The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. Representing more than 7,000 physician members, the Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 94 percent of all board-certified plastic surgeons in the United States.
Consequently, the ASPS recently adopted new guidelines designed to promote ethical interactions between its member physicians and the medical industry.
The new guidelines, published in a document entitled, “Considerations for Interactions with Industry,” provide detailed recommendations for appropriate collaborations between individual plastic surgeons and pharmaceutical, biotechnology, or medical device companies in an effort to prevent industry support from biasing a physician’s professional activities or judgments.
In announcing the new recommendations, ASPS President Phillip Haeck, MD, recognized that, “collaborations between physicians and industry are necessary as they enhance the practice of medicine.” Accordingly, Dr. Haeck noted that, “following these new guidelines will help to ensure that interactions with industry will be for the benefit of patients and remain consistent with AdvaMed and PhRMA Industry guidelines.”
The document details standards related to the acceptance of gifts, educational products, meals and entertainment from industry; protocols for seeking industry support for educational programs; consulting arrangements; promotional speaking -- and the regulations associated with each.
Dr. Haeck further noted that, “the new guidelines are voluntary and serve as a recommendation for behavior that ASPS members should adhere to.” He asserted that, ASPS “members’ primary duty is to act in the best interest of patients and it’s vital they be independent and industry’s ability to influence professional judgements be limited.”
ASPS Recommended Guidelines
In the preamble of the guidelines, ASPS recognized that, “pharmaceutical, biotechnology, and medical device companies (“Industry”) develop, produce, market, or distribute drugs, devices, therapies, or services used to diagnose, treat, monitor, manage, and alleviate health conditions that allow individuals to live longer and healthier lives.” Moreover, ASPS acknowledged that, “industry can help serve the interests of patients through beneficial collaborations with Members.”
Additionally, the preamble recognizes that, “ethical relationships between ASPS members and industry are necessary to ensure public confidence in the objectivity of ASPS members which is critical for them to carry out their mission of serving patients.” Accordingly, ASPS adopted the Considerations for Interactions with Industry to reinforce the core principles that help ASPS maintain actual and perceived independence, and ensure ethical relationships between our members and industry.
Basis of Interactions with Industry
ASPS asserted that interactions and relationships with industry are already regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Accordingly, they noted that such interactions should be focused on receiving information about products, technologies and services that allow us to serve the best interests of ASPS Members’ patients.
Receiving Items of Value from Industry
The guidelines state that ASPS members should not accept the following from Industry:
- Items that do not advance treatment education, including pens, note pads, mugs, and similar “reminder” items with company or product logos.
- Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs, or tickets to a sporting event) Payments in cash or cash equivalents (such as gift certificates) should not be accepted either directly or indirectly, except as compensation for bona fide services.
It is appropriate to receive a reasonable quantity of product samples for patient use for purposes of product education, evaluation, and demonstration.
Receiving Educational Items from Industry
ASPS members, where permitted by law, may accept from Industry items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to Members outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is appropriate. Items designed primarily for the education of patients or healthcare professionals should not be accepted by Members on more than an occasional basis.
Entertainment and Recreation
ASPS Members should not accept, any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or
vacation trips. Such entertainment or recreational benefits should not be accepted, regardless of (1) the value of the items, (2) whether Industry engages the healthcare professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose.
Informational Discussions and Meals with Industry
The guidelines recognize that “informational discussions with Industry representatives and others speaking on behalf of a company provide ASPS Members with valuable scientific and clinical information about products, technologies, treatments, and services that may lead to improved patient care.
Accordingly, the guidelines state that In order to facilitate these “important scientific and medical discussions, while respecting Members’ abilities to manage their schedules and provide patient care, Industry representatives may take the opportunity to present information at mealtimes.
Additionally, ASPS noted that, “in connection with such presentations or discussions, it is appropriate for occasional meals to be offered by Industry as a business courtesy to Members as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals
- Are modest
- Are not part of an entertainment or recreational event, and
- Are provided in a manner conducive to informational communication.
ASPS members cannot bring a spouse or other guest in a meal accompanying an
informational presentation made by or on behalf of an Industry representative is not appropriate. In addition, accepting “take-out” meals or meals to be eaten without an Industry representative being present (such as “dine & dash” programs) is not appropriate.
Continuing Medical Education
The ASPS recommendations acknowledge that continuing medical education (CME) “helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular product.”
Accordingly, ASPS recommends that any financial support from Industry should be given to the CME provider (ASPS), which, in turn, can use the money to reduce the overall CME registration fee for all participants. ASPS noted that, “industry should respect the independent judgment of the ASPS as the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME activity.”
In addition, this guideline recognizes that, “when companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the CME provider in accordance with their guidelines.” As a result, ASPS noted that, “industry should not be asked to provide any advice or guidance to the CME provider or Members involved in the CME program regarding the content or faculty for a particular CME program funded by Industry.”
Additionally, ASPS recommends that Members should not accept direct financial support from Industry for the costs of travel, lodging, or other personal expenses related to attending CME programs. Similarly, funding should not be accepted by Members to compensate for the time spent by Members attending the CME program.
It is appropriate for Members serving as faculty at ASPS educational programs to receive honorarium and financial support for travel, lodging, and related expenses from ASPS (as the CME Provider) in accordance with its written policies governing faculty reimbursement. Members serving as ASPS faculty should not accept additional financial support directly from Industry for their role as faculty
Industry Support for ASPS Meetings
The guidelines also recognized that educational conferences or professional meetings of ASPS or its Members can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. A conference or meeting is any activity, held at an appropriate location, where:
- The gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering); and
- The main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented.
Similar to CME, any financial support should be given to the conference’s sponsor (ASPS), which, in turn, can use the money to reduce the overall conference registration fee for all attendees.
Financial support should not be accepted by Members for the costs of travel, lodging, or other personal expenses of Members attending third-party scientific or educational conferences or professional meetings. Similarly, funding should not be accepted by Members to compensate for the time spent attending the conference or meeting.
Serving as a Consultant for Industry
The ASPS guidelines recognize that “consulting arrangements with Industry allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas, and the needs of patients. Industry uses this advice to inform their efforts to ensure that the products they produce and market are meeting the needs of patients.”
Accordingly, the guidelines assert that it is appropriate for Members who provide advisory services to be offered reasonable compensation based on fair market value for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services.
However, ASPS Members should not participate in recreational or entertainment events in conjunction with these meetings and it is not appropriate to accept honoraria or travel or lodging expenses for spouses or guests of Members attending Industry-sponsored consultant meetings. Modest meals or receptions may be appropriate during Industry-sponsored meetings with healthcare professional consultants, but token consulting or advisory arrangements should not be used to justify compensating Members for their time or their travel, lodging, and other out-of-pocket expenses.
Serving as a Promotional Speaker for Industry
ASPS guidelines also recognize that members participate in Industry-sponsored speaker programs “in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of Industry products.” The guidelines note that Member engaged by a company to participate in such external promotional programs should be selected based on their medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Industry and Members should not enter speaking arrangements as inducements or rewards for prescribing or using a particular medicine or product.
Speaker training is an essential activity because the FDA holds speakers accountable for presentations made on behalf of Industry. It is appropriate for Members who participate in programs intended to train speakers for Industry-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be accepted by Members when
The participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications (including prohibition of promoting “off label”)
- This training will result in the participants providing a valuable service to the company; and
- The participants meet the general criteria for bona fide consulting arrangements.
Any compensation or reimbursement for a speaking arrangement should be reasonable and based on fair market value. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. ASPS also recognized that speaker programs are distinct from CME programs, and speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.