Patient Groups View FDA Modernization/PDUFA Bill

Voicing objections to the Senate version of the US Food and DrugAdministration reform legislation because it does not strengthen protections for patients, patient organizations are now concentrating on the House version, which is currently under discussion in the Commerce Committee.

BioWorld Today reports that Committee staff who will produce the bill (which also reauthorizes the Prescription Drug User Fee Act of 1992) have already met several times with various groups, including the Center for Science in the Public Interest, the Consumer Federation of America, Public Citizen and the Patients' Coalition.

Had patient advocacy groups been involved in early discussions on consumer issues which the Senate staff had with industry and the administration, the Senate version of the FDA Modernization and Accountability Act would have made it to the floor before the August recess, says Jeff Bloom of the Patients' Coalition. It is now expected that the Senate will vote on the bill this week.