FDA aims to make more prescription drugs available over the counter

FDA Commissioner pushes to make more drugs over-the-counter

FDA Commissioner Marty Makary wants to make most prescription drugs available over the counter. He argues that unless a drug is unsafe, addictive, or requires monitoring, it should not require a prescription.

Makary told CNBC the agency aims to make regulatory changes this year to allow more companies to sell their medicines OTC. The FDA is updating its official rulebooks, called OTC monographs, to facilitate this shift.

The effort targets what Makary calls "basic, safe" prescription drugs. Initial categories include nausea medications and vaginal estrogen, which is used for menopausal symptoms. The administration frames this as a key part of its strategy to lower drug costs.

FDA to drop two-study approval standard

In a separate major policy shift, the FDA plans to drop its long-standing requirement for two rigorous studies to approve new drugs. This change is detailed in a New England Journal of Medicine piece by Makary and top deputy Vinay Prasad.

Going forward, the FDA’s default position will be to require only one study for new drugs and novel health products. Officials state this reflects modern advances that have made drug research more precise.

Makary and Prasad predict this shift will lead to “a surge in drug development.” They position the move as part of a broader push to slash bureaucracy and accelerate the availability of new medicines under the Trump administration.

Industry and experts question the changes

The push for widespread OTC availability has been questioned by some in the pharmaceutical industry. Critics have raised concerns in public comments to the FDA’s regulatory docket about safety and appropriate use.

Similarly, the decision to abandon the two-trial standard represents a dramatic departure from decades of regulatory practice. This standard has been a cornerstone of FDA approval, intended to ensure that a drug’s benefits are reproducible and outweigh its risks.

The changes are part of a series of rapid alterations to FDA standards and procedures under Makary’s leadership. The stated goal is to speed innovation, but the moves are likely to spark significant debate about the balance between access and safety.

Key drugs targeted for OTC switch

The initial focus for OTC conversion includes specific, common medications. Makary cited two primary examples in his announcement.

• Nausea medications: Common anti-emetic drugs used for a variety of conditions.
• Vaginal estrogen: A treatment for menopausal symptoms like vaginal dryness and pain.

These categories represent the first test cases for the FDA's new, more permissive OTC framework. The success or failure of these switches will likely inform future decisions on other drug classes.