FDA impropriety charged on pill

May 26--Two high-ranking U.S. Food and Drug Administration officials claimed under oath they were kept out of the loop on the politically charged decision to postpone action on Barr Pharmaceuticals Inc.'s request to sell its Plan B emergency contraceptive over the counter, according to documents released Thursday.

The non-profit Center for Reproductive Rights released transcripts of depositions taken last month from Dr. Janet Woodcock, an FDA deputy commissioner, and Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in connection with a lawsuit filed by the advocacy group against the regulatory agency.

Both Woodcock and Galson said in their depositions that the FDA commissioner at the time, Lester Crawford, failed to consult with them in early 2005 before delaying a decision on whether to allow sales of Barr's so-called morning-after pill without a prescription to women over 16.

The Center for Reproductive Rights has sued the FDA in an effort to force a decision on the controversial issue.

Woodcliff Lake-based Barr Pharmaceuticals has been seeking approval to sell Plan B over the counter since 2003. The contraceptive, which is now sold only with a prescription, can prevent pregnancy if taken within 72 hours of sexual intercourse.

Carol Cox, a Barr spokeswoman, declined to comment Thursday.

The FDA did not respond to efforts seeking comment.

The Center for Reproductive Rights has alleged that the FDA allowed politics to override its societal responsibilities. Conservative religious groups oppose allowing easier access to the pills and have put pressure on like-minded politicians.

Crawford was acting director of the FDA in January 2005 when the FDA was expected to rule on whether to allow over-the-counter sales of Plan B for women ages 16 and older. But the agency announced instead that it was delaying a decision indefinitely.

President Bush appointed Crawford commissioner in July 2005.

According to the depositions released Thursday, neither Woodcock nor Galson was told of the decision until shortly before it was announced.

Furthermore, both officials said they were not asked for their input as the decision was being made.

Asked if the process under Crawford was unusual, Woodcock responded: "Ordinarily, I would have been more involved, but not in all cases. In this case, I was not involved."

Woodcock went on to say that when she questioned Crawford, he told her he planned to make the decision himself.

Moreover, she said, Galson had speculated to her that Crawford was under political pressure to delay a decision.

Galson said he was leaning in favor of recommending that the contraceptive be sold over the counter.

"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 toward this recommendation, and he told me that he was going to make the decision on what to do with the application," Galson told lawyers representing the Center for Reproductive Rights.

Simon Heller, an attorney with the center, said in a statement: "Dr. Crawford's interference in the Plan B decision is yet another major departure from the FDA's usual process.

A commissioner has never made this kind of decision alone. The more we learn about the FDA's decision-making around Plan B, the more we know that the agency violated its own precedents in order to deny women the means to avoid unwanted pregnancies and to reduce the need for abortions."

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