Friday, December 15, 2017

GlaxoSmithKline fined $3 billion for marketing ploys

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.

"Let me be clear, we will not tolerate health care fraud," Cole told a news conference at the Justice Department. He would not say whether any company executives were under investigation. The company's guilty plea and sentence have to be approved by a federal court in Massachusetts.

GlaxoSmithKline CEO Sir Andrew Witty expressed regret and said they have learned "from the mistakes that were made."

"Today brings to resolution difficult, long-standing matters for GSK," he said in a statement. "Whilst these originate in a different era for the company, they cannot and will not be ignored."

Crimes and civil violations like those in the GlaxoSmithKline case have been widespread in the pharmaceutical industry. Some have said the industry regards the fines as simply a cost of doing business because aggressively promoting drugs to doctors for uses not officially approved has quickly turned numerous drugs from mediocre sellers into blockbusters, with more than $1 billion in annual sales.

The prior record-setting case involved Pfizer Inc., the world's biggest drugmaker. Pfizer paid the government $2.3 billion in criminal and civil fines for improperly marketing 13 different drugs, including Viagra and cholesterol fighter Lipitor.

It is illegal to promote uses for a drug that have not been approved by the Food and Drug Administration — a practice known as off-label marketing.

Prosecutors said GlaxoSmithKline illegally promoted the drug Paxil for treating depression in children from April 1998 to August 2003, even though the FDA never approved it for anyone under age 18. The corporation also promoted the drug Wellbutrin from January 1999 to December 2003 for weight loss, the treatment of sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depressive disorder.

Justice Department officials also said that between 2001 and 2007 GlaxoSmithKline failed to report to the FDA on safety data from certain post-marketing studies and from two studies of the cardiovascular safety of the diabetes drug Avandia. Since 2007, the FDA has added warnings to the Avandia label to alert doctors about potential increased risk of congestive heart failure and heart attack.

Comments
Here are this week’s pop culture winners and losers

Here are this week’s pop culture winners and losers

Salma HayekSalma Hayek has spoken out against Harvey Weinstein, calling the producer a "monster" who threatened her career and her life after she reportedly denied his sexual advances. Hayek said working with Weinstein on the film Frida was like "goi...
Updated: 5 hours ago
What to watch this weekend: ‘A Christmas Story Live,’ Star Wars movie marathon, Hollywood Christmas Parade

What to watch this weekend: ‘A Christmas Story Live,’ Star Wars movie marathon, Hollywood Christmas Parade

OH, FUDGE! A CHRISTMAS STORY LIVE!The trend of live musicals broadcast on television isn't slowing down anytime soon, and A Christmas Story Live! — based on the classic holiday movie and Broadway musical — was ripe for the next taking. Fo...
Updated: 5 hours ago
Craig Fugate says Floridians should brace for stronger hurricanes

Craig Fugate says Floridians should brace for stronger hurricanes

Many Hurricane Irma evacuees say they're apprehensive of packing up and leaving their homes again because forecast models failed to match the final track of the September storm.That is worrisome for Craig Fugate, a former director of the Federal Emer...
Updated: 4 hours ago
Florida education news: Free speech, term limits, Schools of Hope and more

Florida education news: Free speech, term limits, Schools of Hope and more

FREE SPEECH: The pending arrival of white nationalist Richard Spencer sent the University of Florida and the surrounding community into high gear, as people tried to figure out how to keep him away. Now some state lawmakers want to clarify the r...
Updated: 2 hours ago
Why the Bucs need a Dungy more than a Gruden

Why the Bucs need a Dungy more than a Gruden

TAMPA — The worst week of Dirk Koetter’s life rolls on.It’s Gruden Week, just like Shark Week, only with smaller teeth and a bigger playbook. It’s the big build-up to Gruden’s induction into the Buc Ring of Honor this Monday night, with the accompany...
Updated: 8 minutes ago
Arrest made as former gay bathhouse in Ybor City is hit by arson a third time

Arrest made as former gay bathhouse in Ybor City is hit by arson a third time

TAMPA — Tampa police arrested a man Friday on charges he set fire to a vacant Ybor City bathhouse hit by at least two earlier arsons this year.Police said Carroll DeMoss, 46, was found early Friday inside the building at 1512 E 8th Ave. after patrols...
Updated: 8 minutes ago
The meta-soap opera of Omarosa Manigault’s White House exit

The meta-soap opera of Omarosa Manigault’s White House exit

WASHINGTON — As the spooling drama of Omarosa Manigault Newman’s White House departure spun into its 36th hour, Washington began asking itself: "Does it actually matter whether Omarosa quit or was fired?"Dumbest story ever," tweeted John Harwood, the...
Updated: 12 minutes ago
3 car gurus from 'The Grand Tour' ponder the car's future

3 car gurus from 'The Grand Tour' ponder the car's future

Jeremy Clarkson, Richard Hammond and James May from 'The Grand Tour' talk about why we love cars so much and why the internal combustion engine isn't going away as soon as you think
Updated: 12 minutes ago

AP Top News at 10:08 a.m. EST

AP Top News at 10:08 a.m. EST
Updated: 12 minutes ago
Americans pessimistic about Trump, country: AP-NORC Poll

Americans pessimistic about Trump, country: AP-NORC Poll

Americans are painting a pessimistic view of the country and President Donald Trump as 2017 comes to a close
Updated: 15 minutes ago