As of late August, the Senate Committee on Finance had finished collecting an initial set of responses from pharmaceutical companies concerning educational grants but had not yet begun reviewing the responses; nor did it have a set timeline for finishing the review process. After going over the materials, the Committee will decide whether it will ask pharmaceutical companies for more detailed information and/or hold a hearing on the issue.
As we reported in the July/August issue, in June, Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Montana) sent letters to major pharmaceutical companies asking them to explain their practice of providing educational grants to organizations and state officials that might be in a position to influence Medicare and Medicaid drug purchasing decisions. The senators are concerned that grants may sometimes be used for influence-peddling, rather than education. Grassley is the chairman and Baucus is the ranking Democrat of the Senate Committee on Finance, which oversees Medicare and Medicaid spending.
Following a report in The New York Times describing how Johnson & Johnson continued to market its heartburn medication Propulsid in the 1990s, despite growing evidence linking the medication to heart problems and deaths, the Committee extended the inquiry to examine those allegations. The Propulsidcampaign did not fall under the scope of the original letter, which asked for information dating back to 2000.
One of the questions the Committee asked pharma companies was whether they had awarded grants to non-Accreditation Council for CME-accredited providers in the past five years. While it is too early to say whether the Committee will look more favorably on grants to accredited organizations,has learned that the Committee does recognize that the Standards for Commercial Support are strict and intended to keep things on the up-and-up. While grants given to ACCME-accredited organizations will not be excluded from scrutiny, the Committee understands those grants were most likely legitimate and used for educational purposes.
The Senate Committee on Finance also asked about educational grants provided for activities that “may promote or discourage” off-label drug usage. This aspect of the inquiry could potentially cause more problems for beleaguered CME providers who are already contending with numerous obstacles due to pharma companies' tough new grant-approval systems. While off-label promotion is illegal, historically the government has recognized that independent activities are a legitimate forum for education about off-label and unapproved uses of drugs and devices. However, the recent investigations into pharma companies' off-label marketing practices, such as the Neurontin case, have resulted in some companies becoming wary about funding activities that include off-label discussion. Senate Committee on Finance clarifies that it is not aiming to curtail legitimate business practices.