Grandfathered drugs BANNED by the FDA!

[Guest guest]

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, "

, " Swezey, Brad "

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

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