Lawmakers Release Bipartisan Draft Legislation to Reform Over-the-Counter Monograph System
Congressman Bob Latta (R-OH) and a group of bipartisan Members of Congress have released a discussion draft of reforms to the over-the-counter (OTC) monograph system. Joining Latta in releasing the draft are Energy and Commerce Committee members Rep. Michael Burgess (R-TX), Rep. Gene Green (D-TX), Rep. Diana DeGette (D-CO), Rep. Brett Guthrie (R-KY), and Rep. Debbie Dingell (D-MI). The draft would modernize the monograph framework to allow the FDA to make scientific determinations for OTC ingredients through an administrative order process, an approach closer to new drug application procedures. These updates will allow new, safe products to come to market more quickly, rapidly address safety issues, and expand consumer choice.
“The outdated OTC monograph system stifles innovation and harms consumer confidence,” said Latta. “Moving to a more flexible system that uses new information and scientific advancements ultimately means more certainty for manufacturers and better products for consumers. Working in a bipartisan manner, we’ve released this draft legislation that adds predictability to the monograph process and would create a more robust over-the-counter marketplace.”
“This bipartisan initiative is a victory for patients and consumers,” said Burgess. “The current over-the-counter monograph system is outdated and deters updates and innovations to over-the-counter medications. This bill will allow for meaningful modifications to the monograph that will equip manufacturers to continue to deliver high-quality products to consumers. We must continue to strive to do more to reform approval processes at the FDA and subsequently increase access to care.”
“Americans utilize over-the-counter products dozens of time every day” said Green. “The FDA’s regulatory framework for oversight of most over-the-counter products has not been updated for decades and is widely regarded as flawed. The current system is unable to keep pace with scientific discovery or respond quickly to safety concerns. We have been working in a bipartisan manner with the FDA and stakeholders to create a more flexible, modern process and give the FDA the resources is needs to respond to new drugs and keep patients safe. This draft is the next step in that process, and we will continue to work across the aisle to advance this important issue.“
“Virtually every American uses over-the-counter medications to treat headaches, colds, and other common ailments,” said DeGette. “The market for these products has grown substantially and the science has advanced, but the system for reviewing them remains outdated. It’s virtually impossible for the FDA to respond to safety risks promptly, which needlessly puts consumers in harm’s way. Our bipartisan bill will give the FDA new tools to protect consumers, provide badly-needed resources, and streamline the FDA review process.”
“As our medical and pharmaceutical technology rapidly advances, we must ensure that the FDA keeps up with innovations in over-the-counter drugs,” said Guthrie. “I was proud to join Rep. Latta and other members of the Energy and Commerce Committee to introduce this bipartisan legislation that will give the FDA more flexibility to help get new medicines to Americans faster.”
“Our over-the-counter drug system has been broken for years,” said Dingell. “New and innovative products do not have a consistent or reliable pathway to market, which ultimately hurts patients. I’m pleased to be working with my colleagues in a bipartisan manner on draft legislation to reform this broken system so we can ensure these products get to the patients 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.