Findings from these studies could lead to the FDA requiring genetic tests to determine risk before the drug is prescribed, Woodcock added.
A recent survey found that most Americans are more concerned with drug safety than with speeding more medications to the marketplace.
Members of the consortium include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Roche, Sanofi-Aventis and Wyeth. In addition, the FDA will consult on the design and conduct of SAEC studies.
The actual research will be done at academic centers in Europe and the United States.
The results of the studies will be made public domain, and none of the companies will have early access or be allowed to patent the findings. When the results are made public, any company can develop and sell the genetic tests that predict side effects.
SAEC is one of several consortiums formed by the pharmaceutical industry to conduct basic research. One of the first was started in 1999 and was headed by Holden. That consortium looked for DNA variations among people. Their data were also put into the public domain.
For more on drug safety and side effects, visit the U.S. Food and Drug Administration.
SOURCES: Sept. 27, 2007, teleconference with Janet Woodcock, M.D., deputy commissioner and chief medical officer, U.S. Food and Drug Administration; Arthur Holden, chairman, International Serious Adverse Events Consortium; and Paul Watkins, M.D., Verne S. Caviness Distinguished Professor of Medici
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