OTC Monograph Reform Momentum Carries Potential Exclusivity Snag

Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.

Businessman looking through a magnifying glass to documents

Legislation on reforming FDA's process for adding OTC drug monograph ingredients and indications will arrive at the House Energy and Commerce Committee loaded with concerns about the two-year market exclusivity it would allow for some new products.

Support was unanimous during the Health Subcommittee's Jan. 17 markup to send to Energy and Commerce draft legislation...