Dr. Rost: The FDA is Finished READ MORE: 2006, Investigations ... Ilena posted on Google

[Guest guest]

> The FDA is Finished READ MORE: 2006, Investigations

> The FDA is here to protect us and to ensure, among

> other things, safe drugs.

>

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>

<http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.htm

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http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...

>

>

> This is a tough task, a task which will often result

> in criticism.

>

> And when the FDA is caught red handed making

> decisions that have

> nothing to do with science, and everything to do

> with politics and

> religion, the trust in the FDA effectively ends.

>

> The FDA, as we know it, is finished, and here's why:

>

>

> It was just revealed that two key Food and Drug

> Administration

> officials recently testified that former FDA

> Commissioner Lester

> Crawford took them out of the agency's normal drug

> approval process,

> in order for him to personally block

> over-the-counter sales of an

> important early pregnancy contraceptive or

> " morning-after pill. "

>

> We're talking about Crawford's decision in August

> 2005 to block

> nonprescription sales of Plan B even though the key

> agency officials

> wanted to approve them.

>

> And who's behind this decision? The usual suspects.

> Conservative

> groups and religious fundamentalists have lobbied

> the FDA and the

> White House against nonprescription Plan B sales.

>

> Religious fanatics argue that Plan B causes

> abortions, although the

> scientific truth is that the drug, when it's taken

> within 72 hours of

> unprotected sex, simply prevents pregnancy.

>

> According to transcripts of the depositions, Dr.

> Galson,

> director of the FDA's drug evaluation center, and

> Dr. Janet Woodcock,

> deputy operations commissioner, Crawford removed

> them from involvement

> in the agency's decision on Plan B.

>

> Galson, who testified he was unhappy with the FDA's

> Plan B process,

> said: " What happened around that time frame is that

> Dr. Crawford, who

> was the acting commissioner then, told me that he

> was concerned about

> where we were heading because he knew that I was

> heading towards this

> recommendation [approval], and he told me that he

> was going to make

> the decision on what to do with the application. "

>

> He, he. Sounds different than when Galson motivated

> FDA's rejection of

> Barr's application for Plan B non-prescription sales

> earlier, in May

> 2004.

>

> On May 6, 2004, Galson wrote in a memo: " Some staff

> have expressed the

> concern that this decision is based on non-medical

> implications of

> teen sexual behavior, or judgments about the

> propriety of this

> activity. These issues are beyond the scope of our

> drug approval

> process, and I have not considered them in this

> decision. "

>

> Right. The truth doesn't always get out, but

> sometimes it does.

>

> So, in August 2005, Crawford blocked Plan B and said

> the FDA needed

> more time to consider a revised application from

> Barr to allow Plan B

> sales without a prescription to women 16 and older

> but with a

> prescription to girls 15 and under.

>

> Dr. F. Wood, the FDA's top women's health

> officer, then resigned

> in protest over Crawford's handling of this matter.

>

> The end of the saga is that the drug is still not

> approved without a

> prescription and Dr. Crawford the former, eminent

> FDA czar, is now

> under investigation himself.

>

> The criminal investigation of Dr. Crawford by a

> federal grand jury

> over accusations of financial improprieties and

> false statements to

> Congress, was revealed only a month ago. Dr.

> Crawford resigned in

> September 2005, less than three months after the

> Senate confirmed him

> as the permanent FDA commissioner, a position which

> he had held on an

> " acting " basis for a couple of years. He said then

> that it was time

> for someone else to lead the agency.

>

> Yep, criminal charges can do that to you. Time to

> move on.

>

> Question is when the clowns who are messing with our

> healthcare system

> and approval of vital drugs will be charged with

> their crimes.

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