CHPA advocates for modernized OTC Monograph system

WASHINGTON — The OTC Monograph system that regulates over-the-counter medicines is more than four decades old and in need of modernization, according to Consumer Healthcare Products Association president and CEO, Scott Melville who testified earlier this week in strong support of OTC Monograph reform before the House Energy and Commerce Committee, Subcommittee on Health.

“CHPA member companies produce the vast majority of OTC medicines in our country and provide millions of Americans with safe, effective and affordable therapies to treat and prevent many common ailments and conditions,” Melville said. “The availability of self-care treatment options saves money, reduces burdens on the healthcare system, and keeps consumers active and productive.”

Citing the importance of OTC medicines to consumers and our nation’s healthcare system, Melville emphasized that it is essential for the OTC regulatory structure to promote efficiency, transparency and innovation. To ensure the U.S. Food and Drug Administration is adequately funded and resourced to accomplish this important work, the subcommittee is considering a draft of OTC Monograph reform legislation.

CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use. And, as emphasized in the Congressional hearing, CHPA, health professionals and manufacturers in the OTC marketplace support modernization.

“The legislation we are discussing today is incredibly important and, if enacted, will impact the health of nearly every American for decades to come," Melville said. "It’s the product of months – and even years – of consideration and compromise between many stakeholders,” he said. “We look forward to continuing to work with members of this committee to finalize the text and support its introduction and consideration by the Congress.”