FDA officials' sworn testimony confirms commissioner's political intervention

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Fri, 26 May 2006 18:37:52 -0400

[sSRI-Research] FDA officials' sworn testimony confirms

commissioner's political intervention

 

 

 

 

 

FDA officials' sworn testimony confirms commissioner's political

intervention

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

The political intervention by (then) FDA Commissioner, Dr. Lester

Crawford--who is under investigation for financial conflicts of

interest--is not just about the " morning-after " pill.

 

This issue is but an example of how politicized the decision-making

process at the the FDA actually is.

 

It is unfortunate that FDA senior officials have not yet been deposed

about the agency's biased approval process which has been corrupted by

industry's influence.

 

What prevents litigating lawyers from deposing FDA officials in the

Vioxx cases? in the antidepressant cases? in the antipsychotic cases?

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

Published on Thursday, May 25, 2006 by Reuters

 

Top FDA Staff Say Left out of Contraceptive Ruling

by Lisa Richwine

 

The former U.S. Food and Drug Administration chief shut out two senior

agency officials from a decision to indefinitely postpone action on

Barr Pharmaceuticals Inc.'s " morning-after " contraceptive, the

officials said in legal depositions released this week.

 

Transcripts of the sworn statements were released by the non-profit

Center for Reproductive Rights, which sued the FDA, claiming that the

agency allowed political opposition to the Plan B contraceptive to

interfere with science.

 

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation

and Research, testified that around January 2005 he was leaning toward

approving Barr's plan to sell Plan B over the counter.

 

But then-Acting FDA Commissioner Lester Crawford " told me that he was

concerned about where we were heading because he knew that I was

heading toward this recommendation, and he told me that he was going

to make the decision on what to do with the application, " Galson said,

according to deposition transcripts.

 

Galson said Crawford voiced concerns about the packaging for Plan B,

which the company proposed selling over the counter for women age 16

and older, while keeping the prescription requirement for younger girls.

 

Galson, a doctor and career scientist who has worked at the FDA since

2001, said he had never before had his authority to make a decision

removed by a commissioner. The FDA commissioner is appointed by the

president and confirmed by the Senate.

 

He said he wrote a memo to Crawford saying scientific evidence

supported over-the-counter sales.

 

Plan B, now sold by prescription, is a set of pills that can prevent

pregnancy if taken within 72 hours of sexual intercourse.

 

Some conservative groups oppose allowing the product to be sold

without a prescription, fearing it could lead to greater promiscuity.

Women's groups say easier access to Plan B would help reduce the

number of abortions.

 

Galson made the remarks last month during depositions in a lawsuit

brought against the FDA by reproductive rights group.

 

The group's lawyers deposed Crawford on Wednesday. His attorney,

Barbara Van Gelder, declined to comment on his testimony, and a

transcript was not immediately available.

 

Crawford was confirmed as permanent FDA commissioner in July 2005. The

following month, Crawford announced the FDA was delaying a decision on

Plan B and taking public comments because some regulatory issues

remained. He resigned in September 2005.

 

Dr. Janet Woodcock, a deputy FDA commissioner and a career scientist

who joined the FDA in 1986, said in a deposition she asked Crawford

" repeatedly " about Barr's application and " he just said it was under

evaluation. " She agreed with a lawyer's characterization that she was

" informed " about the decision " rather than included in the

decision-making process. "

 

" Ordinarily, I would have been more involved, but not in all cases. In

this case, I was not involved, " Woodcock said, according to

transcripts made available by the Center for Reproductive Rights.

 

Woodcock and Galson said they did not know if anyone outside the FDA

provided input to Crawford on the decision. Their depositions were

taken April 26 and 27.

 

FDA spokeswoman Susan Bro said the transcripts " reflect the thorough,

thoughtful back and forth discussion among the agency's scientific and

policy leadership about unprecedented issues " raised in the Plan B

application.

 

The reproductive rights group said the testimony supported its view

that the FDA departed from usual procedures in the Plan B case.

 

" The more we learn about the FDA's decision-making around Plan B, the

more we know that the agency violated its own precedents, " attorney

Simon Heller said.

 

2006 Reuters Limited

 

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