Competitive Enterprise Institute | 1899 L ST NW Floor 12, Washington, DC 20036 | Phone: 202-331-1010 | Fax: 202-331-0640
New Study Shows Benefits of “Off-Label” Promotion for Patients, Doctors
Court to Weigh In on Pharmaceutical Free Speech
Washington, D.C., April 13, 2010 – The Food and Drug Administration will see its rules governing “off label” drug promotion challenged in federal court this month, and a new study from the Competitive Enterprise Institute explains why doctors and patients could benefit from the decision.
Drug manufacturer Allergan Inc. seeks a declaratory judgment that the FDA may not forbid drug and medical device makers from distributing truthful information about safe and effective uses of medicines that the agency has already approved, but for other conditions. A hearing on procedural motions in the case is scheduled for April 26 in the federal District Court for the District of Columbia.
In a new CEI OnPoint, Truth or Consequences: the Benefits of Off-Label Drug and Device Promotion , Senior Fellow Gregory Conko  and Dr. Jerome Arnett, Jr . argue that the FDA ban on off-label promotion violates the First Amendment and makes it more difficult for doctors and patients to learn about beneficial treatment options.
“Off-label prescribing is not just useful, but essential to the proper provision of necessary medical care,” the authors explain. “Doctors and their patients both reap tremendous benefits from the distribution of truthful and non-misleading information about off-label uses. It is long past time for Congress and the FDA to loosen these restrictions.”
The FDA approves drugs and devices for specific “on-label” uses, but doctors routinely – and legally – prescribe FDA-approved drugs for other “off-label” uses. Many cancer and cardiac treatments, as well as oral contraceptives and Allergan’s Botox, are all commonly prescribed for uses other than those on the FDA-approved label. Studies estimate that at least 20% of all prescriptions are written for off-label use, a practice that has been defended by the American Medical Association and other expert bodies.
Yet, the FDA forbids drug manufacturers from informing physicians about off-label uses or even providing physicians with safety information regarding drugs and devices they already use off-label. “Large majorities of physicians say they value this information,” write Conko and Arnett. “And the FDA ban makes it harder for them to learn about beneficial new uses of drugs and medical devices.”
> View the CEI OnPoint Truth or Consequences: the Benefits of Off-Label Drug and Device Promotion 
> Read more from CEI on pharmaceutical regulation .