An advisory committee of the US Food and Drug Administration (FDA) has unanimously approved making an oral contraceptive available without a prescription. If the FDA follows this advice, the drug, sold under the name Opill, will be the first non-prescription birth control pill in the United States. A final decision from the agency is expected in the coming months.
Because the FDA often follows its advisors’ recommendations, the two-day meeting, which ended May 10, was eagerly awaited. Associations such as the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association have been insist on the desk to make oral contraceptives available over the counter.
“The scientific evidence is clear that over-the-counter access to birth control without age restrictions can be achieved safely, and the benefit of improved access is significant,” said Kristyn Brandi, a gynecologist who represented ACOG at the meeting. She pointed out that many people seeking medications to prevent unwanted pregnancies face obstacles, including cost barriers and difficulties getting a doctor’s appointment. “People from marginalized communities, including racial and ethnic minorities, the uninsured and those who don’t speak English, are more likely to face these barriers,” she said.
The decision is especially important in light of recent restrictions on access to abortion in the United States, says Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH), a research program at the University of California, San Francisco. “People in about a third of the country don’t have access to abortion care,” he says. “Now it is even more important that the remaining barriers to effective contraception are removed.”
Oral contraceptives are available without a prescription in many other countries, although access to some requires a conversation with a pharmacist. In 2021, two brands of contraceptive pills became available in the UK without a prescription, with only this requirement.
No prescription needed
There are two types of hormone-based birth control: one contains progestin, a synthetic form of the hormone progesterone, and the other uses a combination of progestin and the hormone estrogen.
Opill, known by its generic name norgestrel, is a progestin-only medication. This type of drug has fewer risks compared to the combination pills, which have been associated with blood clots, for example. Norgestrel was first approved by the FDA in 1973. In June 2022, the maker of Opill, HRA Pharma, based in Paris, filed to switch the medication from requiring a prescription from a healthcare provider to not needing it have a prescription.
To be available over the counter in the United States, a drug must meet certain criteria. It is to be used for a condition that the recipient can self-diagnose – in this case, the desire to avoid an unwanted pregnancy. The user must also be able to administer the drug safely and effectively without the help of a healthcare provider. With Opill, that means taking one pill at the same time every day. The final criterion is that the drug must have a low potential for misuse and abuse.
In applying for the switch to over-the-counter status, HRA Pharma submitted data to the FDA from studies examining whether consumers understand how to use Opill unsupervised and whether they can correctly identify whether they have contraindications. These are medical conditions, such as a history of breast cancer, that would prevent them from taking the drug.
Concerns expressed
At the advisory meeting, FDA scientists criticized the data presented by HRA Pharma, particularly the results of the study evaluating how the drug could be used in a real world. About a third of the study participants reported taking more pills than were made available to them, leading the scientists to question the study’s conclusions. Also, the scientists were not entirely convinced that users were able to recognize that they had contraindications for the pill.
The agency’s scientists even questioned the drug’s efficacy and safety. They noted that the clinical trials leading to its approval in 1973 might have produced different results had they been conducted today, citing an increased incidence of obesity that could potentially reduce the effectiveness of the medication.
It’s unusual to bring up this issue, says Grossman. “In this kind of application to move a drug to over-the-counter status, all you have to look at is whether people are using it properly, following instructions, and whether they can appropriately choose to use or not,” he says.
The scientists’ intense research comes at a time when there is a lawsuit challenging the agency’s approval decades ago of the abortion pill mifepristone – as well as his authority. It’s unclear if these concerns will affect the FDA’s final decision on Opill.
During the portion of the meeting that allowed members of the public to participate, some brushed off concerns. “Women can understand labels, including contraindications,” says Caroline Renko, a manager at PharmedOut, a project at Georgetown University in Washington DC that educates physicians about how drug companies influence prescribing. “Birth control pills are so commonly used that information about the importance of not missing doses or taking doses too late is well known,” she said. “These patronizing concerns are no reason to take a woman’s choice away from her.”
During the advisory committee’s discussion, panelists acknowledged some of the limitations of the HRA Pharma data, but ultimately concluded that there is ample evidence that the benefits of having an over-the-counter birth control pill outweigh the risks.
Do I think we have perfect data? No,” said committee member Cynthia Baur, a health literacy and health communication specialist at the University of Maryland at College Park. “Whether I thought it was a perfect study? No. Do I think it was enough to be reassured that a large number of people can take this drug as intended? Yes.”
This article is reproduced with permission and was first print on May 11, 2023.