Lack of FDA Resources Puts Public Health at Risk, GAO Report Says
January 28, 2009The U.S. Food and Drug Administration is being stretched beyond capacity – a problem that puts the public at risk of bad drugs and unsafe products, especially from abroad, according to a report by the Government Accountability Office (GAO).
The agency’s resources have not kept pace with “the growing demands placed on it,” according to the report.
“New laws, the complexity of items submitted to FDA for approval, and the globalization of the medical-products industry are challenging FDA’s ability to guarantee the safety and effectiveness of drugs, biologics, and medical devices,” according to the 2009 “high-risk” list assembled by the GAO.
The assessment also found fault with the manner in which the FDA inspects – or, more often, doesn’t inspect – drugs abroad, saying that “the agency conducts relatively few inspections of foreign establishments.”
The report said the FDA may inspect only about eight percent of nearly 3,300 estimated foreign drug-manufacturers subject to inspection in a given year, a pace that would take the FDA more than 13 years to complete.
“As a result, the American consumer may not be adequately protected from unsafe and ineffective medical products,” the assessment said.
The assessment said the FDA is further crippled by language barriers and the inability to conduct unannounced inspections of foreign manufacturers, something that is done often domestically.
The “risk-list” is a biennial report released at the beginning of each Congress that details what it deems to be threatening flaws within government programs and practices, and outlining issues that carryover from past administrations.
“Federal waste and troubled programs don’t leave office with an outgoing President,” Rep. Darrell Issa (R-Calif.) said of the assessment. “If President Obama takes 30 minutes to review this report he won’t read about the failures of three predecessors, but about the continuing failure of a nonpartisan federal bureaucracy that is resistant to reform.”
The report’s release coincided with President Barack Obama’s plan to increase the amount of drugs imported from other countries in order to help make health care affordable for all Americans.
According to the health care agenda posted on the White House Web site, the president’s administration will be looking to “lower drug costs by allowing the importation of safe medicines from other developed countries.”
The GAO report, meanwhile, noted several other areas where the FDA is falling behind, including oversight of clinical trials and monitoring the post-market safety and promotional materials of medical products.