Pfizer To Resolve Unlawful Marketing of Drugs

DALLAS - Texas Attorney General Greg Abbott and 33 other state attorneys general today reached a $60 million settlement with Pfizer Inc. Today's agreement resolves an enforcement action involving Pfizer of New York and subsidiary, Pharmacia, Inc., which unlawfully marketed two prescription pain medicines - Bextra and Celebrex. Under the settlement, the state of Texas will receive $3.8 million.

The states' enforcement action charged Pfizer with unlawfully marketing the "Cox-2 inhibitors" Bextra and Celebrex for the treatment of acute and surgical pain. The U.S. Food and Drug Administration (FDA) had only approved Bextra and Celebrex for reducing common pain and inflammation. The Texas Department of State Health Services referred the case to the Office of the Attorney General for enforcement.

According to court documents, Pfizer and Pharmacia launched a marketing campaign that encouraged physicians, hospitals and health plans to prescribe Bextra in higher doses for "off-label" uses. The marketing effort occurred after the FDA rejected the applications seeking authorization to use Bextra at higher doses. While a physician may prescribe drugs for off-label uses, the law prohibits a drug manufacturer from marketing drugs to physicians for off-label purposes.

The state's enforcement action contends that significant safety concerns led the FDA to reject the marketing of high-dose Bextra for acute and surgical pain. Despite that rejection, the defendant conducted a systematic, multi-pronged "off-label" promotional campaign for the uses FDA refused to approve. Evidence uncovered by the states indicated the defendant distributed hundreds of thousands of 20-milligram doses of Bextra to medical professionals, such as orthopedic surgeons, in an effort to promote the drug's use to treat acute pain. At the time, the 20-milligram dosage was only approved for the treatment of menstrual pain.

The states also charged the defendant with exaggerating Celebrex's properties in promotional materials. For example, marketing materials suggested Celebrex could prevent the progression of arthritis. In fact, the drug only relieves arthritic pain. The exaggerated marketing effort catapulted Celebrex to "blockbuster" status among drugs in this class.

Government investigators also discovered that the defendant formed alliances with influential physicians. High volume off-label use prescribers were offered paid consultancies and lavish resort weekends as rewards. Over time, as more patients consumed Cox-2 drugs and more credible research appeared, safety concerns about the drugs escalated. Ultimately, the companies withdrew Bextra from the market, and Celebrex now contains a warning about its side effects.

Included in the judgment are terms that will help prevent:

  • deceptive use of scientific data when marketing to doctors;
  • "ghost writing" of articles and studies;
  • conflicts of interest for Pfizer promotional speakers;
  • dissemination of information about an off-label use rejected by the FDA;
  • distribution of samples with the intent to encourage off-label prescribing;
  • incentives from being offered to sales staff to increase off-label prescribing; and
  • grants from being provided to encourage use of Pfizer products.

In addition, the judgment requires Pfizer to submit all "direct-to-consumer" television drug advertisements to the FDA for approval and comply with any FDA comment before launching the advertisement.