This bill — the OTC Monograph Safety, Innovation, and Reform Act — would change the monograph rulemaking process to an administrative order process (which is the same legal authority used for other medical product approvals. It would allow the Dept. of Health & Human Services (HHS) to take rapid action to protect public health if safety issues emerge.
The bill would also establish processes for manufacturers to request administrative orders, or for the secretary to initiate administrative orders at the recommendation of the FDA or in response to citizens’ petitions; and for drug developers to request meetings with the FDA, similar to existing processes for prescription drug development.
A new incentive would be created to bring innovative over-the-counter products to consumers by providing an 18-month period of product differentiation to reward innovation.
The Food & Drug Administration (FDA) would be required to provide an annual update to Congress on its evaluation of the cold & cough monograph with respect to children under the age of 6. The FDA would be authorized to collect user fees so that it has the necessary resources to evaluate & monitor the over-the-counter market.
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