(WASHINGTON, D.C.) — The Consumer Healthcare Products Association (CHPA) applauds today’s passage in the U.S. Senate of S. 2740, the Over-the-Counter Drug Safety, Innovation, and Reform Act by a vote of 91-2.
“Thanks to today’s decisive Senate action, our nation is one step closer to having a modern over-the-counter (OTC) regulatory framework that will better serve consumers and facilitate a new wave of innovation in OTC medicines,” said CHPA President and CEO Scott Melville. “I want to commend sponsors Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA), Senate Health, Education, Labor and Pensions Committee members, and their staff for getting this important legislation, after several years of consideration, across the finish line in the Senate. We now hope for prompt consideration of S. 2740 by the House of Representatives that will send this bipartisan healthcare accomplishment to the president’s desk for his signature into law. It is especially important to note that after years of leadership in healthcare policy, this bill is one of the final bills sponsored by Senator Johnny Isakson to pass the Senate prior to his retirement later this month.”
On October 31, 2019, the Senate Committee on Health, Education, Labor & Pensions (HELP) Committee approved S. 2740 by voice vote, and since then Senators Isakson and Casey have continued to advocate for its advancement. OTC Monograph reform legislation also has bicameral support with similar legislation having already passed in the U.S. House of Representatives three times in the past 2 years.
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 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 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:
- 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
