Opill, a birth control pill that has been around for 50 years, will soon be available for sale over the counter. | Bettmann Archive
The FDA has signed off on selling a birth control pill over the counter without a prescription.
The United States reached a major milestone in reproductive health care on Thursday: The FDA approved a birth control pill for over-the-counter sale without a prescription.
The medication, known as Opill, is already available with a prescription and has been approved for contraceptive use for half a century. It is more than 90 percent effective at preventing pregnancies, making it more effective than other over-the-counter options like condoms or spermicides. It uses only one hormone, progestin, which needs a few days to take effect; other birth control pills usually include estrogen as well and can be effective immediately if started at the appropriate time in the menstrual cycle.
The OTC version of Opill is expected to reach the market in early 2024. When it finally arrives on shelves, the US will join more than 100 other countries that already allow for certain contraceptives to be sold over the counter. Advocacy groups and some politicians have been calling for years for OTC birth control to be approved. That approval is finally happening after the Supreme Court’s Dobbs decision and amid the fiercest public debate over reproductive rights in a generation.
OTC birth control has, however, been a rare area of bipartisan agreement in recent years, receiving support from both progressive Rep. Alexandria Ocasio-Cortez and conservative Sen. Ted Cruz. Some GOP state legislatures have sought to make it easier for people to get birth control without a prescription.
So the chief obstacle to Opill’s success is not likely to be political, though some anti-abortion groups are opposed to this approval. Rather, as with so many novel offerings in US health care, the challenge will be cost.
So, how easy will it be to afford over-the-counter Opill?
The Affordable Care Act requires health insurers to cover at least one prescription contraceptive as part of their benefits, but not any over-the-counter medication. So, barring any policy change, people’s ability to access Opill over the counter will depend on the price its manufacturer, Perrigo Company, sets.
The company has said it would make the pill affordable and accessible and provide assistance to some women who may struggle to pay the list price. But research tells us that even a small cost burden, as little as $10, can discourage people from using a medicine that they need.
Right now, the main hurdle to somebody getting a contraceptive is getting a doctor to prescribe it. The most important “cost” is the time it takes to find and see a physician.
In a world with OTC Opill, Americans will no longer need to find a doctor to act as the conduit between them and birth control. And four in 10 women of reproductive age say they would take OTC birth control. But many of them will have to cover the cost of the drug. One exception could be people on Medicaid in the 10 states that already cover over-the-counter contraceptives without a prescription. (Other states still require a doctor’s prescription for OTC products, and, in at least six states, OTC birth control of any kind has not been covered historically.)
Efforts are already underway to try to ease the cost burden of Opill. Biden has ordered his administration to consider various strategies for covering the cost of the drug. He asked the federal Health, Labor, and Treasury Departments to consult with employers, pharmacists, and insurers about how they could provide that coverage. He also asked the relevant agencies to draft guidance for best practices for providing “seamless coverage” of OTC birth control. Those discussions could draw on the examples of states like Delaware, which already cover OTC contraceptives through their Medicaid program.
A federal requirement, passed through Congress, would be the most airtight way to guarantee insurance coverage for OTC birth control and eliminate the risk that some people could not afford it and end up pregnant as a result. (About half of all US pregnancies are not planned.) Sen. Patty Murray has reintroduced a bill that would create such a mandate but it remains to be seen whether that gains traction. Republicans may be okay with making over-the-counter birth control available to people who wish to purchase it, but they are generally skeptical of federal regulations of any kind for health insurance.
And so, the notable breakthrough of Opill becoming available over the counter must be tempered by the same concerns about access that have met the weight-loss drugs like Ozempic and the new Alzheimer’s drug Leqembi. Those drugs were more of a clinical breakthrough than Opill, which has been around for 50 years, but the problem of cost remains the same.
Even as the US health system continues to bring important products to market, Americans may struggle to take full advantage of them because of the byzantine US system for providing health insurance and the costs it imposes on patients.