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Contraception Debate Delays Nomination of FDA Chief
[FINAL Edition]
The Washington Post - Washington, D.C.
Author: Marc Kaufman
Date: Apr 7, 2005
Start Page: A.07
Section: A SECTION
Text Word Count: 511

The FDA approved emergency contraception in 1999 as a prescription-only drug. Its manufacturer, Barr Laboratories, applied for approval to sell Plan B without a prescription in April 2003, and an agency advisory panel voted 23 to 4 to support the application later that year. FDA's scientific staff also strongly recommended approval.

Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, surprised many by rejecting the application last May. The FDA was supposed to decide on a revised application in January, but it has taken no action.

During his confirmation hearing, [Lester M. Crawford] appeared to say that the Plan B application would ultimately be approved, but [Patty Murray] said he was unclear on that question yesterday. She said the FDA voiced two remaining concerns -- that the easier availability would effect the behavior of young women and that a lawsuit filed by advocates of Plan B against the FDA in January had made the review more complicated.

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