FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Lawmakers Introduce Legislation to Reform OTC Monograph System

July 5, 2019
A A

A bipartisan group of U.S. lawmakers introduced a bill aimed at increasing the availability of over-the-counter medications to help bring down healthcare costs.

The lawmakers noted it can take years for drug companies to gain approval for safety information changes, new drug ingredients and other adjustments. The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 would provide a new approval pathway for drugmakers seeking to update their existing OTC products.

The proposed bill, sponsored by Reps. Diana DeGette (D-Colo.), Bob Latta (R-Ohio), Debbie Dingell (D-Mich.) and Brett Guthrie (R-KY), would reform the OTC monograph system to speed up FDA’s reviews and approvals of OTC drugs.

Latta called the decades-old monograph system “unnecessarily inefficient, leading to higher prices and fewer choices,” and said the system needs to be “as modern as the innovations being presented” to the agency.

The bill also calls for a new electronic infrastructure to speed the OTC process and for additional FDA funds to hire staff specifically for OTC-related tasks.

View today's stories