The FDA’s Advisory Committee for Reproductive Health Drugs yesterday reviewed a new drug application for ulipristal acetate, an emergency contraception that prevents pregnancy after intercourse. This particular drug has been available in Europe under the brand name ellaOne since May of 2009 and is intended for use up to five days after unprotected sex or contraceptive failure.
Most other emergency contraceptions sold over the counter in the United States are officially approved for use up to three days (72 hours), although it is widely accepted that these others drugs (such as versions of Plan B) are also effective for up to five days. See our previous post on the topic for further discussion of this aspect, as well as some fairly recent studies and anti-choice objections to the product.
The FDA committee voted unanimously to recommend approval; the Agency itself will now need to decide whether the drug is approved. The National Women’s Health Network released a statement [PDF] urging the FDA not to reverse the committee’s recommendation (as the FDA did in the initial, controversial Plan B decision in 2004), and commenting on anti-choice opposition, which has centered on whether the drug could be used for abortion or otherwise affect pregnancies:
As longtime drug safety advocates, NWHN would like to point out that there are hundreds, even thousands, of drugs approved by the FDA and prescribed by clinicians whose effect on pregnancy is unknown. The critics who are raising questions about ulipristal’s possible effect on pregnancy don’t raise those questions about other drugs that come before the agency, and there’s a reason for that. Their underlying agenda is to prevent women from having access to another contraceptive option by raising questions about abortion that are intended to confuse the issue. In this, they are out of step with the American public – rather than making more safe and effective options for preventing unintended pregnancy available, as the majority of people in this country would like to do, they are trying to block a new option.
A transcript of the advisory committee meeting is not yet available; we’ll update with a link when it is posted. We’ll also have discussion of flibanserin, the drug being reviewed today “for the proposed indication of the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women,” next week.