A GlaxoSmithKline logo is seen outside one of its buildings in west London.–Photo by Reuters

BOSTON: A US judge approved an agreement by British drug-maker GlaxoSmithKline to pay $3 billion for criminal and civil violations involving 10 drugs, the largest health care fraud settlement in US history.    

The amount of money involved led US District Judge Rya Zobel to remark in court that she was having trouble keeping track of the numbers.

GlaxoSmithKline pleaded guilty to promoting the popular antidepressants Paxil and Wellbutrin for unapproved uses.

Government officials said in the original complaint that the company promoted Paxil as safe for children and adolescents, even though the US Food and Drug Administration hadn't approved it for those patients and the company's clinical trials raised concerns about an increased suicide risk.

Prosecutors had charged that the drug-maker promoted Wellbutrin for unapproved uses that included treating attention deficit disorder, bipolar disorder, obesity, sexual dysfunction and anxiety when it wasn't shown to be safe and effective for those uses.

The company also admitted that it failed to report to the government some safety problems with Avandia. In 2010, the diabetes drug was restricted in the US and banned in Europe after it was found to sharply increase the risks of heart attacks and congestive heart failure. Defense lawyer Geoffrey Hobart and Assistant US Attorney Sara Bloom declined to comment immediately following Thursday's hearing.

A GlaxoSmithKline spokesman referred later to comments CEO Sir Andrew Witty made, including that the company has learned ''from the mistakes that were made.''

When the government announced the settlement, US Deputy Attorney General James M. Cole called it historic, saying it sent a clear warning to any company that chooses to break the law.

Follow Dawn Business on Twitter, LinkedIn, Instagram and Facebook for insights on business, finance and tech from Pakistan and across the world.

Opinion

Editorial

Tough talks
Updated 16 Apr, 2024

Tough talks

The key to unlocking fresh IMF funds lies in convincing the lender that Pakistan is now ready to undertake real reforms.
Caught unawares
Updated 16 Apr, 2024

Caught unawares

The government must prioritise the upgrading of infrastructure to withstand extreme weather.
Going off track
16 Apr, 2024

Going off track

LIKE many other state-owned enterprises in the country, Pakistan Railways is unable to deliver, while haemorrhaging...
Iran’s counterstrike
Updated 15 Apr, 2024

Iran’s counterstrike

Israel, by attacking Iran’s diplomatic facilities and violating Syrian airspace, is largely responsible for this dangerous situation.
Opposition alliance
15 Apr, 2024

Opposition alliance

AFTER the customary Ramazan interlude, political activity has resumed as usual. A ‘grand’ opposition alliance ...
On the margins
15 Apr, 2024

On the margins

IT appears that we are bent upon taking the majoritarian path. Thus, the promise of respect and equality for the...