FDA to vote on whether to make birth control pills available over the counter ... trends now
Federal regulators will convene this spring to decide whether to make a birth control pill available to women without a prescription.
Opill, manufactured by French drugmaker HRA Pharma, could become the first progestin-only over-the-counter birth control pill ever approved in the US.
The Food and Drug Administration will meet in May to discuss the company’s application to make Opill, a daily birth control pill that can cost up to $50 per pack without insurance, an over-the-counter medication available without a prescription.
The firm initially submitted the request last summer in the weeks following the Supreme Court’s decision to revoke the federal guarantee to legal and safe abortion. The FDA review process can take about a year.
The agency's move to deliberate on OTC birth control comes about nine months after Justice Clarence Thomas, in his opinion supporting the Supreme Court's decision to nix the federal guarantee to abortion, hinted that legal access to contraception should be reexamined.
Opill and other oral contraceptives like it have been used safely by millions of women for about 60 years, but the US is an outlier when it comes to making the pills available without a prescription
Roughly three dozen organizations of health experts such as the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been calling for a non-prescription birth control pill option for years.
Opill and other oral contraceptives like it have been used safely by millions of women for over 60 years, but the US is an outlier when it comes to making the pills available without a doctor’s order.
With recent upheavals in the US legal system over abortion procedures and pills in the US, pressure is mounting on health officials to safeguard the already tenuous access many women have to contraception.
Two FDA advisory committees — the Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee — will come together on May 9 and 10 to consider HRA Pharma’s Rx-to-OTC switch application for Opill.
Sometimes referred to as the ‘mini pill,’ Opill contains progestin only, unlike many oral contraceptives that contain both progestin and estrogen.
This is the appeal of the mini-pill. Because it does not contain estrogen, which increases the risk of blood clotting by several-fold, the progestin-only pills is seen as lower-risk.
Its modus operandi is to thicken mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.
Progestin-only pills do not prevent ovulation as well as combination birth control pills. Therefore, its effectiveness is slightly
