Earlier this week, I made a post based on an Xconomy article covering the FAST and TREAT bills in the congress presently aimed at speeding up the drug approval process. In a nutshell, these bills would create a pathway for drugs for to be approved more quickly (after small phase II studies) for serious conditions without better treatment options. It is essentially taking the idea of the AIDs drug approval model and applying it more widely. Companies would have to do serious post-market follow up as well and drugs could be pulled from the market if they didn't live up to their pre-approval billing.
Now BIO has come out for the bills, but PhRMA has NOT. Some observers and analysts are viewing this very cynically with regard to Big Pharma behaviour and are essentially accusing them of scuttling the bill for their own purposes. Namely? Big Pharma wants to keep Biotechs as a novel drug producing farm system from which they can acquire new drugs, rather than give the Bio's the possible ability to launch drugs on their own.
"Sen. Hagan's proposal would have been devastating to the big pharma R&D oligopoly," writes Roy. "If small biotech companies could get their drugs tentatively approved after inexpensive phase II studies, they would have far less need to partner those drugs with big pharma. They could keep the upside themselves and attract far more interest from investors. Big pharma, on the other hand, would be without its largest source for innovative new medicines: the small biotech farm team."
Pretty strong words and sounds a bit too true to just dismiss doesn't it? Let's hope not. I hope that Big Pharma can stand on its own two feet to develop its own products if it has to do so. If not, they should become investment bankers not drug developers. See Fierce Biotech and In the Pipeline.
Posted by Bruce Lehr Mar 16th 2012.