OTC monograph reform clears House, Senate committees


The U.S. House Energy and Commerce Committee on Wednesday approved the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. The legislation – which passed by voice vote – will modernize the regulatory system that oversees the majority of OTC medicines.

On April 24, the Senate Health, Education, Labor and Pensions Committee approved its companion bill, S. 2315, by a 22-1 vote.

“Today’s Energy and Commerce Committee vote is a significant development for OTC Monograph reform,” Scott Melville, Consumer Healthcare Products Association president and CEO, said. “OTC Monograph reform will create a modern regulatory system for the modern OTC marketplace. The House and Senate legislation include several important policy reforms that will streamline the regulatory process, allow for faster safety label changes, provide more resources for FDA to regulate OTC medicines and enable innovation to provide consumers with additional self-care choices.”

OTC medicines comprise approximately 60% of medicines sold in the U.S., CHPA reported. The current OTC regulatory framework requires notice and comment rulemaking, an increasingly slow administrative process. As a result, when FDA needs to make updates to an existing monograph based on new science, the process can take years to complete.

This has led to delays in completing OTC monographs and difficulties in updating product labels with new safety information.

OTC Monograph reform is supported by a diverse group of advocacy organizations including the American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American Dental Association, American Public Health Association, March of Dimes, National Association of County and City Health Officials, Society for Maternal-Fetal Medicine, The Pew Charitable Trusts.

The bipartisan legislation was sponsored by Reps. Bob Latta, R-Ohio, Diana DeGette, D-Colo., Michael Burgess, R-Texas, Brett Guthrie, R-Ky., Gene Green, D-Texas, and Debbie Dingell, D-Mich.