FDA urges lawmakers to reauthorize OTC drug program

The FDA is urging lawmakers to reauthorize a key user fee program that could expand access to over the counter medications, reducing barriers to treatment.

At a recent hearing before the Senate Health, Education, Labor and Pensions Committee, FDA officials highlighted the success of the over-the-counter Monograph Drug User Fee Program, first authorized in 2020, according to hearing testimony reviewed by Becker’s.

First enacted under the CARES Act in 2020, the program has helped modernize the regulatory process for nonprescription drugs, helping to speed up approvals and improve transparency and safety, Jacqueline Corrigan-Curay, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in her testimony. She pointed to the example of over-the-counter naloxone, which can reverse opioid overdoses.

The proposed five-year reauthorization of the program to 2030 would include additional resources for faster reviews, improved product safety oversight and expanded transparency around FDA decision-making.

https://www.beckershospitalreview.com/pharmacy/fda-urges-lawmakers-to-reauthorize-otc-drug-program/