The Pew Charitable Trusts and nine organizations representing public health advocates, health care providers, and makers of nonprescription drugs and sunscreens urged the U.S. Senate’s Health, Education, Labor, and Pensions Committee to approve a bill to streamline the Food and Drug Administration’s regulatory system for over-the-counter (OTC) medications.
The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (S. 2740) would enable FDA to respond rapidly to safety concerns and evidence that a product needs dosage or labeling updates, the groups noted in an Oct. 30 letter to the committee’s leaders. The legislation incorporates Pew’s principles for reforming OTC oversight and would require that product manufacturers pay fees to FDA to help fund agency oversight.
The letter is signed by the American Academy of Allergy, Asthma & Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products Association; March of Dimes; National Association of County and City Health Officials; Pew; Protecting Access to Pain Relief Coalition; Public Access to SunScreens Coalition; and Society for Maternal-Fetal Medicine.
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