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Women's Health Chief Quits FDA Over Delays on 'Morning After' Pill

Susan F. Wood says scientific evidence supporting the sale of the contraceptive over the counter had been 'overruled.'

September 01, 2005|Ricardo Alonso-Zaldivar | Times Staff Writer

Crockett said she thought Plan B should remain available only by prescription. That way, she said, women who use it could receive counseling from their doctors and be tested for sexually transmitted diseases.

"I have more of a concern about the public health aspects," she said. "As a gynecologist, I see good reasons for it to stay as a prescription drug so I get to see my patients, and they get to see me, and they are well taken care of."

Plan B, made by Barr Laboratories, won FDA approval as a prescription drug in 1999. Its path to over-the-counter designation has been convoluted.

Last year, the FDA overruled an advisory panel recommendation and decided to keep Plan B as a prescription drug. But the agency invited Barr to reapply after submitting additional data, and the company asked that the drug be made available to women 16 and older. Younger girls would need a prescription.

The FDA's Center for Drug Evaluation and Research has determined that the product can be safely sold without a prescription to women 17 and older. An FDA fact sheet said Plan B worked "like other birth-control pills to prevent pregnancy."

The medication consists of two high-dose contraceptive pills. The first must be taken within 72 hours of unprotected sex, and the second 12 hours after the first. No deaths have been reported among women using Plan B.

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