Agreement Near On FDA Reforms And PDUFA

Consensus is close for adding non-controversial US Food and DrugAdministration reforms to the Prescription Drug User Fee Act re-authorization bill now pending in Congress. The FDA and the Pharmaceutical Research and Manufacturers of America have agreed on this issue, according to PhRMA president Alan Holmer. He told those attending a press briefing that Health and Human Services Secretary Donna Shalala, Senator Edward Kennedy and the Patients Coalition have agreed in principle, but are stressing that these need to be broadly-acceptable issues.

At a recent hearing of the Senate Labor and Human Resources Committee on the subject of PDUFA re-authorization and FDA reform, Amgen chairman Gordon Binder spoke on behalf of both the PhRMA and the Biotechnology Industry Organization in support of the re-authorization and also made some concrete suggestions about FDA reform.

Conservatives, as well as moderate legislators from each party on the this Senate Committee are likely to support consensus items, Mr Holmer said. There also seems to be agreement on the Senate side that this bill should be dealt with before the end of the current fiscal year (ending September), with Senator Jeffords noting that he would like a bill presented by mid-year. As for the House, Mr Holmer noted that the education of the House staffers on this issue continues, and there seems to be a substantial level of enthusiasm here too to get something meaningful passed.