Under the new PhRMA code, CME providers and commercial supporters will be playing by the same rules
The newly updated Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals, released in July, is much more specific about CME than the original 2002 version. It states that companies should separate their grants offices from sales anddepartments — something many companies have already done — and stipulates that companies should develop objective criteria for making CME grant decisions.
It also adheres to CME guidelines, saying that companies should follow the Accreditation Council for CME's Standards for Commercial Support. Further, it specifies that companies should not provide any advice or guidance to providers, even if asked by them, regarding content or. This guideline aligns with the policy which says that CME providers “cannot receive any guidance, either nuanced or direct,” about CME content or faculty. Those changes are good news for CME professionals, say experts.
“The new code in my mind seems to be in line with Accreditation Council for CME [guidelines],” says Andrea L. Gaymon, vice president, Office of Compliance and Regulatory Affairs, Vindico Medical Education, Thorofare, N.J. “The code reinforces what CME providers are already doing and helps to make sure all parties are on the same page.”
The voluntary code, which goes into effect January 2009, spells out that CME is intended to support education on a full range of treatment options and not to promote a particular medicine. “It is incredibly hard to believe that in 2008 there are still commercial supporters out there who don't understand that statement,” says Barbara A. Fuchs, MSA, CPHO, CCMEP, former director of independent medical education with a major pharmaceutical company. “It's never been the spirit or intention of CME to promote particular medications, but to educate healthcare professionals about all the treatment options available to patients. The ACCME's Standards for Commercial Support say that you're not to promote specific proprietary interests of the supporter. This should not come as any big news flash.”
While the original code included CME in the same section as third-party educational or professional meetings, the new version separates out CME. “The separation is important for us CME providers, because it will, I hope, cut down on the confusion between certified CME and other types of education and professional meetings that may have different guidelines,” says Gaymon.
Unlike the previous code, this one does not allow companies to provide meals directly at CME events. “This is in line with ACCME; it's requiring all providers to control the management of the funds associated with the activity,” Gaymon says. “I don't think it's telling us, the provider, anything new or different.”
In the Q&A appended to the code, the answer to question 20 says companies may sponsor meals/receptions at certain conferences. Again, this is not a change, says Fuchs. It's still allowable for companies holding satellite symposia at association annual conferences, for example, to host a dessert bar after the education, as long as the company follows the organization's guidelines and the reception is clearly separate from the CME portions of the program.
Under question 21, the new code says companies may communicate their interest in supporting certain topic areas. Would this conflict with the new ACCME proposal, which is currently out for comment, stipulating that accredited providers cannot receive communications from commercial interests announcing specific content/therapeutic areas available for funding? “The code's wording is not sufficient to meet the ACCME's proposed expectations,” responds Murray Kopelow, MD, chief executive, ACCME.
Expect more discussion on this issue — especially if the ACCME proposal becomes policy. “Industry should be able to provide information on their grant application process,” says Pamela L. Mason, FACME, CCMEP, director, Medical Education Grants Office, AstraZeneca, Wilmington, Del. “Completing applications for grants is time-consuming and educational providers need to know if their activities will be considered when seeking commercial supporters. Information provided on the commercial interest's Web site, including therapeutic areas of interest, can assist them in determining whether or not they want to submit a grant application.”
Another area of potential difference that is likely to generate lively debate: The updated code says that companies should train speakers about the distinction between CME and promotional activities. However, the American Association of Medical Colleges report, approved in June, recommends that faculty should be discouraged from participating in industry speakers bureaus. And, the recent ACCME call for comment proposes that physicians involved in product promotion should be precluded from speaking at or developing CME activities covering the same content area.
For more on the code, see “Clarifying the Code,” page 34, and “Danger Zone,” page 36.