OTC Monograph Reform Draft Bill Advanced by Energy and Commerce Health Subcommittee

WASHINGTON, D.C. (January 17, 2018)—Today, the House Energy and Commerce Health Subcommittee approved bipartisan draft legislation to reform and modernize the regulatory system that oversees the majority of over-the-counter (OTC) medicines – the OTC Monograph system. The draft bill, authored by Representatives Bob Latta (R-OR), Diana DeGette (D-CO), Subcommittee Chairman Michael Burgess (R-TX), Vice Chairman Brett Guthrie (R-KY), Ranking Member Gene Green (D-TX), and Rep. Debbie Dingell (D-MI), was reported out of the subcommittee by voice vote. 

More than 60 percent of pharmaceuticals on the U.S. market today are OTC medicines which provide Americans with safe, effective, and affordable therapies to treat and prevent many common ailments and conditions. Despite the prevalence and value of OTC medicines to consumers, the current OTC regulatory framework is based on a 45-year-old model that requires notice and comment rulemaking, an increasingly slow administrative process that has led to delays in completing OTC monographs and difficulties in updating product labels with new safety information. Additionally, the current system does not provide a mechanism for innovation for new and/or improved products under the regulatory structure.

“Today’s subcommittee vote marks a major step forward for OTC Monograph reform,” said CHPA President and CEO Scott Melville. “CHPA applauds the subcommittee along with Chairman Burgess, Vice Chairman Guthrie, Ranking Member Green, and Reps. Latta, DeGette, and Dingell for their leadership in advancing draft legislation that reflects more than two years of collaboration and compromise between regulators, lawmakers, public health stakeholders, and industry.”

 “While CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use, it has become gridlocked and needs to be modernized,” continued Melville, who testified before the subcommittee in September in strong support of OTC Monograph reform. “This legislation would not only help increase the efficiency and responsiveness necessary to protect consumer health, it would also spur innovation to provide consumers with additional self-care choices. And, to ensure FDA is adequately funded and resourced to accomplish this important work, the OTC industry would supplement government resources with modest user fees, similar to the process in place for other medical products and devices regulated by the FDA.”

“We are encouraged by the ongoing, bipartisan momentum behind Monograph reform and look forward to seeing the legislation move forward in the House as well as the Senate.”

The draft 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/electronic 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 for 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, and The Pew Charitable Trusts. 

The Consumer Healthcare Products Association (CHPA) is the 137-year-old national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to empowering self-care by preserving and expanding choice and availability of consumer healthcare products. chpa.org


Contact: Lauren Bloomberg (lbloomberg@chpa.org)