U.S. rules morning-after pill can’t be sold over the counter
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.”
Wendy Wright, senior policy director at Concerned Women for America, a conservative women’s organization, said that the agency had ignored political pressure and made its decision based on science.
“The F.D.A. is right to be cautious about having a potent drug that can be harmful to women sitting next to candy bars and toothpaste,” Ms. Wright said. Broad availability of Plan B would allow people to slip the medicine to women without their knowledge, Ms. Wright said.
A spokesman for the Food and Drug Administration declined last night to comment.
The company said that the decision will delay the product’s introduction onto store shelves but not for long, said Bruce Downey, Barr’s chief and chairman.
“It’s the kind of objection that can be addressed in weeks or months, not years,” Mr. Downey said. “We are committed to taking one or both of these approaches.”
Still, others pointed out that clinical trials usually take at least a year to undertake, analyze and submit to the agency. And constructing a system to prevent young girls from having access to an over-the-counter medication could be difficult.
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.
When deciding whether to allow a product to be sold over the counter, federal regulators ask three crucial questions: Can patients diagnose the problem themselves; can they be trusted to treat the problem effectively; and can they understand the drug’s label — all without a physician’s intervention.
In a letter faxed yesterday evening to Barr Pharmaceuticals, the agency said that Plan B’s application failed to mount the final hurdle. It noted that just 29 of the 585 women and girls in the company’s label-comprehension study were 16 years of age or younger.
“Based on the review of the data, we have concluded that you have not provided adequate data to support a conclusion that Plan B can be used safely by young adolescent women,” the letter states.
The agency wrote that Barr had two choices to get its application approved. Either it can undertake a new study among girls 16 years old and younger to show that they can use the drug safely without the help of a doctor. Or the company must write a new label and construct a system that would allow women older than 16 to buy the drug over the counter while those younger than 17 would be forced to get a prescription.
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.
“We will have to assure ourselves that your proposed approach is consistent with our statutory authority,” the agency’s letter to Barr states.
Mr. Downey noted that cigarettes are freely sold to adults but that it is illegal to sell them to minors. “There is more than one way to solve that logistical problem,” he said. Autor: Gardiner Harris