The Pharmaceutical Research and Manufacturers of America's revisions to its code on interactions with health care professionals will strengthen the influence of the Accreditation Council for Continuing Medical Education.

The ¹ revised code states that when funding CME programs, firms "should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME."

While that statement does not mandate that firms adhere to ACCME's standards - many medical societies also offer their own accreditations - the outfit's prominence in the code means that firms would have difficulty adopting a lower standard.

And ACCME's standards may be changing. Like all aspects of pharmaceutical communication to doctors, CME has been increasingly scrutinized by Congress, and the council has engaged in frequent correspondence with the Hill.

Last month, ACCME outlined proposed revisions to its standards that could limit industry-support for CME only to areas where a government agency has determined there is a valid educational purpose (² Also see "ACCME Poses Four Conditions For Acceptable Industry-Supported CME" - Pink Sheet, 23 June, 2008., p. 5).

PhRMA's code, with its limits on free lunches and elimination of gifts, is designed specifically to forestall increased government regulation of Rx marketing (see ³ Also see "PhRMA’s Cap On Speaker Reimbursement Illustrates Code’s Balancing Act" - Pink Sheet, 21 July, 2008.).

By citing ACCME in the code, PhRMA members can rely on the expertise and reputation of the other organization, but they also risk losing some control of their own operations in the process.

FDA itself recently wrestled with this kind of issue when it decided to uncouple its human subject protection regulations from the Declaration of Helsinki (⁴ Also see "FDA Takes Ethics Into Its Own Hands; Foreign Trials Now Subject To Only GCP" - Pink Sheet, 5 May, 2008., p. 24).

For PhRMA, referring to another association in the CME section of the code may not be as limiting because many firms already have even stricter procedures (see chart: "⁵ PhRMA's Next Re-Coding Project: Revision Of Its DTC Principles").

"Most of the companies are even ahead of where the code is and have been moving very aggressively over the last many years," Arnold Friede, counsel at McDermott, Will & Emery, said.

For example, Pfizer just announced that it would no longer fund CME organized by commercial firms (⁶ Also see "Pfizer CME Restrictions: No Support For Education Firms, Caps Everywhere Else" - Pink Sheet, 7 July, 2008., p. 4).

"The ACCME proposals, by the same token, go beyond where the ACCME currently stands," Friede noted. "Under the PhRMA code the companies may not suggest content; under the ACCME proposals, companies would be foreclosed from even suggesting topics." Friede previously served as senior corporate counsel with Pfizer before moving into private practice.

PhRMA's code also specifies that a firm "should separate its CME grant-making functions from its sales and marketing departments" and that a firm cannot sponsor a reception as part of a CME event.

PhRMA may again face the issue of linking its guidelines to those of another association - in this case the American Medical Association - as it revises its direct-to-consumer advertising principles.

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

CME Reforms Under PhRMA Code Increase The Influence Of ACCME

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