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GlaxoSmithKline Agrees to Record Settlement Over Avandia, Paxil Drug Marketing Charges

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Drug maker GlaxoSmithKline just agreed to a record settlement over Avandia and Paxil drug marketing charges. According to the Justice Department, GlaxoSmithKline agreed to pay a massive $3 billion to settle the matter. The financial settlement is the largest of its kind to the government over illegal drug marketing, to date.

The drug maker also agreed to plead guilty to both criminal and civil charges concerning its off-label marketing of several medications that included the diabetes medication and anti-depressant, said Philly.com.

Avandia was, at one time, GlaxoSmithKline’s blockbuster Type 2 diabetes drug. The drug maker agreed to stop marketing Avandia as a treatment for Type 2 diabetes, respecting the demands of the U.S. Food & Drug Administration (FDA) and other regulatory agencies worldwide, which all feel Avandia carries increased risks for heart attacks and stroke over other available treatments, explained NewsInferno. In fact, GlaxoSmithKline did not note these risks in any clinical data; however, those filing lawsuits against the drug maker believe it had been presented with sufficient evidence of those risks.

Since 2004, GlaxoSmithKline has been the focus of a federal investigation over alleged illegal marketing and suppression of negative evidence on the side effects of Avandia and several other of its top-selling drugs, including its popular anti-depressant, Paxil, which remains on the market, said NewsInferno. The government has alleged that from April 1998 to August 2003 Paxil was illegally promoted by GlaxoSmithKline for use in pediatric patients under the age of 18 years of age, despite that the drug has never received FDA approval for this use, said Philly.com.

“Today’s multi-billion dollar settlement is unprecedented in both size and scope,” James M. Cole, Deputy Attorney General, said in a statement, wrote Philly.com. “It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud. At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust—and this historic action is a clear warning to any company that chooses to break the law,” Cole added.

GlaxoSmithKline CEO, Sir Andrew Witty, said, in part, in a statement, “Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.” GlaxoSmithKline indicated that this settlement was its “most significant ongoing Federal government investigation,” saying in a press release that the settlement will be “covered by existing provisions and will be funded through existing cash resources.”

The settlement concerns GlaxoSmithKline’s “sales and marketing practices for nine products; the U.S. Department of Justice’s investigation of possible inappropriate use of the nominal price exception under the Medicaid Rebate Program; and the Department of Justice’s investigation of the marketing and regulatory submissions of Avandia,” the drug maker said in its press release. Other products indicated in the release include Wellbutrin, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex, and Advair products.

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