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U.S. Rules Morning-After Pill Can't Be Sold Over the Counter
By GARDINER HARRIS
NY Times
Published: May 7, 2004

Federal drug regulators yesterday rejected a drug maker's application to sell a morning-after pill over the counter because of concerns about whether young girls would be able to use it safely.

The Food and Drug Administration told the pill's maker, Barr Pharmaceuticals, that before the drug could be sold without a prescription the company must either find a way to prevent young teenagers from getting it from store shelves or prove, in a new study, that young girls can understand how to use it without the help of a doctor.

Company executives expressed confidence that they could clear those hurdles, although it was unclear how long that would take. The decision was a surprise because in December, a panel of independent experts assembled by the Food and Drug Administration voted 23 to 4 to recommend that the drug be sold over the counter. The majority concluded that the drug was not only effective but that women could be trusted to use it correctly without a doctor. The Food and Drug Administration normally follows the recommendation of its advisory panels.

The drug, called Plan B, is presently available only by prescription. But Barr's application to sell the medicine without a prescription has been embroiled in a controversy that has now spilled into the presidential campaign. Advocates say that making the pill more broadly available will prevent unwanted pregnancies while opponents say it will encourage promiscuity and risky sex.

"By overruling a recommendation by an independent F.D.A. review board, the White House is putting its own political interests ahead of sound medical policies that have broad support," said Phil Singer, a spokesman for Senator John Kerry's presidential campaign. "This White House is more interested in appealing to its electoral base than it is in protecting women's health." Plan B consists of two high-dose birth control pills that either interfere with ovulation or prevent implantation of a fertilized egg. It can be taken up 72 hours after unprotected sexual intercourse and may prevent up to 89 percent of unplanned pregnancies.

James Trussell, director of the office of population research at Princeton University and a member of the advisory board, said that the agency never raised the issue of label comprehension among young teenagers when it approved other products to be sold over the counter. "The White House has now taken over the F.D.A.," Mr. Trussell said.

In some European countries, drugs are offered by prescription, over the counter and behind the counter. For the latter, patients must discuss the drug's purchase with a pharmacist but need not get a doctor's prescription. In the United States, there is no widespread "behind the counter" system of drug delivery. And it is not clear that federal drug regulators have the authority to construct or approve one.