$3 billion, FDA, Food and Drug Administration, GlaxoSmithKline, GSK, Paroxetine, UNited States, United States National Library of Medicine
Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case – Yahoo! News.
Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case
By PIERRE THOMAS and JACK DATE | ABC News – 19 hrs ago
Pharmaceutical Giant GSK to Pay …
Healthcare giant GlaxoSmithKline has agreed to an unprecedented $3 billion settlement with the U.S. government over allegations that the company advertised drugs for uses not approved by the Food and Drug Administration and then used lavish gifts to convince doctors to prescribe the drugs.
The multi-billion dollar settlement is the largest in U.S. history for alleged healthcare fraud, government officials said.
In one instance, a drug was widely promoted to help treat depression even though the FDA had never tested it for such a use, according to the Department of Justice. In another, prosecutors said GlaxoSmithKline, or GSK, advertised the drug Paxil for use on children, despite the FDA not having approved antidepressant for anyone under 18. A notice posted on the website for the U.S. National Library of Medicine warned that a small number children to young adults taking Paroxetine — which is sold under the brand name Paxil — in clinical studies “became suicidal.”
The government also said that GSK failed to report relevant safety information about the popular diabetes treatment Avandia to the FDA and even directly paid medical professionals to push the product on doctors for its alleged benefits for the heart — even though GSK had no scientific data to back up that claim.
In all, GSK pleaded guilty to three criminal charges for which it will pay $1 billion and another $2 billion will be paid in civil liabilities under the False Claims Act.
GSK is a major manufacturer of prescription medication, vaccines and consumer healthcare products. On its website, the company boasts, “every minute more than 1,100 prescriptions are written for GSK products.”
In a 2011 Corporate Responsibility Report, GSK addressed the government’s allegations broadly, saying, “Some people are concerned that marketing by pharmaceutical companies may exert undue influence on doctors, that sales representatives may not always give doctors full information about the products they are promoting, or that there may be promotion of medicines for unapproved uses.”
GSK goes on in that document to say that the company has “fundamentally changed our procedures for compliance, marketing and selling in the USA to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”
But critics at the Taxpayers Against Fraud non-profit group said that while recovering the money was a positive step, little is being done on a personal level to combat widespread fraud from the industry’s top moneymakers – including putting executives behind bars.
“The bad news is that monetary penalties are not enough to stop rampant fraud… If we want to stop fraud, we need to recover America’s stolen billions and we need to make sure that key players lose their jobs, their bank accounts, and their freedom,” said Patrick Burns of Taxpayers Against Fraud. “Once the pain is personal and well-timed, the change in conduct in fraudster-companies will be very rapid.”
- Largest health care fraud settlement (cbsnews.com)
- Pharma Giant GSK To Pay $3 Billion Settlement (newsy.com)
- Pharmaceutical Giant GlaxoSmithKline To Pay $3 Billion In Largest Care Fraud Case (freeinternetpress.com)
- Mass. to get $35M from Glaxo’s $3B settlement (bostonherald.com)
- GlaxoSmithKline settles health care fraud case for $3 billion (jurist.org)
- GSK to pay $3B in largest healthcare fraud settlement over Paxil, Wellbutrin, Avandia (medcitynews.com)
- Drug giant hit with $3b fine after safety fraud (nzherald.co.nz)
- Drug Abuse – GlaxoSmithKline Admits Criminal Action (pavlovscouch.com)
- GlaxoSmithKline settles healthcare fraud case for S$3.8b (todayonline.com)
- Pharma Giant GSK to Pay $3B in Largest Ever Healthcare Fraud Case (abcnews.go.com)
The Press Association
While doctors are allowed to prescribe medicines for any use, pharmaceutical firms cannot promote them in any way not approved by the Food and Drug Administration. “Let me be clear, we will not tolerate health care fraud,” US deputy attorney general James Cole said at the Justice Department in Washington
Although James Cole’s statement as to not tolerating health care fraud maybe accurate I have serious questions as to the continued corruption that is apparent in the medical device world, these manufacturers are repeat offenders of paying kickbacks in order to get their devices marketed, thus the rate of return to the investor is more important than the safety and well being of human beings in some instantces.
What the justice department should consider is hiring an ” Elliot Ness ” to clean the corruption up and out. If the medical device world is to regain the trust of people this is the first and most important thing need be done.
Maybe Mr. Cole should be asked how it is a medical device is approved, under questionable means after being denied with the same data and now it has caused pain and suffering for the rest of my and others lives and the very manufacturer is protected by the preemption laws. When in essence these laws were to protect the health and well being of human life. How is it the oil, auto industry are held accountable for their malfunctions and the Church is accountable for their miss deeds
how does a medical device manufacturer get to hurt you and then gets a free pass?