In the largest such deal to date, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. Two guilty counts involve introducing misbranded drugs, the Paxil and Wellbutrin antidepressants, into interstate commerce, and another count is for failing to report safety data about the Avandia diabetes pill to the FDA. Under the terms of the plea agreement, Glaxo will pay a total of $1 billion, which includes a criminal fine of $956.8 million and forfeiture of $43.2 million. The drugmaker will also pay $2 billion to resolve civil charges with the federal government under the False Claims Act, as well as state governments. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, and other drugs, and also resolves pricing fraud allegations.“Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” Jim Cole, deputy Attorney General for the US Department of Justice, says in a statement [Here is the complaint against Glaxo and the plea agreement]. As part of the deal, Glaxo must also sign a Corporate Integrity Agreement [here it is], although there is no indication yet whether any Glaxo execs will be excluded from further dealings with federal healthcare programs. Such a move would be made by the US Department of Health & Human Services.
The $3 billion settlement dwarfs previous agreements reached by Pfizer and Eli Lilly for assorted marketing infractions, although the $1.6 billion deal reached by Abbott Laboratories for its Depakote anti-seizure med continues to hold the record for the largest payout by a drugmaker over violations involving just one particular medication [back story here]. This is also the latest in a long series of such settlement involving similar allegations that have been brought against nearly every large global drugmaker over the past several years. Another such deal involving Johnson & Johnson and its Risperdal antipsychotic is expected to be announced shortly [read here]…
If only some Glaxo officials had listened to Greg Thorpe in 2001, perhaps the big drugmaker would not be doling out $3 billion to settle a raft of criminal and civil charges for off-label marketing, failing to disclose safety data and reporting false prices [back story]. But Glaxo officials failed to heed the warnings that Thorpe, a former sales rep and a Glaxo whistleblower, repeatedly made more than a decade ago, according to court documents…
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