GAO Designates 3 New 'High-Risk' Areas: EPA, FDA, Financial Reg System

Since 1990, the U.S. Government Accountability Office has issued biennial reports on areas of the federal government it deems as "high risk" and therefore in need of special attention by the president and Congress. Areas are identified in some cases as high risk because of their greater vulnerabilities to fraud, waste, abuse, and mismanagement, but also if they are found needing broad-based transformation to address major economy, efficiency, or effectiveness challenges. In GAO's latest 2009 update for the 111th Congress and President Obama, the agency designated three new high-risk areas, focusing on the U.S. Financial Regulatory System, the FDA's oversight of medical products, and EPA's processes for assessing and controlling toxic chemicals.

The U.S. Financial Regulatory System, GAO says in the report, is outdated and needs to be modernized. Significant market developments have, in recent decades, outpaced a fragmented and outdated regulatory structure, GAO says, making significant reforms to the system critically and urgently needed. According to the report, the current regulatory approach has significant weaknesses that if not addressed will continue to expose the U.S. financial system to serious risks. Determining how to create and implement a regulatory system that reflects new market realities is a key step to reducing the likelihood that our nation will experience another financial crisis similar to the current one.

GAO's report also lists as a high risk the ability of government to protect public health through oversight of medical products and devices, and says that oversight must be enhanced. The report focuses on concerns involving FDA's ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and medical devices. "GAO's work examining a variety of issues at FDA echoes the conclusions reached by others that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results," says the report.

Finally, according GAO, EPA needs to transform its processes for assessing and controlling toxic chemicals. EPA does not have sufficient chemical assessment information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks, the report says, adding that actions are needed to streamline and increase the transparency of the Integrated Risk Information System and to enhance EPA's ability under the Toxic Substances Control Act to obtain health and safety information from the chemical industry.

To access the 99-page report and read GAO's recommended solutions, go to www.gao.gov/new.items/d09271.pdf.

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