GAO adds drug safety programs to high-risk list

The FDA program's management weaknesses are aggravated by soaring demand, older computer systems and a lack of clear decision-making processes, auditors report.

The Government Accountability Office has said questions about the ability of the Food and Drug Administration to ensure the safety and effectiveness of pharmaceuticals and medical devices have generated so much concern that GAO included the program area in its latest high-risk list. GAO updates its list every two years of federal programs, policies and operations that have a high risk of waste or mismanagement.

The FDA, an agency of the Health and Human Services Department, faces major problems that “compromise its ability to protect Americans from unsafe and ineffective products,” GAO said in its high-risk report released Jan. 22.

Demands on the FDA have soared in recent years with the annual applications of thousands of new drugs to be approved; monitoring of clinical trials of drugs that are being investigated; overseeing the quality of drugs already on the market; and reporting adverse events from medical products on the market, GAO said. The FDA also must inspect drug manufacturers’ facilities, an increasing number of which are overseas.

Many of the FDA’s problems are aggravated by the quality of its data sources, older computer systems and a lack of clear and effective processes for making decisions about the safety of drugs after they are on the market, GAO said.

Although the FDA recently announced plans to hire more employees and to modernize its information technology, “these initiatives will require effective implementation, and their success cannot yet be evaluated,” the report noted.

The FDA’s management of its programs to inspect drugs and medical devices made in other countries is of particular concern, said Gene Dodaro, the acting U.S. comptroller general. The databases for the FDA’s foreign inspection program are not integrated and cannot communicate with each other, so the data they produce may be unreliable, the report said. The agency is not certain of the number of foreign drug manufacturers it must inspect, and the number it inspects annually is very low, Dodaro said. GAO found the FDA inspected an average of 8 percent of its foreign drug manufacturers a year, meaning “it would take 13 years for FDA to inspect each foreign drug facility once, without any additions,” he said.

Other HHS programs that continue on the high-risk list showed improvement, GAO said. The Centers for Medicare and Medicaid Services (CMS) has strengthened Medicare’s program management, reformed Medicare's payment methods and improved its program integrity, according to the report. For example, CMS has taken steps to revamp Medicare contracting by conducting competitions for medical claims administration services and has transferred 40 percent of the Medicare claims workload to nine Medicare administrative contractors, the report noted.

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