(WASHINGTON, D.C.) — Today, the U.S. House Energy and Commerce Committee approved 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 by voice vote — would reform and modernize the regulatory system that oversees the majority of over-the-counter (OTC) medicines – the OTC Monograph system. On April 24, 2018, the Senate Health, Education, Labor and Pensions (HELP) Committee approved its companion bill, S. 2315, by a 22-1 vote.
“Today’s Energy and Commerce Committee vote is a significant development for OTC Monograph reform,” said Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville. “CHPA applauds the Committee along with Representatives Latta, DeGette, Burgess, Guthrie, Green, and Dingell for their ongoing leadership and commitment to modernizing the OTC Monograph system.”
“OTC Monograph reform will create a modern regulatory system for the modern OTC marketplace,” said Melville. “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.”
“FDA, industry, and public health stakeholders agree that modernizing the OTC Monograph system should be a priority for this Congress,” said Melville. “Now that both the Senate HELP Committee and House Energy and Commerce Committee have advanced legislation, we are optimistic that OTC Monograph reform will cross the finish line this year.”
“We are encouraged by the ongoing, bipartisan momentum behind this reform and look forward to seeing the legislation move forward in the House as well as the Senate.”
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
OTC Monograph reform is supported by a diverse group of advocacy 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.
