CONTINUING MEDICAL EDUCATION
injunction. 54 The FDA then issued a notice regarding the WLF II case,
stating that it would continue to use the CME guidance in its enforcement
but that a manufacturer may raise the First Amendment defense if the FDA
brought an enforcement action. 55 After the WLF moved to reaffirm the
prior injunction, the district court expressed disapproval of the FDA’s
notice, describing it as a “farce” and suggesting that its policy of inviting
constitutional challenges does not solve any constitutional issues. 56
Nonetheless, the court did not reaffirm the prior injunction. 57
D. Current Federal Approach: FDA and OIG Enforcement
of Off-Label Promotion, False Claims Act, and
Anti-Kickback Statute Violations
As a result of the WLF cases, the FDA has little room to regulate CME
activities directly. However, industry support for CME may implicate
several federal laws in specific circumstances. One example is the FDA
and OIG’s regulation of off-label marketing. Under the Food, Drug, and
Cosmetic Act (FDCA), a drug or device manufacturer may not introduce a
new drug, biologic, or device into interstate commerce without having
obtained approval from the FDA for the product’s label. 58 When its label
contains information that has not been approved by the FDA pursuant to the
drug’s new drug application (NDA) or supplemental NDA, a new drug’s
label is illegally false or misleading. 59 Further, while physicians may
prescribe drugs or devices for unapproved, or “off-label” use, the FDCA
prohibits any company from marketing such products for any off-label
Realizing the opportunities to increase drug sales through physicians
prescribing drugs for off-label uses, drug companies seek to promote their
drugs for off-label uses in any legal (and illegal) way possible. Drug
companies often fund CME activities specifically because they can
effectively promote off-label uses for their products under the regulatory
protections enjoyed by accredited CME, as its content is scientifically
54. Id. at 337.
55. Decision in Wash. Legal Foundation v. Henney, 65 Fed. Reg. 14,286 (Mar. 16,
56. Wash. Legal Found. v. Henney, 128 F.Supp.2d 11, 15 ( D. D. C. 2000).
57. Id. at 16.
58. 21 U.S. C. A. § 355(a)-(b) (West, WestlawNext through P.L. 113-31).
59. Id.; see also § 331(a) (providing that introducing a misbranded drug into interstate
commerce is a “prohibited act”); § 334(a)( 1) (providing that prohibited drugs introduced into
interstate commerce are subject to seizure by the FDA).
60. See § 352(a).