Practical Tips for Mitigating Risk - Pharmaceutical Executive

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Practical Tips for Mitigating Risk


Pharmaceutical Executive



Karen M. Overstreet
Governmental attention to grant-supported continuing medical education (CME) has never been higher. This past April, the Senate Finance Committee (SFC) issued its report The Use of Educational Grants by Pharmaceutical Manufacturers. The SFC report was the result of a two-year investigation of CME and concluded that oversight of accredited CME providers is "insufficient to guarantee the required independence" of medical education and that there are still risks of kickbacks, veiled advertising of drugs, efforts to bias clinical protocols, and off-label promotion.

The Office of the Inspector General and Department of Justice have brought—and continue to bring—numerous cases against pharmaceutical and devices companies in the risk areas outlined by the SFC. In addition to those agencies, several states now have their own fraud and abuse legislation and successfully prosecute such actions at the local level.


Jane M. Ruppenkamp
In this time of increased governmental scrutiny, companies would do well to turn to a familiar scientific tool to guarantee the quality and independence of CME and minimize the risks of issuing CME grants. Perhaps it's time for peer review in CME.

Internal Versus External

Many accredited providers use a peer-review process of one form or another, but the process can vary considerably from provider to provider. One fundamental difference is the use of internal versus external content review.

External content review—review by an independent third-party peer reviewer—can validate and document scientific integrity and freedom from commercial bias. It can help ensure that the discussion of off-label use is fair and balanced in the context of available treatment options and that it is supported by evidence and adequately addresses efficacy and safety.

Internal content review—review by employees or permanent contractors of the accredited provider—although useful for program management, should not be confused with independent peer review. An internal content reviewer's objectivity can be affected by personal income, job security, organizational revenue, and internal politics.

Two things set these two types of reviewers apart:

Independence An independent third party does not have relationships with the manufacturers of the products being discussed, the authors of the content, the activity chair, or the accredited provider.

Peer status "Peer" has been defined as someone of equal stature; in the case of reviewer qualifications, criteria should include relevant demonstrated experience, knowledge of the subject matter under review, and absence of real or perceived conflict of interest. Specifically, the reviewer should be a qualified expert for the topic area of the proposed activity. For example, a physician subject-matter expert would be most appropriate for clinical topics that discuss patient-care recommendations, while a pharmacist may be more appropriate for drug interaction or pharmacoecomomic topics.

Independent by Design

Although companies providing grants, may not make requirements of grant recipients, they may consider independent peer review as an objective criterion for grant review. Here are some other tips for building independent peer review into the CME your company sponsors:


Risks Associated with CME Grants
Put it in the budget Companies considering providing grants to CME providers should include the provision of independent peer review in their own budgeting, request information detailing the content-review process in their grant application, and look for a line item for independent peer review in the submitted activity budget.


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