Last week a group called the Congress of California Seniors sued pharmaceutical giants Pharmacia and Pfizer for allegedly promoting one of their drugs for a use not approved by the Food and Drug Administration. (The FDA approved the drug in question, Bextra, to control arthritis pain but not for acute pain caused by impacted molars, which the lawsuit alleges is the new promotional strategy.)
Regardless of whether the claim is true, the lawsuit needs serious rethinking.
Doctors routinely prescribe drugs for off-label uses without ill effect. One third of all prescriptions in cancer treatments were for off-label treatments, according to a 1991 study by the General Accounting Office. In the most famous example of off-label drug use, physicians recommended aspirin to their patients at risk for heart attacks long before the FDA recognized the efficacy of this treatment. Clearly, there is no reason to believe that a federal agency has the knowledge or incentive to know as much about the latest medical discoveries as the pharmaceutical firms’ top researchers or the physicians looking for the best treatment for a patient.
Moreover, there’s an important economic reason to rethink opposition to off-label prescriptions. The allegedly pro-senior, pro-consumer group may believe that it is battling high drug prices because the non-approved use creates an additional demand for a drug. However, that extra revenue from the non-approved use can become an important source in funding new research — no little concern considering that only a fraction of drugs under study go on to become approved and marketed. And the best way to reduce drug prices is to lift regulatory burdens and expand supply.
It’s common these days for a group to claim moral authority by proclaiming its benevolent intentions. Unfortunately, as the anti-off-label lawsuit shows, elevating good intentions over good analysis is a prescription for disaster.
*”’See: “U.S. Consumer Group Sues Pharmacia Over ‘Off-label’ Drug
Promotion” (Associated Press, Dec. 24, 2002)”’ http://www.independent.org/tii/lighthouse/LHLink4-52-1.html
*”’Assessing the FDA via the Anomaly of Off-Label Drug Prescribing by Alexander Tabarrok (THE INDEPENDENT REVIEW, Summer 2000)”’ http://www.independent.org/tii/content/pubs/review/tir51_tabarrok.htm
*”’Off-label Prescribing of Drugs Calls FDA Role into Question” by
Scott Esposito (PITTSBURGH TRIBUNE-REVIEW, Nov. 25, 2000)”’ http://www.independent.org/tii/news/001125Esposito.html
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