(WASHINGTON, D.C.) — Today, the U.S. House of Representatives passed H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 — bipartisan legislation sponsored by Representatives Bob Latta (R-OH), Diana DeGette (D-CO), Energy and Commerce Health Subcommittee Chairman Michael Burgess (R-TX), Energy and Commerce Health Subcommittee Vice Chairman Brett Guthrie (R-KY), Energy and Commerce Health Subcommittee Ranking Member Gene Green (D-TX), and Rep. Debbie Dingell (D-MI).
The legislation, which passed the House floor by voice vote, would reform and modernize the OTC Monograph system – the regulatory system that oversees the majority of over-the-counter (OTC) medicines.
“Today’s House vote is a very important step forward for OTC Monograph reform,” said Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville. “We are one step closer to creating a modern regulatory system for the modern OTC marketplace that is more transparent, more nimble, and more accommodating to innovation which is precisely what today’s modern consumer desires.”
The House and Senate legislation include several important policy reforms that will streamline the regulatory process, allow for faster safety label changes, provide more resources for FDA to regulate OTC medicines, and enable innovation to provide consumers with additional self-care choices.
“CHPA applauds the House of Representatives for moving this legislative package forward,” said Melville. “We also thank the Energy and Commerce Committee, along with Representatives Latta, DeGette, Burgess, Guthrie, Green, and Dingell for their ongoing leadership and commitment to modernizing the OTC Monograph system. We are encouraged by the ongoing, bipartisan momentum behind this reform effort and look forward to seeing the Senate consider OTC Monograph reform soon. We remain optimistic that this important legislation will be enacted into law this year.”
OTC Monograph reform is also supported by a diverse group of advocacy and public health organizations including the American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American Dental Association, American Public Health Association, March of Dimes, National Association of County and City Health Officials, Society for Maternal-Fetal Medicine, The Pew Charitable Trusts.
Background
OTC medicines comprise approximately 60 percent of medicines sold in the U.S. and provide millions of Americans with safe, effective, and affordable therapies to treat, manage, and prevent many common ailments and conditions. Despite the overwhelming importance and value of OTC medicines to consumers and to the healthcare system overall, the OTC Monograph system has not been updated in over four decades.
While the OTC Monograph system is a balanced framework for regulating OTC medicines, the current OTC regulatory framework requires notice and comment rulemaking, an increasingly slow administrative process. As a result, when FDA needs to make updates to an existing monograph based on new science, the process can take years to complete. This has led to delays in completing OTC monographs and difficulties in updating product labels with new safety information.
The legislation would make key reforms to the OTC Monograph system, including:
Creating a modern regulatory system for the modern OTC marketplace by:
- Reducing the regulatory burden by changing the slow “rulemaking” process to a nimble “administrative order” process, speeding decisions considerably
- Providing FDA with the funding and staff required to oversee their OTC-related work
- Building a critical IT infrastructure
Improving responsiveness and considering emerging science by:
- Assuring FDA remains the final authority on streamlining safety activities; allowing FDA to quickly address emerging issues regarding labeling and safety
- Enhancing transparency, including communication between regulators and industry
Enabling more innovation by:
- Providing a more streamlined regulatory pathway for review of innovations within the OTC Monograph system
- Accommodating marketplace innovations, such as new uses for ingredients, dosage forms, and other advancements with a reasonable submission fee
- Providing a mechanism to encourage investment in data needed for significant innovations to give American consumers greater self-care options.
