FDA Reform Bill Passes House & Senate

Statement of CSPI Integrity in Science Director Merrill Goozner

September 21, 2007

The FDA reform bill that passed the House on Wednesday and the Senate last night represents a step forward in protecting scientific integrity at the Food and Drug Administration. However, given the magnitude of the problems in drug and food safety that have come to light in recent years, the bill falls far short of spurring the dramatic changes that the public needs and deserves.

The bill caps— at the current level— the number of waivers that the agency can grant to scientists and physicians who have conflicts of interest and who are appointed to advisory panels. The bill gradually reduces that number over the next five years. That mild limitation doesn’t go far enough. The FDA certainly could find scientists without ties to industry if it truly wanted to, and we will continue to push for ending a practice that gives drug and food companies undue and unseemly influence over the regulatory process at the FDA.

We congratulate the Congress for including other provisions in the bill that will enhance the integrity of science at the agency. One measure is a requirement that all clinical trials and their results get posted in a publicly available web-based database managed by the National Institutes of Health. And we are glad that scientists at the FDA will gain greater protections to speak out and publish.


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