FDA Releases Statement on Newer Birth Control Pills
The Agency’s release, in full:
FOR IMMEDIATE RELEASE
January 23, 2007
FDA Statement on Effectiveness of Newer Birth Control Pills
Recent wire service stories about today’s meeting of the FDA Reproductive Health Drugs Advisory Committee have created misperceptions about the effectiveness of newer generation hormonal contraceptives.
The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago. In fact, the newer generation products are highly effective in preventing pregnancy.
The stories also mistakenly state that FDA called the meeting to discuss the need for higher standards of efficacy for the newer products.
In fact, as published in the Federal Register Notice announcing this meeting, the purpose of this two-day meeting is to discuss clinical trial designs that reflect the diversity of users of hormonal contraceptives, expectations for efficacy and safety, and user acceptability of the newer generation products, including cycle control.