PhRMA Announces Revised Code Guiding Industry Interactions With Physicians

By Barbara Bein
7/10/2008

The Pharmaceutical Research and Manufacturers of America, or PhRMA, announced today it has strengthened the marketing code it uses to guide relationships between the pharmaceutical research and biotechnology companies it represents and physicians.

The revised "PhRMA Code on Interactions with Healthcare Professionals" (36-page PDF; About PDFs) updates an earlier version of the code (56-page PDF; About PDFs) and takes effect in January 2009. According to a July 10 PhRMA news release, the voluntary code "reaffirms that interactions between company representatives and health care professionals should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education."

Craig Doane, AAFP vice president for corporate development, welcomed PhRMA's action.

"We applaud the direction in which PhRMA is moving, and support any efforts that strengthen the relationship between organizations such as the AAFP and the pharmaceutical industry," Doane said of the announcement.

Gifts, Meals for Physicians

A number of changes in the new code pertain to gifts and meals offered to physicians and their staff members by industry representatives. Among such changes are the following:

Company representatives should no longer offer noneducational gifts to physicians, even those of minimal value, such as pens, pads and mugs. The representatives can, however, offer them educational items (designed primarily for the education of patients or health care professionals) if they are of modest value -- $100 or less -- and have no value to health care professionals outside of their professional responsibilities.
Sales representatives should not provide restaurant meals to physicians, although "occasional, modest" meals may be offered as part of informational presentations. These "incidental" meals should be provided in the office or hospital setting.
Companies should not provide meals or receptions directly for participants at CME events. The CME provider, however, can use unrestricted grant money from a supporting company to provide meals for participants in these events.

Commercial Consultants, Company Speakers

Several provisions affecting industry interactions with health care professionals who serve as commercial consultants or members of companies' speakers bureaus have been added or clarified in the revised code. For example:

Companies should not provide entertainment at company-sponsored meetings with physician speakers and commercial consultants, although "modest meals or receptions" may be appropriate.
Meetings for consultants and speaker training sessions should not be held in resort locations, but instead should take place in venues considered more appropriate for communicating medical information.
Fees or reimbursement paid to speakers and consultants should be not only "reasonable" but also based on "fair market value." Each company should determine a cap on the annual compensation it pays health care professionals acting in these roles.
Company speakers and consultants who also are members of committees that set formularies or develop clinical practice guidelines must clearly disclose their relationships with the companies with which they are affiliated to those committees.

Pfizer Announces New CME Support Policies

Pfizer is changing the way it funds continuing medical education.

It is eliminating all direct funding for physician CME programs provided by medical education and communication companies. It will continue to support CME programs at academic medical centers and teaching hospitals, as well as programs sponsored by associations, medical societies and community hospitals.

Industry Support of CME

Still other changes in the code affect CME support provided by pharmaceutical companies. For example, the revised code states that a company and its speakers must be "transparent" about the differences between promotional speaker programs and independent medical education. Speakers and their accompanying program materials must identify the company that is sponsoring the presentation.

In addition, commercial support for CME should be used to provide education about a range of treatments rather than to promote a particular drug or course of treatment. Companies' CME grants decision-making processes should be kept strictly separate from the promotional activities of their sales and marketing departments. And companies should not provide any input to CME providers regarding content or speakers for a CME program, even if they are asked to do so.

The content of a company's promotional materials and the use of prescriber data also were addressed for the first time in the revised code. The materials must be accurate, not misleading, make claims only when supported, reflect balance between risks and benefits and be consistent with FDA requirements.

Moreover, companies should develop and enforce policies on appropriate use of de-identified prescriber data and should observe physicians' rights to opt out of having their prescribing data disclosed to company sales representatives.

"We absolutely support the commitment of CME providers and of companies to avoid bias," Mindi McKenna, Ph.D., M.B.A., director of AAFP's Division of Continuing Medical Education, said of the changes. She added that she applauds the checks and balances included in the code that aim to ensure objective and appropriate physician education.

Each company is to state its intention to comply with the new code, company CEOs and compliance officers are to annually certify that they have compliance processes in place.

PhRMA has said that it will post on its Web site a list of all the companies that have pledged to abide by the revised code, along with contact information for company compliance officers and information about the companies' annual certification of compliance -- another facet of the new

The enhanced PhRMA code represents the latest development in an ongoing movement to ensure that industry interactions with physicians and other health care professionals do not compromise those professionals' ability to provide high-quality, cost-effective care for their patients. Organized medicine led the way in defining ethical behavior by physicians and pharmaceutical interests, starting with AMA Council on Ethical and Judicial Affairs, or CEJA, Ethical Opinion 8.061, "Guidelines on Gifts to Physicians from Industry," which was adopted by the AMA House of Delegates in 1990. That CEJA opinion since has been bolstered by a number of related actions, such as the AAFP's "Principles for Cooperation" that 16 pharmaceutical firms signed onto in 2001.

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