CME IS ON THE FEDERAL radar screen once again. This time the U.S. Senate is investigating pharma companies' educational grants, including funding for CME. In June, Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Montana) sent letters to 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. Grassley is the chairman and Baucus is the ranking Democrat of the Senate Committee on Finance, which oversees Medicare and Medicaid spending. The first-ever Medicare prescription drug program is slated to begin in January 2006, and federal prescription-drug Medicare and Medicaid expenditures are estimated to reach $100 billion next year.

“We need to know how this behind-the-scenes funneling of money is influencing decision-makers,” Grassley said in a Senate Finance Committee press release. “The decisions result in the government spending billions of dollars on drugs. The tactics look aggressive, and the response on behalf of the public needs to be just as vigorous.”

Baucus said, “I support drug companies giving back to the community through grants for educational programs to educate state governments and health organizations about products that could lead to improved health. However, I am concerned that some grants may be for purposes other than education.”

Their decision to look into the process followed a finding in April that Pennsylvania's lead pharmacist, Steven J. Fiorello, was a paid consultant for Pfizer while being involved in making the state's Medicaid drug-purchasing decisions. Fiorello was fined more than $27,000 for not disclosing his financial ties with a pharma company to the state. His case now is before the state attorney general's office.

The Fiorello case is only one of numerous investigations involving pharma marketing practices. In the letter, the senators say, “The use of educational grants was an element in a recent settlement involving off-label promotion of a prescription drug. Also, educational grants were identified by the Department of Health and Human Services Office of the Inspector General as a key risk area in its OIG Compliance Program Guidance for Pharmaceutical Manufacturers in 2003. In addition, existing Federal and industry guidance is not specific about what activities educational grants may be used to support or what kinds of organizations may provide those activities, and it appears that some manufacturers may be using educational grants to fund activities primarily to promote their products.

“The Committee seeks further information on this topic so that it can assess how educational grants are used, in what contexts and for what purposes, and who receives them. This will assist us in determining whether and to what extent educational grants are used to support activities that are not sponsored or organized by professional organizations or do not involve formal educational presentations, and whether further guidance or legislation is needed.”

The list of 12 questions the senators asked pharma companies includes whether companies have a written or unwritten formal policy regarding educational grants; factors companies take into account when deciding whether or not to award a grant; if the companies have awarded grants to non-Accreditation Council for CME — accredited providers in the past five years; and if the company has offered or awarded an educational or other grant to any state Medicaid agencies, or other state agencies, in the past five years. They also are asking the total dollar amounts of grants awarded by product line, and the total dollar amount of educational grants given to ACCME-accredited providers. And CME providers should note that they also are asking about educational grants provided for activities that “may promote or discourage” off-label drug usage.

Harry A. Gallis, MD, president of the Birmingham, Ala. — based Alliance for Continuing Medical Education, wrote in a letter to Sens. Baucus and Grassley, “The CME community has long recognized the potential bias that commercial support might exert on physician education and worked collaboratively for more than 20 years to create guidelines that serve the public interest through fair and independent accredited education. The Accreditation Council for Continuing Medical Education recently updated its Standards for Commercial Support to assure that CME from all accredited provider organizations is based on fair, balanced, and scientifically rigorous content; effective in improving practice; and independent of commercial interests. The Alliance supports the importance of evidence-based, non-promotional education that is certified by an accredited CME provider organization.”

The companies were given until June 30 to provide the answers and requested documentation to the Committee. Look for further coverage in the September/October issue of Medical Meetings.

To view the full text of the letter, go to http://finance.senate.gov/press/Gpress/2005prg061005.pdf.