Off-label marketing strikes again. Pfizer ($PFE) agreed to pay $325 million to wrap up claims that its Parke-Davis unit touted the epilepsy drug Neurontin for uses not approved by the FDA, costing healthcare payers millions in unnecessary spending.
It's Pfizer's second round of off-label Neurontin settlements: In 2004, the company shelled out $430 million in a settlement with the U.S. Justice Department. The drugmaker's Warner-Lambert unit pleaded guilty to two violations of the Food, Drug & Cosmetic Act and paid civil and criminal penalties for promoting the drug, known generically as gabapentin, as a treatment for bipolar disorder, ADHD, migraine headaches and other types of pain.
And it's the second settlement of Neurontin-related claims in less than 6 weeks. On April 21, Pfizer said it would pay $190 million to settle a federal antitrust lawsuit claiming that the company did some questionable maneuvering to keep cheaper generics off the market.
Pfizer did not admit wrongdoing in the latest settlement deal, which must be approved by a federal judge in Boston. The deal wraps up "all third-party payer claims regarding off-label promotion" of Neurontin, a spokesman told Bloomberg.
Parke-Davis was a unit of Warner-Lambert, which Pfizer acquired in 2000. The claims about off-label marketing stretch back to 1994. But according to the payers' lawsuit, Pfizer "deliberately expanded the promotion of off-label uses" after the Warner-Lambert buyout.
That $325 million may seem like a substantial amount of money, but the payers--which include Louisiana Blue Cross/Blue Shield--had claimed "billions of dollars" in damages from off-label Neurontin use. The company marketed Neurontin "for a variety of uses for which it is not approved or medically efficacious," the lawsuit claimed (as quoted by Bloomberg).
The off-label allegations are among many leveled against not only Pfizer, but almost every Big Pharma company. In addition to Pfizer's DoJ settlement involving Neurontin, the company agreed to pay $2.3 billion to resolve Justice Department allegations that it sold a variety of drugs for off-label uses, including the now-withdrawn blockbuster painkiller, Bextra.
That settlement included a record-setting $1.3 billion criminal penalty. Other settlements--some even larger--have followed that deal, but Pfizer retains the record. Most recently, Pfizer last year said it would pay $491 million to resolve claims that its Wyeth unit, acquired in a 2009 megamerger, touted the transplant-rejection drug Rapamune for a variety of off-label uses.
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