FDA Reform Debate Heating Up As Senate, House Propose Bills

House Propose Bills Companies, scientists, and patient-advocacy groups all applaud the ultimate objective of recently introduced legislation designed to get effective drugs to patients more quickly. However, not everyone agrees that the current versions of the Senate and House bills to reform the Food and Drug Administration are the way to accomplish the goal. DISSENTER: Edward Kennedy (D-Mass.) voted against the Senate bill. Proponents say the bills move reform in the right direction. Mean

Written byKaren Young Kreeger

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DISSENTER: Edward Kennedy (D-Mass.) voted against the Senate bill.

Proponents say the bills move reform in the right direction. Meanwhile, detractors worry that an emphasis on speeding drugs through approval could be harmful to patients and pharmaceutical research. They also believe that the proposed bills, which call for privatizing the FDA review process, pose conflict-of-interest problems and create disincentives for clinical investigations, especially for rare and life-threatening diseases.

REVISIONIST: Nancy Kassabaum (R-Kan.) sponsor of the Senate FDA reform bill. In late March, the Senate Labor and Human Resources Committee approved the FDA Performance and Accountability Act, ...

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