Congress asks for investigation of FDA resources and staffing

BMJ 2008; 336 doi: (Published 06 March 2008) Cite this as: BMJ 2008;336:525
  1. Janice Hopkins Tanne
  1. 1New York

    Congressional committees have made two requests for investigations to determine whether the US Food and Drug Administration (FDA) has the resources and staff to do its job of protecting the US public.

    The agency is responsible for ensuring the safety and effectiveness of a wide range of consumer products, including 80% of the nation’s food supply and human and veterinary drugs, biological products, medical devices, cosmetics, and products that emit radiation.

    Four committees of the US House of Representatives and the Senate asked the General Accountability Office, the independent investigative arm of Congress, to look into the FDA’s staffing and resources.

    Congress Daily reported that the accountability office will undertake the investigation. Marcia Crosse, the office’s healthcare director, said that the investigation would involve several teams, but she did not give a time schedule (, 26 Feb, “Probe of FDA gets support from key lawmakers”).

    The request came from four Democratic members of Congress: Californian Henry Waxman, who chairs the House Oversight and Government Reform Committee; the Massachusetts senator Edward Kennedy, who chairs the Senate’s Health, Education, Labor, and Pensions Committee; and the Michigan representatives John Dingell, chairman of the House Energy and Commerce Committee, and Bart Stupak, chairman of the Energy and Commerce Committee’s subcommittee on oversight and investigations.

    In late January some of the same Congressional committees asked the FDA’s own subcommittee on science of its Science Advisory Board to review the FDA’s needs.

    The science subcommittee had reported late last year that “FDA can no longer fulfill its mission without substantial and sustained additional appropriations.”

    Last year the General Accountability Office said that the FDA was failing to inspect drug and device manufacturers as required and could not ensure the safety of food and the products it oversees because of lack of funding, staff shortages, and problems with its information technology (BMJ 2008;336:297, 9 Feb doi: 10.1136/bmj.39482.413137.DB). The FDA has faced criticism recently over the recall of heparin produced from Chinese ingredients (BMJ 2008;336:412-3, 23 Feb doi: 10.1136/bmj.39496.419248.DB).

    Last month the Washington Post reported that the FDA had issued 14 drug safety advisories since November 2007—more than the agency has issued in some entire years (, 26 Feb, “Why all the drug alerts”).

    Critics had said that the FDA was too slow in issuing alerts. Now the FDA issues an “early communication” about new drug problems, a “public health advisory” to the public telling people to consult their doctors about a drug that may be a serious risk, and a “question and answer” communication for doctors that helps them answer questions from their patients.

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