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Bipartisan legislation introduced by Congressman Bob Latta (R-Bowling Green) to reform the outdated over-the-counter (OTC) monograph system was approved by the Energy and Commerce Committee this morning. The bill, H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, modernizes the monograph framework and allows new, safe products to come to market more quickly while addressing safety issues and expanding consumer choice. This would allow the Food and Drug Administration (FDA) to make scientific determinations for OTC ingredients through an administrative order process, which is much more efficient than the current rulemaking system.
 
“Even though nearly all Americans use over-the-counter products, the OTC approval system hasn’t been updated in more than four decades,” said Latta. “The current process is too slow, hasn’t kept pace with technological advances, and stifles innovation. The legislation passed by the Energy and Commerce Committee today will be a big win for consumers as they are able to access affordable, safe, and reliable over-the-counter medication without bureaucratic delays. While this bill has been a long time coming, it’s a testament to what working in a bipartisan manner can achieve for the American people.”
 
The OTC monograph system was established in 1972 by the Food and Drug Administration (FDA) to review the safety and efficacy of the OTC medicine ingredients then on the market, including doses, formulations, and labeling. Any OTC product that conforms to a monograph may be manufactured and sold without an individual product approval. In the 46 years since the system was created, the process has not been completed and movement on unfinished items has been slow. The system has become a hindrance that does not allow for advances in science and new information concerning the safety of an ingredient.
 
The draft legislation updates the monograph process by specifically adding a new section to the Food, Drug, and Cosmetic Act to:
•    Move away from the cumbersome current monograph finalization process to an administrative order procedure. Additional processes will be in place to ensure recourse should issues arise.
•    Create new pathways to innovation for monograph products benefiting consumers, where none currently exits.
•    Ensure the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected.
•    Include by reference existing OTC Review Final Monographs and deem final Tentative Final Monographs by statute.

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