Congress seeks to update OTC monograph system

Rep. Bob Latta, R-Ohio, on Monday introduced bipartisan legislation along with members of the Energy and Commerce Committee to reform the outdated over-the-counter monograph system.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.

“While the OTC Monograph system is a smart, balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use and efficacy, it relies on notice and comment rulemaking which has become an increasingly slow and unresponsive administrative process," Scott Melville, president and CEO for the Consumer Healthfare Products Association, said. "As a result, the Monograph system has become cumbersome and, essentially, has ground to a halt. Today, it can take several years or more to update product labels with new safety information, approve new ingredients or make other important changes for consumers. Moreover, the current system does not provide a mechanism for innovation."

“Nearly every American uses over-the-counter products in some way,” Latta said. “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 Americans depend on today. 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 new bill would allow 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. The current system has not had a significant update since 1972.

“With more than 300,000 over-the-counter products on the market, that is far too long to wait," Rep. Michael Burgess, R-Texas, said. "The bill introduced today will ensure that American development remains at the helm of over-the-counter drug innovation. I am grateful to Congressman Latta for his leadership on this issue, and I look forward to bringing our over-the-counter monograph system into the 21st century.”

Introducing the legislation with Latta and Burgess are Reps. Gene Green, D-Texas, Diana DeGette, D-Colo., Brett Guthrie, R-Ky., and Debbie Dingell, D-Mich.

“Over-the-counter drugs provide an affordable way for Americans to seek medical treatment,” Guthrie said. “Unfortunately, the current FDA approval process for over-the-counter products is too slow, delaying important innovations that can help patients more quickly.”

The OTC monograph system was established in 1972 by 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; and

  • Include by reference existing OTC Review Final Monographs and deem final Tentative Final Monographs by statute.