When's the last time they were more concerned about ANYTHING than politics?
U.S. Rules Morning-After Pill Can't Be Sold Over the Counter
By GARDINER HARRIS
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."
