Top Officials Excluded From Decision on Plan B
Two top FDA officials last month testified that former FDA Commissioner Lester Crawford excluded them from the approval process regarding Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, according to depositions from a lawsuit released this week by the Center for Reproductive Rights, the Long Island Newsday reports (Kerr , Long Island Newsday, 5/25).
CRR -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others -- filed a lawsuit against FDA in a U.S. District Court in New York, claiming the agency did not follow procedure when it first denied Barr's application for Plan B -- which can prevent pregnancy if taken up to 72 hours after sexual intercourse. The lawsuit also said that by not approving nonprescription sales, the agency violated women's rights to equal protection and privacy as guaranteed by the U.S. Constitution.
FDA in May 2004 issued a "not approvable" letter in response to an original application submitted by Barr to authorize nonprescription sales of Plan B citing inadequate data on its use among girls age 16 and younger. After FDA rejected Barr's first application, the company submitted a revised application to make the drug available only to girls and women age 17 and older.
In January 2005, FDA announced a delay in its decision on the revised application (California Healthline, 2/28).
Crawford in August 2005 opened a 60-day public comment period on the application, saying science supported approval, but the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls age 16 and younger from obtaining the drug. The comment period expired in November 2005, and the agency did not indicate when it might make a decision on the application (California Healthline, 3/10).
Steven Galson, director of FDA's Center for Drug Evaluation and Research, last month testified that he was inclined to recommend that Barr's second application be approved, Reuters reports (Richwine, Reuters, 5/25). Galson said, "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, and he told me that he was going to make the decision on what to do with the application" (Long Island Newsday, 5/25).
Galson added that he had never had a comparable decision on an application taken from him, the Los Angeles Times reports.
FDA Deputy Commissioner for Operations Janet Woodcock testified that she often was consulted by the agency's commissioner on major decisions but was not told about Crawford's August 2005 decision to open the comment period until about one day before he made the announcement (Alonso-Zaldivar, Los Angeles Times, 5/25). "Ordinarily, I would have been more involved, but not in all cases," Woodcock said, adding, "In this case, I was not involved" (Reuters, 5/25).
Woodcock also said that Galson told her Crawford might be facing pressure on the application from the Bush administration, Congress or both (Rockoff, Baltimore Sun, 5/25).
According to Crawford's attorney Barbara Van Gelder, Crawford on Wednesday in a deposition "answered all questions about Plan B" and said the application "was his decision" (Kerr , Long Island Newsday, 5/25).
FDA and HHS on Wednesday did not comment when asked about Galson and Woodcock's testimony, according to the Times (Los Angeles Times, 5/25).