The changing landscape of pharmaceutical medicine

Physician Executive, July-August, 2004 by Arthur Lazarus

IN THIS ARTICLE ...

Examine the sweeping changes taking place in pharmaceutical medicine including a new code of conduct, federal regulations and industry changes designed to improve drug companies' standards and elevate their performance.

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Pharmaceutical companies frequently are perceived as exerting too much influence on physician prescribing and education. Loss of credibility--generated by an almost daily barrage of bad publicity that has inundated the pharmaceutical industry--may be the most serious challenge for physician executives working within and with the pharmaceutical industry.

Government regulations and new industry guidelines are changing the pharmaceutical landscape, altering the way drug companies interact with professional audiences. Here's a look at recent developments and their impact with physician executives.

PhRMA code

The Pharmaceutical Research and Manufacturers of America (PhRMA) is an organization that represents research-based pharmaceutical and biotechnology companies. In July 2002, the organization approved its' PhRMA code that focuses on interactions with health care professionals.

Although compliance with the code is voluntary, its two main purposes are to eliminate potentially inappropriate influences on health care prescribing decisions and to minimize any appearance of impropriety. In contrast to the American Medical Association guidelines on gifts to physicians, the focus of the PhRMA code is on the value of the information provided.

The preamble of the PhRMA code openly acknowledges the pharmaceutical industry's concern about the public perception of industry relations with health care professionals. It reads, in part:

"In interacting with the medical community, we are committed to following the highest ethical standards as well as legal requirements. We are also concerned that our interactions with health care professionals not be perceived as inappropriate by patients or the public at large. This code is to reinforce our intention that our interactions with health care professionals are to benefit patients and to enhance the practice of medicine. 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 main points of the PhRMA code address:

* Interactions -- The purpose of interacting with health care professionals is to share scientific and educational information and support medical research to benefit patients.

* Informational meetings -- Meetings should occur at a venue conducive to providing scientific or educational information. The audience should be comprised of professionals (no spouses). Only modest meals or refreshments should be served. Entertainment and recreational events are not permitted.

* Continuing education -- When companies underwrite medical conferences or meetings other than their own, they should not control the content, faculty, educational methods, materials and venue. Companies may provide support to the conference sponsor but should not fund individual participants. However, financial assistance for scholarships or other educational funds to permit trainees to attend carefully selected conferences may be offered as long as the trainees are selected by the academic or training institution.

* Consultants -- Consulting or advisory arrangements must serve a legitimate need of the company. Consultants should be selected and compensated based on their expertise, not as a reward or inducement for prescribing. There should be a sufficient (but not excessive) number of consultants for the specific program. The pharmaceutical company should maintain records of the meeting and make appropriate use of the feedback provided by the consultants.

* Practice-related items -- Health care professionals may receive items primarily for the benefit of patients if the items are valued under $100. Items for the personal benefit of the health care professional should not be offered or distributed. In short, nothing should be offered or provided that would create a conflict of interest or interfere with the independence of the health care professional's prescribing practices.

FDA regulations

The U.S. Food and Drug Administration also regulates promotional programs sponsored by pharmaceutical companies. The underlying theme of the FDA regulations is to ensure that drug promotion is not false or misleading. Physician executives who speak on behalf of pharmaceutical companies must provide fair balance, stay "on label," and be truthful.

Fair balance means that a product's risks and benefits are discussed, including a discussion on safety information such as contraindications, warnings, precautions and adverse effects.

Staying "on label" means that the information provided by a speaker is consistent with the FDA-approved prescribing information that appears in the package insert. The only exception is when answering unsolicited questions on unapproved uses. In such instances, brief answers to questions are permissible.