P.M. BRIEFING : New Generic Drug Questions Raised
The congressman leading the yearlong federal investigation of the generic drug industry today raised new questions about the safety of generic epilepsy drugs and other generics whose effectiveness depends on exact dosage.
Rep. John D. Dingell disclosed that he has asked the U.S. Food and Drug Administration to expand its surveillance of the generic drug industry to cover all epilepsy drugs as well as all other generic drugs for which dosage must be kept within a narrow range to work.
“The demonstrated failures in the generic drug approval process make essential a review of the dissolution and potency of sensitive generic drugs currently being marketed,” the Michigan Democrat wrote to FDA chief Frank E. Young.
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