The Damaging Impact of PDUFA and Why It Should be Repealed

The prescription drug user fee act (PDUFA, 1992), which is up for renewal
this year, linked the Food and Drug Administration to the pharmaceutical
industry in a way that radically transformed the FDA from an oversight
agency into a financially-dependent service provider/client.  PDUFA fees pay
for expedited drug approvals. Unlike other government user fee programs, the
FDA negotiates with user agents-the Pharmaceutical Research and
Manufacturers of America (PhRMA)-about how the agency may allocate these
fees. User fees set FDA priority on speeding up the drug approval process.
The re-prioritization of rapid approvals occurred at the expense of drug
safety standards, and the consequences are documented by mounting
drug-induced injuries, hospital emergency admissions, and preventable

Drug safety scandals in the post-PDUFA era brought to light evidence that
drug companies failed to disclose results that revealed their drugs were not
only ineffective but posed life-threatening risks. A review in the Journal
of the American Medical Association (J-AMA) found: “The reporting of trial
outcomes is not only frequently incomplete but also biased and inconsistent
with protocols. Published articles, as well as reviews that incorporate
them, may therefore be unreliable and overestimate the benefits of an
intervention.” [1]  Read More…


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