CONTINUING MEDICAL EDUCATION
demonstrated by the WLF line of cases, courts tend to disfavor federal
enforcement of laws in contexts that inhibit commercial speech in the
medical fields. 68 Thus, the Anti-Kickback Statute, the FDCA, and the FCA
are largely ineffective in regulating commercial bias in CME.
E. The OIG Guidelines
In 2003, the OIG issued proposed guidelines that restricted
pharmaceutical and medical device funding of CME activities. 69 After the
AMA, PhRMA, and more than twenty-five medical societies requested that
OIG drop the restrictions on CME funding, the OIG, in its 2003 final
guidelines, conceded. 70 As the OIG stated in its final guidance, “support for
educational activities sponsored and organized by medical professional
organizations raise little risk of fraud or abuse.” 71 Still, OIG explained that
commercial sponsors risk prosecution when they control CME content. 72
The guidelines recommend that drug and device companies separate
marketing activities from grant making activities. 73 These guidelines,
however, still leave much of the enforcement and compliance monitoring
up to the ACCME and their Standards for Commercial Support.
F. The ACCME’s Standards for Commercial Support
In addition to compliance with the federal laws described above and
voluntary compliance with the OIG guidance, CME providers must comply
with the ACCME accreditation guidelines and Standards for Commercial
Support. While the FDA and OIG largely defer to the ACCME – a non-
governmental fee-funded group – for compliance monitoring, the ACCME
standards fall short of minimizing commercial influence on CME activity.
For example, the ACCME Standards for Commercial Support allow
providers to show potential and current funders their draft program and
receive suggestions from industry sponsors. 74 The standards only prohibit
an industry sponsor from requiring a CME provider to accept advice or
services concerning teachers, authors, participants, or other education
68. See, e.g., WLF II.
69. Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 67
Fed. Reg. 62,057 (Oct. 3, 2002).
70. Rodwin, supra note 10, at 811; see OIG Compliance Program Guidance for
Pharmaceutical Manufacturers, 68 Fed. Reg. 23,731 (May 5, 2003).
71. 68 Fed. Reg. at 23,738.
74. See Rodwin, supra note 10, at 811.