Marketing unapproved drugs has landed Pfizer in big trouble

By Jeni Bauser in New York

The world’s largest pharmaceutical company, Pfizer, will pay a record $2.3bn as a result of the US criminal charges that it illegally misbranded the pain medicine Bextra, pulled from the market in 2005, and misrepresented other medicines and courted healthcare providers to promote its drugs.

Pfizer marketed Bextra for uses unapproved by the US Food and Drug Administration (FDA). The company was also charged with illegally promoting the drugs Geodon, Zyvox and Lyrica and giving kickbacks to healthcare providers. This is Pfizer’s fourth settlement over illegal marketing activities in the past seven years.

According to the US Department of Justice, Pfizer will pay $1.3bn for the illegal promotion of Bextra and $1bn in civil fines because it illegally promoted other medicines for symptoms unapproved by the FDA. The settlement also requires Pfizer to take part in a corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services, which will create procedures to avert future abuses. Six whistle-blowers at Pfizer were awarded more than $100m.

In a Department of Justice statement Mike Loucks, acting US attorney for the District of Massachusetts, said: “The size and seriousness of this resolution, including the huge criminal fine of $1.3bn, reflects the seriousness and scope of Pfizer’s crime … At the same time as Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws.”

Amy Schulman, Pfizer’s general counsel, said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls.”

Agency collaboration

This is the largest of several healthcare corruption cases that have recently been uncovered in the US. The Pfizer prosecution involved close collaboration between a handful federal and local agencies including the Department of Justice, the FDA, and several state attorneys’ offices.

The Pfizer case comes to light in a pivotal time as the US Congress and the Obama administration seek to overhaul the US healthcare system.

The dangerous lack of accountability of US drug companies is hurting patients and costing the country millions of dollars. While the case represents a record health-care settlement and the largest criminal fine ever in the US, the $2.3bn sum is less than a month’s sales for Pfizer. This should not be the price paid for doing business in the pharmaceutical industry.

“Pharmaceutical companies are too big to wipe off the map and no one has the political courage, and frankly you can see why,” says W Scott Simmer, an attorney at Blank Rome, which represented three whistleblowers in two of nine lawsuits being settled with Pfizer.

For the most part there is no price regulation of drugs in the US, outside specific federal programmes, allowing pharmaceutical companies to charge large premiums over the prices the drugs might be sold for abroad.

But there is some hope for the future of US healthcare. The historic case demonstrated remarkable coordination by various agencies and whistleblowers to bring Pfizer to justice, and drug companies are starting to train their sales reps on where the line must be drawn in their marketing tactics. The Pfizer verdict suggests that no company can ultimately get away with such behaviour forever.

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