The Department Of Health should not be telling you what to prescribe to your patients.
Off-label drug use is an accepted part of medical treatment. Once FDA-approved, prescription drugs can be prescribed by doctors for both FDA-approved and unapproved uses; the FDA generally does not regulate how physicians use approved drugs. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); accord United States v. Caronia, 703 F.3d 149, 153-54 (2d Cir. 2012) citing with approval John E. Osborn, Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, 10 Yale J. Health Pol’y L. & Ethics 299, 303 (2010) (“Physicians may prescribe FDA – Approved drugs … for any therapeutic use that is appropriate in their medical judgment.”). Indeed, courts and the FDA have recognized the propriety and potential public value of unapproved or off-label drug use. See Buckman, 531 U.S. at 350 (Off-label use is an “accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”); see also In re Zypresxa Products Liability Litigation, 671 F.Supp.2d 397 (E.D.N.Y.2009) (“doctors may voluntarily prescribe FDA-approved medicines for approved and unapproved uses as they belief appropriate in the exercise of their own professional judgment.”). FDA approved indications are not intended to limit or interfere with the practice of medicine nor to preclude physicians from using their best judgment in the interest of the patient. Caronia, 703 F.3d at 153, citing with approval U.S. Food and Drug Administration, Draft Guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices 3 (2009). The FDA itself has observed:Once a drug has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patent populations that are not included in approved labeling. Such “unapproved” or, more precisely, “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.U.S. Food and Drug Administration, FDA Drug Bulletin, 12 FDA Drug Bull. 1, 5 (1982). In fact, off-label uses of prescription drugs are a “mainstay of the industry…” In re Zypresxa Products Liability Litigation, 671 F.Supp.2d at 415.