FDAnews Drug Daily Bulletin

Expert: Leave FDA Free to Create Biogenerics Approval Path

Oct. 3, 2008
As Congress drafts legislation to create a pathway for biogeneric approval, lawmakers should limit mandates that could hinder the FDA’s ability to make decisions about clinical trials and bioequivalence testing, Gregory Conko, a senior fellow at the Competitive Enterprise Institute, said at the Generic Pharmaceutical Association’s Annual Policy Conference. For instance, Congress should not mandate clinical trials but allow the FDA to decide on a case-by-case basis whether such testing is needed, he said. Giving the FDA discretion in this area will spur innovation and development of assays to prove bioequivalence.