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FDA is an agency in dire need of major reform

Statement of Ami Gadhia
Concerning Discussion Draft of “FDA Globalization Act”
Subcommittee on Health, Energy & Commerce Committee
U.S. House of Representatives
May 1, 2008

Good morning, Chairman Dingell, Ranking Member Barton, Subcommittee Chairman Pallone, Subcommittee Ranking Member Deal, and members of the Subcommittee. My name is Ami Gadhia, and I am Policy Counsel with Consumers Union1, the non-profit publisher of Consumer Reports magazine. I am here today to testify about the Drug, Device, and Cosmetic Safety provisions of the Discussion Draft of the Food and Drug Administration (FDA) Globalization Act. Consumers Union commends the Chairman for his leadership on the proposed legislation, and commends members of the Energy and Commerce Committee for holding today’s hearing on this critical consumer safety issue.
The FDA is the federal agency responsible for the regulation of myriad foods, drugs, devices, and cosmetics. The products regulated by this one agency represent about 25 cents of every consumer dollar spent, and are among the most intimate and important ones in our lives, including the drugs we take when we are sick and the medical devices implanted in our bodies to improve our lives. However, serious safety scares over the past few years have cast major doubt upon the ability of this beleaguered agency to adequately protect American consumers.
The call for a major overhaul of the FDA has now become a roar. According to a 1998 study by the Government Accountability Office (GAO), ten years ago, as much as 80 percent of the bulk drug substances used by U.S. drug manufacturers was imported. No doubt this number has increased in the past ten years. A more recent GAO report, issued in November 2007, put the problem in stark relief: of all foreign plants, at most only seven percent of them are inspected in a year. Of those that are inspected, these inspections are all announced to the plant owners in advance, despite FDA policy guidelines requiring that inspections be conducted without prior notification. In recent years we have seen a slide towards lax oversight and neglect of safety of imported products at the FDA. According to an April 2008 New England Journal of Medicine article, “. . .the evidence suggests that inspection needs have overwhelmed the agency’s capacity.”
For the complete testimony, click here (PDF format).