OIG issues drug marketing guidelines

It's unclear whether physicians also will be subject to investigation for violations.

By Andis Robeznieks, AMNews staff. Oct. 21, 2002.

Pharmaceutical marketing practices are likely to face more scrutiny now that the federal government has weighed in on what could make the companies the subject of fraud and abuse investigations.

The making and marketing of pharmaceutical products was the subject of a 44-page document released by the Dept. of Health and Human Services' Office of Inspector General on Sept. 30.

The federal government report is the latest look at the relationship between pharmaceutical representatives and physicians and others who interact with them.

The Pharmaceutical Research and Manufacturers of America in July enacted stringent guidelines for its members, and the AMA has stepped up its campaign to educate doctors on guidelines it has had for several years.

In some areas, the document -- signed by Inspector General Janet Rehnquist -- hints that it is merely a handy guide to be used for manufacturers' own in-house policing efforts:

"This guide is not a compliance program," the OIG document states. "Rather, it is a set of guidelines that pharmaceutical manufacturers should consider when developing and implementing a compliance program or evaluating an existing one."

In other passages, it warns that adhering to the PhRMA Code on Interactions with Healthcare Professionals is merely a "good starting point" and "will not necessarily protect a manufacturer from prosecution or liability for illegal conduct."

"The OIG recommends that pharmaceutical manufacturers at a minimum comply with the standards set by the PhRMA code," the document states. "Arrangements that fail to meet the minimum standards set out in the PhRMA code are likely to receive increased scrutiny from government authorities." [...]