E&C Committee Members Propose Overhaul of OTC Monograph System

A bipartisan group of members of the House Energy and Commerce Committee introduced new legislation to reform the FDA’s monograph system for over-the-counter ingredients and replace the agency’s rulemaking process for approving OTCs with a system based on administrative orders.

The Over-the-Counter Monograph Safety, Innovation and Reform Act would expedite the arrival of new products to market, while broadening consumer choice and addressing safety issues, according to the lawmakers.

 “By modernizing the decades-old monograph system and improving the way OTC drugs are approved, this bill will provide more certainty for manufacturers, ensure consumer confidence, and foster innovation,” said lead sponsor Rep. Bob Latta (R-Ohio).