FDA Advisory Panel Unanimously Endorses Five-Day Emergency Contraceptive

June 18, 2010 — On Thursday, FDA's Reproductive Health Drugs Advisory Committee voted unanimously to recommend that the agency approve the emergency contraceptive ulipristal acetate, or UPA, because evidence shows it is safe and effective for preventing most pregnancies for up to 120 hours after sex, NPR's "Morning Edition" reports. FDA usually follows the recommendations of its advisory panels, but it is not required to do so (Rovner, "Morning Edition," NPR, 6/18).

UPA is manufactured by Paris-based HRA Pharma and sold in 22 European countries as ellaOne. Pending FDA approval, UPA will be marketed in the U.S. under the brand name "ella" by Watson Pharmaceuticals (Rubin, USA Today, 6/18).

FDA's decision on whether to approve ella is expected by late July or early August, according to Charlie Mayr, a spokesperson for Watson.

If approved, ella would be available by prescription only. Mayr said he is unable to say how much ella would cost because ella has not yet received FDA approval (USA Today, 6/18).

According to the New York Times, studies have found ella to be more effective over a longer period of time than Plan B, an emergency contraceptive product currently available in the U.S. Because ella is a chemical relative to the medical abortion drug known as RU-486, antiabortion-rights groups took issue with claims that the drugmaker was seeking approval of the drug as a contraceptive (Harris, New York Times, 6/18). Several medical experts speaking at the hearing said that there is no scientific evidence that the recommended dose of ella acts as an abortifacient, as some antiabortion-rights groups contend ("Morning Edition," NPR, 6/18).

'Nightly News' Examines Hearing

On Thursday, NBC chief medical editor Nancy Snyderman discussed the next steps in the approval process on NBC's "Nightly News" (Holt, "Nightly News," NBC, 6/17).