House FDA Bill Fails to Address Conflicts of Interest

Includes protections for scientists, promotes openness

September 19, 2007 -- The U.S. House of Representatives passed the Food and Drug Administration Amendments Act that takes steps to protect science and federal scientists at the agency, but fails to address serious conflict of interest issues, according to the Union of Concerned Scientists (UCS). The Senate is expected to pass this legislation.

The agency is in need of major reform, according to UCS experts. When UCS surveyed nearly 1,000 FDA scientists in 2006, 20 percent of the respondents stated that they had been asked by FDA managers to provide the public, the news media and government officials with "incomplete, inaccurate or misleading information."

"This legislation takes important first steps to protect FDA science and scientists and ensure public health and safety. Many reform-minded members of the House and Senate and their staffs worked very hard to produce substantive changes that begin what we hope will be an era of greater scientific integrity and reduced political interference at the agency.

"But this bill should have been much stronger. Hearing after hearing in Congress has explored the FDA's sorry record of approving unsafe drugs despite the warnings from the agency's own scientists. The bill could have ensured even greater openness and accountability inside the agency and more aggressively promoted a culture that respects scientific integrity. Our lawmakers did not go far enough.

"The biggest failing of the bill is that it doesn't adequately address the conflict-of-interest problem at the agency. Given the huge pool of qualified physicians, epidemiologists and other medical experts in this country, there is no reason that the FDA should staff its advisory panels with individuals with financial ties to the pharmaceutical and medical device companies whose products are under review. Independent science protects public health."

Source: UCS

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