Posted on 07/02/2012 3:54:47 PM PDT by Moose4
WASHINGTON -- GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.
Accompanying the criminal case was a civil settlement in which the government said the company's improper marketing included providing doctors with expensive resort vacations, European hunting trips, high-paid speaking tours and even tickets to a Madonna concert.
The $3 billion combined criminal-civil fine will be the largest penalty ever paid by a drug company, Deputy Attorney General James M. Cole said. The corporation also agreed to be monitored by government officials for five years to attempt to ensure the company's compliance, Cole said.
(Excerpt) Read more at newsobserver.com ...
bfl
From Glaxo in $3 Billion Settlement - WSJ (sub), by Jeanne Whalen, Devlin Barrett and Peter Loftus, 2012 July 02
Under the deal, which requires court approval, Glaxo will plead guilty to criminal charges involving three drugs — the antidepressants Paxil and Wellbutrin and the diabetes drug Avandia. The settlement includes $1 billion in criminal fines and $2 billion to resolve civil liabilities owed to the federal government and the states, the Justice Department said. Glaxo had announced the settlement's size in November. The guilty plea covers a range of behavior by the U.K.-based company, including illegally promoting the antidepressants in the U.S. for uses that weren't approved by the Food and Drug Administration, a practice known as off-label marketing, and withholding important safety data about Avandia from the U.S. regulator. The settlement was Glaxo's fourth with the U.S. government in the past several years but is by far its costliest and most far-reaching. Over a period of more than a decade, the government's latest investigation found, the company plied doctors with perks such as free spa treatments, Colorado ski trips, pheasant-hunting jaunts to Europe and Madonna concert tickets, Justice Department officials said. Meanwhile, it encouraged those doctors to write prescriptions for the two antidepressants that went beyond their sanctioned uses. U.S. law bars companies from marketing a drug for uses not approved by the Food and Drug Administration, though doctors may prescribe approved drugs as they see fit. ..... < snip > Drug maker GlaxoSmithKline PLC agreed to plead guilty to criminal charges of illegally marketing drugs and withholding safety data from U.S. regulators, and to pay $3 billion to the government in what the Justice Department called the largest health-care fraud settlement in U.S. history.
Pheasant-hunting jaunts and tickets to Madonna concerts? That SHOULD BE criminal.
Oh, about the settlement's fines, money... The money goes to DoJ and SAOs... Sorry, Charlie... and Joan Q. Public. No real harm was done to the consumers, just "illegal marketing" of product "not approved by FDA."
Notice it doesn’t say that the meds were ineffective in their off labelnuses, just that the uses were not government approved.
Need to think about that one.
Glaxo settled without admitting to any wrongdoing to both criminal and civil charges as well as "compensatory" amount to government for their "investigations".
The beneficiaries, outside of DoJ and SAOs, will be 3 (or possibly more) whistleblowers (and their lawyers) who provided the basis for the charges and settlement by filing the lawsuit in 2003 in Boston, under the whistleblower statutes on a qui tam provision on the government behalf under the Federal False Claims Act.
They are former senior management employees of Glaxo, Thomas Gerahty and Mathew Burke; lawyers say that plaintiffs are usually entitled to between 15% and 30% of government's civil suit "recovery" amount.
Let's not forget that doctor have prescribed off-label use of many drugs that were deemed either more effective or cheaper substitute with the same efficacy as the FDA-approved drug for certain diseases.
The most recent highly publicized "controversy" was the use of cancer drug Avastin instead of much more expensive and difficult to obtain Lucentis, for the treatment of wet AMD (age-related macular degeneration) which is the leading cause of blindness, usually in the elderly. Some ophthalmologists even considered Avastin more effective than Lucentis for certain forms of AMD.
Caver, define your concept of Conservative, please.
1: crony capitalism:
When did crony capitalism, knowing, intentional, ongoing conduct constituting direct violations of activities already prohibited by law, and socialist redistribution become Conservative Values?
Here’s what it costs drug companies to Buy FDA approval for their products.
PDUFA user fee archive
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm152775.htm
Here’s what Congress has just done
PDUFA fee increase
http://www.fiercepharma.com/story/pdufa-goes-president/2012-06-27
“The FDA user fee reauthorization bill has passed Congress and now only needs to be signed by President Obama. It kicks off a five-year stretch in which the FDA will have more money and new authorities in hopes that it will approve drugs faster (which is good for the industry) and theoretically cut costs for consumers and taxpayers through faster approval of generics.
The law will provide more than $6 billion in user fees over the five years”
Before the recent PDUFA user fee increase, FDA was already receiving over a Fifth of its operating budget from drug and device manufacturers. Do you find any potential conflict of interest there? Whose interests do you believe FDA is more concerned with protecting? The consumer or the manufacturer? Up from $600 Million to $1.2 Billion a year?
2: GSK Illegal Conduct
Engaging in monetary transactions in property derived from specified unlawful activity.
US 18C95 Sec 1957
http://uscode.house.gov/download/pls/18C95.txt
3: Socialism
Most of those tens of Billions flowing into GSK’s coffers are Not a Voluntary Financial Transaction on your part or anyone else’s part. Those tens of Billions are predominantly coming out of Medicare and Medicaid through the Center for Medicare Services. You are being forced, by Government, to Pay GSK those tens of Billions.
http://pogoblog.typepad.com/pogo/2011/08/janet-woodcock-miss-piñata-meets-clue-stick.html#more
http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html
http://www.pogo.org/pogo-files/letters/public-health/ph-fda-20120529-fda-secrecy.html
FDA is a trainwreck of industry corrupted politicking. The author, Paul Thacker, has street cred. He was Sen. Charles Grassley’s chief investigator when Grassley on the Senate Finance Committee was investigating drug industry corruption of Medical Research at the University level. Crooked Academics were taking Big Money from drug makers and not reporting it while simultaneously ginning up crap research which was used as a marketing device to sell and oversell drug company products.
Study 329 is very old news, and barely the tip of the iceberg.
When did crony capitalism, criminal misconduct, and socialist redistribution become Conservative Values?
There are far more Federal Criminal statutes which are applicable to GSK just for their Seroxat, Paxil and the 1 I’ve quoted, if You violate it, will get You jail time in a heartbeat. Is it a Conservative Value to look the other way when You are being charged through CMS to sell Suicide and Murder at GSK’s behest?
People will steal 10’s of BILLIONS from Obamacare !
Amen!
Like I said, a felony conviction is the last thing any drug co. wants and DOJ let’s them get away with all kinds of criminal abuse.
Check the Vioxx settlement.
http://www.bloomberg.com/news/2011-11-22/merck-agrees-to-pay-950-million-to-settle-u-s-government-s-vioxx-probe.html
Merck paid a $950 Million Fed Fine and plead guilty to a Misdemeanor Misbranding charge.
AFTER, they’d ALREADY PAID the surviving family members of 3,468 people they Killed with Vioxx while they were breaking the law by marketing the stuff illegally.
http://www.bloomberg.com/news/2010-07-27/merck-paid-3-468-death-claims-to-resolve-vioxx-suits.html
They admitted they broke the law, and that they were responsible for killing 3,468 people, and DOJ let them buy their way out of it.
Or How about Pfizer?
They got popped for $2.3 Billion and they had their shell co, Pharmacia Upjohn take the fall for it because that fall was a felony, no more Medicare bucks for 5 years if Pfizer ate the felony themselves.
http://en.wikipedia.org/wiki/Pfizer
“Bextra settlement of off-label marketing investigation
In September 2009, the United States Department of Justice announced that Pfizer had agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed four drugs: Bextra, Geodon, Zyvox, and Lyrica “with the intent to defraud or mislead” by promoting the drugs for non-approved uses; this marks Pfizer’s fourth such settlement in a decade.[4][5][39] Pharmacia & Upjohn Company, Inc., a Pfizer subsidiary, agreed to plead guilty to mis-branded promotion of Bextra, a FELONY violation of the Food, Drug and Cosmetic Act. “
To salute these companies as examples of Free Market Capitalism is as ridiculous as writing a bank robber a ticket for an expired meter out front while he was robbing the bank.
It's going to get soooooo much worse.
Here’s analysis of GSK’s press release re: the $3 Billion charge.
http://www.pharmalot.com/2012/07/the-glaxo-ceo-his-public-relations-debacle/
It includes a link to the actual GSK release, below
http://www.gsk.com/media/pressreleases/2012/2012-pressrelease-1164663.htm
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