FDA delays nonprescription morning-after pill rule

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U.S. regulators have delayed a decision on whether to approve over-the-counter sales of a “morning-after pill” to prevent pregnancy, drugmaker Barr Pharmaceuticals said on Friday.

The company said it was optimistic the Food and Drug Administration ultimately would grant its request to sell the product, called Plan B, without a prescription to women and girls age 16 and older.

The FDA said it would complete the review “in the near future,” according to a statement from Barr.

Plan B, sold now only by prescription, is an emergency contraceptive that may prevent pregnancy if taken within 72 hours after sexual intercourse.

The FDA is under political pressure from advocates and opponents of expanding access to Plan B. Women’s groups argue it would reduce abortions, while some conservatives say it would lead to more promiscuity and sexually transmitted diseases, especially among teenagers.

“At this stage, every delay is another denial to women,” said Amy Allina, policy director for the National Women’s Health Network.

The Planned Parenthood Federation of America, which is also pushing for approval of over-the-counter Plan B, said it was “considering legal remedies to this very serious situation.”

In May 2004, the FDA rejected an earlier proposal from Barr to sell Plan B over the counter without age restrictions, overruling an advisory panel that had voted 23-4 in favor of the application. Critics said they were worried young girls might not be able to take the pills safely.

The FDA faced a Friday deadline to rule on Barr’s new application but told the firm it was not done with its review, the company said.

FDA spokeswoman Kathleen Quinn said a decision on Barr’s application was pending.

“We’re glad that the FDA is taking a very hard look at this,” said Wendy Wright, senior policy director for the conservative women’s group Concerned Women for America, which opposes Barr’s request.

Plan B pills contain higher doses of the hormone progestin that is used in birth control pills. Women are supposed to take two pills 12 hours apart.

A study published this month in the Journal of the American Medical Association found emergency contraceptives did not influence the degree to which women have unprotected sex.

Plan B is different from RU-486, a pill that causes an abortion early in pregnancy. RU-486 also is known as Mifeprex or mifepristone. 

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