The push for more over-the-counter (OTC) medications continues, with Food and Drug Administration Commissioner Marty Makary advocating for increased accessibility to these drugs. The idea behind this movement is that OTC medications provide more price transparency, competition, and convenience for consumers. However, despite this push, switch activity from prescription-only to OTC status has been on a downward trend in recent years.
President Trump’s executive order, titled Lowering Drug Prices by Once Again Putting Americans First, aims to streamline the process of switching prescription drugs to OTC status. The FDA is currently seeking comments to help plan a public meeting on this topic in 2026, while Congress is awaiting a progress report on OTC switches from the Government Accounting Office.
One recent development is a Biden administration rule that took effect in May 2025. This rule allows for the expansion of medications that can make the switch to OTC status by implementing an “additional condition for nonprescription use” protocol. This protocol may involve consumers answering questions on a mobile app or automated telephone system to ensure understanding of a product’s instructions and appropriate use.
Despite these efforts, the pace of switches remains slow. In 2023, only two products were switched to OTC status, and there have been no switches in 2024 or 2025. Most switches in recent years have been in therapeutic areas that already had OTC options available.
The process of switching a prescription drug to OTC status involves ensuring the product is safe, effective, and easily understood by consumers. Evidence from safety and effectiveness studies, as well as label comprehension studies, are typically required for this transition.
In order to facilitate more novel switches, the U.S. may need to consider implementing a third class of medicines known as “behind-the-counter” products. This would involve products that require pharmacist consultation before purchase, similar to the system in place in the UK. This could open up new possibilities for switches in therapeutic areas that currently lack OTC options.
Overall, while there is a push for more OTC medications, the process of switching prescription drugs to OTC status remains complex and slow-moving. Implementing new policies and potentially introducing a behind-the-counter classification system could help facilitate more switches in the future.
