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WASHINGTON — Consumer Healthcare Products Association (CHPA) president and chief executive officer Scott Melville issued the following statement upon final passage of the CARES Act, which includes provisions to update and modernize the regulatory system overseeing most over-the-counter medicines and to restore O-T-C eligibility under tax-preferred HSA and FSA accounts.
“During this unprecedented public health crisis, American consumers are relying heavily on over-the-counter (O-T-C) medicines to help ensure their families’ health needs are being met, while also following CDC guidelines regarding social distancing. O-T-C medicines not only provide safe and effective relief for a wide variety of symptoms and conditions, but they also make an important contribution to health system sustainability and alleviate unnecessary burden by allowing people with self-manageable symptoms to safely treat themselves without visiting their healthcare provider.
“CHPA is encouraged that lawmakers recognize the important role these medicines play in the lives of consumers and the broader U.S. health care system. The legislative package which passed both the House and Senate with broad support includes a bipartisan measure that will reform the nearly 50-year-old regulatory framework that oversees the majority of O-T-C medicines, called the O-T-C Monograph system. While the Monograph system is a sound regulatory framework that has served the nation well, it needs to be modernized to reflect changes in science and regulatory processes and to incentivize innovation in O-T-C medicines. CHPA and public health stakeholders have long supported these commonsense reforms which will provide FDA with more resources and help increase the efficiency and responsiveness necessary to protect and promote consumer health.
“The legislative package being sent to the President also includes a measure to help millions of health care consumers save money in the near term by reinstating their ability to purchase O-T-C medicines with tax-preferred savings accounts, including Flexible Spending Arrangements and Health Savings Accounts and extending eligibility, for the first time, to menstrual care products. This is welcome news to the nearly 60 million Americans who enroll in these accounts to responsibly manage their health care expenses.