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Editor's Correspondence
April 9, 2007

Sweeping Changes to Food and Drug Administration and Drug Safety Regulations

Author Affiliations

Copyright 2007 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2007

Arch Intern Med. 2007;167(7):732. doi:10.1001/archinte.167.7.732-a

In their recent commentary, Furberg et al1 make recommendations to improve Food and Drug Administration (FDA) and current drug safety regulations. The authors fail to address 2 critical points: (1) the need to improve mechanistic assessments of new drug safety prior to FDA approval and (2) the need for sweeping changes in practice of medicine.

Their proposal for empirical determination of drug safety through postmarketing study commitments and for FDA authority over their conduct may improve our long-term understanding of safety. However, this approach assumes that a safety issue has already been identified by the time of FDA approval. Also, it benefits only those who begin using the product after such safety studies are completed, results published, and clinical care modified.

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