Here's some comic relief ...
Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.
According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.
Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)
Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.
Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.
Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.
Hey Mo -- that's a good one -- separating safety from effectiveness.
Take my legislation -- please.
Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.
According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.
Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)
Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.
Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.
Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.
Hey Mo -- that's a good one -- separating safety from effectiveness.
Take my legislation -- please.
