FDA adcomm votes unanimously in favor of benefit-risk profile of over-the-counter contraceptive Opill
An FDA adcomm voted unanimously that the benefits of making Opill, a progestin-only daily oral contraceptive, available over-the-counter outweighs the risks.
All 17 members of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted in favor, agreeing that there were enough data provided by drugmaker Perrigo to conclude that consumers will be likely to use it properly. The adcomm was also in favor of the pill’s eventual approval in order to improve access to women trying to prevent unwanted pregnancies, although that was not part of the vote.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
