Drug Industry Responds to Complaints About Marketing

Those pens, pads, and stethoscopes emblazoned with company logos and bold product names are all still O.K., but not the concert or baseball tickets. And all-expenses-paid “educationally oriented” long weekends in Puerto Rico or Las Vegas are most likely out as well, according to the pharmaceutical industry’s new guidelines for interacting with physicians during its marketing activities

The new “marketing code” was promulgated by the pharmaceutical industry’s largest member organization, the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading research-based pharmaceutical and biotechnology companies. PhRMA “strongly encourages” its member companies to “adopt procedures to assure adherence” to the voluntary code, which went into effect July 1.

“The new code makes it crystal clear that the interactions of company sales representatives with health care professionals are to benefit patients and enhance the practice of medicine,” said PhRMA President Alan F. Holmer in a prepared statement. “It explicitly spells out that all interactions should be focused on informing health care professionals about products, providing scientific and educational information, and supporting medical research and education.”

APA President Paul Appelbaum, M.D., told Psychiatric News, “The new PhRMA guidelines, if consistently followed, will represent a clear advance over the status quo in which physicians are offered money and gifts in an obvious effort to persuade them to prescribe a company’s medications.” Appelbaum emphasized, however, that “these guidelines do not remove the necessity for psychiatrists and facilities to draw their own lines about pharmaceutical company practices.”

While Holmer believes the guidelines are “crystal clear,” there may be room for differing interpretations. For example, the code indicates that an all-expenses-paid trip to a resort location for a large number of physicians to “discuss company products” may not be appropriate, but that there may be situations in which “compensation and reimbursement that would be inappropriate in other contexts can be acceptable for bona fide consultants in connection with their consulting arrangements.”

The code defines “bona fide consultants” as physicians who have a written contract with the company to provide services that are “legitimate” and defined in advance and who have been selected using criteria directly related to the identified services. It stipulates that the number of consultants not be greater than the “number reasonably necessary to achieve the identified purpose,” and specifies that “it is not appropriate to pay honoraria or travel or lodging expenses to nonfaculty and nonconsultant attendees at company-sponsored meetings.”

The same guidelines apply to physicians who are recruited and trained at company meetings to participate in the company’s speaker bureau, as long as the participating physicians receive “extensive training on the company’s drug products and on compliance with FDA regulatory requirements for communications about such products.”

Scholarship and educational funding to students, residents, fellows, and other health care professionals to attend “carefully selected educational conferences”—a major educational, scientific or medical association conference—is permissible, “so long as the selection of the individuals is made by the academic or training institution.”

As far as those pens, notepads, and other “reminder” items of minimal value that carry company or product logos, they are permitted “if they are primarily associated with a health care professional’s practice.” Items that are “not of substantial value ($100 or less)” may be provided to physicians if they are primarily for the benefit of patients, and should be offered only on an “occasional basis.” The code indicates that a stethoscope or anatomical model would be acceptable; however, a VCR or CD player, music CDs, artwork or floral arrangements for the office, and those tickets to concerts and sporting events are out of the question.

Unless a physician is a contracted speaker or consultant to a company, the code declares that “cash or equivalent payments of any kind [such as a gift certificate] create a potential appearance of impropriety or conflict of interest” and therefore should not be offered.

The code concludes that “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.”

Yet, that is exactly what marketing is all about, Appelbaum noted.

“I haven’t yet met a psychiatrist,” he concluded, “who couldn’t afford to buy his or her own pens, rather than carrying around a subtle reminder of whose medication should be prescribed.”

It is not yet apparent which pharmaceutical companies will adopt the new code; however, spokespersons for companies contacted by Psychiatric News indicated their companies already have in place internal policies that are at least as stringent, if not more so, than the PhRMA guidelines.

The “PhRMA Code on Interactions with Healthcare Professionals” is posted on the Web at www.phrma.org/press/newsreleases//2002-04-19.390.phtml. ▪