Reform Needed at the Food and Drug Administration

Reform Needed at the Food and Drug Administration

One-Size-Fits-All Mandates Don’t Work for Individual Patients
August 14, 2008

Washington,
D.C., August 14, 2008—In order to
best serve the interests of the nation’s patients and doctors, the structure of
the Food and Drug Administration desperately needs to be systematically reformed,
according to a new study published by the Competitive Enterprise Institute.

In FDA’s
Bad Medicine: How the Dispersed Knowledge Problem Affects Drug Safety Analysis
,
authors Jerome Arnett, M.D.,
and Gregory Conko argue that
the very structure of the FDA prevents it from doing its job—making sure safe
and effective medical treatments reach patients in need.

“Every day, thousands of physicians and patients make
myriad choices from available drug options,” write Conko and Arnett. “They take
into account differences in effectiveness, side effects, and drug interactions
for each individual patient. FDA scientists may know a lot about the drugs they
evaluate and their average effects on thousands of users, but they know nothing
about the individualized physiology of each patient. On the other hand,
intensively trained clinical physicians, who do have knowledge of individual
patients, are best able to advise them if a drug is appropriate.”

Because the FDA uses the blunt tool of completely banning drugs
that aren’t safe for all patients, there will almost always be those who lie
outside the average, and for whom unapproved treatments are not just
appropriate, but medically necessary. The government should be encouraging a
more personalized approach to treatment, with physicians utilizing multiple
sources of information and guidance in tailoring the best possible strategy for
each individual patient.

“A market-based approach to drug safety information,
combined with technological advances in diagnostic science, will lead to a more
vibrant medical marketplace—and better outcomes for patients,” conclude Arnett and
Conko.

Additional
Resources

* Read the executive
summary
or the full
report
(in PDF).

* Watch the CEI video
on the problems with the FDA drug approval process.

* Watch “The Simpleton’s Guide
to the Food and Drug Administration” on YouTube.

* Read more on CEI’s work on health and safety policy.

CEI is a non-profit, non-partisan
public policy group dedicated to the principles of free enterprise and limited
government. For more information about
CEI, please visit our website at www.cei.org.