Comment: Benefits exceed risks for over-counter birth control

The FDA should follow a panel’s recommedation to approve Opill for non-prescription sales.

By Lisa Jarvis / Bloomberg Opinion

On Wednesday, a panel of independent advisers to the Food and Drug Administration unanimously voted in favor of approving over-the-counter availability for a birth control pill called Opill. Regulators at the FDA will now have to decide whether to follow their advice. They should.

The barriers to access contraception have long been unacceptably high, particularly for the people most likely to experience unintended pregnancies: teens and young women, people of color, and people living in poverty. The stakes have only gotten higher following the Supreme Court’s reversal of Roe v. Wade. Millions of women now have limited or no access to abortion. Meanwhile, the rate of maternal mortality in the United States is also disturbingly high and expected to grow.

The recommendation from the FDA’s panel of advisers came after hearing two days of presentations from the agency and Perrigo, the manufacturer of Opill. Perrigo laid out data supporting the switch from prescription to over-the-counter use, the FDA presented several major concerns, and the panel members weighed the evidence in the context of their real-world experience. The big debate was over whether adolescents and women could safely and effectively take it without the guidance of a health-care provider.

Much of the debate centered on a few sticking points based on Perrigo’s study of how women in the real world might use an over-the-counter option: whether women could appropriately “de-select” from taking the pill (in other words, would choose not to buy it if they were part of the small group for which it isn’t safe); whether people, and in particular adolescents and anyone with low literacy skills, understand the instructions to take the pill at the same time each day; and whether consumers would follow those instructions close enough to avoid unwanted pregnancies.

The committee spent a lot of time analyzing whether consumers could decide whether the pill was right for them. In particular, questions from FDA regulators focused on breast cancer survivors, who shouldn’t take the pills because they could increase their risk of the disease recurring. What if they took the pills despite the clear warning on the box? The concern stemmed from one woman with a history of breast cancer enrolled in the study who incorrectly opted to buy the pills. (A second woman said she was interested but wanted to check with her doctor.)

But Perrigo pointed out that few women with a history of breast cancer would even be interested in the pills — most are past the age of needing birth control or already use other forms of contraception, like IUDs — and often have regular contact with a doctor.

The discussion also turned to whether teens were capable of correctly using the pills, although a large number of teens already use hormonal birth control, many with only minimal supervision.

Some of the most compelling testimony at the hearings came from young women themselves. Several spoke eloquently and persuasively about the barriers to consistent contraceptive supply; long waits for an appointment with a health-care provider, a lack of insurance or the lack of a car to get to a pharmacy.

Moreover, teens who can’t get prescription birth control pills often don’t turn to other forms of effective contraception but rather turn to low-efficacy methods; or nothing at all. According to the Guttmacher Institute, teens 15 to 19 have the highest rate of unintended pregnancies among sexually active women.

Perrigo’s clinical trial did show vast discrepancies in how often women were supposed to take the pill versus how often they did. The FDA scientists seemed concerned by this, weakening its confidence in the over-the-counter option. But, as the advisory panel repeatedly noted, context matters. People who are prescribed contraception by a physician also don’t use it perfectly.

Over-the-counter availability could make things better by increasing access. According to a 2022 survey by health policy research nonprofit KFF, 33 percent of hormonal contraceptive users between the ages of 18 and 49 missed doses — whether that was pills, a patch, a ring or a shot — because they couldn’t get their next supply. That’s why so many people — medical professionals, the majority of women of childbearing age, members of Congress — have called for prescription-free pills.

My hope is that the FDA regulators will consider Opill’s approval in the context of the real world. The agency does typically follow the advice of its advisers, but is not required to do so. (A recent controversial example of it acting counter to its panel’s advice was its approval of Biogen’s Alzheimer’s drug, Aduhelm.) And regulators’ sharp critique of aspects of Perrigo’s data, along with a request for the advisory panel to discuss what it would like to see in the design of a new study, are worrisome.

Even if the FDA allows Opill without a prescription, there’s one last barrier to access: affordability. The best scenario would be for the pill to be free, and certainly insurers should consider covering it even in an over-the-counter setting. A 2020 study by Ibis Reproductive Health found that more than 14.2 million women and teens would be open to using Opill if it were free. That population is still substantial — just under 8 million women and teens — if the pill was priced between $10 and $15 a month. The researchers estimated that level of access would translate into a 5 percent drop in unwanted pregnancies among adults in the United States.

For a growing number of women in the United States, the consequences of an unintended pregnancy are grave. An affordable, accessible, effective over-the-counter form of birth control is a necessary step toward bodily autonomy.

Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.

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