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The effects of recent regulatory changes the Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals, the Accreditation Council for CME's new Standards for Commercial Support, and the Office of Inspector General's pharmaceutical compliance guidance have made a marked change in the way people are approaching CE.

The most recent of these regulations, the Officer of the Inspectors General Final Compliance Program Guidance for Commercial Pharmaceutical Manufacturers, has the most teeth. Violate its precepts and CE providers, medical education and communication companies (MECCs) and commercial supporters could wind up the target of a government investigation. In fact, the pharmaceutical industry is facing increasing fines and penalties for what OIG terms "wrongful behavior." It is no surprise that in today's regulatory climate, industry's decision to invest in CE is heavily weighted by attempts to reduce exposure to real and perceived risk.

To reduce the risk of inappropriate grant programs, commercial supporters are separating their grant-making functions from their sales and marketing functions. This represents a dramatic change, say experts. Some companies still have the majority of CE funding driven by brand teams. However, a number of companies have already made the grant application process more stringent and are funneling requests for CE funds and independent education through a medical education or medical affairs unit. Drug firms also are developing more sophisticated standards for choosing CE partners and providers.

Many major commercial supporters already require written proof that communication companies have a nonpermeable firewall. This means MECCs need to make big structural changes; most are forming new companies, which is the trend. Some are putting their promotion and education offices on different floors or in different buildings. All are making sure that "the decision-makers in the educational company are not also the decision makers in the promotion company."

Of course, a major concern for CE professionals is whether these issues will discourage commercial supporters from funding CE. The consensus seems to be no. Because other methods of communicating with the medical community will be under increased scrutiny, such as promotional dinner meetings and speakers bureaus, funding is expected to migrate to CE.

Although there are indications in the marketplace that a lot of things are on hold, with commercial supporters waiting for answers to come down, in the long run it is expected that more money will be put into legitimate CE.

 
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