Annals of Health Law - Vol 23 Issue 1

CONTINUING MEDICAL EDUCATION
pediatricians, and geriatricians. 29 AstraZeneca allegedly unduly influenced
speakers participating in company-sponsored CME by providing them with
content to use during presentations. 30 In response to these allegations that it
engaged in a widespread scheme to illegally promote off-label uses for
Seroquel, the company settled for $520 million. 31

Topic bias, on the other hand, occurs when CME covers topics that have the most commercial ( i.e., industry) support, rather than topics that fill gaps in medical education geared toward achieving better patient outcomes. 32 CME providers develop programming that attracts funding from drug and device companies - programming that involves treatments using the drug and device companies’ products. 33 Topic bias is detrimental to patient care because it results in physicians learning about treatments that involve use of specific drugs or medical devices rather than treatments that achieve the best outcomes. 34 As this article explains below, most CME regulation aims to limit content and topic bias, 35 thereby ensuring that CME programming does not serve as a platform for drug and device companies to engage in off-label promotion.

C. History of the FDA’s Regulation of CME
In the 1980s, drug and device companies began increasing their funding
for CME seminars and they routinely paid physicians’ expenses for
registration, travel, and lodging for CME programming. 36 Recognizing the
dangers of too much industry influence on CME, the FDA considered
stepping in to regulate CME in the early-1990s. 37 In response, the
American Medical Association (AMA) and the Pharmaceutical Research
Manufacturers Association (PhRMA) issued voluntary guidelines
prohibiting such funding in an effort to prevent stricter federal oversight. 38
Nonetheless, in 1992 the FDA issued a draft policy indicating that although
drug company-controlled CME programs could not recommend off-label