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[quote=Anonymous]If you REALLY want to attack the system, you need to basically kill off PDUFA mandates.  The FDA isn't even really funded by the US govt and taxpayers.  They are funded through user fees paid by the pharmaceutical industry.  Every 5 years the FDA has to beg like lapdogs with pharma industry lobbyists and reps for funding (PDUFA negotiations). In exchange, pharma asks for certain things in return.

It does open the door for undue influence by industry on the institution that regulates it since they control the purse strings.  You could kill PDUFA.  The problem is that Congress would have to step in and fill in the billions of dollars in loss of funding. The whole program exists in the first place because the US govt would never provide enough money before to allow FDA to keep up with technology and hire enough staff to keep up the number of submissions that came in.  Pharma industry itself came up with this solution in order to give FDA more money to hire more staff to review drugs.  Before this existed, it would take years and years for drugs to be reviewed since there wasn't enough staff.  Companies had to file things on paper because FDA couldn't afford to modernize its IT infrastructure.  Drugs that would potentially be able to treat people were stuck in review for years.

If you could give iron clad guarantees that FDA would be adequately funded by USG going forward, then I'd agree - kill PDUFA and get rid of the conflict of interest.  But we all know the USG can't do that since funding will always be politicized or held hostage (e.g. block FDA funding because of abortion pills). So we are back to square one again and have to rely on PDUFA.  Otherwise, it will take far too long to approve drugs since they won't have nearly enough staff to handle the volume (for vaping alone they received over 1,000,000 applications to review).  It will kill one for the US' biggest industries that makes it a technical super power in the world.  Love it or hate it, pharma is a golden goose for the US that provides tons of high paying jobs and is a symbol of US power. China is desperate to try to catch-up to the US in biotech. [/quote]

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