Making birth control pills over-the-counter 

On November 18, 2022, the FDA advisers will meet to review the application for making available the hormonal contraceptive “Opill” over-the-counter (OTC).

Opill is a progestin-only oral contraceptive, with the active ingredient norgestrel. It has been available with a prescription in the U.S. since 1973.

A partner at the law firm Goodwin who specializes in the FDA’s regulation of drugs and biologics said that two advisory committees will consider switching the drug from prescription to over-the-counter and weigh how the drug itself is used.

If the application to make Opill OTC is approved, all women in the United States will be able to purchase Opill without health provider oversight. This includes teenagers, who will be able to purchase this drug without parental knowledge.

According to the American College of Obstetricians and Gynecologists ACOG, “the potential toxicity of the medication and whether the medication can benefit consumers without endangering their safety” is the principal factor the FDA considers to make OTC a medication. Progestin-only contraceptives are often advertised as being “safer” than contraceptives that contain estrogen, but they are associated with many health risks. Total synthetic progestins have been associated with an increased risk of breast cancer, increased risk of clinical depression, and increased risk of ectopic pregnancy

The Food and Drug Administration is receiving comments on the proposal before November 3.  Follow this link to make your voice heard:

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