CHPA Applauds Passage of Bipartisan Monograph Reform Legislation in the House

WASHINGTON, D.C. (January 8, 2019) — The Consumer Healthcare Products Association (CHPA) applauds the introduction and passage of H.R. 269 (by a 401-17 vote), which includes the Over-the-Counter Monograph Safety, Innovation, and Reform Act, legislation to modernize the regulatory system overseeing the vast majority of over-the-counter (OTC) medicines – called the OTC Monograph system. The legislation is packaged with another bipartisan bill, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, and is sponsored by House Energy and Commerce Committee members, including Representatives Anna Eshoo (D-CA), Susan Brooks (R-IN), Diana DeGette (D-CO), Bob Latta (R-OH), Brett Guthrie (R-KY), Debbie Dingell (D-MI), Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR).

“Today marks the third time the House has passed OTC Monograph reform, demonstrating the members’ ongoing commitment to bringing the OTC Monograph system into the 21st Century,” said CHPA President and CEO, Scott Melville. “This legislation has received overwhelmingly bipartisan support because it would make commonsense regulatory reforms to increase the efficiency and responsiveness necessary to protect consumer health and spur innovation. We are encouraged that the momentum behind Monograph reform is carrying over into the new Congress.”
 
While the OTC Monograph system is a smart, balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use and efficacy, it relies on notice and comment rulemaking which has become an increasingly slow and unresponsive administrative process. As a result, the Monograph system has become cumbersome and, essentially, has ground to a halt. Today, it can take several years or more to update product labels with new safety information, approve new ingredients, or make other important changes for consumers. Moreover, the current system does not provide a mechanism for innovation.
 
“We thank Representatives Eshoo, Brooks, DeGette, Latta, Guthrie, Dingell, Pallone, and Walden for their leadership on this issue,” said Melville. “This legislation is the product of years of collaborative discussion between regulators, lawmakers, public health stakeholders, and industry. It has been a bipartisan effort from the onset and we are hopeful that the legislation will be quickly considered by the full Senate.” 

On December 19, 2018, the House passed H.R. 7328, the combined PAHPA/OTC Monograph reform bill by an overwhelming vote of (367-9). Earlier in 2018, the House passed H.R. 5333 by voice vote 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). In April, the Senate HELP Committee approved a similar bill, S. 2315, sponsored by Senators Johnny Isakson (R-GA) and Bob Casey (D-PA) by a 22-1 vote.
 
OTC Monograph reform is widely supported by a diverse and influential 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, and 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 previous OTC regulatory framework required notice and comment rulemaking, an increasingly slow administrative process. As a result, when FDA needed to make updates to an existing monograph based on new science, the process took years to complete. This led to delays in completing OTC monographs and difficulties in updating product labels with new safety information. The legislation makes 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 with multiple clearance layers beyond FDA on scientific decisions to a nimble “administrative order” process within the agency, 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 new, 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

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The Consumer Healthcare Products Association (CHPA) is the 138-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

202.429.3534