FDCA (cont’d) Practice of Medicine The FDCA does not limit a physician’s ability to prescribe a drug for off-label use.

FDCA (cont’d) “While manufacturers may not themselves promote [off-label] uses, it is not unlawful for doctors to employ or prescribe medical products for “unapproved” uses. Indeed, the FDA claims that it has ‘long recognized the important role that some unapproved uses may play in the practice of medicine.’” Washington Legal Foundation v. Kessler, 880 F. Supp. 26, 28 n1 (D.D.C. 1995) (citing FDA’s memorandum supporting motion to dismiss).

FDCA (cont’d) “Once [a] new drug is in a local pharmacy after interstate shipment, the physician may, as a part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration.” 37 Fed. Reg. 16, 503 (Notice of Proposed Rule Making) (Aug. 15, 1972).

FDCA (cont’d) Nor was it Congress’s intent in enacting the FDCA for the FDA to interfere with the practice of medicine: “Throughout the debate leading to enactment, there were repeated statements that Congress did not intend the Food and Drug Administration to interfere with medical practice and references to the understanding that the bill did not purport to regulate the practice of medicine as between the physician and the patient.” 37 Fed. Reg. 16,503 (Aug. 15, 1972) (referring to the legislative history of the 1938 Act and the Drug Amendments of 1962).

FDCA (cont’d) Off-label use of a medical device “is an accepted and necessary corollary of the FDA’s mission to regulate... without directly interfering with the practice of medicine.” Buckman Co. v. Plaintiff’s Legal Comm., 351 U.S. 341, 350 (2001).