FDA is failing to inspect drug and device makers, government reports say

doi:10.1136/bmj.39482.413137.DB

BMJ 2008;336:297 (9 February), doi:10.1136/bmj.39482.413137.DB

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FDA is failing to inspect drug and device makers, government reports say

Janice Hopkins Tanne

¹ New York

The first 150 words of the full text of this article appear below.

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

The reports, both released on 29 January, said that the FDA’sscience base, scientific workforce, and information technologyinfrastructure were weak and inadequate.

In November the FDA’s subcommittee on science and technologyfound "substantial weaknesses across the agency."

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