FDA’s Role in Access to Reproductive Health Care

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Recent abortion pill litigation underscores the significance of calls to make birth control pills available over the counter.

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The Food and Drug Administration (FDA) plays a key role in access to reproductive health care in the United States. Recently, FDA decisions about abortion pills have been thrust into the spotlight. Over twenty years ago, FDA approved use of a mifepristone pill for abortions. That approval came with restrictions on its distribution, which FDA amended over time. More recently, FDA approved a generic version of the pill. Each of these decisions has a major impact on whether and how abortion pills can be obtained.

Recently, two district court cases infused uncertainty into access to abortion pills. FDA’s response to the mifepristone litigation—regardless of how it is ultimately resolved—will be crucial for reproductive health care and freedom going forward.

But FDA decisions about abortion pills are not the only FDA decisions that affect access to reproductive health care. Beyond abortion pills, another type of pill plays a critical role in reproductive freedom: birth control pills.

Just like with abortion pills, FDA makes significant decisions about access to birth control pills. It decides whether to approve birth control pills and whether to place limits on their distribution. Currently, FDA is considering an application from a drug manufacturer that would greatly expand access to birth control if approved.

That application proposes to make birth control pills available over the counter. In July 2022, HRA Pharma requested that FDA allow Opill, a daily birth control pill, to be sold over-the-counter without a prescription. If approved, Opill will become the first daily birth control pill that is available in the United States over the counter. Currently, the only birth control pills that are available over the counter in the United States are emergency contraceptives, such as Plan B.

Despite this status quo, significant evidence demonstrates that over-the-counter birth control pills would be safe and effective, and birth control has been available without a prescription in many other countries for years.

Approval of nonprescription daily birth control pills would thus be transformative for access to contraceptives. Prescription requirements create barriers to birth control access. Doctor appointments can require money, time off work, and childcare. Barriers are even higher for young people, low-income individuals, and other marginalized communities. Removing the requirement to obtain a prescription would promote personal liberty interests by making it easier for individuals to make their own choices about their own bodies and reproductive futures.

Over-the-counter birth control also has widespread, bipartisan public support. Multiple medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, support making birth control pills available over the counter. Twenty-four states, from California to Tennessee, have loosened prescribing requirements by allowing pharmacists to prescribe birth control—although these states cannot eliminate the prescription requirement completely without FDA approval.

Despite the high stakes for reproductive freedom and public support for the over-the-counter switch, FDA recently delayed its expected decision date for the over-the-counter Opill application. FDA originally scheduled an advisory committee meeting for November 2022. But in October, it postponed the meeting “to allow time for the FDA to review new information.” The meeting has since been rescheduled for May 9 and 10, 2023—with FDA soliciting public comments through April 25 that it plans to share with the committee.

The advisory committee meeting is a critical step toward making a decision on the Opill application. Advisory committees consist of independent experts who make recommendations to FDA about whether to approve drug marketing applications. Although advisory committee recommendations are not binding on FDA, it typically follows them.

In the wake of the mifepristone decisions, the need for FDA to complete its review of the application for over-the-counter Opill is even more urgent.

FDA’s decision about the switch will depend on whether evidence supports that Opill can be used safely and effectively without a prescription. With respect to safety, Opill has been used for nearly 50 years. Because it is progestin-only, it creates a lower risk of blood clots than estrogen-containing pills. Opill is also not toxic, not addictive, and does not risk overdose.

In addition to safety evidence, FDA will consider whether patients can understand the label and self-select the pill appropriately. FDA has approved dozens of other over-the-counter switches for medicines treating a range of conditions, including allergies, acne, and heartburn. Just a few weeks ago, it approved Narcan nasal spray to be used over-the-counter to treat opioid overdoses. Substantial evidence demonstrates that over-the-counter Opill would be appropriate too.

Over-the-counter birth control pills are not a substitute for access to abortion services. And merely making Opill available over the counter will not solve all access issues. Birth control must also be affordable and stocked in pharmacies. But nonprescription access to birth control would be a critical step in making reproductive health care regulation more supportive of reproductive freedom.

The over-the-counter debate shows how FDA’s regulatory choices can impact individuals’ liberty to make choices about their own bodies. In the current political climate, these regulatory choices are pressing. FDA should move swiftly to make Opill available over the counter.

Laura Dolbow

Laura Dolbow is a Sharswood Fellow at the University of Pennsylvania Carey Law School.