FDA approves first over-the-counter birth control pill

Perrigo’s president and CEO Patrick Lockwood-Taylor called the decision “a truly momentous day for women’s health nationwide” and said the drug “has the potential to radically transform women’s access to contraception.”

Progressive reproductive rights advocates and some medical groups praised the Thursday announcement, saying it will meaningfully expand contraception access for the uninsured, teenagers and other groups who face barriers to obtaining a prescription.

Several groups stressed, however, that while they’re confident the pill’s sale will help lower the number of unwanted pregnancies, they don’t see it as a replacement for broad abortion access. According to the FDA, there are about 3 million unintended pregnancies in the U.S. annually. These pregnancies come with higher risks of negative health outcomes, including preterm birth.

“We know that increasing access to birth control is not a solution to the ongoing attacks on abortion access and sexual and reproductive health,” said Alexis McGill Johnson, president and CEO of Planned Parenthood. “But it is a critical part of protecting our reproductive freedom, especially as states across the country continue to double down on their unpopular abortion bans and restrictions.”

In a call with reporters, Perrigo declined to share a retail price for Opill. “We will communicate manufacturers’ suggested retail pricing in the coming months ahead of in-store availability,” said Frédérique Welgryn, Perrigo’s Global Vice President for women’s health. She added that the company was working on a patient assistance program for those who may not be able to afford it.

Welgryn said that Opill will be available in stores and online in early 2024. CVS, one of the nation’s largest pharmacy chains, has already pledged to carry the drug in its 10,000 locations. Other retailers have not yet revealed whether they will stock the drug.

It’s not clear whether health insurance plans will cover Opill. Most insurance coverage doesn’t cover over-the-counter products. But the Affordable Care Act requires coverage of certain over-the-counter products, including emergency contraception — the catch is that it still would require a prescription, said Greer Donley, an associate professor at the University of Pittsburgh law school. And that may put the same burden on patients that previously existed. “The whole point of over-the-counter products is that you don’t have to get a prescription,” he added.

“We know that access is … influenced by price and insurance coverage,” said Welgryn. She said the company is working to get Opill included in Medicaid coverage and by private insurers — with a prescription, but was not able to say whether that would be completed by the time the drug reaches store shelves next year.

“This is probably a really good moment for the Biden administration to re-evaluate the contraceptive mandate,” said Donley, noting that removing the prescription requirement for Opill would be key to ensuring that as many people access it as possible.

Some anti-abortion and religious groups, including the Catholic Medical Association and the National Association of Catholic Nurses, vehemently opposed FDA approval of Opill and previously requested the FDA block over-the-counter approval of the pill. The groups say the drugs’ availability will lead to an increase in unprotected sex and “carry potentially life-threatening side effects.” The FDA on Thursday said the pill’s most common side effects include “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.”

Opill is a progestin-only birth control pill from Perrigo. It works by thickening cervical mucus and disrupting ovarian activity. Several progestin-only birth control pills are currently available with a prescription in the United States, and hormonal birth control pills have long been available over the counter in dozens of other countries. According to the CDC, they are about 93 percent effective at preventing pregnancy.

Two independent panels for the the FDA comprised of 17 experts voted unanimously in May to recommend the agency approve Opill without a prescription. HRA Pharma, which has since been acquired by Perrigo, submitted data from its study of more than 880 participants showing that the vast majority correctly took the pill at the same time every day — which is crucial to its effectiveness — or used an alternative form of birth control if they didn’t.

At that meeting in May, however, FDA scientists expressed concern that the study’s findings on the pills’ effectiveness were based on 50-year-old data that didn’t reflect the current demographics of those able to become pregnant in the U.S. today. The staffers also flagged that the company’s data indicated that users may have taken more pills than they were supposed to in a given month. Company representatives said this was more likely a result of study design issues, rather than participants actually taking more pills.

Jack Resneck, the immediate past president of the American Medical Association, told POLITICO in an interview earlier this year why the group endorsed the drug’s approval for sale without an age restriction.

“First of all, these are medications that we know are safe and effective from decades of use and millions of women in countries around the world,” he said. “Secondly, I think there’s a particularly acute need for this right now in the post-Dobbs era, as the consequences of unintended pregnancies are even more substantial than they had been before.”

Several health advocacy groups, including the National Latina Institute for Reproductive Justice and Ibis Reproductive Health, said Thursday that they will continue pressuring insurance companies and state Medicaid programs to cover the over-the-counter pills and will push the manufacturers to set an affordable price.

Another company, Cadence OTC, is working with the FDA toward approval for a different kind of daily oral contraceptive — a combined estrogen-and-progestin pill — for eventual over-the-counter sale. The company expects to begin late-stage trials on the pill next year.


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