[Excerpts from "Liability Of Physicians For Promoting The Off-Label Use Of Prescription Drugs" by Paul W. Shaw, Robert A. Griffith, and Benjamin M. Welch]
Although physicians may prescribe a drug for an "off-label" purpose, drug manufacturers cannot market or promote the drug for such unapproved uses. See 21 C.F.R. § 314.54. Additionally, manufacturers are strictly limited in what they can communicate to physicians about the off-label use of a drug. See, e.g., 21 U.S.C. § 396; Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001); Washington Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000); James M. Beck and Elizabeth D. Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 76-80 (1998). However, such limitations do not apply to physicians communicating with other physicians about their observations and experiences with the off-label use of a drug.
In addition to allowing doctors to prescribe approved drugs for “off-label” uses, the FDA has never sought to restrict the ability of third parties to publish and disseminate scientific information about “off-label” uses. The FDA has repeatedly recognized the importance of “open dissemination of scientific and medical information regarding these treatments.”
While physicians have a First Amendment right to discuss off-label uses, when those discussions are, or even appear to be, controlled by a pharmaceutical company, physicians can find themselves wrapped up in very expensive civil lawsuits, or facing criminal charges. The FDA has stated that discussions of off-label uses “are not permissible in programs that are or can be subject to substantive influence by companies that market products related to the discussion.”
In order to avoid potential liability, physicians who choose to speak about the various uses of certain drugs should only do so with a complete awareness of who is funding such presentations and who controls the agenda.
