A need for reorganization of the Food and Drug Administration

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.