CONTINUING MEDICAL EDUCATION
uses, the CME, independent of industry influence, could recommend off-
label uses. 39 This 1992 draft still allowed commercial funders, such as drug
and device companies, to recommend speakers for individual events. 40
CME providers and faculty were required to disclose their financial
relationships with commercial funders, and faculty that discussed off-label
drug uses had to state that the FDA had not approved the uses. 41
1. 1997 CME Guidance
In 1997, the FDA published its final guidance document relating to the
commercial support of CME that was less stringent than the 1992 guidance:
the Final Guidance on Industry-Supported Scientific and Educational
Activities (CME Guidance). 42 The CME Guidance contained a list of
twelve factors that industry and CME providers could use to help keep
CME activities independent of industry influence. 43 The FDA stated that it
would not prosecute CME providers that discussed off-label uses for failing
to meet one of its criteria for independence. 44
The 1997 guidance made it clear that the FDA did not intend to regulate
industry-supported CME programs that are independent of the influence of
the supporting company. 45 Rather, the FDA published the guidance
document to provide a list of factors on which companies and CME
providers can rely, to ensure that their activities are free from the supporting
manufacturer’s influence. 46
2. Washington Legal Foundation Cases
In 1997, the Washington Legal Foundation (WLF) challenged the CME
guidance alleging that it unconstitutionally restricted commercial speech.
The WLF sought to enjoin the FDA from enforcing or relying on its
policies restricting manufacturer off-label promotion of drugs and devices
39. Draft Policy Statement on Industry-Supported Scientific and Educational Activities,
57 Fed. Reg. 56,412 (Nov. 27, 1992).
42. 62 Fed. Reg. 64,074 (Dec. 3 1997).
43. Id. at 64,097-99 (indicating that some of the factors included control of content and
selection of presenters and moderators; disclosures; the focus of the program; the audience
selection; the opportunities for discussion; provider involvement in sales or marketing;
44. See Rodwin, supra note 10, at 810-11.
45. 62 Fed. Reg. at 64,076.