Pharmaceutical Industry Sets New Guidelines for Marketing to Physicians
The Pharmaceutical Research and Manufacturers of America (PhRMA) has developed a set of guidelines for how drug company sales representatives should interact with physicians and other health care professionals. PhRMA, the largest member organization of the country's leading research-based pharmaceutical and biotechnology companies, has strongly encouraged its members to adopt procedures to ensure adherence to the voluntary code, which took effect on July 1.
The preamble to the nine-page PhRMA "Code on Interactions With Healthcare Professionals" describes the pharmaceutical industry's concerns that such interactions not be perceived as inappropriate by patients or the public. It further states that the code "is based on the principle that a health care professional's care of patients should be based, and should be perceived as being based, solely on each patient's medical needs and the health care professional's medical knowledge and experience."
The guidelines permit industry representatives and others speaking on behalf of a company to engage in informational presentations and discussions that provide scientific and educational benefits. The code states that meals may be offered in connection with such presentations as long as they are "modest as judged by local standards" and "occur in a venue and manner conducive to informational communication." The code specifically cites as inappropriate "dash and dine" programs—in which meals are consumed without a company representative being present.
In addition, the code stipulates that no entertainment or recreation, such as tickets to sporting events, should be provided in association with informational presentations and that the inclusion of a health care professional's spouse or other guests is inappropriate. The code states that "token consulting or advisory arrangements" should not be used to justify compensating health care professionals for their time or for their travel, lodging, and other out-of-pocket expenses.
According to the code, items primarily for the benefit of patients may be offered to health care professionals if their cost is $100 or less. "For example," the code states, "an anatomical model for use in an examination room primarily involves a patient benefit, whereas a VCR or CD player does not." The code permits distribution of items of minimal value, such as pens, notepads, and similar "reminder" items with the company name or logo, as long as they are primarily associated with a health care professional's practice.
The code states that payments in cash or equivalents, such as gift certificates, should not be offered to health care professionals either directly or indirectly except as payment to bona fide consultants. Six criteria are set forth that define a bona fide consulting arrangement. For example, a consultant should have a written contract specifying the nature of the services, and a legitimate need for the services should be documented in advance. The code also states that the number of health care professionals retained as consultants should not be greater than the number reasonably necessary to achieve the identified purpose of the consulting arrangement.
The code also provides that no grants, scholarships, subsidies, support, consulting contracts, or educational or practice-related items should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products. "Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices," the code states. Guidelines are also set forth for continuing medical education and other third-party scientific and educational conferences, speaker training meetings, and scholarships and educational funds.
The final section of the code lists ten frequently asked questions. One question, for example, is whether golf balls and sports bags may be provided if they bear a company or product name. The answer: "No. Golf bags and sports bags, even if of minimal value, do not primarily entail a benefit to patients and are not primarily associated with the health care professional's practice, even if they bear the name of a company or product." However, other questions about whether certain activities that involve company-sponsored meetings in resort locations comply with the code are more complex and highlight areas that may allow some companies to abide by the letter but not the spirit of the code.
The code and background information are available at http://www.phrma.org/.
News Briefs
Materials for Addiction Recovery Month in September: The Substance Abuse and Mental Health Services Administration (SAMHSA) has released new materials for use by organizations and coalitions to observe National Alcohol and Drug Addiction Recovery Month. The theme for this year's Recovery Month, which is observed in September, is "Join the Voices of Recovery: A Call to Action." Among the materials are public service announcements for television and radio that have two distinct themes aimed at motivating the audience to support people in recovery and to refer those in need of treatment to SAMHSA's 24-hour help line, 800-662-HELP. One set of announcements highlights the widespread problem of co-occurring mental illness and substance abuse. The other emphasizes the role that families play in supporting a teen in recovery. All of the materials are designed to complement SAMHSA's Changing the Conversation: The National Treatment Plan Initiative to Improve Substance Abuse Treatment. Information about the Recovery Month materials is available at www.samhsa.gov and by calling 800-729-6686.
New Freedom Commission Web site. The Bush administration's New Freedom Commission on Mental Health has a new Web site at www.mentalhealthcommission.gov. The site allows mental health care professionals, advocates, and families to follow the progress of the commission's work. President Bush announced the creation of the commission in April and charged it with conducting a comprehensive study of the nation's public and private mental health service delivery system and making recommendations for improving it. The 15-member commission is chaired by Michael Hogan, Ph.D., director of the Ohio Department of Mental Health. The Web site identifies the group's members and describes its mission, schedule, and agenda. Visitors to the site are invited to submit comments on what is working and what is not in the current mental health system and to make suggestions for change.
Minority research training in psychiatry: The National Institute of Mental Health has provided a five-year $2.5 million grant to the Program for Minority Research Training in Psychiatry of the American Psychiatric Institute for Research and Education. The program aims to increase the number of psychiatrists from minority groups who enter the field of psychiatric research. The program provides medical students and psychiatric residents with funding for stipends, travel, and tuition for an elective or summer experience in a research environment. Training takes place in research-oriented departments of psychiatry at major U.S. medical schools and other appropriate sites. Stipends are also available for one- or two-year postresidency fellowships for minority psychiatrists. For residents seeking a year or more of training and for postresidency fellows, the deadline for applications is December 1. For medical students, the deadline is three months before training is to begin. For more information, call the program's toll-free number, 800-852-1390, or call Ernesto Guerra, the program's project manager at the American Psychiatric Institute for Research and Education, at 202-682-6225 (e-mail, [email protected]).
NAMI's Global Partnership Initiative: The National Alliance for the Mentally Ill (NAMI) has formed a partnership that pairs four NAMI state organizations with similar advocacy groups on three continents—Brazil, Japan, South Africa, and Taiwan. The initiative is structured as an international exchange program intended to strengthen community-based, grassroots education and advocacy through the exchange of information, electronic networking, and technical assistance. The paired organizations are NAMI Connecticut and APOIAR of Brazil, NAMI Montgomery County (Maryland) and Zenkaren of Japan, NAMI Oklahoma and the Depression and Anxiety Support Group of South Africa, and NAMI Texas and the Alliance for the Mentally Ill of Taiwan. In a prepared statement announcing the initiative, NAMI national board president James P. McNulty described the effort's goal: "NAMI's Global Partnership Initiative seeks to build a worldwide community of hope—a community that recognizes mental illnesses as real and treatable. Universally, for every individual, in every racial and ethnic community, the hope for recovery also must be made real." The initiative is funded with a grant from the Pfizer Foundation.
CED report on U.S. employers and health care: A report by the Committee for Economic Development (CED) argues that a retreat by U.S. employers from active efforts to improve health care will harm their businesses, their employees, and the nation. A New Vision for Health Care: A Leadership Role for Business describes the health care system as structurally flawed and argues that the policy debate about improving it should not focus on managed care but on the lack of incentives for both providers and users. It calls on businesses to become smarter and more demanding purchasers of care and to work with government and labor "to transform health insurance into a market-oriented, user-friendly service industry with accountability to purchasers and patients for cost and quality." The report recommends fundamental changes in the way businesses and government purchase health care and outlines modifications in public policies to improve quality and reduce costs. The CED is a nonprofit, nonpartisan group of more than 200 business and education leaders. The full text of the report is available on its Web site at www.ced.org.
Self-help booklets promote recovery: The Substance Abuse and Mental Health Services Administration (SAMHSA) has released six guides to help people living with mental illness achieve higher levels of wellness and recovery. Among the topics covered in the brief practical guides are building self-esteem, making friends, and dealing with the effects of trauma. Copies are available free of charge by calling 800-789-2647 or visiting SAMHSA's Web site at www.samhsa.gov.
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Published online: 1 August 2002
Published in print: August 2002
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