FDA Approves First Non-Prescription Birth Control Pill

Facts

• On Thursday, the Food and Drug Administration (FDA) approved the first-ever nonprescription, daily hormonal contraceptive pill in the US. Approval of the drug, Opill, comes six decades after birth control pills were introduced in the nation.¹
• Opill, sold by the company Perrigo (PRGO.N), was initially approved for prescription use in 1973. The over-the-counter version, which is available without a prescription, is expected to be in stores and online in early 2024.²
• In a news release, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Opill “is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”³
• This approval covers every one of reproductive age, including teenagers.⁴
• The company has said it would keep the drug affordable and offer financial assistance to people who qualify. Under the Affordable Care Act, insurance companies are required to cover birth control, but this doesn't apply to nonprescription drugs.¹
• In addition, another company, called Cadence OTC, is seeking FDA approval for its own over-the-counter daily oral contraceptive, with the company scheduled to start late-stage trials on the drug in 2024.⁵

Sources: ¹Washington Post, ²Reuters, ³U.S. Food and Drug Administration, ⁴NBC, and ⁵POLITICO.

Narratives

• Left narrative, as provided by Washington Post. This approval is probably 60 years overdue and should reduce barriers to access by allowing people to obtain birth control without needing to see a healthcare provider. In the wake of SCOTUS overturning Roe v. Wade, it’s important to do whatever it takes to reduce the number of unintended pregnancies. Now Perrigo must make good on its promise to make Opill affordable for whoever needs it.
• Right narrative, as provided by NCR. This over-the-counter approval is irresponsible and dangerous. Opill has documented and potentially life-threatening side effects, and any patient with access to the drug should, at the very least, be medically evaluated for contraindications to the drug. Vulnerable people, especially teenagers, could be seriously harmed by this approval.