The Accreditation Council for Continuing Medical Education (ACCME) recently announced several changes to its Standards for Commercial Support (SCS) and related policies. Importantly, these changes include a reversal of ACCME’s earlier policy regarding permissible interaction between accredited providers and organizations providing commercial support for Continuing Medical Education (CME) programming. When reading the summary of key changes to ACCME policies below, please keep in mind that these rules only apply to ACCME accredited CME providers. Unless otherwise specified, the changes are effective January 1, 2008.

Changes that Directly Impact Pharmaceutical and Biotechnology CME Policies

Companies should evaluate their current CME and educational grants policies against these new standards, outlined below.

Speaker Suggestions

The ACCME previously permitted accredited providers to ask commercial supporters for speaker suggestions. We are aware of several pharmaceutical/biotechnology companies that have implemented internal processes to better control these interactions, e.g., how and by whom the request is received and processed, requirements for the number of names provided, limits on suggested speakers’ relationships with company, and requirements for disclosure of financial relationships and other possible conflicts of interest.

In October, the ACCME reversed its earlier position and decided to prohibit providers from asking commercial interests for speaker suggestions. The ACCME explains that, “[t]here is no reason for the CME provider to request suggestions for speakers …. from commercial interests – since it is unacceptable [under the SCS] to act upon their suggestions.” FDA’s position adopted in its 1997 CME guidance remains in place—whether a company suggests speakers who promote company products is a factor that the agency will consider in determining whether the activity is independent education, but the agency will not ordinarily infer undue influence based on this conduct alone provided that the company discloses relevant financial relationships with speakers.

Review of CME Content

For many years, the ACCME permitted accredited providers, at their discretion, to ask commercial supporters to review CME content for accuracy. The ACCME has always prohibited arrangements that make review of CME content a condition of financial support.

In October, the ACCME reversed this policy and decided to prohibit accredited providers from asking commercial supporters to review CME content prior to delivery. The ACCME advises commercial supporters who believe that CME content is inaccurate or unreasonably favors their product to report the provider to the ACCME. FDA has not communicated a position specifically on the review of CME content but has noted that company scripting, targeting points for emphasis, etc. is prohibited and that limited “technical assistance” is permitted only in response to an unsolicited request by a CME provider.

Topic Suggestions

In its October policy changes, the ACCME states that accredited providers are no longer permitted to ask commercial interests for CME topic suggestions, possibly reversing (at least in part) its policy articulated in a January 2007 response to an inquiry by the US Senate Committee on Finance. In its response to the Senate Committee, the ACCME stated that commercial supporters can suggest certain topics, including a particular disease state or improving diagnosis for a particular disease state, to accredited providers. The ACCME was more cautious regarding suggestions for programs about pharmacologic treatments for disease states because these types of suggestions may result in improper influence over the CME programming. A contact at the ACCME clarified that although the organization is still working to reconcile the organization’s response to the Senate Committee with its new policies, the ACCME is informally counseling providers that commercial supporters can at least make suggestions (e.g., in a grant brochure) for programs about disease states. We understand that the ACCME plans to follow-up with the Senate Committee and make its response public.

Changes that May Impact Pharmaceutical and Biotechnology CME Policies

Companies should review the changes to ACCME provider standards below, but these may not directly impact company CME and educational grant policies.

Definition of “Commercial Interest”/Eligibility for Provider Accreditation

The ACCME expanded its definition of “commercial interest” from entities “producing health care goods or services consumed by, or used on, patients” to “entities producing, marketing, re-selling, or distributing” these goods and services. This definition continues to exempt certain organizations from inclusion (e.g., 501-C organizations, government entities, for-profit hospitals). Recently, the ACCME clarified that the definition does not cover most publishers.

Importantly, commercial interests and the organizations which they own or control are not eligible for ACCME accreditation. Consequently, under the new definition of commercial interest, companies with distinct divisions that provide promotional services and educational programming and subsidiaries of companies that offer promotional services will no longer be eligible for accreditation. This applies regardless of whether the organization has established appropriate firewalls between educational and promotional functions. The new definition is effective immediately. Currently accredited organizations that now fall within the definition of commercial interest or that are owned or controlled by a commercial interest will have until August 2009 to transition to a different corporate structure.

Written Agreements for Commercial Support

The ACCME clarified that accredited providers are not permitted to enter into a commercial support agreement that specifies the manner in which the provider will fulfill the requirements of ACCME’s Elements, Policies, and Standards. Interestingly, some pharmaceutical companies have included such language in CME grant agreements to ensure provider compliance with ACCME standards. Although it is our understanding that general provisions requiring that providers comply with ACCME requirements will continue to be permitted, accredited providers will no longer be able to enter into agreements that dictate how this will be achieved (e.g., how educational objectives will be determined, feedback collected).

Internet CME

The ACCME revised its Internet CME policy to require that all information that accredited providers must disclose to learners before a CME activity (e.g., purpose/objectives, financial relationship information) must be transmitted, not just made accessible, to internet CME learners before engaging in the CME activity. Making this information accessible in a tab that the learner can avoid is not sufficient. Internet CME includes CME delivered via the Internet, CD-ROM, and satellite broadcast. In addition, the ACCME revised its current policy of prohibiting accredited providers from placing CME activities on a pharmaceutical or device manufacturer’s product websites to prohibit placement of CME on any website owned or controlled by a commercial interest.

Journal CME

In early 2007, the ACCME proposed a revision to its Journal CME policy that would have prohibited product-promotion or advertising of any type within, or between, the elements of a journal-based CME activity. The final revisions adopted by ACCME in August temper this proposal, and merely clarify that the elements of journal-based CME activities include the information required to be communicated before a CME activity, the CME content, content-specific post-tests, and evaluation. Advertising, trade names, and product messages are prohibited within each element, but some advertising between elements continues to be permitted. This revision to the Journal CME policy is effective immediately.