Trump Administration Says It Wants More OTC Meds, But So Far No Action
The push for more over-the-counter (OTC) medications continues as Food and Drug Administration Commissioner Marty Makary recently tweeted about the benefits of making more drugs available without a prescription. This move towards OTC status is seen as a way to increase price transparency, competition, and convenience for consumers. However, despite this push, the number of switches from prescription-only to OTC medications has been declining over the years.
President Trump’s executive order in 2025, titled Lowering Drug Prices by Once Again Putting Americans First, aims to improve the process of switching prescription drugs to OTC status. The FDA is now seeking comments to guide a public meeting on this topic in 2026, while Congress is waiting for a progress report on OTC switches from the Government Accounting Office.
One recent policy change by the Biden administration involves a new rule that went into effect in May 2025. This rule allows for the expansion of medications that can switch to OTC status through an “additional condition for nonprescription use” protocol. This could potentially include requiring consumers to answer questions to assess their understanding of a product’s label and appropriate use.
Despite these efforts, the pace of switches has been slow, with no switches recorded in 2024 or 2025. Most switches in recent years have been in therapeutic areas that already have OTC options available. To facilitate more novel switches, experts suggest implementing a behind-the-counter system, similar to what is seen in other countries like the UK. This system would involve pharmacist consultations for certain medications that are not available over the counter.
The history of switches in the US shows a decline in the number of products switched per year, with only a few switches occurring in the past decade. Efforts to reform the reclassification system, such as the NSURE initiative in 2013, have not led to significant changes. Without a comprehensive behind-the-counter alternative that involves pharmacist consultations, it may be challenging to see a significant increase in novel switches in the near future.
Overall, the push for more OTC medications continues, but significant barriers and challenges remain in the process of switching prescription drugs to OTC status. It will be interesting to see how future policy changes and initiatives will impact the availability of OTC medications for consumers.
