FDA weighs first over-the-counter birth control pill

FDA to Consider Making Birth Control Pill Available without Prescription

The US Food and Drug Administration (FDA) may grant the first-ever request to make a birth control pill available without prescription. Drugmaker Perrigo has submitted an application to sell its product, Opill, over-the-counter. The request’s review is to take place at a two-day public meeting where FDA advisers will raise concerns about the reliability of the company’s data and query whether women with particular medical conditions would be precluded from taking it. Additionally, regulators will examine whether younger teenagers would be able to comprehend the drug’s instructions. Perrigo’s application does not relate to the ongoing lawsuits surrounding the abortion drug mifepristone.

Opill could offer a vital alternative for the 15 million US women who do not use contraceptives, according to Perrigo executives. Opill was approved in the US 30 years ago, and if approved for over-the-counter sales, would be the first such contraceptive pill to move from behind the pharmacy counter to store shelves or online. The FDA is likely to reach a final decision later this summer. Progestin-only contraceptive pills come with reduced risks (related to clots), but also have a lower efficacy than the combined hormone versions, when not taken at the same time each day.

Despite the many advantages of over-the-counter medication, non-prescription drugs are not generally covered by insurers. Forcing insurers to cover over-the-counter birth control would necessitate regulatory change from the Department of Health and Human Services. Several large US medical groups, including the American Medical Association, back the availability of over-the-counter medications. However, Catholic groups, including the United States Conference of Catholic Bishops, oppose Opill’s application, stating that women should be seen by a doctor before receiving it.

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