Healthy Skepticism Library item: 12767

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Publication type: Journal Article

Hopkins Tanne J.
FDA is failing to inspect drug and device makers, government reports say
BMJ 2008 Feb 9; 336:(7639):297
http://www.bmj.com/cgi/content/extract/336/7639/297?etoc

Abstract:

The US Food and Drug Administration has not met its legal requirements to inspect US and foreign medical drug and device manufacturers, and it has not provided effective oversight of domestic and imported food, according to two reports by the General Accountability Office, the independent investigative arm of Congress.

The reports, both released on 29 January, said that the FDA’s science base, scientific workforce, and information technology infrastructure were weak and inadequate.

In November the FDA’s subcommittee on science and technology found “substantial weaknesses across the agency.”

At a hearing of the subcommittee on oversight and investigations of the committee on energy and commerce of the House of Representatives on 29 January, Peter Barton Hutt, the FDA’s former chief counsel, said that the FDA’s annual budget of $2bn (£1bn; 1.4bn) should be doubled and its staff increased by 50% over the next two years.

Andrew von Eschenbach, the FDA’s head, . . .