GAO Tags FDA, EPA Programs For Reform

The Food & Drug Administration's oversight of drugs and the Environmental Protection Agency's assessment of chemicals are among the federal programs in greatest need of reform, the Government Accountability Office (GAO) says in a report released on Jan. 22.

The investigative arm of Congress, GAO added these two programs along with the regulation of U.S. financial systems to its list of some two dozen government programs at high risk for waste, fraud, abuse, and mismanagement. GAO updates the list every two years, when a new Congress convenes.

Gene L. Dodaro, acting comptroller general of the U.S. and head of GAO, hopes that the addition of these programs to the list of high-risk federal operations will lead to greater scrutiny of them by Congress and spur reform.

Saying the U.S. consumer may not be adequately protected from unsafe and ineffective medical products, GAO makes several recommendations for FDA. For instance, the agency needs to conduct more inspections of foreign plants that make pharmaceuticals exported to the U.S., GAO says. In addition, FDA needs to review more systematically the claims made in advertising of and promotional materials for drugs, GAO continues. The agency also needs to ensure that drugmakers accurately report the results of clinical trials.

Meanwhile, GAO, a longtime critic of EPA's Integrated Risk Information System for commercial chemicals, takes aim at this database, which is widely used by regulators in the U.S. and abroad. According to GAO, EPA struggles to keep information on individual chemicals current and to augment the database with assessments of additional substances. The agency finished only nine chemical assessments in the past three years and has scores of pending assessments that have been in process for more than five years, GAO says. EPA needs to streamline and allow greater public scrutiny of its chemical assessment process, GAO concludes.

GAO also recommends that Congress amend the law that EPA uses to regulate the manufacture of chemicals and that it require companies to generate more health and environmental data about their products. 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," it says.

The report is available at www.gao.gov/new.items/d09271.pdf.