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FDA reverses course on morning-after pill

Proposal would allow Plan B sale to women over 18 without prescription

HEALTH LIBRARY

• Women's Health

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WASHINGTON (CNN) -- The Food and Drug Administration said Monday that it will consider allowing over-the-counter sales of a morning-after emergency contraceptive to women 18 and older, re-starting a stalled decision-making process.

The pill, called Plan B, is made by Duramed, a subsidiary of Barr Pharmaceuticals, and is already available by prescription. But for three years the company has been trying to get permission to sell the drug over the counter.

Plan B works by stopping ovulation, or, if the egg has been fertilized, by decreasing the chance it will attach to the uterus. It contains a high dose of the ingredient in birth control pills and when used within 72 hours of unprotected sex it can lower the risk of pregnancy by almost 90 percent.

Critics charge that the drug's action amounts to an abortion. The American Life League in a statement called Plan B "a deadly cocktail of drugs" and said, "The FDA should not have authorized any use of this risky drug regimen in the first place and it certainly should not make it readily available over the counter."

But advocates say that if a woman is already pregnant the pills have no effect. Proponents of the pill say women often had trouble getting a prescription filled within 72 hours, so over-the-counter sales would make the drug more accessible and could theoretically prevent more pregnancies.

The government had agreed that Plan B was safe to be sold over the counter to adults over 18 but had delayed a final decision out of concerns that younger teens would have access to the medicine.

The FDA wants the pill to be sold behind the counter much as cigarettes are now. That way a pharmacist could check the age of a woman before they were sold.

The move comesa day before the FDA's acting commissioner, Dr. Andrew von Eschenbach, is scheduled to appear at his Senate confirmation hearing where he was expected to face tough questions on the status of Plan B.

Sens. Patty Murray, D-Washington, and Hillary Rodham Clinton, D-New York, said they plan to hold up von Eschenbach's nomination until a decision is made.

"Today's announcement is nothing more than another delay tactic," the two said in a statement. "The FDA continues to shirk its duty to serve as an independent agency dedicated to no other goal than the promotion of sound science and the well-being of the American people. ... Rather than moving this process forward and doing right by the American people, the administration is continuing to play a game of smoke and mirrors the day before Dr. von Eschenbach's Senate confirmation hearing."

FDA spokeswoman Susan Bro said von Eschenbach did not want to spend a lot of time on the issue during the hearing, preferring instead to outline his plans for the agency if confirmed. "He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA."

The FDA received about 47,000 comments from the public on the change in status, the majority supporting selling the drug both as a prescription and over the counter.

Bro says it's hard to tell how soon the pill will be available over the counter. She said the next step is for the FDA and Duramed to meet to resolve all outstanding issues, such as restricted distribution and a risk management plan.

Barr spokeswoman Carol Cox said they're pleased with the outcome and looking forward to that meeting.

"We believe that the FDA letter and their request for a meeting with Barr is a positive development," she said.