FDA Advisers Back Approval Of First OTC Birth Control Pill In US
Two advisory panels voted unanimously in support of the FDA allowing Opill, a progestin birth control pill produced by HRA Pharma, to be sold in the U.S. without a prescription. An FDA decision, which is not required to follow the advisers' recommendations, is expected this summer.
The 19th:
Over-The-Counter Birth Control Moves One Step Closer To FDA Approval
An influential advisory panel recommended that the Food and Drug Administration (FDA) approve an oral contraceptive pill for over-the-counter use without an age restriction. While hormonal birth control is available without a prescription in many other countries, this medication, Opill, would be the first such option in the United States. (Luthra, 5/10)
NBC News:
FDA Panels Back Making Opill Birth Control Pill Available OTC
The 17-0 vote by two advisory panels came despite serious reservations from agency officials about the quality of the data used to support switching the birth control pill, called Opill, from prescription to over the counter. The agency did not have concerns about the safety and effectiveness of the drug. The FDA is not required to follow the recommendation of the committees, though the vote is expected to weigh heavily on its final decision, expected in late summer. (Lovelace Jr., 5/10)
In other reproductive health news —
NPR:
A Plastic Sheet With A Pouch Could Be A 'Game Changer' For Maternal Mortality
It's a startling statistic. Every year, 70,000 women around the world basically bleed to death after childbirth. That averages out to nearly 200 deaths a day and makes postpartum hemorrhage a leading cause of maternal deaths. Now a new study points to a surprisingly simple and inexpensive solution: Basically, if the woman lies on a plastic sheet with a small transparent pouch at the other end to collect the blood, the medical team has an immediate sense of how much danger she's in and can take swift action. The cost of the sheet-with-a-pouch: Between $1-2. (Chatterjee, 5/10)
