An interactive case study session on regulations at the National Task Force on CME Provider/Industry Collaboration conference sounded great on paper. The audience got to vote on whether a case presented any violations to the myriad regulations and guidances, then a panel of experts from (pardon the alphabet soup) , AMA , FDA, OIG, and PhRMA weighed in with their perspectives. The problem was that, with so many people commenting on each case, it got pretty dragged out—especially for those who have been around for a while and knew the answers. I won't go through all 10 cases they presented, but here's one example:
- The Case: A commercial supporter initiates a conversation with an accredited CME provider and indicates that they have recently concluded a needs assessment study which identified topics and therapeutic support. In response, the CME provider conducts its own needs assessment, including a survey of their audience and a literature search, in addition to the data it initially received from the commercial supporter. The needs assessment results in the provider identifying several of the same topics and therapeutic areas. They pursue a CME activity, and the commercial supporter agrees to provide grant support.
Does this scenario cross the boundaries of any regulations, standards, codes, or guidelines?
Using an audience response system, 18 percent of participants voted yes, 69 percent voted no, 1 percent said they didn't know, and 12 percent needed more information to make a judgment.
The ACCME rep said, "this is the sort of thing that blurs the line," and said they would want more information to see if it presented issues related to the Standards of Commercial Support 1 and 5. AMA CEJA said that it doesn't cross any of its ethical guidelines, but while it follows the letter of the law, it doesn't go well with its spirit. The FDA rep also wanted more information, saying it depends on the relationship between the supporter and the provider, including who initiated the contact, and how much the commercial supporter knew about the program before agreeing to support it. The OIG also wanted more information to see who initiated the contact. "Intent is key," he said. "If one's intent is to sway behavior to use the drug information to induce and reward, it could be in violation. According to the PhRMA Code representative, it doesn't violate any of the Code's guidelines.
After each case discussion by the panel, they opened up the floor to questions. For this case, people asked, if the company data was good enough to be published in peer-reviewed journals, why isn't it good enough for the FDA and OIG? "The point is that the need came from pharma," said the FDA person. Another audience member asked why, if the theme of the conference is collaboration, are we concentrating on moving the two sides even further apart. "They have information we could use, not to promote their drug, but to provide better CME."
To which the AMA representative responded, "I'm concerned about using raw data from drug companies for CME until the data has been arranged, peer-reviewed, and corrected. But to share raw data from a company, there's reason to be concerned."