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Editor: Christopher J. Robinette
Widener Univ. School of Law

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Saturday, September 23, 2006

New Drug Safety Study

The NYT summarizes the Institute of Medicine study:

The nation’s system for ensuring the safety of medicines needs major changes, advertising of new drugs should be restricted, and consumers should be wary of drugs that have only recently been approved, according to a long-anticipated study of drug safety.

The actual report can be found here.  More specific proposals (again from the NYT):

The report made these recommendations, most of which would require Congressional authorization:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

(My usual disclosure: I did pharmaceutical tort defense in practice and remain a consultant to pharmaceutical companies in mass tort litigation.)

http://lawprofessors.typepad.com/tortsprof/2006/09/new_drug_safety.html

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