Med Ed Unlimited, a full-service communication company, has developed a publication plan and is drafting several review articles on an investigational rheumatoid arthritis product for Make U Well, a mid-sized biotech company. Theteam at Make U Well is thrilled with the knowledge and quality of work of the two writers assigned to these projects — they hold PhD degrees in molecular biology — and asks that those writers also be assigned to work on several CME activities that will be developed by the group's sister company, Best Accredited MECC.
Polly Paranoid, the education director at the accredited provider, is concerned that this would violate guidelines that stipulate the separation of education from promotion. The account director at Med Ed Unlimited assures her that the client doesn't care about separation issues. Polly considers calling the supporter (she does not refer to the supporter as a “client”) but she is conflicted about potentially damaging the long-standing relationship with the company.
Prevention and Cure
How well do supporters understand the need for firewalls — for their companies and for providers?
Overstreet: In my experience, supporter knowledge and processes vary widely. Some grantors are very aware of the various issues related to separating education from promotion, but many others are really lagging behind. Surprisingly, there are still supporters who have not completely separated their grant-making process from marketing and who do not insist that their providers (I hate the word “vendor”) do either education or promotion but not both.
Parochka: Karen, I couldn't agree more. Some grantors have developed sophisticated procedures that protect their individual interests but may not necessarily address issues of importance to accredited providers. Others are living in the dark ages. Accredited providers should stay alert and keep their supporters informed. This requires a high degree of diplomacy and tact.
How can training and education help fortify the firewall between the provider and its sister company?
Overstreet: It is incumbent on all providers — both accredited and nonaccredited — to ensure that their staff understand the relevant guidelines and how to apply them appropriately to their own business model.
Parochka: Amen! Participating in professional development activities (such as Alliance for CME and Accreditation Council for CME workshops) and creating internal training sessions is critical in order to keep staff members current regarding constantly changing regulatory issues.
Overstreet: I also believe that the provider needs to take steps to protect itself as well as its supporter by complying with the letter and spirit of the's Standards for Commercial Support, as well as the Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities, which dictates a firewall for providers and joint sponsors that plan and implement both CME-certified and noncertified activities
How would you handle this?
Overstreet: Polly needs to have a frank but cordial discussion with her contact at the supporting company. She should explain her own policies regarding independence and that the policies are designed in part to protect the supporter.
Parochka: MECCs have a unique opportunity to inform and educate their commercial partners [supporters] by asking questions, explaining the issues, and providing gentle reminders of the consequences of noncompliance from an FDA and Office of Inspector General perspective.
Karen Overstreet, EdD, RPh, FACME, is president, Indicia Medical Education, LLC, North Wales, Pa. Reach her at Karen.Overstreet@indiciaed.com Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education, Ltd., Gurnee, Ill. Reach her at JacquelineParochka@comcast.net.