Incentives And Risks From OTC Drug Monograph RevampMay 29, 2020 Download PDF
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.
- Steven J. Gonzalez