US PDUFA renewal debates generic biologics

The US Senate's Committee on Health, Education, Labor and Pensions has discussed the regulatory framework for generic biologics, as part of a wider review of the Prescription Drug User Fee Act, which is up for renewal by Congress this year.

Republican Senators Orrin Hatch (Utah) and Michael Enzi (Wyoming) expressed concerns about proposals to authorize generic biotechnology drugs on safety and intellectual property grounds.

According to analysts Lehman Brothers, there could be competing bills presented to the Senate to vote on for inclusion in the renewed-PDUFA. However, time constraints make it possible that seperate legislation for a follow-on biotechnology drug approval process will be required.