With the Senate poised to vote tomorrow on PDUFA, the House is taking up consideration of legislation that would create a regulatory pathway for generic biotech drugs, or follow-on therapies. Rep. Henry Waxman introduced the biogeneric bill last February. Advocates say that the best shot to gain passage of the bill would come if it is folded into PDUFA reauthorization, which would enable the FDA to gather fees from drug developers for another five years. So far, however, that hasn't happened, which could endanger any follow-on legislation from gaining acceptance. The Senate dropped a move to add the generic legislation to the PDUFA bill and lawmakers say they will take up the issue separately. One of the first biotech companies to face generic competition, if it is approved, is Amgen, which makes Epogen and Neupogen.
- read the report from CNN
- and here's the article on PDUFA from The New York Times