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Journal of Environmental Pathology, Toxicology and Oncology
IF: 1.241 5-Year IF: 1.349 SJR: 0.519 SNIP: 0.613 CiteScore™: 1.61

ISSN Print: 0731-8898
ISSN Online: 2162-6537

Journal of Environmental Pathology, Toxicology and Oncology

DOI: 10.1615/JEnvironPatholToxicolOncol.v29.i2.10
pages 81-84

A Need for Reorganization of the Food and Drug Administration

Richard Edlich
Legacy Verified Level I Shock Trauma Center Pediatrics and Adults, Legacy Emanual Hospital; and Plastic Surgery, Biomedical Engineering and Emergency Medicine, University of Virginia Health System, USA
Shelley S. Mason
Multiple Sclerosis Research Fund, Brush Prairie, WA, USA
Jill S. Reddig
Multiple Sclerosis Research Fund, Brush Prairie, WA, USA
K. Dean Gubler
Surgical Critical Care, Legacy Verified Level I Shock Trauma Center for Pediatrics and Adults, Legacy Emanuel Hospital, Portland, OR, USA
William B. Long III
Trauma Specialists LLP, Legacy Verified Level I Shock Trauma Center for Pediatrics and Adults, Legacy Emmanuel Hospital Portland, OR, USA

ABSTRACT

The associate director for science and medicine in the Office of Drug Safety at the Food and Drug Administration (FDA), Dr. David Graham, reported that the FDA was incapable of protecting Americans from unsafe drugs. In testimony to the Senate Finance Committee, he stated that the FDA has let the American people down and betrayed public trust. Drastic changes and measures within the FDA must be made to ensure the safety of American consumers of drugs, products, and medical devices. Efforts such as the introduction of the Grassley-Dodd Bill, allowing the FDA to order immediate drug recall or increased risk warnings, followed by the FDA Safety Act of 2007, are still not enough to ensure the safety and efficacy of drugs, biological products, and medical devices that the American public use every day. In this report, we describe past and present efforts by congressional leaders, FDA representatives, and American citizens to effect changes within the FDA in order to protect America from unsafe drugs and medical devices. We describe our own struggles in passing a citizen’s petition to ban cornstarch in medical gloves, and the lack of response and responsibility that the FDA has displayed.


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