U.S. Panel Recommends Licensing Thalidomide
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BETHESDA, Md. — A government advisory panel voted Friday to recommend approval of thalidomide, a drug notorious for causing birth defects but which offers dramatic cures for diseases ranging from leprosy to AIDS. The Food and Drug Administration committee heard two days of testimony about the safety and efficacy of Celgene Corp.’s version of the drug, known as Synovir, in treating a painful side-effect of leprosy.
In an unusual move, the panel advised licensing of all versions of the drug, not just Celgene’s formulation. However, they recommended severely restricting access to the drug.
The FDA is not bound to follow the panel’s advice, but usually does.
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