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Congressman Bob Latta (R-OH) has introduced bipartisan legislation with members of the Energy and Commerce Committee to reform the outdated over-the-counter (OTC) monograph system.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-TX), Rep. Gene Green (D-TX), Rep. Diana DeGette (D-CO), Rep. Brett Guthrie (R-KY), and Rep. Debbie Dingell (D-MI).

“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. 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.”

“As a physician and more recently as a congressman, I have witnessed much change in the health care industry over the last 40 years; however, the over-the-counter monograph system has not had a significant update since 1972,” said Burgess. “With more than 300,000 over-the-counter products on the market, that is far too long to wait. 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.”  

“I’m pleased to work together with my colleagues on a very important bipartisan bill that will streamline and modernize FDA’s Over-the-Counter (OTC) monograph system and create user fees to provide much needed resources to improve the oversight and approval of OTC products,” said Green. “The monograph system will become more flexible, better reflect the top science we have, and be more responsive to public health concerns when they emerge. I believe it will also encourage innovation in OTC products by assuring sponsors of future applications that they will not be faced with unhelpful administrative burden or delay.”

“I’m proud to have shepherded this legislation along from research to writing to this latest step,” said DeGette. “It will modernize how the FDA reviews over-the-counter medicines, a process that has not been updated since the 1970s. The current system simply has not kept pace with science, innovation and growth in the OTC market. Most importantly, this bill takes commonsense steps that will help the FDA prevent and address safety issues rapidly and efficiently.”

“Over-the-counter drugs provide an affordable way for Americans to seek medical treatment,” said Guthrie. “Unfortunately, the current FDA approval process for over-the-counter products is too slow, delaying important innovations that can help patients more quickly. The Over-the-Counter Monograph Safety, Innovation, and Reform Act will reform and modernize the antiquated monograph approval system and allow more innovative drug treatments to enter the market safely. I was proud to work with Representatives Latta, Burgess, Green, DeGette, and Dingell on this bill, and I am working with all of our colleagues on the Energy and Commerce Committee to move this bill as soon as possible.”

“Americans rely on over-the-counter medicines to treat everything from colds to headaches,” said Dingell. “As scientific research advances, we must ensure that the approval process for these products keeps pace with innovation. Unfortunately, the over-the-counter drug system hasn’t been updated in decades, delaying innovative treatments and making it harder for FDA to do its job of keeping people safe. I’m pleased to introduce this bipartisan legislation with my colleagues to modernize this broken system so we can ensure that new, safe and reliable products get to those who need them.”

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.
 
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