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Bipartisan legislation authored by Congressman Bob Latta (R-Bowling Green) to reform the over-the-counter (OTC) monograph system passed the U.S. House of Representatives this evening by voice vote. 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. H.R. 5333 allows the Food and Drug Administration to make scientific determinations for OTC ingredients through an administrative order process, which is much more efficient than the current rulemaking system. 

“Our current process for approving over-the-counter products is cumbersome, slow, and inefficient,” said Latta. “When innovation is stymied, it’s ultimately the consumers that lose. The problems in the OTC monograph system have been apparent for years, but Congress hasn’t taken the necessary steps to modernize the process. H.R. 5333 will mean more certainty for the manufacturers of these products, and that means greater innovation. Greater innovation means products that are more effective, affordable, and safer for consumers. The passage of this bill is an example of how working together in a bipartisan way can deliver real results for the American people.”

The legislation received support from numerous health care organizations and consumer groups including the American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American Dental Association, American Public Health Association, Consumer Health Care Products Association, March of Dimes, National Association of County and City Health Officials, The Pew Charitable Trusts, and Society for Maternal-Fetal Medicine.

For video of Congressman Latta speaking in favor of the bill on the floor, click here. 

Background

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 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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