CONTINUING MEDICAL EDUCATION
supported and peer-reviewed. Thus, the FDA cannot directly regulate CME
content unless it has sufficient evidence that the drug company’s role in the
CME program amounted to off-label promotion.
Another law that is implicated when a drug company promotes off-label
uses for a drug during a CME event is the Federal False Claims Act
(FCA). 61 The FCA provides that anyone who knowingly presents or causes
to present a false or fraudulent claim for payment or reimbursement for
medical items or services, or makes or causes to be made a false record or
statement material to an obligation to pay the government is liable for a
civil monetary penalty plus treble damages, which can be hundreds of
millions of dollars. 62 The FCA is implicated when a pharmaceutical
manufacturer engages in a scheme to promote off-label uses for its drugs
and the illegal marketing campaign results in the submission of claims for
payment from federal healthcare programs. 63 Conspiring to submit false
claims, such as a CME provider knowingly collaborating in the promotion
of an off-label use, could also lead to a cause of action under the FCA.
CME programs funded by drug or device manufacturers may also
implicate the Federal Anti-Kickback Statute. 64 The Anti-Kickback Statute
prohibits payments to induce the referral of beneficiaries of federal
healthcare programs. 65 It targets any person or entity that knowingly and
willfully solicits or receives any remuneration or offers or pays any
remuneration related to furnishing or obtaining items or services paid by a
federal healthcare program. 66 In the CME context, the Anti-Kickback
Statute is implicated when a pharmaceutical manufacturer directs a CME
provider to pay a physician to speak at a CME event in exchange for the
physician prescribing more of the drug company’s products.
While these laws are expansive and largely effective in deterring or
punishing illegal kickbacks and off-label marketing, 67 they were not
developed to limit industry influence on CME activity specifically. As
61. See 31 U.S. C. A. § 3729 (West, WestlawNext through P.L. 113-31).
62. Id.; see also Katie Thomas & Michael S. Schmidt, Glaxo Agrees to Pay $3 Billion in
Fraud Settlement, N. Y. TIMES (July 2, 2012), http://www.nytimes.com/2012/07/03/business/
63. See § 3729(g).
64. See 42 U.S. C. A. § 1320a-7b(b) (West, WestlawNext through P.L. 113-31).
65. See id.
67. Notably, illegal kickback and off-label marketing are still widespread practices, as
evidenced by the many settlements drug companies enter into with the federal government.
See, e.g., Katie Thomas, Johnson & Johnson Unit Settles State Cases Over Risperdal, N.Y.
TIMES (Aug. 30, 2012), http://www.nytimes.com/2012/08/31/business/johnson-johnson-unit-
settles-state-cases-over-risperdal.html; Glaxo Agrees to Pay $3 Billion in Fraud Settlement,
supra note 62.