Opinion ID: 799929
Heading Depth: 3
Heading Rank: 2

Heading: FDCA Labeling and Marketing Regulations

Text: The off-label marketing claims are at least partially predicated on Schering's alleged violations of the labeling and marketing restrictions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (FDCA). The FDCA regulates the manufacturing, marketing and sale of prescription drugs, and provides that a drug cannot be sold in interstate commerce unless it is approved by the FDA for the specific medical use, or indication, listed on the drug's labeling. See 21 U.S.C. § 355(a) (No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.). To obtain FDA approval, drug companies generally must submit evidence from clinical trials and other testing that evaluate the drug's risks and benefits and demonstrate that it is safe and effective for all of the indications prescribed, recommended, or suggested on the drug's label. See id. at § 355(d). Prescription drugs frequently have therapeutic uses other than their FDA-approved indications. The FDCA, however, generally prohibits manufacturers from marketing, advertising, or otherwise promoting drugs for such unapproved or off-label uses. See 21 U.S.C. § 331(a) and (d) (prohibiting manufacturers from introducing a drug into interstate commerce with an intent that it be used for an off-label purchase, or by misbranding it by including information about unapproved uses on its label). Because the FDCA does not regulate the practice of medicine, physicians may lawfully prescribe drugs for off-label uses. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (recognizing off-label usage as an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine.); Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C.Cir.2000) (A physician may prescribe a legal drug to serve any purpose that he or she deems appropriate, regardless of whether the drug has been approved for that use by the FDA.). Thus, there is a certain asymmetry in the regulation of off-label uses: while physicians may lawfully prescribe drugs for off-label uses, the FDCA generally prohibits manufacturers from marketing these uses to physicians. See id. at 332-33 (referring to the FDCA's asymmetricalif not necessarily inconsistentregulatory treatment of off-label uses). Indeed, the FDCA's regulatory regime prohibits manufacturers from directly advertising off-label uses, such as through labeling claims or explicit statements made by sales representatives. Moreover, it is also unlawful for manufacturers to engage in certain indirect methods of off-label marketing. For example, in certain circumstances it is unlawful for manufacturers to sponsor continuing medical education (CME) courses that focus on off-label uses. The FDCA does, however, permit manufacturers to distribute information about off-label uses in certain limited circumstances. See id. at 333. The drugs involved in these consolidated appeals (the Subject Drugs) are certain oncology and Hepatitis drugs, including Intron®-A (Intron-A), PEG-Intron® (PEG-Intron), Rebetol® (Rebetol) and Rebetron® (Rebetron) (collectively the Intron Franchise Drugs), and Temodar® (Temodar). The FDA has approved these drugs for specific purposes.