Congresswoman Diana DeGette

Representing the First District of Colorado
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Making OTC Drugs Safer: DeGette’s Bipartisan Bill to Reform Regulations Clears Committee

May 9, 2018
Press Release

Washington, DC – Needless delays in bringing safe over-the-counter medicines to market – and in clarifying the use of existing OTC medicines – will soon be a thing of the past thanks to committee approval today of a bipartisan bill led by Congresswoman Diana DeGette (D-CO) that reforms the way the Food and Drug Administration reviews and approves such products.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act (H.R. 5333), unanimously approved today by the House Energy and Commerce Committee, lets new products come to market more quickly while addressing safety issues and expanding consumer choice. It updates the FDA’s outdated OTC monograph system, allowing the agency to make scientific determinations for OTC ingredients through an administrative order process, which is much more efficient than the current rulemaking system.

“Just about every person in this country uses over-the-counter products, whether for relief of cold symptoms, treating allergies, or any number of other common health issues,” DeGette noted. “This bill will modernize how the FDA reviews these medicines. It takes commonsense steps that will help the FDA prevent and address safety issues quickly, which will encourage innovation and increase consumer confidence.”

At the hearing, DeGette noted that updating the system will also save lives: In 2006, the FDA found that several toddlers had died due to cough medicine, but revised guidelines warning parents about the medicine’s risks to young children have yet to be written due to internal hurdles at the agency, where this process hadn’t been updated since the 1970s. DeGette’s bill helps remove these obstacles for more than 300,000 commonly-used drugs.

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 additional resources 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. 

Introducing the legislation in March with Congresswoman DeGette were Reps. Bob Latta (R-OH), Michael Burgess, M.D. (R-TX), Gene Green (D-TX), Brett Guthrie (R-KY) and Debbie Dingell (D-MI).