Key Takeaways

A finalized FDA rule allows certain drugs to be sold over-the-counter ("OTC") with Additional Conditions for Nonprescription Use ("ACNUs") like educational programs or questionnaires, potentially expanding OTC drug availability. Companies should consider coordinating closely with the FDA to navigate potential legal challenges and ensure compliance with this novel program.

This rule, released on December 26, 2024, enables certain drugs, which could not previously be safely used without professional supervision, to be available over-the-counter OTC by incorporating ACNUs such as educational programs, questionnaires, or other technological aids. An ACNU could, for example, be a questionnaire that consumers are required to complete on a secure website or mobile application created by the drug manufacturer. If the drug is appropriate for the consumer based on their responses, the consumer could then determine whether to purchase the drug for themselves. By enabling drug makers to offer a more extensive patient education regime via ACNU than would be possible through an OTC package label, the new rule expands the universe of drug products that may qualify for OTC approval.

One important aspect of the new rule involves the simultaneous marketing of prescription and nonprescription drugs with the same active ingredient. The FDA has long recognized that for simultaneous marketing to occur, there must be a meaningful difference between the OTC and prescription products, making the prescription version necessary for conditions requiring medical supervision. For example, higher doses of a medication may be available only via prescription, while lower doses are marketed OTC. The new rule clarifies that the presence of an ACNU constitutes such a meaningful difference, permitting simultaneous marketing under the Food, Drug, & Cosmetic Act. As such, the same medication in the same dosage may be available by prescription without an ACNU or available OTC with an ACNU. 

Considering the rule’s potential application to medications that receive political attention, such as oral hormonal birth control, companies considering an ACNU approach may consider closely coordinating with the FDA under the new administration to determine how the agency will apply the new rule going forward.