CONGRESS REFOCUSES ON GENERIC BIODRUG APPROVALS

Pharmacy Times, Volume 0, 0

Congressional leaders are puttingrenewed pressure on the FDA to streamlineapprovals of generic drugs, especiallybiogenerics. In a letter to FDA CommissionerAndrew von Eschenbach, MD,House Energy and Commerce CommitteeChairman John Dingell (D, Mich) andOversight Subcommittee Chairman BartStupak (D, Mich) called on the agency toprovide Congress with an accounting ofthe generic drug approval backlog for thepast 4 years.

A key objective of the inquiry is to determinethe effectiveness of the FDA's Officeof Generic Drugs, they said. "Among theissues of particular interest in this inquiry isthe failure of the FDA to use its existingauthority to approve generic biopharmaceuticaldrugs," they told the agency.Renewed House interest in this area couldlead to the resurrection of legislation introducedlast year directing the FDA to establishprocedures for reviewing and approvinggeneric versions of biologic drugs.