Senior FDA staff left out of contraceptive ruling

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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.

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