Recently, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued their response to the ACCME Call for Comment.
SUPPORT-FREE ACCREDITED CME
ACCME: Proposes to consider a new designation and review process for providers that wish to identify their program of CME as one that does not utilize funds from commercial interests that have been donated to support continuing medical education, e.g., Commercial Support -Free.
PhRMA: Under the PhRMA Code on Interactions with Healthcare Professionals effective January 2009 (the "Revised PhRMA Code"), manufacturers have no role in developing content for CME programs or requesting specific educational programs to be conducted, and signatory companies are committed to respecting the independence of CME Providers.
As a result, PhRMA feels that identifying some CME as "Commercial Support-Free", particularly with a trademarked designation suggesting something positive, implies that there is something improper with commercially supported CME or that commercially
supported CME is not evidence-based.
However, PhRMA firmly asserts that there is no evidence to support such inferences, and there is no conclusive evidence that industry support of CME creates bias in CME. Accordingly, they acknowledge that any distinction that creates such an inference potentially harms physicians and patients because educational programs may not be funded, notwithstanding documented need, because Providers may believe that such a designation is important for their program.
In addition, since ACCME already requires that CME Providers that accept commercial support disclose that support in their programs—both private and public, for profit and not for profit–further distinction in the designations is unnecessary. Further designations would require ACCME to ensure that such CME Providers not accept any funding from industry, including for exhibits, advertising revenue, or other sources of commercial support that could be used to support the CME activity, which would prevent doctor’s necessary education.
CALL FOR COMMENT ON PROMOTIONAL TEACHER AND AUTHOR FREE
ACCREDITED CME
ACCME: Proposes that activities designated "Promotional Teacher and
Author Free" would not allow persons with ACCME-defined relevant financial relationships derived from marketing and promotional activities to teach in or write for any part of a CME program that carries this designation.
PhRMA does not support this proposed policy, although they share ACCME's interest in ensuring that promotional speaker programs sponsored by pharmaceutical companies are separate and distinct from CME and that such distinction is clear to an audience. As stated in the Revised PhRMA Code:
– Promotional speaker programs are necessary to communicate their products and convey new information and developments.
– These are company-sponsored events and promotional programs that are not CME, and they are regulated by the FDA.
– Health care professional speakers are chosen because they meet criteria such as medical expertise, reputation, educational ability, and therapeutic area knowledge.
– Speakers must "receive extensive training on the company's drug products or other specific topics to be presented and on compliance with FDA requirements for communication."
– Companies must clearly identify company sponsorship in promotional speaker messages and materials.
In fact, PhRMA believes that Identifying some CME as Promotional Teacher and Author Free implies that there is something wrong with CME that includes a faculty member who also has a relationship with a manufacturer that is promotional in nature. Moreover, it is extremely important that scientific leaders, whose involvement in clinical studies regarding a new compound, are allowed for CME programs because they can communicate safety, efficacy, indications and science from their experiences. Limitations on the use of these clinicians could significantly impact the dissemination of information on new compounds and the understanding of health care professionals in using these new medicines for the benefit of patients. Specifically, PhRMA notes that:
“Physicians would be put in an awkward position of not being able to participate in CME activities that might need their expertise because they had a previous financial relationship with a manufacturer.”
Therefore, as long as transparency and disclosure of funding and participation are provided, physician educators should not be forced to make a choice about which types of programs in which to participate.
CALL FOR COMMENT ON INDEPENDENT CME FUNDING ENTITY
ACCME is now considering the creation of a granting entity independent of ACCME that will accept unrestricted donations that will be designated for the special purpose of funding accredited continuing medical education. The funds would be distributed to ACCME Recognized and Accredited organizations to be used for the development and presentation of ACCME-compliant continuing professional medical education.
PhRMA: Without any addition detail about the proposal for an independent CME funding entity, they could not provide any stance on the issue, but only questions and suggestions:
– How is an entity created by ACCME but independent of ACCME? The tpe of infrastructure needed?
– How it would be funded and whether the funding to support that infrastructure would actually divert support from important educational activities.
– What kind of governance structure would be shaped and whether commercial supporters would be permitted to participate in it.
– The proposal also does not indicate whether ACCME accredited organizations could receive funds from this new granting entity, but also remain free to accept commercial support directly from pharmaceutical companies and other commercial entities consistent with current ACCME standards.
– Most importantly, the proposal does not address how educational needs would be identified, what type of criteria will be established for allocation to various educational activities;
– How to assure that physician educational and patient needs are fully satisfied, or
– How a single funding entity that funds all CME for all regions of the country and in connection with all types of conditions as well as wellness and prevention could meet all needs.
– Whether pharmaceutical manufacturers may in fact provide restricted grants for the direct educational activities and not generally to cover operational or capital needs.
Ultimately, PhRMA concluded that a single funding entity that funds all CME for all regions of the country and in connection with all types of conditions as well as wellness and prevention is unlikely to meet all needs. Seemingly, PhRMA’s firm stance that CME should work with industry to support advances in medical and patient care comes at a perfect time. Hopefully, ACCME will take note of these comments, as well as other legislators and health care reformists when considering new issues as the health care system is overhauled. We as consumers and patients cannot afford inexperienced doctors missing out on these opportunities, both as a matter of economics and health.
PhRMA Response to the ACCME Call for Comment