Incentives And Risks From OTC Drug Monograph Revamp

On March 27, President Donald Trump signed into law the Coronavirus Aid, Relief and Economic Security Act, also known as Phase 3 of the coronavirus stimulus legislation. Title III, Subtitle F of the CARES Act, a provision unrelated to the current coronavirus pandemic, is an overhaul to the over-the-counter drug monograph system in the U.S.

This article analyzes the five key provisions of the OTC monograph reform, with a particular focus on the first four:

An outline of the status of currently marketed OTC monograph drugs;

An administrative process by which the U.S. Food and Drug Administration will establish/amend a monograph (as opposed to notice and comment rulemaking), including expedited procedures for imminent public health hazards;

An 18-month exclusivity period for certain administrative orders;

The creation of a user fee program; and

Proposed modifications to the Sunscreen Innovation Act of 2014.