FDA panel recommends approval of 5-day ‘morning after’ pill
Reported June 21, 2010
A Food and Drug Administration advisory panel Thursday recommended that the agency approve a “morning after” pill that is effective for five days after unprotected sex, providing an alternative to existing drugs that can be used only for three days. The agency is not required to follow the advice of its advisory panels, but usually does.
The new drug, whose proposed brand name is ella, is already marketed in Europe as ellaOne. It blocks the effect of progesterone, a female hormone that spurs ovulation. There has been spirited debate about whether the drug simply blocks ovulation or, because it is related to the abortion drug RU-486, whether it actually produces an abortion. The Washington Post and the New York Times have outlined the parameters of the debate.
The agency has set no timetable for a decision. The drug will most likely be available only by prescription, at least initially.
