OTC Monograph Reform Legislation Advances in the Senate

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Press Releases and Statements | Apr 4, 2018

(WASHINGTON, D.C.) — Today, the United States Senate Health, Education, Labor and Pensions (HELP) Committee approved S. 2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act by a 22-1 vote. The bipartisan legislation, sponsored by Senators Johnny Isakson (R-GA) and Bob Casey (D-PA), would reform and modernize the regulatory system that oversees the majority of over-the-counter (OTC) medicines — the OTC Monograph system.

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. 

“Today’s HELP Committee vote marks a major step forward for OTC Monograph reform,” said Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville. “CHPA applauds the Committee along with Senators Isakson and Casey for their leadership in advancing legislation that reflects more than two years of collaboration and compromise between regulators, lawmakers, public health stakeholders, and industry.”

“The current OTC regulatory framework requires notice and comment rulemaking, an increasingly slow administrative process,” said Melville. “As a result, when FDA needs to make updates to an existing monograph based on new science and data, 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” 

“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. “The Over-the-Counter Drug Safety, Innovation, and Reform Act 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.”

“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.”

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/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 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, and others.

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products. www.chpa.org