Generic biotech drug deal looks set to fail in negotiations for final PDUFA renewal

The decision by the US House of Representatives to carry, by 403 votes to 16, the Food and Drug Administration Amendments Act of 2007 (HR 2900; Marketletter July 16) appears to ensure that the issue of renewing the FDA's prescription drug user fees will be resolved in time for the present legislation's lapsing in the fall of this year. The Senate passed its version of the bill (S 1082) at an earlier date. Together, the bills represent the renewal of the 1992 Prescription Drug User Fee Act (Marketletters passim).

The failure of the House, however, to discuss the creation of a regulatory framework for generic biotechnology drugs to get FDA approval looks set to scupper the efforts of Senators from both Democrat and Republican sides to resolve this question.

The expressed safety concerns of Representative John Dingell (Democrat, Michigan), who chairs the House Energy and Commerce Committee, on bioequivalence for generic versions of biotechnology products suggest that no deal is to be expected at the bicameral conference. Rep Frank Pallone (Democrat, New Jersey) the chairman of the Health Subcommittee, told the CongressDaily: "I don't want to be too positive." He added that negotiations were due to begin almost immediately after passage of the FDA Amendment Act.