FDA officials give Plan B suit depositions

April 25, 2006 at 3:50 PM
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WASHINGTON, April 25 (UPI) -- Senior Food and Drug Administration officials will be giving depositions in a suit to force over-the-counter sales of Plan B.

The lawsuit, which claims that the agency did not follow its own procedures when it denied Barr Laboratories' May 2004 application to sell the emergency contraceptive without a prescription, will be questioning former FDA Commissioner Lester Crawford, Deputy Operations Commissioner Janet Woodcock and Steve Galson, director of the Center for Drug Evaluation and Research, Long Island Newsday reported Tuesday.

The FDA said Barr's 2004 drug application was not approvable because the company did not have data about the effects of the medication on women younger than 16. The company then resubmitted its application in January 2005 to include only sales to women 17 and older, but the agency announced it would be delaying its decision.

Plan B, also known as the morning-after pill, can reduce the likelihood of pregnancy after unprotected or unwanted intercourse for several days, but is more effective the sooner it is taken.

The lawsuit was filed by the Center for Reproductive Rights on behalf of the Association of Reproductive Health Professionals and other groups and will be heard in a New York U.S. District Court.

The attorneys have said they plan to question the officials about internal communications indicating there may have been non-medical reasons for rejecting the application.

The FDA did not comment for the story.

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