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FDA Delays Decision on 'Morning After' Pill

Agency Opens 60-Day Public Comment Period to Discuss Over-the-Counter Sale of Plan B
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Aug. 26, 2005 - The FDA has put off deciding whether to allow over-the-counter sales of the Plan B "morning after" pill.

The problem isn't safety, says FDA Commissioner Lester Crawford, DVM, PhD. The agency is convinced the emergency contraceptive is safe for all women.

The problem, Crawford says, is that the FDA isn't convinced that women under the age of 17 can understand the product's instructions for use. That's why last year it rejected the full over-the-counter status requested by manufacturer Barr Pharmaceuticals.

Following that May 2004 refusal, Barr asked the FDA to approve Plan B for over-the-counter sale to women 16 and older. But the long-awaited decision on that request -- expected by the end of this month -- is once again on hold.

The main problem, Crawford said in a news conference, is how the FDA can enforce a rule restricting over-the-counter sale of Plan B to women 17 and older (the agency decided to up the age limit requested by Barr).

"There are unique regulatory issues that need to be addressed," Crawford said in a news conference. "We can only decide these issues in an open process. That will let us decide whether FDA can approve a drug for both over-the-counter and prescription use, for the same indication, sold in the same package."

Open for Public Comment

The FDA is opening a 60-day public comment period -- shorter than its usual 90- and 120-day comment periods. But Crawford would not commit to a timetable for making a decision after that period is over.

"I make the commitment we will ... ensure this process is expeditious and thorough," Crawford said. "Expediting this process will be a personal priority of mine."

In a statement, Barr expressed regret at the FDA's lack of action.

"We are disappointed that the FDA did not approve our application," Barr CEO Bruce L. Downey says in a news release. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an over-the-counter/prescription product."

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