FDA Delays Ruling on Morning-After-Pill
WASHINGTON (Reuters) - U.S. regulators delayed a decision Friday on whether to approve over-the-counter sales of a Barr Pharmaceuticals "morning-after pill" to prevent pregnancy, prompting a lawsuit from a women's rights group.
Barr 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 its 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 Center for Reproductive Rights, a legal advocacy group, said it sued the FDA in U.S. District Court for the Eastern District of New York, charging the agency failed to follow proper procedures in its reviews of Plan B.
"The FDA is ignoring the medical and scientific facts. Emergency contraception meets all the criteria for over-the-counter availability for women of all ages," said Simon Heller, a lawyer for the group.
Proposal rejected in May
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.
A top FDA official, Dr. Steven Galson, said at the time he had overruled agency staff who favored the approval because of concerns that young girls might not be able to take the pills safely without a doctor's guidance.
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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