Close-up of young woman's hand holding birth control pills

The French drug maker HRA Pharma is seeking approval from the Food and Drug Administration (FDA) to sell its birth control pill, which contains a single synthetic hormone, progestin, over-the-counter (OTC) in the U.S.

Since their introduction in the 1960s, hormone-based birth control pills have been prescription-only in the U.S. The rationale for this has been that medical professionals can then evaluate individual patients for conditions that raise the risk of rare, but dangerous, blood clots.

HRA Pharma is trying to convince the FDA that women can screen themselves in order to use its product, called Opill.

The year 2020 marked an end to a long drought in switching of prescription-only drugs to over-the-counter status. In 2020, five products with four separate active ingredients switched in four different therapeutic classes, which was reminiscent of the most recent heyday of switches in the mid 1990s.

However, the increased switch activity in 2020 appears to be an anomaly. In 2021, the tepid pace of switches resumed with only two switches, and only one switch thus far in 2022. All switches in 2021 and 2022 are in the allergy space, an area in which there had already been switches for decades.

The more than a decade-long slump in prescription-to-OTC switches has included years with zero switches, like 2018 and 2019, and several years with only one switch, including 2010, 2011, and 2015.

What’s conspicuous regarding the dearth in switch activity is that there have been precious few switches lately in novel OTC therapeutic classes, particularly those in which self-diagnosis may be difficult, or professional monitoring and follow-up may be advised.

Part of the problem is the (mostly) binary nature of categorization of drugs in the U.S.: Prescription-only versus over-the-counter. With a few exceptions, such as insulin and the Plan B oral contraceptive, there isn’t a behind-the-counter alternative.

Moreover, the term over-the-counter (OTC) as it applies to the U.S. pharmacy system has always been somewhat of a misnomer. Off-the-shelf is probably a better way of describing it. Most OTC drugs are retrieved from shelves in stores that any customer can access, and then paid for at the check-out counter; usually with no learned intermediary present. And so, once a drug is off-the-shelf there’s little or no control over who gets access to it. This includes, among others, sleep aids, maximum strength pain relievers, proton pump inhibitors, anti-histamines, cough medicines, and medications for yeast infections.

By contrast, many of these OTC products in Europe are actually behind-the-counter, which means that to obtain them a customer must request the product from a pharmacist.

FDA’s new plan to facilitate more switches

Besides oral contraceptives, other prescription-to-OTC switches in new switch categories may be in the offing, as the FDA proposes to restructure the switch process.

The FDA’s recently unveiled proposal - called the Additional Condition for Nonprescription Use (ACNU) - may help to facilitate more switches by offering a pathway for drugs that can be marketed as both prescription and OTC drugs. Under the proposed rule, an OTC drug could have the same active ingredient, dosage form, strength, route of administration, and indication as its prescription-only counterpart.

Here, switches would be contingent on consumers filling out a questionnaire via a mobile application or display screen at a pharmacy kiosk to determine whether a particular OTC drug is appropriate. This raises the question what happens if it’s determined that the drug is not appropriate. Does a pharmacist intervene at this point to prevent the customer from purchasing the drug? The proposed rule does not state that such OTC drugs would be behind-the-counter. And so, if the drug is available off-the-shelf, such an intervention would be difficult in practice.

Additionally, it’s unclear whether such OTC drugs could be sold in any location, or whether they would be limited to sale in pharmacies where a pharmacist is present?

More clarity is needed, particularly since the FDA’s plan lacks important details on the practicality of proposed changes. Moreover, the FDA’s proposal to expedite switches doesn’t involve a behind-the-counter alternative.

Placing certain drugs behind-the-counter implies that they can be purchased only after consulting with a pharmacist. The possibility of this third class has been discussed in the U.S. for decades. But each time there was a policy discussion policymakers and regulators have stopped well short of pursuing this pathway.

Ten years ago, for instance, FDA launched the NSURE (Nonprescription Safe Use Regulatory Expansion) initiative to switch certain prescription-only drugs to OTC status with the proviso for “conditions of safe use.” Observers incorrectly perceived NSURE as representing an initiative for the creation of a third class of drug product or a behind-the-counter class of drugs.

And so, with ACNU, as was the case with the NSURE initiative, there’s more ambiguity than there is clarity. A clearly delineated third class of drugs would obviate the need for a potentially confusing set of new rules for OTC products. The third class of drugs, which can only be accessed from a pharmacist, is is what many other countries have instituted. This includes countries like the U.K. which have already switched birth control pills, statins, and erectile dysfunction agents.

Insurer coverage of oral contraceptives

Besides OTC availability, there’s the relevant question of insurer coverage. Lack of insurer coverage is an issue with many switched products. Convenient access improves with OTC availability, but as insurers don’t cover most OTC products, affordability can be problematic.

Prior to enactment of the Affordable Care Act (ACA) in 2013, approximately 30 states and territories required that health insurance plans provide coverage of prescription contraceptives.

Then, federal law, under a provision of the ACA, expanded on the state policies mentioned, in particular, by voiding all patient cost-sharing for most products. The federal contraceptive coverage guarantee applies to most private health plans nationwide. But, under the contraceptive coverage guarantee, insurers only have to cover OTC for which enrollees have a prescription. This could create an affordability problem once oral contraceptives become available OTC.

FDA may soon approve the first OTC birth control pill in the U.S. And, more novel prescription-to-OTC switches could be on tap. But, the FDA’s proposed plan to facilitate more switches in new therapeutic categories lacks clarity, and it doesn’t include a behind-the-counter alternative. In addition, once products are switched, the affordability of OTC products remains a concern.