Editor's Correspondence
July 11, 2011

The FDA's Defensive Status and How It Affects Patient Care

Author Affiliations

Author Affiliation: Integrated Health Associates and Department of Internal Medicine, University of Michigan, Ann Arbor.

Arch Intern Med. 2011;171(13):1217. doi:10.1001/archinternmed.2011.291

The US Food and Drug Administration (FDA) has an immense task in assuring that our medications are safe for our patients. The FDA must respond to the pressures of politicians, media outlets, public interest groups, vocal physicians, and manufacturers. I have been a practicing internist for 30 years, and currently it appears that the FDA has swung into a defensive mode, resulting in fewer new drug approvals and more withdrawals of older drugs that were approved using different standards.

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