What Price Off-Label? For Pfizer — It’s a Huge Penalty

In a very understated press release, Pfizer, Inc (no, it’s not a typo there is no period after Inc in the Pfizer name) has just announced its settlement with the Justice Department. The headline reads “Pfizer Concludes Previously Disclosed Settlement Agreement with the U.S. Department of Justice Regarding Past Promotional Practices.”

Contrast that with the AP headline “Pfizer to Pay Record $2.3 Billion Penalty Over Off-Label Promotions.”

This is big. And no matter how the facts are spun, this is big.

As part of this settlement, Pfizer will pay a $1.2 billion criminal penalty. The largest criminal fine in United States history.

What happened? The government found that the company engaged in the promotion of four prescription drugs to treat medical conditions that had not been approved by federal regulators.

This meant that the company was selling these drugs, including Bextra, for uses that had not been approved by the FDA. Off-label use of drugs is not an uncommon practice. But drug companies are not allowed to promote their drugs for medical conditions for which those drugs have not been approved — as occurred in this case.

Pfizer senior vice president and general counsel, Amy Shulman, stated that “corporate integrity is an absolute priority…”

But New York State Attorney General Andrew Cuomo had some choice words to describe the company’s actions in this case. “Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line,” he said. “Pfizer’s corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company’s drugs for patients in taxpayer-funded programs.”

As part of this settlement, Pfizer will pay $1 billion to compensate government healthcare programs such as Medicare and Medicaid. Six whistleblowers who first brought these practices to light will also share in the recovery in this matter.

The lawyers of Hersh&Hersh have extensive experience in representing plaintiffs in pharmaceutical cases, drug company fraud and whistleblower representation. Please feel free to contact our firm for a free consultation at any time.