Are drug makers buying FDA approval?
In 1992, the U.S. Food and Drug Administration began
receiving much of its income from the companies it's supposed to
regulate: the drug manufacturers. At the time -- and ever since --
critics said the plan, called the Prescription Drug User Fee Act (PDUFA),
is like asking the wolf to guard the sheep. When their salaries come
from the drug makers, there can be little assurance that FDA officials
will put public safety first.
Time has proven the critics right. A new government
report shows that since the PDUFA was implemented, an increased number
of newly approved drugs have been found to be unsafe and have been
withdrawn.
This isn't the first time that flaws in the FDA
policy have been exposed.
In 1998, the health consumer advocacy group Public
Citizen conducted a survey of the physicians who review new drug
applications -- the people who are supposed to be the final judges as
to whether a drug is approved. It found that, in the previous three
years, the reviewing physicians had opposed the approval of 27 drugs
-- yet all got the go-ahead from the FDA! The report documented how
physicians were precluded from presenting data adverse to the drugs
they were reviewing at FDA Advisory Committee meetings.
The General Accounting Office's (GAO) conclusions
confirm the major public health consequences of PDUFA, which
introduced private money, and therefore influence, into the drug
approval process, creating a massive conflict of interest. One result
of PDUFA has been the diversion of agency funds to the review process
from other areas, including post-marketing safety surveillance.
FDA approvals of unsafe drugs have led to
unnecessary patient deaths and illnesses, as well as poor morale among
drug reviewers (the GAO report also documents that staff turnover is
higher among FDA scientists than among scientists in other government
agencies).
"Congress should immediately conduct meaningful
oversight hearings on each of the drugs that has been withdrawn for
safety reasons," argued Peter Lurie, deputy director of Public
Citizen's Health Research Group. "Drug makers have benefited from
PDUFA, making millions in profits off drugs that should never have
been brought to the market. Congress must adequately fund the FDA's
drug approval activities and remove private influence from the
equation."
SOURCE: GAO Report Backs Link Between
Drug User Fees and Higher Rate of Drug Withdrawals, Public Citizen,
Sept. 25, 2002.
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