Bipartisan Senate OTC Monograph Bill is the Reform that FDA, Industry, and Public Health Groups Want and Need

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Press Releases and Statements | Oct 31, 2019

(WASHINGTON, D.C.) — The Senate HELP Committee made a strong bipartisan move to modernize the regulatory system overseeing most over-the-counter (OTC) medicines by approving S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act by voice vote. The bill, introduced by Senators Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.), would be the first significant reform of the regulatory system overseeing OTC medicines – the OTC Monograph system – in over four decades.

Last year, the Senate HELP Committee approved a Monograph reform bill by a nearly unanimous 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 two years.

“We’re very thankful that Senators Isakson and Casey continue to push OTC Monograph reform toward the finish line,” said Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA). “This bill is an important step forward and a culmination of nearly four years of discussions between regulators, lawmakers, public health stakeholders, and industry.”

FDA, industry, and public health groups have been eagerly awaiting modernization of the OTC Monograph system. The bill includes several important policy reforms to streamline the regulatory process, allow for faster safety label changes, increase the efficiency and responsiveness of FDA in its oversight of this category, provide more resources for FDA to regulate these medicines, continue to protect consumer health, and spur innovation in the marketplace resulting in more self-care choices for consumers. 

“We already know that OTCs save the healthcare system $146 billion each year by reducing the need for clinical visits and prescription drugs,” said Melville, “so an improved regulatory system that may result in even more OTC choices for consumers could save the U.S. economy, and the family budget, even more.”

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.