Pew Testifies to Congress on Over-the-Counter Drug Regulation Reform

Pew Testifies to Congress on Over-the-Counter Drug Regulation Reform
Pew Testifies to Congress on Over-the-Counter Drug Regulation Reform
over-the-counter drug regulation reform

Kirsten Moore, director of The Pew Charitable Trusts’ health care products project, testified Sept. 13 before the House of Representatives Energy and Commerce Subcommittee on Health.

© Evelyn Hockstein for The Pew Charitable Trusts

Kirsten Moore, director of The Pew Charitable Trusts’ health care products project, testified Sept. 13 before the House of Representatives Energy and Commerce Subcommittee on Health about the need to reform over-the-counter (OTC) drug regulation. A bipartisan group of subcommittee members has released a discussion draft of a bill that would abolish a burdensome notice and comment rulemaking process that is required to make changes to OTC drugs and would give the Food and Drug Administration the authority to make decisions about the safety and efficacy of these products. It also would give the agency more funding through industry-paid user fees. Moore offered a public health perspective on the draft legislation and voiced support for the bill’s considerations of safety, efficiency, innovation, and additional resources for FDA.

The subcommittee also invited FDA, the American Academy of Pediatrics, the Consumer Healthcare Products Association, the Pharma & Biopharma Outsourcing Association, and the Public Access to SunScreens Coalition to testify.

OTC products
OTC products
Fact Sheet

Regulation of Over-the-Counter Drug Products Should Be Streamlined

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Fact Sheet

Americans routinely reach for over-the-counter (OTC) drugs to treat a wide variety of ailments. And they have a growing number of choices at their local drugstore: The OTC market now includes more than 300,000 products with annual sales of $32 billion. The items are diverse, ranging from antiperspirants and sunscreens to cough and cold medications and pain relievers.