COALITION RESPONSE TO NEW ACCME “STANDARDS FOR COMMERCIAL SUPPORT” PROVISIONS

In April 2004, the ACCME proposed several revisions of its Standards for Commercial Support. The revisions, which place more responsibility on CME providers to ensure the integrity of their programs, will be voted upon by ACCME’s member organizations and can take effect on September 28, 2004. (Click here for the latest version of ACCME’s Standards for Commercial Support).

The Coalition has reviewed the new proposals and finds them to be responsible and reasonable in helping to insure the integrity of ACCME. The Coalition also applauds ACCME and their Task Force’s work on this sensitive and complicated endeavor.

The Coalition points out, however, that the language in one of the new provisions, Standard 2.3, which deals with questions of what constitutes a conflict of interest and how potential conflicts can be resolved, is left to interpretation by individual CME providers. Standard 2.3 reads “The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners.” The Coalition believes that this provision can be interpreted differently by different CME providers.

It is understood that ACCME will issue a Frequently Asked Questions document after the Standards have been approved that are intended to clarify this new provision. However, the Coalition believes that the Q&A’s can have significant substantive and practical impact on CME, its providers, and its sponsors, and thus should be as carefully vetted as the policy statements themselves to avoid potential distortion.

COALITION POSITION ON CME

It has always been the Coalition’s position that full and complete disclosure before any CME activity is the most appropriate method of alerting learners to the potential for bias. In addition, the Coalition supports those commercial organizations that are taking further actions to protect the integrity of the CME process by establishing procedures to ensure that there is no undue influence over the providers. However, the challenge is to make sure that these efforts do not become so cumbersome that CME will be strangled in bureaucracy.

The role of industry supported continuing medical education in establishing and maintaining a high standard of patient care for people throughout the world cannot be understated. It is imperative that implementation of this essential form of professional development for practicing physicians continues with high standards and without unnecessary bureaucratic intervention.

The Coalition position is that compliance with the ACCME Standards, the PhRMA Code, and the AMA’s “gifts” guidance assure the integrity of scientific exchange at CME meetings. Together they continue to demonstrate the constructive efforts of industry and the professions to protect the integrity of this invaluable medical resource through voluntary self-regulation.