Major Changes To ACCME Standards; Proposed Comments by August 11, 2008

Continuing its efforts to increase the independence of

continuing medical education (CME), the ACCME announced last

month several clarifications and proposed changes concerning

its Standards for Commercial Support and enforcement

priorities. This announcement comes on the heels of a recent

acknowledgment that the ACCME met with Lewis Morris, Chief

Counsel of the Department of Health and Human Services Office

of Inspector General (OIG) "to further the ACCME's

understanding of government regulation in the U.S. and to gain

insights into the areas of interest of the OIG of

HHS."1 It also follows growing discussion

during ACCME Board of Director meetings concerning the need to

assure the independence of CME, particularly with regard to

content and speakers.

The June announcement continues ACCME's strong march

towards more rigorous enforcement of the relationship between

accredited CME providers and commercial supporters. In a series

of clarifications concerning existing standards, announcements

about its enforcement priorities, and major proposed policy

changes, the ACCME moves closer to a standard that prohibits

all communication on CME topics and content between accredited

CME providers and commercial supporters. These clarifications

and proposals will have a significant impact on the terms of

pharmaceutical and biotechnology company-sponsored CME.

Policy Clarifications/Pronouncements

ACCME states that, "[o]ur continued goal will be

no communications or interactions about the

activity between commercial supporters and any teachers,

authors, planners, or staff of the provider about

topic or content" (emphasis added). Though

ACCME adopted language in October 2007 prohibiting CME

providers from acting upon topic recommendations by

commercial interests, it was unclear how ACCME would

reconcile this position with its January 2007 response to

Senators Grassley and Baucus suggesting that discussion about

CME topics, albeit limited, is permissible. The June

announcement clarifies that there should be no interaction

between CME providers and commercial interests concerning CME

topics.

ACCME states that, "there is no role for

ACCME-defined commercial interests in the development or

evaluation of accredited CME activities. The process of

activity development must proceed absolutely

independently of the commercial supporter"

(emphasis added).

ACCME explains that, "Accredited Providers

cannot engage in dialogue or collaboration

with commercial supporters...

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