Noncompliant promotional practices cost Pfizer $2.3 Billion
Pharmaceutical giant Pfizer will pay $2.3 billion in the largest health care fraud settlement in history. The settlement with the U.S. Department of Justice resolves criminal and civil allegations that the company used illegal tactics to promote several of its drugs, most notably the painkiller Bextra. Additionally, as part of the agreement, the Department of Health and Human Services will monitor Pfizer's marketing more closely over the next five years. That agreement, according to the FBI, provides “for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.”
The settlement also covers Pfizer's promotions of epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Authorities called Pfizer a repeat offender, saying it is the company's fourth settlement of government charges in the last decade.
Off Label Promotion
Bextra, an anti-inflammatory drug, had been approved in 2001 for treating rheumatoid arthritis, osteoarthritis, and menstrual pain. Pfizer sought FDA approval of Bextra for prescribed use to treat all types of pain and use of the drug at higher doses. The FDA refused citing concerns about the drug causing blood clots in the heart. However, according to a Department of Justice website, “Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.”
While no traditional marketing or advertising promotions for these off-label uses were conducted by Pfizer, the company systematically sought to induce doctors to prescribe the drug for these indications. Part of the organized effort involved Pfizer’s practice of inviting doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said. "They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. Attorney in Massachusetts.
Physicians are free to prescribe a drug for any use that they deem necessary. However, Pfizer was systematically attempting to get doctors to engage in off-label use. According to government reports, Pfizer paid some doctors to be consultants and to participate in meetings to develop strategies on how to get other doctors to use the drug for these unapproved uses. The activity involved a concerted effort by the company to get physicians to prescribe the drugs for off-label uses rather than doctors coming to those conclusions on their own.
Comments from officials indicate that the government intends to increase efforts to enforce regulations and appears to be making an example of Pfizer as a warning to other pharmaceutical companies.
“This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare,” said Tony West, Assistant Attorney General for the Civil Division.
“Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner,” added Kevin Perkins, FBI Assistant Director, Criminal Investigative Division.
The $2.3 billion settlement is the second action in recent months against pharmaceutical manufacturers. Eli Lilly settled with the government earlier this year for $1.4 billion due to similar allegations around the marketing of antipsychotic drug Zyprexa.
The action against Pfizer is one of several enforcement actions FDA has taken since June 2006 when the Agency announced its new unapproved drug initiative to remove unapproved drugs from the market and issued its final Compliance Policy Guide (“CPG”) on the topic. More on this topic and other relevant guidance can be found by following the links below:
Article posted October 28, 2009