Pew, 7 Other Groups Urge FDA to Keep Focus on OTC Drug Regulation Reform

The Pew Charitable Trusts and seven other organizations sent a joint letter to Norman E. “Ned” Sharpless, acting commissioner of the Food and Drug Administration, urging the agency to continue working with congressional leaders toward final passage of the bipartisan Over-the-Counter Monograph Drug Safety, Innovation, and Reform Act, which would modernize oversight of most OTC drugs. Pew and these groups—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, and Society for Maternal-Fetal Medicine—support this bill because it incorporates principles that the groups agree are necessary for reform, including eliminating the burdensome rule-making process for changing OTC monographs (FDA-approved recipes for nonprescription drugs) and expanding funding for FDA through new user fees.