FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Health Advocacy Groups Urge Sharpless to Get Behind OTC Reform

May 7, 2019
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Eight public health advocacy groups are urging Acting FDA Commissioner Ned Sharpless to push over-the-counter monograph reform through the agency.

“Though millions of Americans depend on nonprescription OTC products, oversight of the market has been burdened by an outdated framework and a lack of agency resources,” the groups said, in an April 24 letter.

The groups called on Sharpless to work with Congress to pass the Over the Counter Drug Safety, Innovation and Reform Act, which would scrap the notice-and-comment rulemaking process of over-the-counter approval that critics say is delaying needed medicines from reaching the market.

The letter was signed by the American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American Public Health Association, the Consumer Healthcare Product Association, the March of Dimes, the National Association of County and City Health Officials, the Pew Charitable Trusts and the Society for Maternal-Fetal Medicine.

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