While the past few weeks have repeatedly thrown reproductive healthcare into headlines across the country, a bright spot has emerged in contraceptive access. As of July 11, 2022, HRA Pharma has submitted an application to the Food and Drug Administration (FDA) to convert a birth control pill they currently manufacture from prescription-only to over-the-counter (OTC) status in the United States. If approved, this would become the first regular hormonal method of contraception available without a prescription in the United States.

It may seem obvious that the FDA should approve this pill for OTC status based on already available medical evidence. But with such a major shift in the availability of one type of birth control pill, it is critical to examine how this could influence contraceptive decisions. It is also important to review the potential impact of an OTC shift on contraceptive access, as well as the FDA guidelines for OTC drugs.

How will an OTC pill affect consumer choice?

If the HRA Pharma application is approved, it will put one progestin-only (also known as the “mini pill”) birth control pill on the OTC market. Progestin-only pills are one of the two types of birth control pill formulations. The other, a combined oral contraceptive pill, contains progestin and estrogen. Combined oral contraceptives are more commonly prescribed than the progestin-only pill, contain higher levels of progestin than its counterpart and can be slightly more effective in pregnancy prevention. This is because progestin-only pills must be taken at the same time every day to be the most effective. Each pill also comes with its own set of potential side effects and non-contraceptive benefits, meaning that preferences can differ greatly among users.

However, as with any product on the market, if access between two competing products becomes imbalanced, the one with fewer barriers will gain in popularity. Making a progestin-only pill available OTC is a net benefit to Americans currently unable to access birth control at all because of the prescription barrier and would put them on par with the rest of the world when it comes to hormonal birth control access.

But if the FDA wants to ensure it is not skewing women’s contraceptive choices toward particular methods, then it must also consider putting combined oral contraceptives on the OTC market. Otherwise, the FDA is effectively pushing more women toward one particular birth control pill—and that is bad public policy.

The Current Prescription Landscape for Birth Control Pills

Currently, no regular method of short-acting hormonal contraception is available without a prescription. While states determine who can prescribe these forms of birth control (for example, many states now allow pharmacists to prescribe the pill, patch and in some cases, the ring), the FDA is still charged with determining whether drugs can be offered with or without a prescription. If an application for an OTC birth control pill is approved, it would represent a major shift in the FDA’s attitude toward hormonal contraception’s prescription status, and would likely usher in more applications for OTC birth control pills.

This attitude shift would not be possible without a long history of support from within the medical community. It has long been argued that, in applying the FDA’s own guidelines for making a drug available without prescription, hormonal birth control pills have met the standards for OTC status for some time.

In general, the FDA’s considerations for prescription status include:

  1. Whether the condition that a drug is used for is self-diagnosable;
  2. If the drug can be used safely without direct medical oversight; and
  3. If the potential for abuse is low.

Determining one’s own family planning goals is certainly self-diagnosed, and there is no potential for abuse with a birth control pill. Research has also shown that women can accurately self-assess whether they have contraindications for hormonal birth control and use these methods in accordance with directions.

Based on this, legislators and regulators should urge the FDA to also review combined oral contraceptive pills for OTC status. This would ensure a more equitable framework, based on established medical evidence, for obtaining birth control based on preference instead of convenience.


Approve HRA Pharma’s application for an OTC progestin-only pill

The FDA is overdue in allowing OTC access to birth control pills. Decades of data finds that the pill is safe for OTC use, and that women can understand potential risks and use the pill in accordance with directions.

Make combined oral contraceptives also available OTC

While the HRA Pharma application is a necessary step in the right direction, the FDA should swiftly consider further OTC options for hormonal birth control so that it does not skew women’s choices toward one pill formulation over another based on access. Progestin-only pills are very effective contraceptives, but are more sensitive to being taken at the exact same time daily than the combination pill. In practice, this could mean the progestin-only pill is not the best choice for some compared to combined oral contraceptives. To ensure that the burden of regulation is not the reason for making particular family planning choices, the FDA must resolve this discrepancy and actively review combined oral contraceptives for OTC status.

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