On April 25, 2007, the Senate Finance Committee released the results of a Committee inquiry into drug company grants to fund continuing education for medical providers. The Finance Committee report was two years in the making and addresses the Committee's belief that the pharmaceutical industry uses educational grant funding to promote the use of their drugs, including unapproved uses of some medicines. This report will likely fuel the government's continued crackdown on pharmaceutical companies engaged in off-label promotion and signals the government's continued skepticism of the use of Continuing Medical Education (“CME”) programs to transmit off-label information.
The Committee contacted the 23 largest pharmaceutical manufacturers to inquire about their use of educational grants and subsequently sent questions to the Accreditation Council for Continuing Medical Education (“ACCME”), the primary accrediting body for CME providers. The Committee found that “drug companies have used educational grants as a way to increase the market for their products in recent years. This practice is of particular concern when the companies use educational grants to encourage physicians to prescribe products for uses beyond their FDA approval.” The Committee cited ACCME’s records, which the Committee believed showed numerous cases over the past 3 years in which companies exercised too much influence over the content of supposedly independent educational programs.
The Committee stated that drug manufacturers have implemented compliance policies that separate the grant-making process for educational programs from their marketing efforts. In most instances, drug manufacturers have limited the direct involvement of field sales representatives and sales and marketing departments in the educational grant-making process. The Committee concluded that the “major drug companies have adopted corporate policies that, on their face, do not allow educational grants to be awarded for unlawful purposes. However, corporate policies still allow this industry to walk a fine line between violating rules prohibiting off-label promotion and awarding grant money in a manner likely to increase sales of their products, including sales for off-label uses.” According to the Committee, risks still exist for kickbacks, unveiled advertising of drugs, efforts to bias clinical protocols, and off-label promotion. Another concern expressed by the Committee is the lack of proactive or real-time oversight for educational grant programs.
In a follow-up letter to the ACCME, the Committee was quite critical of the ACCME's oversight activities of CME providers, noting that the ACCME considered CME providers to be in compliance with ACCME standards, even if a substantial minority of CME providers' programs were not in compliance with ACCME standards, including the requirement that the program be free of commercial influence or bias. The Committee noted that “[i]t also appears that compliance with ACCME standards still allows CME providers to accommodate the business interests of their commercial sponsors and affords drug companies the ability to target their grant funding at programs likely to support sales of their products.”
The report did not provide any recommendations on how to address the concerns. However, a press release issued by Senators Max Baucus (D-MT) and Charles Grassley (R-IA) stated that the Committee will follow up on its findings with participating drug manufacturers and with organizations that have issued guidelines on medical educational grants, including the FDA, the Inspector General at the Department of Health and Human Services, and the ACCME.