HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, March 2, 2005

FDA Requests Greater Labeling Authority

Yesterday, the Food and Drug Administration (FDA) asked Congress for authority to require label changes for drugs to end disputes with pharmaceutical companies that occur when a health risk arises.  The Associated Press reports that Sandra L. Kweder, the FDA's deputy director for new drugs, testified that after the dangerous side effects of Vioxx became known, the FDA had to negotiate the wording of the new warning label with Merck & Co. (the manufacturer of Vioxx), which delayed information to the public about health concerns.  The Senate Committee on Health, Education, Labor and Pensions will hold a second day of testimony concerning potential changes to the FDA later this week.  [bm

Meanwhile, the Consumer's Union, an organization created to help improve the access and safety of prescription drugs, provides a different option for improving drug safety.   Click here.  Thanks to blog.bioethics.net for this website.

http://lawprofessors.typepad.com/healthlawprof_blog/2005/03/fda_requests_gr.html

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