? Do so> IMMEDIATELY. My pharmacist was the one who told me about it because> she found out when she tried to order more thyroid from her> distributor.> > I have been trying to hoard the drug and have found good luck> contacting Sam's Clubs. They can buy in mega-bulk and you don't> have to go through your

insurance....which means you can fill as> many times as you want.> > One more thing: Joan Powers told me that the FDA would be trying to> get Homeland Security to tighten up on banned drugs coming from> Canada and Mexico.> > We also have to keep in mind that this isn't JUST our dessicated> thyroid medication: THIS IS ALL OF THE DRUGS THAT WERE GRANDFATHERED> IN WHEN THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE THROUGH> THE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.> > I'd give anything if this wasn't true and if any of you have any> more insight to this and if there is anything I can do to help? I> will.> > I really have contacted three senators (with NO reply from any of> them) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-> Massachusetts.) I have also tried to contact Ralph Nader and all of> the

television stations in my area.> I have an attorney looking into a class action lawsuit AND an> immediate lift on the ban by a federal judge.> If any of you find out about a class action lawsuit already in the> works...please post it in here so I can call my attorney and let him> know.> > I want you all to know that this makes me feel better that all of> you are here and that I'm not fighting this alone now.> > Day day,> > > P.S. SERIOUSLY, CHECK WITH SAM'S CLUBS OR BULK PHARMACIES IN YOUR> AREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO STILL> HAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROM> THEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID EVEN IF> THEY HAVE IT!!!!!> > Fri Jan 11, 2008 9:47 am > > Show Message Option >

----------------------------------------------------------> -----------> > View Source> Use Fixed Width Font> Unwrap Lines> > ----------------------------------------------------------> -----------> > "" > jerry_lee_le... > Offline > Send Email > > Forward | Delete Message #1514 of 1514 < Prev | Next > > > > > > > > ---------------------------------> Never miss a thing. Make Yahoo your homepage.>

Looking for last minute shopping deals? Find them fast with Yahoo! Search.

[Guest guest]

,

The other yahoo thyroid site that I put this info on has a few

people who seem to be angry at me and think I don't know what I'm

talking about.

They have contacted Armour (and so have I...twice) and Armour is

still telling them that they are on back order.

They really are on back order up until this time because one of

their batches failed a 6-month potency test and was recalled.

I already knew that info going into this and knew that Armour reps

were covering up the fact that they had a bad batch. I knew that

the Armour reps were talking about something completely different

than what I was talking about.

They had meds recalled because of a failed test. I was trying to

tell them there is now an FDA ban on further manufacture.

The other group seems to think they are going to continue to get

Armour....from what I've heard from Joan Powers at the FDA? That is

not the case.

I do hope I am seriously wrong about this. I hope I have been given

some really CRAPPY misinformation. I don't want this to be true,

but I do know that the manufacturer of MY thyroid medicine isn't

making it anymore and I am frantically trying to hoard it.

One woman from the other site also said that her insurance company

no longer pays for her to get Armour....they will only pay for

Synthroid or Levothyroxine. Perhaps this is another clue that they

are taking the dessicate thyroid away from us?

I don't know.

I have to go now. I'm driving over to Lakeland, Florida to the

Sam's Club. They seem to have some of the thyroid left. (I take a

drug just called " thyroid " from Qualitest and Major Pharms.)

If you are anywhere near Lakeland? Perhaps you could try to get the

meds there?

I'll check back in when I get back from Lakeland, but keep in mind

it might be late as that is on the other side of Tampa from me and I

will have to go on I-4 where the horrible wrecks were.

All the best,

> > This is the second post from another thyroid yahoo group

> I joined.

> >

> > I found out on New Year's Eve day that my thyroid medication was

> no

> > longer going to be able to be manufactured because the FDA has

> > stopped further manufacture of ALL drugs that were grandfathered

> in.

> >

> > These drugs HAVE to seek FDA approval before they can be made

> again!

> >

> > This DOES include Armour thyroid and thyroid.

> >

> > You'll have to wade through this message...because it was in

> > response to someone else asking me about my first post alerting

> them

> > to the ban.

> >

> > Good luck to everyone.

> >

> > Joan Powers from the FDA called and left me a message yesterday

> > (Thursday Jan. 10th) and told me that Armour thyroid is NOT on

the

> > approved drug list.

> >

> > From my previous FRANTIC phone call to Ms. Powers I already knew

> > that if they are NOT on the FDA's approved drug list? They will

> > have to seek FDA approval...they are NO longer going to be

allowed

> > to be manufactured.

> >

> > Here is Joan Power's info from the FDA:

> >

> > Joan Powers

> > Consumer Safety Officer

> > Division of Drug Information

> > Center for Drug Evaluation and Research

> > Food and Drug Administration

> > Phone:

> >

> > The two times I have phoned her? It has taken her 24 hours to

> return

> > the call.

> > " , " <.@>

> > 01/10/2008 04:48 PM

> > To nwatson@

> > cc " McDermott, "

> > <.McDermott@>, " Swezey, Brad "

> > <Brad.Swezey@>

> > Subject Armour-Thyroid

> >

> > This is the email forwarded to me last night (Thurs. Jan. 10)

from

> > at the St. Pete Times who is helping me

investigate

> > and draw attention to this situation.

> >

> > From what I can glean from this, Armour thyroid faced a recall

> > because their last batch didn't pass the 6 month potency test? Is

> > that what you all read, too?

> >

> > When I called Armour (Forest Pharmaceuticals) about the

> > grandfathered in drugs being banned, I spoke with a gentleman

named

> > . (I called Armour in the hopes that they had maybe

> > already sought approval since they are a bigger manufactuer of

> > dessicated thyroid OR that they might have the money $$$ to seek

a

> > quicker approval than the smaller manufacturers.)

> > When I spoke with Mr. at Forest Pharm., he was really

> > flustered and seemed to think that I thought Armour had been

> > RECALLED. I kept assuring him that wasn't what I thought...that I

> > only wanted to know if Armour was ALSO not going to be

manufactured

> > anymore. He told me I did not know what I was talking about (even

> > thought I just gotten off the phone with Joan Powers of the FDA

and

> > I REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.

> > POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.)

> > at the St. Pete Times also talked to a rep from

> > Armour/Forest Pharm. who also gave her the same song-and-dance.

> > She and I were BOTH told that the reason Armour wasn't on our

> > pharmacy's shelves was because it was on " back order " at the

> > manufacturing plant because of " high demand for the product. "

> > Okay...I SMELL COVER-UP THERE because of this next item I've

pasted

> > in here from @ the SP Times...which she got from Chris

>

> > at the FDA:

> >

> > Naomi:

> >

> > This is a recalled product.

> >

> > Here is the web link (I've pulled the action information and put

it

> > into the message, below).

> >

> > My colleagues McDermott and Brad Swezey, who cover

recall

> > issues, should be contacted if you have additional questions.

They

> > are copied here. At this point the posted informaton is the most

> > accurate and available.

> >

> > Regards,

> >

> >

> >

> > http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.html

> >

> > PRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240

mg),

> > each tablet contains 152-mcg levothyroxine and 36-mcg

> > liothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008;

> > Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg), each

> > tablet contains 114-mcg levothyroxine and 27-mcg liothyronine,

> > 100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)

> > Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots:

1,000-

> > tablet bottles: 030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-

> > tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;

> > 030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;

> > 040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;

> > 090724, Exp. Feb-09RECALLING FIRM/MANUFACTURERRecalling Firm:

> Forest

> > Pharmaceuticals Inc, Earth City, MO, by letter date November 9,

> > 2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH.

Firm

> > initiated recall is ongoing. REASONProduct failed disintegration

> > specification at 6-months.VOLUME OF PRODUCT IN COMMERCEa) 41,745

> > bottles totalb) 35,222/100-tablet bottles and 422/1,000-tablet

> > bottlesDISTRIBUTIONNationwide and Belgium

> >

> > I really don't give a rat's *** about their failing the 6 month's

> > potency, because now they're really screwed and so are all of us:

> > Armour can't manufacture again without a federal judge lifting

this

> > ban immediately so all of our dessicated thyroid makers can get

> back

> > to work! Then the manufacturers are going to have to seek FDA

> > approval...which costs money.

> >

> > This whole thing reeks. I am in the process of trying to hoard

the

> > meds, because this next thing I'm posting is from Joan Powers and

> > is the PROCESS we have to go through to get our drugs from a

> > Canadian pharmacy.

> >

> > By the way? My doctor has already said that she will NOT go

> > through this process because of the legalities of it. Basically,

> > what Joan Powers told me I would have to do is:

> > Have my doctor write me a new script every three months.

> > Contact an online Canadian pharmacy and submit the script.

> > That pharmacy will fill the script AFTER they contact my doctor

for

> > an okay.

> >

> > My doctor said there is NO way she will prescribe a drug that is

> > banned by the FDA and okay me to have that script filled in

another

> > country.

> >

> > Anyway, here's the email from Joan Powers from the FDA:

> >

> > FDA's Personal Importation Policyþ

> > From: CDER DRUG INFO (DRUGINFO@)

> > You may not know this sender.Mark as safe|Mark as unsafe

> > Sent: Wed 1/02/08 6:40 PM

> > To: greenestgurl@

> >

> > Thank you for your message to the Division of Drug Information in

> > the Center for Drug Evaluation and Research (CDER).

> >

> > The United States Federal Food, Drug, and Cosmetic Act (the Act)

> > prohibits (21 USC ' 331) the interstate shipment (which includes

> > importation) of, among other things, unapproved new drugs. Thus,

> the

> > importation of drugs that lack FDA approval, whether for personal

> > use or otherwise, violates the Act. Unapproved new drugs are any

> > drugs, including foreign-made versions of U.S. approved drugs,

that

> > have not been manufactured in accordance with and pursuant to an

> FDA

> > approval. Under the Act, FDA may refuse admission to any drug

> > that " appears " to be unapproved, placing the burden on the

importer

> > to prove that the drug sought to be imported is, in fact,

approved

> > by FDA. Absent evidence that the specific drug sought to be

> imported

> > from a foreign country has been manufactured pursuant to an

> approved

> > new drug application, in the manufacturing facility permitted

under

> > the application, such drug would appear to be an unapproved new

> drug

> > subject to FDA enforcement action. In addition, drugs from

foreign

> > countries often fail to meet FDA's labeling and prescription

> > dispensing requirements.

> >

> > FDA recognizes some individuals may seek treatment with an

> > unapproved new drug in a foreign country and may wish to continue

> > such treatment upon their return to the USA. Likewise, FDA

> > recognizes some individuals suffer from conditions for which

there

> > exists no FDA approved treatment. FDA has developed guidance

which

> > identifies circumstances in which FDA may consider exercising

> > enforcement discretion to allow entry of such drugs. Generally

> > referred to as the personal importation policy, this guidance

> > provides FDA field offices the opportunity to exercise

enforcement

> > discretion in allowing entry of drugs when certain criteria are

> met.

> > These include: (1) the drug is unapproved and intended for use

for

> a

> > serious condition for which effective treatment may not be

> available

> > domestically either through commercial or clinical means; (2)

there

> > is no known commercialization or promotion of the drug to persons

> > residing in the U.S. by those involved in the distribution of the

> > product; (3) the product is considered not to represent an

> > unreasonable risk; and (4) the individual seeking to import the

> > product affirms in writing that it is for the patient's own use

> > (generally not more than a three-month supply), and provides the

> > name and address of the doctor licensed in the U.S. responsible

for

> > his/her treatment with the product, or provides evidence that the

> > product is for the continuation of treatment begun in a foreign

> > country.

> >

> > This FDA guidance is not, however, a license for individuals to

> > import unapproved (and therefore illegal) drugs for personal use

> > into the U.S. Even if all of the factors noted in the guidance

are

> > present, the drug remains illegal and FDA may determine that such

> > drugs should be refused entry or seized. The guidance does not

> > create any legally enforceable rights for the public; nor does it

> > operate to bind FDA or the public. Most importantly, this policy

is

> > not intended to allow importation of foreign versions of drugs

that

> > are approved in the U.S.

> >

> > For additional information, visit FDA's web site at

> > http://www.fda.gov/importeddrugs. Some informative pages include

> > IMPORTS, INFORMATION FOR CONSUMERS, and the CDER home page (FDA's

> > Center for Drug Evaluation and Research).

> >

> > For more consumer information on buying medicines from outside

the

> > U.S., visit FDA's website:

> > http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htm

> >

> > If, after reviewing the suggested information, you have

unanswered

> > questions, please again contact the Division of Drug Information

by

> > phone (1-) or e-mail (druginfo@). An

> > additional resource for information on human drug products can be

> > found on the Center's website http://www.fda.gov/cder. Thank you

> > again for your message. We hope that the above information will

> help

> > answer your question.

> >

> > Joan Powers

> > Consumer Safety Officer

> > Division of Drug Information

> > Center for Drug Evaluation and Research

> > Food and Drug Administration

> > Phone:

> >

> > This communication is consistent with 21CFR10.85(k) and

constitutes

> > an informal communication that represents our best judgment at

this

> > time but does not constitute an advisory opinion, does not

> > necessarily represent the formal position of the FDA, and does

not

> > bind or otherwise obligate or commit the agency to the views

> > expressed.

> >

> > If you haven't already checked with your pharmacist? Do so

> > IMMEDIATELY. My pharmacist was the one who told me about it

because

> > she found out when she tried to order more thyroid from her

> > distributor.

> >

> > I have been trying to hoard the drug and have found good luck

> > contacting Sam's Clubs. They can buy in mega-bulk and you don't

> > have to go through your insurance....which means you can fill as

> > many times as you want.

> >

> > One more thing: Joan Powers told me that the FDA would be trying

to

> > get Homeland Security to tighten up on banned drugs coming from

> > Canada and Mexico.

> >

> > We also have to keep in mind that this isn't JUST our dessicated

> > thyroid medication: THIS IS ALL OF THE DRUGS THAT WERE

> GRANDFATHERED

> > IN WHEN THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE

THROUGH

> > THE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.

> >

> > I'd give anything if this wasn't true and if any of you have any

> > more insight to this and if there is anything I can do to help? I

> > will.

> >

> > I really have contacted three senators (with NO reply from any of

> > them) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-

> > Massachusetts.) I have also tried to contact Ralph Nader and all

of

> > the television stations in my area.

> > I have an attorney looking into a class action lawsuit AND an

> > immediate lift on the ban by a federal judge.

> > If any of you find out about a class action lawsuit already in

the

> > works...please post it in here so I can call my attorney and let

> him

> > know.

> >

> > I want you all to know that this makes me feel better that all of

> > you are here and that I'm not fighting this alone now.

> >

> > Day day,

> >

> >

> > P.S. SERIOUSLY, CHECK WITH SAM'S CLUBS OR BULK PHARMACIES IN YOUR

> > AREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO

STILL

> > HAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROM

> > THEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID EVEN

IF

> > THEY HAVE IT!!!!!

> >

> > Fri Jan 11, 2008 9:47 am

> >

> > Show Message Option

> > ----------------------------------------------------------

> > -----------

> >

> > View Source

> > Use Fixed Width Font

> > Unwrap Lines

> >

> > ----------------------------------------------------------

> > -----------

> >

> > " " <jerry_lee_lewis_rox@>

> > jerry_lee_le...

> > Offline

> > Send Email

> >

> > Forward | Delete Message #1514 of 1514 < Prev | Next >

> >

> >

> >

> >

> >

> >

> > ---------------------------------

> > Never miss a thing. Make Yahoo your homepage.

> >

>

>

>

>

>

>

> ---------------------------------

> Looking for last minute shopping deals? Find them fast with

Yahoo! Search.

>

[Guest guest]

Please read this!

http://www.stopthethyroidmadness.com/blog/

--

Artistic Grooming- Hurricane WV

http://www.stopthethyroidmadness.com/

http://health.groups.yahoo.com/group/NaturalThyroidHormonesADRENALS/

[Guest guest]

THANK YOU, VAL!!!!!

Looking for last minute shopping deals? Find them fast with Yahoo! Search.

[Guest guest]

I just got back from the Lakeland Sam's Club in Lakeland, Florida.

This is 50 miles one way from my home in Clearwater.

After they pharmacist gave me my prescription, he said, " Hey.

Aren't they pulling this medicine? "

I hope I'm wrong, people.

I want you to know that it has not been my intention to cause

panic...even though I am very upset. I am not some loon that has

joined your group to create a ruckus. I have researched this since

New Year's Eve Day and only came onto these sites when I kept

getting all the same bad news from everyone.

I am a floral designer, a Notary here in Florida, my son is in law

school, and I've been married for almost 25 years to an electrical

supervisor for a major contractor in Tampa.

Trust me, I don't want this to be happening and I don't have time to

put my life on hold while I try to fight this and hoard drugs at the

same time.

I hope that Joan Powers at the FDA is wrong and that the Armour

thyroid people are right and that Armour continues to be

manufactured.

All the best to you all and I really do pray that I've been given

horrible misinformation.

[Guest guest]

Hi , I wish I thought those other people were right and that Armour has not been banned. Unfortunately, I have now received confirmation from the AARP that Armour Thyroid has, indeed, been banned by the FDA. The AARP has not been wrong about something like this in, well, in my memory. Also, I have been attempting to fill my own prescription for armour thyroid today and I find that both the local pharmacies and the online pharmacies do not have armour thyroid. They do not say it is banned. They say that it is "out of stock." I read Janie's blog on STTM. Janie is a human being and, as such, she is as fallible as any of us. I do know that rumors have gone around before that Armour was being taken off the market, which were false. That is probably the source of the confusion. The present situation does not appear to be a false

rumor; rather, it appears to be a true situation. I have also contacted the FDA and the Florida Attorney General's Office in attempting to discover the truth or falsity of Armour being banned by the FDA. None of these people have given me a straight answer--at least not yet. Maybe we'll have a definitive answer soon. In the meantime, I have seen too much of the FDA not to believe that they are capable of using deception and confusion in order to forestall problems with the actions they are taking. If people here believe that all is well with the FDA and with Armour thyroid, good luck. I hope you are right. wrote: ,The other yahoo thyroid site that I put this info on has a few people who seem to be angry at me and think I don't know what I'm talking about.They have contacted Armour (and so have I...twice) and Armour is still telling them that they are on back order. They really are on back order up until this time because one of their batches failed a 6-month potency test and was recalled.I already knew that info going into this and knew that Armour reps were covering up the fact that they had a bad batch. I knew that the Armour reps were talking about something completely different than what I was talking about.They had meds recalled because of a failed test. I was trying to tell them

there is now an FDA ban on further manufacture.The other group seems to think they are going to continue to get Armour....from what I've heard from Joan Powers at the FDA? That is not the case.I do hope I am seriously wrong about this. I hope I have been given some really CRAPPY misinformation. I don't want this to be true, but I do know that the manufacturer of MY thyroid medicine isn't making it anymore and I am frantically trying to hoard it.One woman from the other site also said that her insurance company no longer pays for her to get Armour....they will only pay for Synthroid or Levothyroxine. Perhaps this is another clue that they are taking the dessicate thyroid away from us?I don't know.I have to go now. I'm driving over to Lakeland, Florida to the Sam's Club. They seem to have some of the thyroid left. (I take a drug just called "thyroid" from Qualitest and Major Pharms.)If

you are anywhere near Lakeland? Perhaps you could try to get the meds there?I'll check back in when I get back from Lakeland, but keep in mind it might be late as that is on the other side of Tampa from me and I will have to go on I-4 where the horrible wrecks were. All the best,> > This is the second post from another thyroid yahoo group > I joined.> > > > I found

out on New Year's Eve day that my thyroid medication was > no > > longer going to be able to be manufactured because the FDA has > > stopped further manufacture of ALL drugs that were grandfathered > in.> > > > These drugs HAVE to seek FDA approval before they can be made > again!> > > > This DOES include Armour thyroid and thyroid. > > > > You'll have to wade through this message...because it was in > > response to someone else asking me about my first post alerting > them > > to the ban.> > > > Good luck to everyone.> > > > Joan Powers from the FDA called and left me a message yesterday> > (Thursday Jan. 10th) and told me that Armour thyroid is NOT on the> > approved drug list.> > > > From my previous FRANTIC phone call to Ms. Powers I already knew> >

that if they are NOT on the FDA's approved drug list? They will> > have to seek FDA approval...they are NO longer going to be allowed> > to be manufactured.> > > > Here is Joan Power's info from the FDA:> > > > Joan Powers> > Consumer Safety Officer> > Division of Drug Information> > Center for Drug Evaluation and Research> > Food and Drug Administration> > Phone: > > > > The two times I have phoned her? It has taken her 24 hours to > return> > the call.> > ", " <.@>> > 01/10/2008 04:48 PM> > To nwatson@> > cc "McDermott, "> > <.McDermott@>, "Swezey, Brad"> > <Brad.Swezey@>> > Subject Armour-Thyroid> > > > This is the email forwarded to me

last night (Thurs. Jan. 10) from> > at the St. Pete Times who is helping me investigate> > and draw attention to this situation.> > > > From what I can glean from this, Armour thyroid faced a recall> > because their last batch didn't pass the 6 month potency test? Is> > that what you all read, too?> > > > When I called Armour (Forest Pharmaceuticals) about the> > grandfathered in drugs being banned, I spoke with a gentleman named> > . (I called Armour in the hopes that they had maybe> > already sought approval since they are a bigger manufactuer of> > dessicated thyroid OR that they might have the money $$$ to seek a> > quicker approval than the smaller manufacturers.)> > When I spoke with Mr. at Forest Pharm., he was really> > flustered and seemed to think that I thought

Armour had been> > RECALLED. I kept assuring him that wasn't what I thought...that I> > only wanted to know if Armour was ALSO not going to be manufactured> > anymore. He told me I did not know what I was talking about (even> > thought I just gotten off the phone with Joan Powers of the FDA and> > I REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.> > POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.)> > at the St. Pete Times also talked to a rep from> > Armour/Forest Pharm. who also gave her the same song-and-dance.> > She and I were BOTH told that the reason Armour wasn't on our> > pharmacy's shelves was because it was on "back order" at the> > manufacturing plant because of "high demand for the product."> > Okay...I SMELL COVER-UP THERE because of this next item I've pasted> > in here from @

the SP Times...which she got from > > > at the FDA:> > > > Naomi:> > > > This is a recalled product.> > > > Here is the web link (I've pulled the action information and put it> > into the message, below).> > > > My colleagues McDermott and Brad Swezey, who cover recall> > issues, should be contacted if you have additional questions. They> > are copied here. At this point the posted informaton is the most> > accurate and available.> > > > Regards,> > > > > > > > http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.html> > > > PRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240 mg),> > each tablet contains

152-mcg levothyroxine and 36-mcg> > liothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008;> > Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg), each> > tablet contains 114-mcg levothyroxine and 27-mcg liothyronine,> > 100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)> > Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots: 1,000-> > tablet bottles: 030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-> > tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;> > 030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;> > 040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;> > 090724, Exp. Feb-09RECALLING FIRM/MANUFACTURERRecalling Firm: > Forest> > Pharmaceuticals Inc, Earth City, MO, by letter date November 9,> > 2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH.

Firm> > initiated recall is ongoing. REASONProduct failed disintegration> > specification at 6-months.VOLUME OF PRODUCT IN COMMERCEa) 41,745> > bottles totalb) 35,222/100-tablet bottles and 422/1,000-tablet> > bottlesDISTRIBUTIONNationwide and Belgium> > > > I really don't give a rat's *** about their failing the 6 month's> > potency, because now they're really screwed and so are all of us:> > Armour can't manufacture again without a federal judge lifting this> > ban immediately so all of our dessicated thyroid makers can get > back> > to work! Then the manufacturers are going to have to seek FDA> > approval...which costs money.> > > > This whole thing reeks. I am in the process of trying to hoard the> > meds, because this next thing I'm posting is from Joan Powers and> > is the PROCESS we have to go

through to get our drugs from a> > Canadian pharmacy.> > > > By the way? My doctor has already said that she will NOT go> > through this process because of the legalities of it. Basically,> > what Joan Powers told me I would have to do is:> > Have my doctor write me a new script every three months.> > Contact an online Canadian pharmacy and submit the script.> > That pharmacy will fill the script AFTER they contact my doctor for> > an okay.> > > > My doctor said there is NO way she will prescribe a drug that is> > banned by the FDA and okay me to have that script filled in another> > country.> > > > Anyway, here's the email from Joan Powers from the FDA:> > > > FDA's Personal Importation Policyþ> > From: CDER DRUG INFO (DRUGINFO@)> > You may not know this sender.Mark as

safe|Mark as unsafe> > Sent: Wed 1/02/08 6:40 PM> > To: greenestgurl@> > > > Thank you for your message to the Division of Drug Information in> > the Center for Drug Evaluation and Research (CDER).> > > > The United States Federal Food, Drug, and Cosmetic Act (the Act)> > prohibits (21 USC ' 331) the interstate shipment (which includes> > importation) of, among other things, unapproved new drugs. Thus, > the> > importation of drugs that lack FDA approval, whether for personal> > use or otherwise, violates the Act. Unapproved new drugs are any> > drugs, including foreign-made versions of U.S. approved drugs, that> > have not been manufactured in accordance with and pursuant to an > FDA> > approval. Under the Act, FDA may refuse admission to any drug> > that "appears" to be unapproved, placing the burden on

the importer> > to prove that the drug sought to be imported is, in fact, approved> > by FDA. Absent evidence that the specific drug sought to be > imported> > from a foreign country has been manufactured pursuant to an > approved> > new drug application, in the manufacturing facility permitted under> > the application, such drug would appear to be an unapproved new > drug> > subject to FDA enforcement action. In addition, drugs from foreign> > countries often fail to meet FDA's labeling and prescription> > dispensing requirements.> > > > FDA recognizes some individuals may seek treatment with an> > unapproved new drug in a foreign country and may wish to continue> > such treatment upon their return to the USA. Likewise, FDA> > recognizes some individuals suffer from conditions for which there>

> exists no FDA approved treatment. FDA has developed guidance which> > identifies circumstances in which FDA may consider exercising> > enforcement discretion to allow entry of such drugs. Generally> > referred to as the personal importation policy, this guidance> > provides FDA field offices the opportunity to exercise enforcement> > discretion in allowing entry of drugs when certain criteria are > met.> > These include: (1) the drug is unapproved and intended for use for > a> > serious condition for which effective treatment may not be > available> > domestically either through commercial or clinical means; (2) there> > is no known commercialization or promotion of the drug to persons> > residing in the U.S. by those involved in the distribution of the> > product; (3) the product is considered not to represent an>

> unreasonable risk; and (4) the individual seeking to import the> > product affirms in writing that it is for the patient's own use> > (generally not more than a three-month supply), and provides the> > name and address of the doctor licensed in the U.S. responsible for> > his/her treatment with the product, or provides evidence that the> > product is for the continuation of treatment begun in a foreign> > country.> > > > This FDA guidance is not, however, a license for individuals to> > import unapproved (and therefore illegal) drugs for personal use> > into the U.S. Even if all of the factors noted in the guidance are> > present, the drug remains illegal and FDA may determine that such> > drugs should be refused entry or seized. The guidance does not> > create any legally enforceable rights for the public; nor does it> >

operate to bind FDA or the public. Most importantly, this policy is> > not intended to allow importation of foreign versions of drugs that> > are approved in the U.S.> > > > For additional information, visit FDA's web site at> > http://www.fda.gov/importeddrugs. Some informative pages include> > IMPORTS, INFORMATION FOR CONSUMERS, and the CDER home page (FDA's> > Center for Drug Evaluation and Research).> > > > For more consumer information on buying medicines from outside the> > U.S., visit FDA's website:> > http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htm> > > > If, after reviewing the suggested information, you have unanswered> > questions, please again

contact the Division of Drug Information by> > phone (1-) or e-mail (druginfo@). An> > additional resource for information on human drug products can be> > found on the Center's website http://www.fda.gov/cder. Thank you> > again for your message. We hope that the above information will > help> > answer your question.> > > > Joan Powers> > Consumer Safety Officer> > Division of Drug Information> > Center for Drug Evaluation and Research> > Food and Drug Administration> > Phone: > > > > This communication is consistent with 21CFR10.85(k) and constitutes> > an informal communication that represents our best judgment at this> > time but does not constitute an advisory opinion, does not> > necessarily represent the formal

position of the FDA, and does not> > bind or otherwise obligate or commit the agency to the views> > expressed.> > > > If you haven't already checked with your pharmacist? Do so> > IMMEDIATELY. My pharmacist was the one who told me about it because> > she found out when she tried to order more thyroid from her> > distributor.> > > > I have been trying to hoard the drug and have found good luck> > contacting Sam's Clubs. They can buy in mega-bulk and you don't> > have to go through your insurance....which means you can fill as> > many times as you want.> > > > One more thing: Joan Powers told me that the FDA would be trying to> > get Homeland Security to tighten up on banned drugs coming from> > Canada and Mexico.> > > > We also have to keep in mind that this isn't JUST our

dessicated> > thyroid medication: THIS IS ALL OF THE DRUGS THAT WERE > GRANDFATHERED> > IN WHEN THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE THROUGH> > THE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.> > > > I'd give anything if this wasn't true and if any of you have any> > more insight to this and if there is anything I can do to help? I> > will.> > > > I really have contacted three senators (with NO reply from any of> > them) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-> > Massachusetts.) I have also tried to contact Ralph Nader and all of> > the television stations in my area.> > I have an attorney looking into a class action lawsuit AND an> > immediate lift on the ban by a federal judge.> > If any of you find out about a class action lawsuit already in the> >

works...please post it in here so I can call my attorney and let > him> > know.> > > > I want you all to know that this makes me feel better that all of> > you are here and that I'm not fighting this alone now.> > > > Day day,> > > > > > P.S. SERIOUSLY, CHECK WITH SAM'S CLUBS OR BULK PHARMACIES IN YOUR> > AREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO STILL> > HAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROM> > THEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID EVEN IF> > THEY HAVE IT!!!!!> > > > Fri Jan 11, 2008 9:47 am > > > > Show Message Option > > ----------------------------------------------------------> > -----------> > > > View Source> > Use Fixed Width

Font> > Unwrap Lines> > > > ----------------------------------------------------------> > -----------> > > > "" <jerry_lee_lewis_rox@> > > jerry_lee_le... > > Offline > > Send Email > > > > Forward | Delete Message #1514 of 1514 < Prev | Next > > > > > > > > > > > > > > > ---------------------------------> > Never miss a thing. Make Yahoo your homepage.> >> > > > > > > ---------------------------------> Looking for last minute shopping deals? Find them fast with Yahoo! Search.>

Looking for last minute shopping deals? Find them fast with Yahoo! Search.

[Guest guest]

,

I'm so sorry to hear this. I just keep hoping and praying that I'm

being given horrible misinformation.

It's hard for me to keep up with who has written what on the two

different yahoo groups and the fact that I'm trying to hoard and

also stay on the phones contacting anyone who'll listen...

So, I know from one person on one of these groups that her health

insurance has alerted her that they will no longer cover Armour

thyroid and told her that they would only pay for Levothyroxine.

Now you're telling me that the AARP has confirmed what Joan Powers

at the FDA told me over the phone that Amour was not an approved

drug.

If Armour can no longer manufacture? We have got to get a federal

judge to lift this ban. This is the only way to take care of this

quickly. None of us have the time to wait for any of the

manufacturers to wait for FDA approval.

I will let you all know as soon as I hear back from Joan Powers. I

left one last message for her: asking if they were going to let

Armour continue to manufacture while Armour seeks approval.

Let's hope and pray that her answer is, " yes. "

> > > This is the second post from another thyroid yahoo group

> > I joined.

> > >

> > > I found out on New Year's Eve day that my thyroid medication

was

> > no

> > > longer going to be able to be manufactured because the FDA has

> > > stopped further manufacture of ALL drugs that were

grandfathered

> > in.

> > >

> > > These drugs HAVE to seek FDA approval before they can be made

> > again!

> > >

> > > This DOES include Armour thyroid and thyroid.

> > >

> > > You'll have to wade through this message...because it was in

> > > response to someone else asking me about my first post

alerting

> > them

> > > to the ban.

> > >

> > > Good luck to everyone.

> > >

> > > Joan Powers from the FDA called and left me a message yesterday

> > > (Thursday Jan. 10th) and told me that Armour thyroid is NOT on

> the

> > > approved drug list.

> > >

> > > From my previous FRANTIC phone call to Ms. Powers I already

knew

> > > that if they are NOT on the FDA's approved drug list? They will

> > > have to seek FDA approval...they are NO longer going to be

> allowed

> > > to be manufactured.

> > >

> > > Here is Joan Power's info from the FDA:

> > >

> > > Joan Powers

> > > Consumer Safety Officer

> > > Division of Drug Information

> > > Center for Drug Evaluation and Research

> > > Food and Drug Administration

> > > Phone:

> > >

> > > The two times I have phoned her? It has taken her 24 hours to

> > return

> > > the call.

> > > " , " <.@>

> > > 01/10/2008 04:48 PM

> > > To nwatson@

> > > cc " McDermott, "

> > > <.McDermott@>, " Swezey, Brad "

> > > <Brad.Swezey@>

> > > Subject Armour-Thyroid

> > >

> > > This is the email forwarded to me last night (Thurs. Jan. 10)

> from

> > > at the St. Pete Times who is helping me

> investigate

> > > and draw attention to this situation.

> > >

> > > From what I can glean from this, Armour thyroid faced a recall

> > > because their last batch didn't pass the 6 month potency test?

Is

> > > that what you all read, too?

> > >

> > > When I called Armour (Forest Pharmaceuticals) about the

> > > grandfathered in drugs being banned, I spoke with a gentleman

> named

> > > . (I called Armour in the hopes that they had maybe

> > > already sought approval since they are a bigger manufactuer of

> > > dessicated thyroid OR that they might have the money $$$ to

seek

> a

> > > quicker approval than the smaller manufacturers.)

> > > When I spoke with Mr. at Forest Pharm., he was really

> > > flustered and seemed to think that I thought Armour had been

> > > RECALLED. I kept assuring him that wasn't what I

thought...that I

> > > only wanted to know if Armour was ALSO not going to be

> manufactured

> > > anymore. He told me I did not know what I was talking about

(even

> > > thought I just gotten off the phone with Joan Powers of the

FDA

> and

> > > I REALLY FELT LIKE I KNEW WHAT I WAS TALKING ABOUT BECAUSE MS.

> > > POWERS' HAD JUST GIVEN ME THE WORST NEWS IN MY LIFE.)

> > > at the St. Pete Times also talked to a rep from

> > > Armour/Forest Pharm. who also gave her the same song-and-dance.

> > > She and I were BOTH told that the reason Armour wasn't on our

> > > pharmacy's shelves was because it was on " back order " at the

> > > manufacturing plant because of " high demand for the product. "

> > > Okay...I SMELL COVER-UP THERE because of this next item I've

> pasted

> > > in here from @ the SP Times...which she got from Chris

> >

> > > at the FDA:

> > >

> > > Naomi:

> > >

> > > This is a recalled product.

> > >

> > > Here is the web link (I've pulled the action information and

put

> it

> > > into the message, below).

> > >

> > > My colleagues McDermott and Brad Swezey, who cover

> recall

> > > issues, should be contacted if you have additional questions.

> They

> > > are copied here. At this point the posted informaton is the

most

> > > accurate and available.

> > >

> > > Regards,

> > >

> > >

> > >

> > > http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.html

> > >

> > > PRODUCTa) Armour Thyroid (thyroid tablets, USP), 4-grain (240

> mg),

> > > each tablet contains 152-mcg levothyroxine and 36-mcg

> > > liothyronine, 100-tablet bottles, Rx only, Recall # D-068-2008;

> > > Armour Thyroid (thyroid tablets, USP). 3-grain (180 mg),

each

> > > tablet contains 114-mcg levothyroxine and 27-mcg liothyronine,

> > > 100 and 1000-tablet bottles, Rx only, Recall # D-069-2008CODEa)

> > > Lots: 030724, Exp. Aug-08 and 050750, Exp. Dec-08; Lots:

> 1,000-

> > > tablet bottles: 030732, Exp. Aug-08, 090724, Exp. Feb-09; 100-

> > > tablet bottle lots: 030714, Exp. Jul-08; 050771, Exp. Jul-08;

> > > 030723, Exp. Aug-08; 050772, Exp. Aug-08; 040726, Exp. Oct-08;

> > > 040727, Exp. Oct-08; 070723, Exp. Nov-08; 070724, Exp. Dec-08;

> > > 090724, Exp. Feb-09RECALLING FIRM/MANUFACTURERRecalling Firm:

> > Forest

> > > Pharmaceuticals Inc, Earth City, MO, by letter date November 9,

> > > 2007Manufacturer: Forest Pharmaceuticals Inc, Cincinnati, OH.

> Firm

> > > initiated recall is ongoing. REASONProduct failed

disintegration

> > > specification at 6-months.VOLUME OF PRODUCT IN COMMERCEa)

41,745

> > > bottles totalb) 35,222/100-tablet bottles and 422/1,000-tablet

> > > bottlesDISTRIBUTIONNationwide and Belgium

> > >

> > > I really don't give a rat's *** about their failing the 6

month's

> > > potency, because now they're really screwed and so are all of

us:

> > > Armour can't manufacture again without a federal judge lifting

> this

> > > ban immediately so all of our dessicated thyroid makers can

get

> > back

> > > to work! Then the manufacturers are going to have to seek FDA

> > > approval...which costs money.

> > >

> > > This whole thing reeks. I am in the process of trying to hoard

> the

> > > meds, because this next thing I'm posting is from Joan Powers

and

> > > is the PROCESS we have to go through to get our drugs from a

> > > Canadian pharmacy.

> > >

> > > By the way? My doctor has already said that she will NOT go

> > > through this process because of the legalities of it.

Basically,

> > > what Joan Powers told me I would have to do is:

> > > Have my doctor write me a new script every three months.

> > > Contact an online Canadian pharmacy and submit the script.

> > > That pharmacy will fill the script AFTER they contact my

doctor

> for

> > > an okay.

> > >

> > > My doctor said there is NO way she will prescribe a drug that

is

> > > banned by the FDA and okay me to have that script filled in

> another

> > > country.

> > >

> > > Anyway, here's the email from Joan Powers from the FDA:

> > >

> > > FDA's Personal Importation Policyþ

> > > From: CDER DRUG INFO (DRUGINFO@)

> > > You may not know this sender.Mark as safe|Mark as unsafe

> > > Sent: Wed 1/02/08 6:40 PM

> > > To: greenestgurl@

> > >

> > > Thank you for your message to the Division of Drug Information

in

> > > the Center for Drug Evaluation and Research (CDER).

> > >

> > > The United States Federal Food, Drug, and Cosmetic Act (the

Act)

> > > prohibits (21 USC ' 331) the interstate shipment (which

includes

> > > importation) of, among other things, unapproved new drugs.

Thus,

> > the

> > > importation of drugs that lack FDA approval, whether for

personal

> > > use or otherwise, violates the Act. Unapproved new drugs are

any

> > > drugs, including foreign-made versions of U.S. approved drugs,

> that

> > > have not been manufactured in accordance with and pursuant to

an

> > FDA

> > > approval. Under the Act, FDA may refuse admission to any drug

> > > that " appears " to be unapproved, placing the burden on the

> importer

> > > to prove that the drug sought to be imported is, in fact,

> approved

> > > by FDA. Absent evidence that the specific drug sought to be

> > imported

> > > from a foreign country has been manufactured pursuant to an

> > approved

> > > new drug application, in the manufacturing facility permitted

> under

> > > the application, such drug would appear to be an unapproved

new

> > drug

> > > subject to FDA enforcement action. In addition, drugs from

> foreign

> > > countries often fail to meet FDA's labeling and prescription

> > > dispensing requirements.

> > >

> > > FDA recognizes some individuals may seek treatment with an

> > > unapproved new drug in a foreign country and may wish to

continue

> > > such treatment upon their return to the USA. Likewise, FDA

> > > recognizes some individuals suffer from conditions for which

> there

> > > exists no FDA approved treatment. FDA has developed guidance

> which

> > > identifies circumstances in which FDA may consider exercising

> > > enforcement discretion to allow entry of such drugs. Generally

> > > referred to as the personal importation policy, this guidance

> > > provides FDA field offices the opportunity to exercise

> enforcement

> > > discretion in allowing entry of drugs when certain criteria

are

> > met.

> > > These include: (1) the drug is unapproved and intended for use

> for

> > a

> > > serious condition for which effective treatment may not be

> > available

> > > domestically either through commercial or clinical means; (2)

> there

> > > is no known commercialization or promotion of the drug to

persons

> > > residing in the U.S. by those involved in the distribution of

the

> > > product; (3) the product is considered not to represent an

> > > unreasonable risk; and (4) the individual seeking to import the

> > > product affirms in writing that it is for the patient's own use

> > > (generally not more than a three-month supply), and provides

the

> > > name and address of the doctor licensed in the U.S.

responsible

> for

> > > his/her treatment with the product, or provides evidence that

the

> > > product is for the continuation of treatment begun in a foreign

> > > country.

> > >

> > > This FDA guidance is not, however, a license for individuals to

> > > import unapproved (and therefore illegal) drugs for personal

use

> > > into the U.S. Even if all of the factors noted in the guidance

> are

> > > present, the drug remains illegal and FDA may determine that

such

> > > drugs should be refused entry or seized. The guidance does not

> > > create any legally enforceable rights for the public; nor does

it

> > > operate to bind FDA or the public. Most importantly, this

policy

> is

> > > not intended to allow importation of foreign versions of drugs

> that

> > > are approved in the U.S.

> > >

> > > For additional information, visit FDA's web site at

> > > http://www.fda.gov/importeddrugs. Some informative pages

include

> > > IMPORTS, INFORMATION FOR CONSUMERS, and the CDER home page

(FDA's

> > > Center for Drug Evaluation and Research).

> > >

> > > For more consumer information on buying medicines from outside

> the

> > > U.S., visit FDA's website:

> > > http://www.fda.gov/cder/consumerinfo/buy_outside_US_text.htm

> > >

> > > If, after reviewing the suggested information, you have

> unanswered

> > > questions, please again contact the Division of Drug

Information

> by

> > > phone (1-) or e-mail (druginfo@). An

> > > additional resource for information on human drug products can

be

> > > found on the Center's website http://www.fda.gov/cder. Thank

you

> > > again for your message. We hope that the above information

will

> > help

> > > answer your question.

> > >

> > > Joan Powers

> > > Consumer Safety Officer

> > > Division of Drug Information

> > > Center for Drug Evaluation and Research

> > > Food and Drug Administration

> > > Phone:

> > >

> > > This communication is consistent with 21CFR10.85(k) and

> constitutes

> > > an informal communication that represents our best judgment at

> this

> > > time but does not constitute an advisory opinion, does not

> > > necessarily represent the formal position of the FDA, and does

> not

> > > bind or otherwise obligate or commit the agency to the views

> > > expressed.

> > >

> > > If you haven't already checked with your pharmacist? Do so

> > > IMMEDIATELY. My pharmacist was the one who told me about it

> because

> > > she found out when she tried to order more thyroid from her

> > > distributor.

> > >

> > > I have been trying to hoard the drug and have found good luck

> > > contacting Sam's Clubs. They can buy in mega-bulk and you don't

> > > have to go through your insurance....which means you can fill

as

> > > many times as you want.

> > >

> > > One more thing: Joan Powers told me that the FDA would be

trying

> to

> > > get Homeland Security to tighten up on banned drugs coming from

> > > Canada and Mexico.

> > >

> > > We also have to keep in mind that this isn't JUST our

dessicated

> > > thyroid medication: THIS IS ALL OF THE DRUGS THAT WERE

> > GRANDFATHERED

> > > IN WHEN THE FDA BECAME AN AGENCY. ANY DRUG THAT HASN'T GONE

> THROUGH

> > > THE FDA APPROVAL PROCESS IS NO LONGER OKAY'D TO MANUFACTURE.

> > >

> > > I'd give anything if this wasn't true and if any of you have

any

> > > more insight to this and if there is anything I can do to

help? I

> > > will.

> > >

> > > I really have contacted three senators (with NO reply from any

of

> > > them) (D-Florida,) Leahy (D-Vermont,) and Kennedy (D-

> > > Massachusetts.) I have also tried to contact Ralph Nader and

all

> of

> > > the television stations in my area.

> > > I have an attorney looking into a class action lawsuit AND an

> > > immediate lift on the ban by a federal judge.

> > > If any of you find out about a class action lawsuit already in

> the

> > > works...please post it in here so I can call my attorney and

let

> > him

> > > know.

> > >

> > > I want you all to know that this makes me feel better that all

of

> > > you are here and that I'm not fighting this alone now.

> > >

> > > Day day,

> > >

> > >

> > > P.S. SERIOUSLY, CHECK WITH SAM'S CLUBS OR BULK PHARMACIES IN

YOUR

> > > AREA TO HOARD YOUR MEDS....THEY SEEM TO BE THE ONLY ONE'S WHO

> STILL

> > > HAVE IT ON THEIR SHELVES. CVS HAS ALREADY PULLED THE DRUG FROM

> > > THEIR SHELVES AND ARE NO LONGER SELLING DESSICATED THYROID

EVEN

> IF

> > > THEY HAVE IT!!!!!

> > >

> > > Fri Jan 11, 2008 9:47 am

> > >

> > > Show Message Option

> > > ----------------------------------------------------------

> > > -----------

> > >

> > > View Source

> > > Use Fixed Width Font

> > > Unwrap Lines

> > >

> > > ----------------------------------------------------------

> > > -----------

> > >

> > > " " <jerry_lee_lewis_rox@>

> > > jerry_lee_le...

> > > Offline

> > > Send Email

> > >

> > > Forward | Delete Message #1514 of 1514 < Prev | Next >

> > >

> > >

> > >

> > >

> > >

> > >

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[Guest guest]

? Can you take thyroid...which is just another

manufacturers' name for dessicated thyroid?

The Sam's Club in Lakeland was going to try to get another bottle of

thyroid for me. I take the 65mg. What dosage do you take?

How close to Lakeland are you?

Call the Sam's Clubs in your area. You can do a store locator

search on their website. I'm sorry, but all of the ones I contacted

over this way did NOT have Armour, but ONLY had thyroid.

I'll let you know what I find out from Joan Powers when she calls

back.

Let's hope and pray that Armour is going to get some sort of " pass "

to continue to market this while seeking approval. Although that is

also worrisome considering their recall and the fact that they are

saying they have a batch coming out at the end of January. I hope

they are allowed to distribute and sell that batch.