Senate HELP Subcommittee Advances OTC Monograph Reform Bill

The Senate Committee on Health, Education, Labor and Pensions advanced a bill aimed at reforming the OTC monograph system.

Introduced by Sens. Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.), the Over-the-Counter Monograph Safety, Innovation, and Reform Act (S. 2740), would speed up the approval process for OTC drugs and grant an 18-month exclusivity period.

The bill would also allow the FDA to collect a $500,000 fee for Tier 1 monograph requests, and a $100,000 fee for Tier 2 requests beginning in fiscal year 2021.

The committee previously approved the bill in April 2018, and a bipartisan group of representatives reintroduced the bill in the House of Representatives in June.

The FDA has said OTC monograph reform is “a top priority” as it looks to spur innovation in the OTC market.