GDUFA? Probably Not This Time

We had an interesting discussion today on the state of the FDA and the impact of the power shift in Washington. Joining me on the conference call, which you can access by clicking here, were biotech PDUFA negotiator Amit Sachdev and former Senate Health Counsel Steve Irizarry.

We touched on way too many issues to discuss here, but one intersting thing to come up was generic drug user fees. The idea of user fees for generic drugs was pushed by senior FDA officials earlier this year. In fact, a senior policy person at the generic drug industry's trade organization - GPhA - just left to join FDA's policy shop to work specifically on generic policy.

But from the sounds of it, generic drug user fees aren't happening for now. It sounds like it could take a while to hammer out. One scenario could have an abbreviated biologics pathway attached to GDUFA legislation at some point down the road, if it doesn't happen in stand-alone legislation proposed by Henry Waxman and co-sponsored by Senator Hillary Clinton.

BIO's Sachdev said that the new Congress gives BIO an "opportunity" to "educate" new members on biologics and the complexities behind the follow-on biologic debate. I think everyone can read between the lines.