Another GAO Report Faults FDAJan 23, 2009 | Parker Waichman LLP
In a recent government report, the U.S. Food and Drug Administration (FDA) has been found incapable of fully protecting Americans. Congress’s U.S. Government Accountability Office (GAO) released its findings yesterday saying that the FDA is, according to Reuters, “hampered by increasing globalization and a rise in complex products,” and might not be up to the task of protecting public health.
SmartBrief also reported that the GAO called federal regulators outdated and inadequate, finding significant problems in federal regulation. Noting that, as concerned the FDA, "… the American consumer may not be adequately protected from unsafe and ineffective medical products," said the GAO, according to Reuters, which also said that the GAO included the FDA in its list of "high-risk" federal government areas. The GAO list is released with each new Congress to better enable it to determine priorities. The report also pointed out that emerging regulations were affecting the agency’s ability to ensure public safety concerning pharmaceuticals, biologic drugs, and medical devices.
The Institute of Medicine, among others, including a number of advocacy groups, have long noted the problems the FDA is facing in preventing dangerous drugs and devices from reaching consumers and even the FDA has acknowledged its shortcomings, reported Reuters. "We need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work," said Acting FDA Commissioner Dr. Frank Torti, quoted Reuters. "For many issues of risk, science does not give us all the answers. When we do not yet know the answers, the FDA will be honest and forthcoming about our uncertainty," Torti added in his statement; the statement was addressed to members of congress, consumers, scientists, and companies.
For one thing, said GAO investigators, the FDA must have improved data on its overseas facilities inspections and must also increase the number of inspections it conducts, said Reuters. It also must "more systemically review the claims made in drug advertising and promotional material, and ensure that drug sponsors accurately report clinical trial results," the GAO said.
The information was released at a news conference this week, said the Washington Post, and listed 30 areas among federal programs or operations that are at high risk for waste, fraud or abuse, or in need of broad transformation. The report said the FDA cannot appropriately manage inspections of foreign products because of problems in its databases and because it lacks staff. "This clearly needs to change since more and more of our drugs and devices are coming from foreign sources," said Gene Dodaro, acting GAO comptroller, according to the Washington Post.
Meanwhile, many critics of the FDA have long been complaining of the corruption, conflicts of interest, and budgeting and system problems that appear to be routine at the agency. This week, in the wake of President Barack Obama’s entry into the White House, one of the FDA’s most outspoken critics—Cleveland Clinic’s Dr. Steven Nissen—contributed to a public opinion piece geared to the new president on what he “needs to do to move beyond the Bush legacy," said WebMd’s The Heart, quoting Nature. Also, eearlier this month, some scientists at the FDA wrote to the president’s transition team basically begging for help and outlining a number of problems with an agency they described as “fundamentally broken,” reported The Wall Street Journal.