GSK to pay North Carolina, 38 states $90M to settle Avandia drug case
Posted November 15, 2012
Updated November 16, 2012
Raleigh, N.C. — GlaxoSmithKline agrees to pay 38 states, including North Carolina, $90 million to settle cases in which the drug giant allegedly misrepresented the safety of the diabetes drug Avandia.
North Carolina will receive some $3.1 million, according to state Attorney General Ray Cooper.
Of the funds, $2.7 million will be used for "consumer protection purposes," and $400,000 goes to the State Health Plan, Cooper's office said.
“Misrepresenting a drug is bad medicine and bad business,” Cooper said. “It’s critical that drug makers give patients and doctors accurate, reliable safety information about their medications.”
The settlement is one of several GSK, which maintains its U.S. headquarters in Research Triangle Park, has made in law suits brought against Avandia.
The settlement resolves claims by state attorneys general that Glaxo misled consumers about whether Avandia caused heart attacks and strokes to pump up sales. The company already has paid more than $3 billion to resolve government probes of its marketing of Avandia and other medications, as well as patient lawsuits over the diabetes drug.
“This settlement, which is covered by existing provisions, marks an important step in resolving long-standing legal matters,” Bernadette King, a U.S.-based spokeswoman for the company, said in an e-mailed statement.
The settlements are part of London-based Glaxo’s push to resolve legal issues stretching back more than a decade. Company officials agreed in July to plead guilty to misdemeanor criminal charges and pay $3 billion to settle U.S. criminal and civil investigations into whether Glaxo illegally marketed Avandia and other medications. One of the criminal charges stemmed from the company’s failure to properly report clinical safety date about Avandia, according to court filings.
The company also agreed to pay more than $700 million to settle patients’ claims that Avandia caused heart attacks and strokes, people familiar with the accords said last year.
"It’s not unusual for there to be multiple settlements in these kinds of cases involving big drug companies, some brought by the states, some brought by the feds, some brought by private individuals, some dealing with consumer protection issues, and some dealing with fraud committed against Medicaid and other taxpayer-funded health programs," said Noelle Talley, public information officer for the N.C. Department of Justice.
The settlement announced Thursday involved a case brought by the Consumer Protection Division, she said.
GSK earlier this year reached a $3 billion settlement with the U.S. Department of Justice involving Avandia and other drugs.
In September, North Carolina received $31.8 million from GSK in a Medicaid fraud settlement that involved several GSK drugs.
The latest settlement requires that GSK "reform how it markets and promotes diabetes drugs"
According to Cooper's office, GSK "may not:
• make any false, misleading, or deceptive claims about any diabetes drug;
• make comparative safety claims not supported by substantial evidence or substantial clinical experience;
• present favorable information previously thought of as valid but rendered invalid by more credible recent information;
• promote investigational drugs; or
• misuse statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials."
Further, for eight years, GSK "must also:
• post summaries of all observational studies or meta-analyses it conducted or sponsors about the effective, safe, and/or appropriate use of its diabetes drugs;
• post summaries of clinical trials of diabetes products it sponsors within eight months of the primary completion date;
• register and post all clinical trials it sponsors as required by federal law; and
• comply with international requirements for manuscripts submitted to Biomedical Journals."
(Bloomberg news contributed to this report.)