FDA Recommends New Emergency Contraceptive

A history of birth control. Click on photo above to view gallery.

On Thursday the Advisory Committee for Reproductive Health Drugs voted to recommend the approval of a drug that can prevent pregnancy if taken up to five days after unprotected sex. The Food and Drug Administration will have the final say on whether the drug will be approved, but the advisory committee supported the drug, slated to be called ella, despite debates about how exactly it works. The New York Times reported that though ella, produced by French pharamaceutical company HRA Pharma, does prevent ovulation by inhibiting the hormone progesterone, its exact mechanisms for preventing pregnancy remain unknown. That element of mystery is what drove debates during the committee’s meeting about whether the drug is an "abortion drug." Unlike the morning-after pill Plan B, ella is effective up to five days (120 hours rather than 72 hours) after unprotected sex. Reuters reports that in addition to preventing the release of a woman’s egg, HRA Pharma and the FDA say that the drug also affects the lining of the uterus.

Ella, related to the "abortion pill" RU-486, worried some at the meeting like Wendy Wright, president of Concerned Women for America, who said that “With ulipristal [ella], women will be enticed to buy a poorly tested abortion drug, unaware of its medical risks, under the guise that it's a morning-after pill.” Others, like the director of the Office of Population Research at Princeton University, James Trussell, argued in support of the drug: “Every woman deserves a last chance to prevent pregnancy.” Despite concerns, HRA Pharma says that “the product does not interrupt an established pregnancy” but could theoretically affect a woman's pregnancy in other ways. In its briefing to the advisory committee, HRA Pharma cited the “prevalence of unintended pregnancy in the U.S.,” as support for the necessity of its drug.

Reuters reports that an HRA Pharma spokesperson says they expect the FDA to make a final decision by October.

Today the committee will decide whether to recommend a different drug produced by a German pharmaceutical company, Boehringer, that claims to increase the sex drive of women suffering from “hypoactive sexual desire disorder.” Like Thursday’s meeting about ella, Friday’s meeting promises plenty of controversy and debate. An FDA staff report recommended against approving Boehinger’s drug, The New York Times reported.