CONGRESS REFOCUSES ON GENERIC BIODRUG APPROVALS

MARCH 01, 2007

Congressional leaders are putting renewed pressure on the FDA to streamline approvals of generic drugs, especially biogenerics. In a letter to FDA Commissioner Andrew von Eschenbach, MD, House Energy and Commerce Committee Chairman John Dingell (D, Mich) and Oversight Subcommittee Chairman Bart Stupak (D, Mich) called on the agency to provide Congress with an accounting of the generic drug approval backlog for the past 4 years.

A key objective of the inquiry is to determine the effectiveness of the FDA's Office of Generic Drugs, they said. "Among the issues of particular interest in this inquiry is the failure of the FDA to use its existing authority to approve generic biopharmaceutical drugs," they told the agency. Renewed House interest in this area could lead to the resurrection of legislation introduced last year directing the FDA to establish procedures for reviewing and approving generic versions of biologic drugs.




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