The world of medical education can be broken down in so many different ways.
First: professional vs. consumer health education
If professional, then: promotional vs. certified continuing education (or certified CME/CE)
Let's talk a bit more about professional health education since we all know about WebMD and Revolution Health.
The world of promotional education is governed by strict FDA guidelines. Plus, don't forget the PhRMA code. There is no off-label discussion within a promotional activity. Also, speakers are recruited directly by the pharma/biotech/device company. The content does not need to be fair-balanced and there is no governing body that certifies those activities for any type of continuing education credit.
In the world of certified CME/CE, the rules are completely different. Here, you can discuss off-label use of medications. As a faculty speaker, you are to have no communications with the pharma/biotech/device company. Also, you don't get paid directly from a drug company. The educational content must be fair-balanced and the ACCME acts as a governing body to provide rules and regulations regarding certified CME (the CE for nurses and pharmacists are governed by other bodies). The PhRMA code has rules regarding CME.
Surprisingly, many healthcare professional are not aware of the distinction between non-certified medical education and certified medical education. Since the rules are constantly changing, it's important to stay updated on the latest guidelines and codes. The PhRMA code just got revised and the ACCME guidelines are constantly in flux.
A very good description of the difference between certified CME and FDA regulated promotion, except that a very strict FDA "fair balance" requirement applies to all FDA regulated marketing, including promotional education.ReplyDelete