(WASHINGTON, D.C.) — The Consumer Healthcare Products Association (CHPA) released the following statement today by President and CEO, Scott Melville, applauding the introduction of 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), to modernize the regulatory system overseeing the vast majority of over-the-counter (OTC) medicines — the OTC Monograph system.
“We thank Representatives Latta, DeGette, Burgess, Guthrie, Green, and Dingell for their ongoing leadership and commitment to modernizing the OTC Monograph system. This legislation would bring the Monograph system into the 21st Century, helping to increase the efficiency and responsiveness necessary to protect consumer health and creating a pathway for innovation that accommodates consumer needs.
“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.
“This has been a bipartisan effort from the onset and we are encouraged by the amount of work put into moving Monograph reform forward in both the House and Senate. OTC Monograph reform legislation, when enacted, will have an impact on the health of nearly every American for decades to come. It is the product of years of collaborative discussion between regulators, lawmakers, public health stakeholders, and industry. We urge timely consideration and a markup of the legislation before the full Energy and Commerce Committee.”
