Finding Alternatives to the Food and Drug Administration
By Richard E. Ralston
March 18, 2005
Since the Federal Food and Drug Act
came into law in 1906, the Food and Drug Administration (FDA) has
had a century to develop their methodology for insuring drug safety.
After expanding to an annual budget of $1.5 billion and a staff of
10,000, they continue to seek additional responsibilities—such as
the same control and approval authority for over-the-counter
vitamins and nutritional supplements that they exercise over
prescription drugs. Now they announce that, whatever their other
priorities are, they have not been able to adequately insure the
safety of prescription drugs and want to establish an additional
bureaucracy in the form of a new "Drug Safety Board" to do so. The
first proposed solution to administrative failure in government, no
matter how vast the agency, always seems to be more regulation, more
staff, and bigger budgets.
The FDA has undoubtedly prevented
much harm from unsafe drugs that might otherwise not have been
vetted—although this could have been accomplished by other means.
But it added enormously to the development cost of new drugs,
thereby substantially adding to their price, and delaying their
benefits being available to patients—sometimes for many years. It
has also, with cruel indifference, prevented access to experimental
drugs by terminally ill patients who are near death and willing to
take some risk to stay alive. With all this control and lengthy
review, we clearly still have drug safety problems, and it is time
to explore options other than adding to the size and power of the
First of all, we need to realize
that neither the FDA nor anyone else can do the impossible. When a
new drug comes to market, no one can know all of its side effects,
nor the impact on all other medical conditions that a patient might
have, nor how it might interact with any dosage of any combination
of an infinite number of other drugs—nor the cumulative effect of
ten, twenty, or thirty years of use. If omniscience is required, no
new drug will come to market. The good news, however, is that
computers and the Internet now provide excellent tools to accumulate
and tabulate data on the impact of every new drug. Unexpected
consequences can now quickly be detected and dealt with. The
incredible benefits to health and longevity that new drugs have
achieved in recent years clearly require that we make it possible
for new drugs to come to market at reasonable cost.
We need to open up the approval
process for new drugs to private laboratories, both corporate and
non-profit. This could take the form of both monitoring and
observation of the testing by the drug companies themselves, and
testing by independent research facilities in the final stages of
development. Independent laboratories would be liable only for the
accuracy, integrity, and robustness of their research, not for all
possible future side effects of new drugs. Such research should be
funded by the drug companies themselves, paid to third party
institutions that would randomly assign the research to the
independent laboratories that meet qualification standards.
These reforms could be undertaken
over an extended period, selecting one category of drugs at a time.
It could apply only to new research, so that work currently underway
would not be interrupted. We should explore this and other
alternatives to placing our health exclusively in the hands of
omniscient and omnipotent government. The FDA cannot be omniscient,
and we must not allow it to seek omnipotence.
The best protection for patients is
the self-interest of drug companies. The beauty of private research
is that is has to get results. Drug companies will prosper only if
they bring drugs to market that are effective without unreasonable
side effects—and as they maintain a reputation for doing so. In
addition to whatever independent review process is used, we may also
rely on the self-interest of legions of trial lawyers to pursue any
malfeasance that might circumvent the review process.
Freedom is a more thorough and
relentless defender of safety than layers of bureaucracy. Expanding
freedom can benefit our health far more than concentrating power.
Richard E. Ralston is Executive Director of Americans for Free Choice in Medicine.
Copyright © 2005 Americans for Free Choice in Medicine. All rights reserved.
For reprint permission, contact AFCM.