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jimmy667

03/21/19 2:23 AM

#185982 RE: Steady_T #185981

The PDUFA is possibly to blame for the mess-up in drug development. For which one can as usual and should blame Congress and the lobbyists for BP. As an upstream tax on research and development is stiffles it. The FDA should not be funded by a development tax but rather downstream tax on all drugs approved and marketed or general revenue as in the DoD.
Pharma Drug User Fee Act favors BP and easy to approve indications or label modifications to existing drugs and disfavors hard to crack indications and smaller market drug indications and of course as intended by BP lobbyists smaller upstart Biotech. The only way rare indications are pursued is by the Orphan designations. It is a complex issue but the way the FDA is currently funded is inconsistent with precision medics as drug are targeted to select individual subsets of an indication as in oncology currently so become a an economic issue.

tradeherpete

03/21/19 2:25 AM

#185983 RE: Steady_T #185981

They tell the companies how they need to go about proving the research that Pharma wants to turn into a marketable drug.


Are you defending Biogen’s right to subject one human being to their outdated methods that have been shown to be worthless?

tradeherpete

03/21/19 12:20 PM

#186100 RE: Steady_T #185981

Quote:
They tell the companies how they need to go about proving the research that Pharma wants to turn into a marketable drug.

Are you defending Biogen’s right to subject one human being to their outdated methods that have been shown to be worthless?


How could the FDA continue to support Biogen without being culpable in a courtroom? The ruse has played out.

imo