Reform Needed at the Food and Drug Administration

One-Size-Fits-All Mandates Don’t Work for Individual Patients

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.

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