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.
Copyright © 2006 Reuters Limited
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