Just after these recent announcements, the FDA sent a letter to each manufacturer of long-acting and extended-release opioids. The letter detailed the manufacturers' responsibilities under REMS. A template of that letter is posted...
Ensuring Independence
Yes. It contains logistical and organizational information and not education materials. It contains maps and floor plans but not slides and not abstracts.
Joint sponsors are expected to routinely have a role in making decisions about the elements of the planning process specified in SCS 1.1. Since these decisions must be "made free of the control of a...
No. The provider must ensure that the content of the CME truly remains beyond the control of the commercial supporter. The process to develop the CME must be independent of the commercial interest. Providers must not allow...
No, in this scenario the commercial interest is giving commercial support and buying promotional and sales opportunities. The commercial interest should buy advertising and...
What follows is an example of how several tactics can be tied together by the Provider into a mechanism to resolve conflicts of interest that could demonstrate the Provider's compliance with the...
No they are not prohibited. Working and learning through meal time is an efficiency often included in bona fide CME activities.
Yes. Refusal to disclosure is not limited to the explicit act of saying "no" to a provider's request for such information. Unresponsiveness that precludes the provider from implementing a mechanism to identify and resolve COI is...
Yes. Commercial support is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CME activity. This is money given to the provider to support the...
No. It is not necessary to collect disclosure information on relevant financial relationships from a speaker, planner, or author each and every time that individual has control over the content of a CME activity....
The ACCME expects that written agreements for commercial support will:
- be between the accredited provider and commercial supporter. (This means that the accredited...
No. Communication or distribution mechanisms that are owned or controlled by a commercial interest cannot be used to transmit or distribute continuing medical education activities to learners (e.g., a cable...
There is no CME reason for commercial supporters to review and comment on CME content prior to its delivery to learners. The ACCME believes that CME can receive commercial support from industry without receiving any advice or...
Yes. The ACCME accepts electronic signatures as evidence that written agreements are signed.
Twenty years ago, most CME occurred in a lecture hall. Now, learning activities occur in many different environments including electronic media, and ACCME intends that all of these places and spaces of CME activity need to be...
Yes. The new CME activity, must demonstrate compliance with all applicable ACCME accreditation requirements, including faculty disclosure and acknowledgement of any commercial support (SCS 6).
For CME activities including...
Yes. A provider can implement practices to designate different categories of commercial supporters for different amounts of commercial support.
Yes. ACCME considers meals arranged by the Provider in conjunction with an activity to be an appropriate part of the expenses of a meeting and can be paid for out of the commercial support.
No. If there is any relevant financial relationship, there is a conflict of interest. A mechanism to resolve conflicts of interest must be implemented in all such cases.
No. All commercial support must be stipulated by a written agreement and must flow through the Provider and/or its educational partner. Only the Provider and/or its educational partner can make payments to...
The ACCME sees content development for REMS as a three-stage process. The first two stages are under the control of the FDA and the final stage is under the control of the accredited provider.
...The potential for increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME - an incentive to insert commercial bias....
Informed learners are the final safeguards in assuring that a CME activity is independent from commercial influence. Regarding personal conflicts of interest, CME providers are to have in place mechanisms to identify and resolve...
YES. The provider always has the option to exclude some presentations or abstracts from their accredited program of CME or present this content in a track that is outside of but in conjunction with accredited CME. This option also...
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