Thursday, February 07, 2013

Hey GSK - what's a weekend boondoggle?

Louisiana attorney general files second suit against GlaxoSmithKline over off-label drug use

GlaxoSmithKline allegedly marketed nine drugs illegally for uses that have not been approved by the Food and Drug Administration and provided doctors with "consulting fees," expensive meals and "weekend boondoggles" to convince them to prescribe those brands, according to a lawsuit filed this week by Louisiana Attorney General Buddy Caldwell. These practices cost the state's Medicaid and medical assistance programs millions of dollars and subjected patients to "non-approved, ineffective and unsafe uses" of the drugs, according to the suit.

Attorney General Buddy Caldwell
"GSK's egregious conduct and greed caused fraudulent claims to be submitted to the Louisiana Medicaid Program," Caldwell said in an emailed statement. "As Attorney General, I will aggressively pursue and expose pharmaceutical companies who defraud our state and its citizens."

The suit lists nine drugs that GlaxoSmithKline allegedly promoted improperly between 1997 and 2010: Paxil, Wellbutrin SR, Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent and Valtrex. GlaxoSmithKline allegedly promoted each of those drugs as treatments for symptoms and diseases that had not been approved by the FDA, according to the suit.

The suit also alleges that medical professionals were treated to perks, rewards and "kickbacks" for prescribing the drugs. The state is seeking a range of fines and penalties, as well as restitution to the state for off-label prescriptions paid for through Louisiana's Medicaid program.

GlaxoSmithKline agreed to plead guilty to claims of fraud and failing to report safety data in a July 2012 settlement with the Department of Justice. The $3 billion settlement with the federal government and the National Association of Medicaid Fraud Control Units covered allegations that two of the drugs included in the Attorney General's suit, Paxil and Wellbutrin, were promoted for uses not approved by the FDA.

That settlement was reached while the Attorney General's Office was in the midst of a lawsuit against the British pharmaceutical company over the improper marketing, pricing and promotion of the diabetes drug Avandia. Louisiana was one of several states that did not sign off on the settlement because of the pending lawsuit.

The suit has been assigned to District Judge Janice Clark of the 19th Judicial District Court. Clark is also the judge in the attorney general's previous case against the GlaxoSmithKline, which is set to go to trial in June.

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