Drug company giant GlaxoSmithKline made U.S. history recently in an agreement with U.S. authorities requiring the company to pay a $3 billion healthcare fraud settlement. The GlaxoSmithKline deal with the U.S. Department of Justice also has the drug maker pleading guilty to three misdemeanor criminal counts.
The criminal counts are linked to three different GlaxoSmithKline drugs: Paxil, Wellbutrin and Avandia.
News about the settlement says that $1 billion will go toward settling criminal complaints leveled against the company, and the other $2 billion will go toward settling civil fines.
A large part of the settlement focuses on attempts by GlaxoSmithKline to get doctors to prescribe certain of its drugs in ‘off-label’ uses. As the American Cancer Society summarizes, an off-label drug use is when “a drug is used in a way that is different from…the FDA-approved drug label..
According to the FDA, the decision to use drugs in an off-label prescription is left up to doctors in most cases. However, while it may be legal for doctors to prescribe drugs for off-label uses, it’s not legal for drug companies to advertise or promote those off-label uses.
According to a Reuters article about the settlement, the Department of Justice says that’s exactly what GlaxoSmithKline did. Some of the off-label uses that U.S. officials say GlaxoSmithKline promoted include prescribing the antidepressant drug Paxil to treat patients under the age of 18 and prescribing the antidepressant drug Wellbutrin for weight loss.
According to the investigation, which the Department of Justice spearheaded, GlaxoSmithKline encouraged doctors to prescribe these drugs off-label to their patients by treating doctors to spa programs, special dinners and other activities.
A different sort of controversy surrounds the charges relating to the diabetes drug Avandia. In the case of Avandia, prosecutors say, GlaxoSmithKline didn’t give important safety information to the Food and Drug Administration. The data, the Department of Justice says, has led to so-called ‘black box’ warnings on Avandia, advising doctors and patients about the increased risk of heart attack and heart failure linked to the drug.
As Reuters coverage of the drug settlements points out, the size of the $3 billion settlement and extent of the criminal charges is a new level of victory for U.S. drug and health regulators. As James Cole, with the U.S. Justice Department said, the GlaxoSmithKline medical fraud settlement is, “a clear warning to any company that chooses to break the law.