The Case: Amy Ambitious, an educational strategy manager for Long Life Medical School, is eager to make an impact in the CME department. Part of her job is to increase funding for CME to augment the department’s annual budget. She is thrilled to find a request for proposal related to hypertension on the independent medical educational Web site of Xcellent Meds, a large and well-known pharmaceutical company.
However, as Amy starts to review the RFP, her enthusiasm wanes. In a section titled “Business Issue,” the document explains that the results of two pivotal trials for Xcellent Meds’ new anti-hypertensive agent will be presented at a cardiology conference in Amsterdam in June, followed by pre-launch initiatives for the product, giving the opportunity “to raise awareness of the product and its clinical program, and support the pre-marketing phase for US physicians.” The RFP specifies the deliverables to be supported (CME-certified electronic activities including videotaped interviews and panel discussions to be conducted with experts during the international conference), and even includes a detailed timeline for completing the funded enduring material. Amy is troubled but wants to find a way to respond to the RFP. She begins her deliberations by charting a list of pros and cons associated with this RFP and the potential grant.
What does Amy need to consider when deciding whether to respond to this RFP?
Overstreet: RFPs continue to garner attention and consternation among CME professionals, and this one illustrates why. Although I believe RFPs still are a viable mechanism through which to support CME, this one crosses the line.
Parochka: It is surprising to find a pharma firm in blatant disregard of the Office of Inspector General’s 2003 Compliance Program Guidance for Pharmaceutical Manufacturers. In order to mitigate any risk, Amy might call Xcellent Meds’ Education Department to ensure she has not misinterpreted the RFP.
Overstreet: Amy needs to weigh her goal of increasing educational grant funding against the risks of noncompliance when deciding whether or not to respond to this opportunity. Although it appears on the grantor’s independent medical education Web site, it reads as if it were written by marketing rather than the education staff.
Are the rules different because the targeted conference is outside the U.S.?
Overstreet: In this case, it is not clear if the funding will come from the U.S. or a global affiliate. Nevertheless, CME credit is being solicited for U.S. physicians, so the Accreditation Council for CME rules should apply.
Parochka: Although the course is intended for U.S. physicians, some non-U.S. physicians may want to register for the event. If this happens, Amy could contact the American Medical Association or the European Accreditation Council for CME and ask for guidance regarding international regulations and to determine whether credit reciprocity exists.
How would you advise Amy?
Overstreet: I’ve seen an RFP very similar to the one described in this case, and I declined to respond to it. I think it is simply too risky.
Parochka: The case illustrates a violation of the Standards for Commercial Support—specifically, Standard 1: Independence. This is rather frustrating, given thatguidance has been in place for several years. If Amy is not satisfied after speaking with Xcellent Meds’ education personnel, she should walk away from this sticky opportunity.
Karen Overstreet, EdD, RPh, FACME, CCMEP, is executive director, Lippincott CME Institute, Wolters Kluwer Health Medical Research, Blue Bell, Pa. Reach her at Karen.Overstreet@wolterskluwer.com
Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education Ltd., Gurnee, Ill.; and partner, PTR Educational Consultants. Reach her at JacquelineParochka@comcast.net.
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