The 2009 PhRMA Code issued by the Pharmaceutical Research Manufacturers of America provides guidelines relevant to situations that can occur during healthcare meetings. The full code can be accessed at www.phrma.org. Here are a few excerpts from the code’s Q &A section:
Under the code, could a company provide healthcare professionals with pens or clipboards designed to be used by healthcare professionals or patients in the healthcare professional’s office along with brochures that provide educational information about that company’s product? No. The code states that providing healthcare professionals with items that do not advance disease or treatment education is not appropriate, even if these items are practice-related items of minimal value, such as clipboards, bags, mugs or similar items with or without company logos or product names printed on them. It would, however, be appropriate for a company to distribute educational brochures without pens or clipboards.
Under the code, may golf balls and sports bags be provided if they bear a company or product name? No. As stated in the prior version of the code, golf balls and sports bags, even if of minimal value, do not advance disease or treatment education and therefore should not be offered, regardless of whether they bear a company or product name.
A national specialty society is holding its three-day annual conference, which includes business meetings, entertainment and a half-day of educational programs for which physicians may receive CME (continuing medical education) credit. May a company sponsor a reception or lunch at the conference? The code provides that a company should not provide or sponsor meals directly at CME events. However, at third-party conferences or professional meetings at which CME activities comprise only a part of the conference or meeting, a company may sponsor a meal or reception at the conference if it is permitted by the group holding the conference or meeting and is clearly separate from the CME portions of the program. In such cases, any meals or receptions sponsored by a company should be modest and clearly subordinate to the amount of time spent at other aspects of the meeting.
May a company publicize its interest in a general topic for a CME program for which a grant would be provided? Yes, a company may communicate to multiple CME providers or the public a general topic for a CME program that might be of interest to physicians. For example, a company may publicize that it will consider funding the topics of new treatments or disease management techniques in a particular therapy area such as diabetes or hypertension. However, the company should follow CME accreditation standards considering the nature and specificity of the CME topics that the company may propose, keeping in mind the code’s statement that financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine. In addition, the company may not suggest the speakers or review or make any suggestions concerning the specific content of a particular CME program, even if asked by the CME provider.
Under what circumstances would the code permit a company to provide entertainment or recreational activities to healthcare practitioners? Under the code, companies may not provide entertainment or recreational activities to healthcare practitioners who are not employees of the companies in any context, including situations where those practitioners are providing a legitimate service to the companies, such as when they act as bona fide consultants on an advisory board or are trained at a speaker-training meeting. Thus, companies should not invite healthcare professionals to sporting events, concerts or shows, or provide them with recreational activities such as hunting, fishing, boating, ski trips or golf outings, even if those entertainment events or recreational activities are intended to facilitate informational interchanges between the company representative and the healthcare professional. Similarly, it would be inappropriate to provide these types of entertainment and recreational events in conjunction with promotional scientific presentations by medical experts.
A company is asked to fund a CME program as a “platinum” level supporter. This level of support includes the opportunity for the company to directly sponsor a lunch at the event. May the company become a “platinum” level supporter? It is appropriate under the code for a company to provide funding to a CME provider, which the provider can use at its discretion to provide meals for all participants. However, a company should not control how the provider spends the funding, and a company should not sponsor or host a meal directly at a CME program. A company may fund a CME program at a particular level of support designated by the CME provider and be publicized for providing that level of support, as long as the company does not separately promote, publicize or otherwise take advantage of any option to be identified as the sponsor of a meal.
Under the code, may a company make a charitable contribution such as purchasing a table at a fundraising dinner or a foursome slot at a fundraising golf tournament? Yes, but the company may not invite healthcare professionals to attend the event at its expense. The company may use some or all of its allotment for its own employees, and return any unused portion to the sponsoring organization to use as it wishes.
Company A considers whether to invite 300 physicians/consultants to a two-day and one-night speaker training program at a regional golf resort. All attendees would be compensated for their participation and their expenses would be reimbursed. Prospective speakers would be selected based on recommendations of the company’s district managers and an assessment of their qualifications by the company’s medical or scientific personnel. Each of the attendees would be required to sign an agreement in advance covering the services they will provide. They would be educated by a faculty on the full range of data surrounding the disease state and the company’s drug product, on presentation skills and on FDA regulatory requirements. The company needs to train 300 speakers in order to ensure that enough speakers will actually be available when needed. Training sessions take both days, and the company provides for a few hours of golf and expensive meals, such as lobster and filet mignon. Does this program conform to the code? If so, is it appropriate to pay for a spouse or the healthcare professional as well? No. This arrangement would not conform with the code. Speaker training is an essential activity because the FDA holds companies accountable for the presentation of their speakers. However, the code provides that speaker training meetings should be held at appropriate venues and specifically states that resorts are not appropriate venues for training speakers. Moreover, providing entertainment (e.g., golf) and expensive meals to a healthcare professional in a speaker training program would not comply with the code, although modest meals may be offered to attendees. The company does appear to satisfy provisions in the code that require potential speakers to be selected on defined criteria such as medical expertise, knowledge and experience and to undergo extensive training that would result in a valuable service being provided to the company. This arrangement also appears to meet reasonable indicia of a bona fide consulting relationship. The number of speakers being trained is important; if significantly more participants were trained than the company plans to use as speakers, this arrangement would not comply with the code. The amount of time spent training speakers should be reasonable in relation to the material that has to be covered. The compensation and lodging offered to prospective speakers should be evaluated to assure that it is reasonable compensation for their time and based on fair market value. It would not be appropriate to pay for the cost of the spouse of the healthcare professional. If the spouse attends, it should be at the cost of the healthcare professional.
