Latta introduces bipartisan OTC drug bill

VW independent/submitted information

WASHINGTON, D.C. — U.S. Representative Bob Latta (R-Ohio) has introduced bipartisan legislation with members of the Energy and Commerce Committee to reform the outdated over-the-counter (OTC) monograph system.

The legislation, 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.

Introducing the legislation with Rep. Latta are Rep. Michael Burgess, M.D. (R-Texas), Rep. Gene Green (D-Texas), Rep. Diana DeGette (D-Colorado), Rep. Brett Guthrie (R-Kentucky), and Rep. Debbie Dingell (D-Michigan).

“Nearly every American uses over-the-counter products in some way,” said Latta. “Whether it’s treating allergies, helping with a cough, or seeking relief for a headache, consumers want medicine that is safe, reliable, and affordable.

“It’s time to create a pathway for industry to enhance over-the-counter medicines and develop new, innovative products that will be a welcome addition to the current products so many American’s depend on today,” he added. “By modernizing the decades-old monograph system and improving the way OTC drugs are approved, this bill will provide more certainty for manufacturers, ensure consumer confidence, and foster innovation. The legislation introduced today was the result of bipartisan collaboration and discussion, and it’s a big win for the countless consumers that purchase over-the-counter products.”

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 that conforms to a monograph may be manufactured and sold without an individual product approval. In the 45 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.