202-331-1010 • www.cei.org • Competitive Enterprise Institue
Recognize the Deadly Effects of Over-Regulating Medicines and MedicalDevices
Over the past century, American consumershave benefited from thousands of new pharma-ceuticals and medical devices to help them com-bat disease, alleviate the symptoms of illnessand infirmity, and improve their well-being.However, the public often demands that suchtreatments meet a near-perfect level of safetyat bargain basement prices. In turn, Congressand the federal Food and Drug Administration(FDA) have steadily raised the regulatory hur-dles that medical products manufacturers mustclear before marketing a new treatment.A strong dose of over-caution when the FDAapproves new drugs and devices may sound likea virtue, but for patients in need of new treat-ments, regulatory over-caution can be deadly.Patients can be injured if FDA approves a treat-ment that is later found to be unsafe, but theyalso suffer when needed treatments are delayedby regulatory hurdles.FDA, however, is predominantly focused onthe first of these two risks, for political reasons.Agency approval of a drug or device that turnsout to be unsafe will lead to front-page head-lines and congressional hearings, while delay ordenial of a needed new treatment stirs little pub-lic notice. Patients may suffer or die as a resultof FDA delays—without them or their familiesever knowing that a possible treatment exists,let alone that it was blocked by the FDA. As aresult, FDA is under constant pressure to assurethe safety of new medical products, but underlittle pressure to speed up their availability.Many doctors, patient groups, and publicpolicy experts recognize that FDA’s lengthyprocess for approving new drugs and devicesoften costs lives by denying patients potentiallybeneficial new treatments. Polls of medicalspecialists commissioned by the CompetitiveEnterprise Institute over the past decade haveconsistently found that majorities of doctors invarious specialties believe that FDA is too slowin approving new medical products.When making safety evaluations, FDAis required, by statute, to determine the ap-propriate balance between patient safety andmedical product effectiveness. But more-thor-ough study of drugs and devices during clini-cal trials (both pre- and post-approval) has itsown weaknesses. First, even very large clinicaltrials generally cannot include enough sub-jects to detect rare side effects. Second, largetrials involve diverse populations with manysubgroups that often are not easy to identify.Consequently, a few individual adverse eventsdo not necessarily mean that a product is in-herently unsafe for all patients. A given ad-verse event may not have been caused by thetreatment, or if it was, it may be confined to asmall subpopulation.