FDA rejects over-counter pill

By Marc Kaufman
The Washington Post

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The decision was an unusual repudiation of the lopsided recommendation of the agency's expert advisory panel, which voted 23-4 in favor of the switch and 27-0 that the drug could be sold safely as an over-the-counter medication.

The denial was a major goal of social conservatives, including members of Congress who lobbied President Bush on the issue. Reproductive-rights advocates lobbied equally hard for its approval, and they criticized the decision yesterday as misguided and a historic blot on the reputation of the FDA as a science-based agency.

In a letter to Barr Laboratories, the agency said the application was denied because only 29 of 585 women studied by the company were younger than 16 — a sample that was too small to assess safety.

The agency held out the possibility of a future approval if the company could prove the drug is safe for girls in their early teens or devise a plan that would keep Plan B on by-prescription-only status for girls younger than 16.

In Washington state women require a prescription, but state law allows pharmacists themselves to prescribe the pills. The FDA ruling will not affect that avenue, said Rod Shafer, head of the Washington State Pharmacy Association.

However, of 11,000 pharmacies statewide, only about 275, mostly in the Puget Sound region, have pharmacists authorized to dispense the pills, said Don Williams, executive director of the Washington State Board of Pharmacy.

"Overall we're in a better place than most states, but not everywhere," said Jane Hutchings of the Seattle nonprofit Program for Appropriate Technology in Health. Hutchings headed the project that made Washington the first state where pharmacists could sell the pills directly, starting in 1998. Alaska, California, Hawaii and New Mexico now have similar laws.

The FDA had no comment last night but will hold a press conference today to explain its decision. The "not approvable" letter was signed by Steven Galson, acting director of the FDA's Center for Drug Evaluation, not by members of the review team, as is usual. Former FDA officials said that generally means the review team had made a different recommendation.

Plan B consists of two high doses of a hormone used for birth control called levonorgestrel, which has been shown to prevent pregnancy if the user takes it within 72 hours of having sex. It is not considered by the medical profession to be an abortion pill, since it prevents a pregnancy from starting. Advocates say it would result in a decline in unwanted pregnancies and abortions.

Wendy Wright of Concerned Women of America, which actively opposed the Plan B switch, said yesterday that she was "pleased that the FDA has put women's health above politics. We had exposed numerous problems with easy access to the morning-after pill, from the potential physical harm to women to the possibility of being used to abuse women."
 
This week, the main organizations that represent doctors who specialize in treating women — including the American College of Obstetricians and Gynecologists — said all scientific questions about safety and proper use of Plan B had been resolved and only politics would prevent its approval.

In a pointed editorial published last month in the New England Journal of Medicine, the editor and two members of the FDA advisory panel that supported the application also wrote that the agency's actions indicate that its "decision-making process is being influenced by political considerations."

Amy Allina, project director for the National Women's Health Network, expressed the anger many in the women's health community said they felt. "It's quite outrageous and flies in the face of the scientific evidence. This has happened because of politics in this election year. They're pandering to the anti-choice extremists."

Seattle Times staff reporter Julia Sommerfeld and The Associated Press provided information on states that allow over-the-counter distribution.