I wasn’t a bit surprised to read in a report by Reuters News that the U.S. Food and Drug Administration hasn’t been adequately protecting the public’s health. The U.S. Government Accountability Office, the watchdog arm of Congress, made findings released on January 22nd that came to this conclusion. The GAO said that “as a result, the American consumer may not be adequately protected from unsafe and ineffective medical products.” They added the FDA to its list of “high-risk” areas of the federal government and that’s not good news for consumers. As previously reported, new laws have challenged the FDA’s ability to ensure the safety of pharmaceuticals, biologic drugs and medical devices. The GAO releases its list at the start of each new Congress to help lawmakers set their priorities. The findings in this report are certainly not good news for American citizens and Congress must get busy correcting things at the FDA.
Numerous other groups, including the Institute of Medicine and various advocacy organizations, have cited the FDA’s challenges in keeping dangerous or ineffective products off the U.S. market. Even the agency itself acknowledges that it needs to be retooled. Acting FDA Commissioner Dr. Frank Torti said to members of Congress in a written statement:
We need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work. 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.
According to the GAO investigators, the FDA needs to have better data on its inspections of facilities in other countries and conduct more inspections. 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. If you would like to see the GAO updated list, go to its website: www.gao.gov/products/GAO-09-271. Also, take the time to contact your U.S. Senators and House members and ask them to get to work on this problem.
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