TRENTON – New Jersey will receive approximately $1.79 million as a result of its participation in a multi-state settlement with Pfizer Inc that resolves allegations the company deceptively marketed two of its drugs – Zyvox and Lyrica, Attorney General Jeffrey S. Chiesa announced today.
Under terms of the settlement, Pfizer has agreed to pay a total of $42.9 million to 33 states and the District of Columbia. The settlement resolves allegations that Pfizer made unfounded claims of product superiority on behalf of Zyvox that broadened indications for the drug, and that it engaged in unfair and deceptive practices by promoting Lyrica for “off-label” uses — those not approved by the U.S. Food and Drug Administration (FDA.)
As part of the settlement, Pfizer has agreed to change the way it markets Zyvox, an antibiotic, and Lyrica, which is used to treat neuropathic pain related to diabetes and shingles. Specifically, Pfizer has agreed to refrain from making deceptive claims about the efficacy of the drugs, and to avoid promoting them for off-label uses.
New Jersey was among the lead states in negotiating the Pfizer agreement, along with Arizona, Illinois, Maryland, Pennsylvania, South Carolina and Texas.
“This is an important settlement because it contains accountability measures designed to ensure that, going forward, these drugs are marketed on the basis of objective product information, not promotion-and-sales-driven hyperbole,” said Chiesa.
In a prior case, Pfizer acknowledged that it failed to provide adequate guidance to its sales force concerning what were permissible statements about Zyvox, specifically with regard to a competing antibiotic known as vancomycin.
“We take seriously the duty pharmaceutical companies have to provide consumers and health care professionals with clear, accurate and complete information about their products, and to avoid deception or misleading claims,” Chiesa said.
A Consent Judgment filed today in New Jersey Superior Court requires that Pfizer refrain in the future from making such claims on behalf of Zyvox or any other drug.
Among other things, the Consent Judgment also prohibits Pfizer from:
- Promoting Zyvox or Lyrica to any health care provider who practices in a specialty that is unlikely to prescribe Zyvox or Lyrica for an FDA-approved purpose.
- Promoting any Pfizer product for any off-label use.
- Seeking the inclusion of Zyvox or Lyrica in hospital protocols or standing orders unless Zyvox or Lyrica have been approved by the FDA for the use included in the protocol or standing order.
- Having financial incentives that provide for compensation based on sales attributable to off-label uses of any Pfizer product.
The Pfizer matter was handled by Deputy Attorney General Patricia A. Schiripo, Assistant Chief of the Division of Law’s Consumer Fraud Prosecution Section, and Deputy Attorney General Cathleen O’Donnell of the Consumer Fraud Prosecution Section.
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