NEW YORK: The corporate-integrity agreement signed by Pfizer as part of a multimillion-dollar fraud case settlement will not affect PR operations, company representatives said.
As part of the plea agreement in a case that involved the illegal marketing of seizure drug Neurontin, Pfizer agreed May 11 to pay $430 million in criminal and civil fines, and to sign a corporate-integrity agreement allowing greater government monitoring of the company's marketing and employee training practices.
The case involved Pfizer business unit Warner-Lambert, which the pharmaceutical giant acquired in 2000, four years after a whistle-blower alleged that the company was promoting Neurontin for purposes not approved by the US Food and Drug Administration.
A key component of the integrity agreement dealt with the training and education of Pfizer employees who engage in "sales, marketing, or promotion of Pfizer products, or the provision of information about or services relating to Pfizer's products," according to the document.
Corporate spokespeople are not covered under the agreement, said Mariann Caprino, senior director of corporate communications for Pfizer.
Katherine Harris, public-affairs specialist in the US Department of Health and Human Services' Office of the Inspector General (OIG), which is overseeing the agreement, said that it would exempt PR employees involved with press releases and media interviews unless "they conduct sales and marketing with healthcare providers."
The document states that Pfizer already has a committee in place to monitor compliance, another major component of the agreement.
With other companies being named in similar cases, attorney Kenneth Berkowitz said he is concerned that the settlement will have a "chilling effect" on appropriate communication.
Berkowitz, who specializes in drug marketing and promotion at law firm Bennett, Turner & Coleman, which is based in Washington, DC, noted that the case represents the first time the OIG and the Department of Justice brought criminal charges in an area typically policed by the FDA.
"There's a new force that is aggressively looking at all kinds of activities that relate to the marketing of pharmaceuticals," he said. "Industry is very concerned about it."