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Morning after pill will have to wait
FDA commissioner delays decision whether to allow over-the-counter sales of pregnancy pill Plan B.
August 26, 2005: 5:13 PM EDT
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ATLANTA (CNN) - The Food and Drug Administration delayed for 60 days a decision on whether to allow nonprescription sales of the emergency contraceptive pill known as Plan B, FDA Commissioner Lester Crawford said Friday.

"There are unique regulatory issues that need to be addressed, and we have decided we can only make these decisions in an open public process," he told reporters.

Crawford said public comments will be sought in the next 60 days, and didn't know how long after that a decision would be announced.

The FDA is trying to determine whether age should be the main criterion in determining who can buy the drug, and how an age limit would be enforced, Crawford said.

The Center for Drug Evaluation and Research has recommended that the drug be available over the counter to women 17 and older, although drug-maker Barr Pharmaceuticals has asked to have that age reduced to 16. Anyone younger would need a prescription.

The FDA also is considering whether any drug used for the same purpose and with identical labeling should be made available by prescription and over the counter, what is termed dual-label status.

There have been instances in which similar drugs were marketed in both ways, Crawford said, but in those cases "there were meaningful differences in how the products were used."

"We need to resolve these policy and regulatory questions before we can reach a final decision on the underlying science that was presented to us."

Plan B will still be available as a prescription drug during the decision-making process.

Two of the Plan B pills, which contain the hormone levonorgestrel, can be taken within three days (72 hours) of unprotected sex to reduce the risk of pregnancy by as much as 89 percent, according to the Plan B Web site. The sooner the pills are taken, the more effective they will be, it says.

Plan B does not protect against HIV infection, the virus that causes AIDS, or any other sexually transmitted disease.

Plan B is different from other birth control pills because it contains a larger dose of hormones. And, unlike many birth control pills, Plan B contains no estrogen.

"We are disappointed that the FDA did not approve our application," said Bruce Downey, Barr's chairman and CEO, in a written statement. "In our submission to the FDA, we provided a detailed legal analysis supporting approval of a dual-label product and continue to believe that a dual-label status can and should be approved.

"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 OTC/Rx Product."

Shares of Barr Pharmaceutical (Research) fell 2.35 percent to close at $45.22 in Friday trade on the New York Stock Exchange.


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