FDA, EPA Programs Tagged For Reform

FDA's oversight of drugs and EPA's assessment of chemicals are among the federal programs in greatest need of reform, the Government Accountability Office (GAO) says in a report (GAO-09-271) released on Jan. 22. The U.S. consumer may not be adequately protected from unsafe and ineffective medical products, GAO says, recommending that FDA conduct more inspections of foreign plants that make pharmaceuticals exported to the U.S. In addition, it says FDA needs to review more systematically the claims made in advertising and promotional materials for drugs and ensure that drugmakers accurately report the results of clinical trials. Meanwhile, GAO takes aim at EPA's Integrated Risk Information System for commercial chemicals, a database that is widely used by regulators in the U.S. and abroad. EPA needs to streamline and allow greater public scrutiny of its chemical assessment process, GAO concludes. In addition, GAO says EPA "requires additional authority than currently provided in the Toxic Substances Control Act to obtain health and safety information from the chemical industry and to shift more of the burden to chemical companies to demonstrate the safety of their products." The authority would have to come from Congress.