Pew and Partners Encourage Congress to Reform Regulation of Over-the-Counter Drugs

On April 28, The Pew Charitable Trusts and six other organizations sent a joint letter to the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee urging members to comprehensively reform the Food and Drug Administration’s monograph system for over-the-counter drugs and allow for industry user fees as part of the FDA Reauthorization Act.  The drug and device industry pays these fees—which are authorized by Congress every five years—to FDA, and they represent a crucial part of the agency’s budget. Manufacturers of over-the-counter drug products do not pay user fees, however, and the system by which they are regulated is inefficient and under-resourced. The letter was also signed by the Consumer Healthcare Products Association, the American Public Health Association, the March of Dimes, the National Association of County and City Health Officials, the American Academy of Allergy, Asthma & Immunology, and the American Academy of Pediatrics.