The Food and Drug Administration announced on Thursday morning its approval of the progestin-only oral contraceptive Opill for over-the-counter use.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, the director of the FDA's Center for Drug Evaluation and Research.
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Expanding access to contraceptives has been a key objective of Democrats in the lead-up to the 2024 election cycle and in the wake of the Dobbs v. Jackson Women's Health Organization decision in June 2022 that overturned federal constitutional protections for abortion.
President Joe Biden issued an executive order on the eve of the Dobbs decision instructing various federal agencies to consider guidance and new regulations to expand access to birth control and coverage options for contraception. Twenty states, most recently Arizona, have also taken steps since 2016 to decrease barriers to hormonal contraceptives by allowing pharmacists to provide the medication directly to consumers without a clinician's prescription.
Today, FDA approved a tablet for nonprescription use to prevent pregnancy — the first daily oral contraceptive approved for use in the U.S. without a prescription. https://t.co/9NTtf2OH2Y pic.twitter.com/iCr75fQvUP
— U.S. FDA (@US_FDA) July 13, 2023
Thursday's decision comes after an advisory panel in May unanimously supported the proposal to grant over-the-counter approval to the contraceptive from Irish-based company Perrigo, in part due to the political pressure to increase access to contraception.
Women's health advocates have pushed for expanded access to hormonal contraceptives, which are on average 93% effective in preventing pregnancy, even when accounting for human error in medication management.
Advocates also noted that 6.1 million pregnancies, approximately 45% of pregnancies in the United States, are unintended, and these disproportionately have negative consequences for teenage girls, women of color, and women with lower incomes.
"Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider," according to the FDA's press release on the approval.
Michael Cannon, director of health policy studies at the libertarian Cato Institute, said the approval is "60 years overdue."
"It is a positive and welcome step," Cannon said. "Yet it highlights the harmful effect the FDA has had for decades on women’s rights and women’s health by imposing this unnecessary obstacle. And this action restores to women their right to make only one of countless medical decisions that the FDA continues to deprive them of their fundamental human right to make themselves."
The FDA granted approval to the generic chemical compound norgestrel for prescription use in 1973. For any drug to be switched from prescription to be sold over the counter, the manufacturer is required to submit documentation proving that patients can follow the safety label instructions independently of clinician guidance.
"When properly used, Opill is safe and effective," the FDA said, outlining that the manufacturer has provided sufficient evidence that patients are safely able to self-administer the drug.
Anti-abortion advocacy groups, such as Susan B. Anthony Pro-Life America, have previously said that their focus is on preventing abortions and therefore have no comment on contraceptive access.
Planned Parenthood called the decision a "historic victory" for decreasing barriers to access for hormonal contraception.
"Now we need to make sure [over-the-counter] birth control pills are on store shelves, affordable, and fully covered by insurance so that they’re accessible for all who want them," the organization tweeted.
Now, we need to make sure OTC birth control pills are on store shelves, affordable, and fully covered by insurance so that they’re accessible for all who want them. pic.twitter.com/4nsgeFTvgL
— Planned Parenthood (@PPFA) July 13, 2023
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Over-the-counter medications are not typically covered by insurance, but in most circumstances, patients can use health savings accounts or flexible savings accounts to purchase nonprescription medications.
"The timeline for availability and price of this nonprescription product is determined by the manufacturer," the FDA said. Opill is expected to be in supermarkets, pharmacies, and online in 2024.