On behalf of the Coalition for Healthcare Communication, I wish to thank you for your invitation to comment on the Standards for Commercial Support. For the benefit of those of you who are unaware of the Coalition for Healthcare Communication, let me take a moment to explain our organization and our mission. We are a coalition of 10 organizations that are involved in varying ways with healthcare communications ranging from journals to textbooks to advertising to continuing medical education. Our mission is to contribute to the free flow of truthful healthcare information to professionals and to the public at large, without undue government influence or outside pressure groups seeking to restrict speech or the processes by which it is delivered. Complete information on the Coalition and its views and activities can be found on our Internet site at www.cohealthcom.org.

In general terms, the Coalition believes that the Standards are solid and quite relevant to today's environment. But with any new policy, one learns certain things over time that could not be anticipated. Thus this review is in order. Let me state up front that the Coalition strongly supports the Standards and any potential changes that work to improve the quality and effectiveness of professional education. As long as the Standards are applied consistently and fairly, our members will do everything possible to support the goals. The most frequent complaint we hear is inconsistency of interpretation of the Standards. Our comments today will be in four basic areas, in no particular order. Further we will not attempt to forge any solutions, as the ACCME and its Task Force are far better equipped than we to process and act on the observations made.

Dinners and Gifts

One of the major concerns the Coalition has these days is the ramp up of "Gifts to Physicians" activities. The regular criticism received by the profession and industry from the press and critics on this subject is an embarrassment to both. While we believe CME is involved in a minority of the cases, it nonetheless is included. "Modest meals" and entertainment are the most frequently sited abuses by critics. The Coalition is participating with the Working Group set up to educate industry and the professions on the AMA guidelines, but I am afraid that more help will be needed. We believe that the ACCME can be an instrument to help curtail this upward spiral of "Gift" spending on the part of the grantors, who feel they have to compete. The Coalition would support a more definitive statement as to what is appropriate for the CME arena, considering that the goal is education, not entertainment. This might include suggesting a flat dollar amount for modest dinners and that entertainment should be at the expense of the participant.

Repeat Events

It is not clear to us why this provision exists. If a CME program has been accredited, then it shouldn't matter how many times it is given as long as it is clear that all presentations are replications of the first. We believe that adequate safeguards are in place to prevent commercialization of repeated CME events without requiring the provider to repeatedly demonstrate that the event meets the Essentials. This issue deserves serious deliberation by the Task Force.

Unlabeled Uses

The Coalition supports clear and appropriately visible alerts when Off-label uses are discussed in both live events and enduring materials. This suggests that the notice be given as close to the actual discussion as possible and that such a policy be clearly delineated to faculty. We have found that this is an area of some confusion and deserves discussion and clarification. It is, of course, also the primary concern of FDA. To that end, it is important that the Task Force keep in mind current FDA guidelines as during deliberations as the regulated industry is obligated to follow them.

Provider Independence

The Coalition believes that independence is the dominant governance for commercially supported CME. We are supportive of any strengthening of the language of the Standards that removes questions about behavior on the part of the grantors in connection with the event. It should be made clear that participation in the planning of a CME event by grantors is not appropriate except possibly by medical department physicians who have a particular expertise in the subject matter. Our caveat is founded on the premise that often they are in a position to know more about a subject than most anyone, so why not take advantage of their input. However, we recognize the potential for bias here and defer judgement to those who have to set the rules.

In short, ACCME has created an enviable model of self-regulation that has stood the test of time. With very little change, it will serve us all well in the next decade. The Coalition for Healthcare Communication looks forward to contributing to its success. We wish you well in your deliberations.