HHS releases marketing guidelines

December 1, 2002

Pharmaceutical Representative

The Office of the Inspector General for the Department of Health and Human Services has released draft guidelines for the marketing of pharmaceutical products.

The Office of the Inspector General for the Department of Health and Human Services has released draft guidelines for the marketing of pharmaceutical products. The guidelines, which were published in the Federal Register (vol. 67, no. 192), state that, "Pharmaceutical companies and their employees and agents engage in a number of … arrangements that offer benefits, directly or indirectly, to physicians or others in a position to make or influence referrals. These arrangements potentially implicate the anti-kickback statute."

Questionable interactions

The interactions the HHS guidelines list as questionable include:


• Entertainment, recreation, travel, meals and other benefits in association with marketing presentations.


• Scholarships and educational funds.


• Gifts and gratuities.

The draft guidance goes on to recommend the "PhRMA Code on Interactions with Healthcare Professionals" as a good place to start when considering compliance. "Arrangements that fail to meet the minimum standards set out in the PhRMA code are likely to receive increased scrutiny from government authorities."

Wholehearted agreement

A spokesman for the Washington-based Pharmaceutical Research and Manufacturers of America said the industry agreed that sales representatives should be focused on providing information to doctors and not on gift-giving.

"We appreciate the inspector general's acknowledgement that the PhRMA code provides useful guidance for evaluating relationships with physicians and other healthcare professionals," said PhRMA spokesman Jeff Trewhitt. "We wholeheartedly agree that the mission of sales representatives is education about new medicines. Sales representatives are focused on informing healthcare professionals about products, providing scientific and educational information, and supporting medical research, and not on providing gifts and entertainment to physicians. We welcome the compliance guidance from the inspector general and the detailed framework for compliance that she has provided."

The guidelines are subject to a brief comment period before they are approved. Said Trewhitt: "We look forward to the opportunity to comment on the detailed provisions later." PR

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