FDA orders GlaxoSmithKline to review manufacturing worldwide

Britain’s biggest drugmaker warned by US watchdog over flu vaccine production at Canadian subsidiary
GlaxoSmithKline sold 26m doses of flu vaccines in the US last year, generating £150m in sales. Photograph: Photofusion/Rex Features

The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval.

It is another serious blow to Britain’s biggest drugmaker, already reeling from corruption allegations in Poland, Iraq, Jordan, Lebanon and China, and facing a criminal investigation by the UK’s Serious Fraud Office into its sales practices. It also recently paid out £63m to settle US marketing allegations. Earlier this week GSK had to apologise for the pitch adopted by a marketing firm working for the FTSE 100 company to recruit unpaid interns for clinical trials in the UK.

In a warning letter to the British company, the FDA cited “deviations from current good manufacturing practice” in the manufacture of FluLaval at GSK’s Quebec-based subsidiary ID Biomedical, which makes the vaccine for Canada and the US.

The US watchdog said when it inspected the site in Sainte-Foy, Quebec, in April it found that the plant had failed to take appropriate steps to prevent microbiological contamination of drug products purporting to be sterile. It also found that controls for the purified water system at the site, which employs 600 people, were inadequate to prevent contamination.

The FDA said it “expects ID Biomedical and GSK to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements”.

The letter piles further pressure on GSK’s boss, Sir Andrew Witty, whopledged a major overhaul of the company two years ago after a £1.9bn US fine for mis-selling drugs. At the same time, he has been behind industry leading measures on data transparency, clinical trials and access to medicines. The company also claims that Witty has transformed sales and manufacturing practices. GSK said on Tuesday that it was working with the FDA and making progress addressing the concerns. “We are committed to working with the agency to fully resolve all outstanding issues,” the drugmaker added.

“Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded.”

Pending FDA approvals, GSK now expects to provide between 28m and 33m doses of flu vaccine to the US health authorities for next winter. It had planned to supply 36m doses, 23m of which would be made in the Sainte-Foy site in Quebec. GSK is also working with the Canadian health authorities to meet its supply commitments for 2014-15.

GSK sold 26m doses of flu vaccines (Fluarix and FluLaval) in the US last year, which generated £150m in sales. While it is still working to determine the impact the FDA concerns will have on supply, it expects to increase output this year. Its sites in Dresden in Germany and Rixensart in Belgium, which make Fluarix, are not affected by the warning letter.

Vaccines is one of GSK’s key growth areas. The company won plaudits within the industry when it unveiled a complex asset swap with Switzerland’s Novartis in April. GSK beefed up its vaccines business with the acquisition of Novartis’s vaccines divisions for up to $7.1bn and offloaded its portfolio of cancer drugs.

GSK points out that it had six new medicines approved by the FDA last year, nearly a fifth of all approvals and the highest number of any drugmaker.

In early June, GSK settled allegations by 44 US states and the District of Columbia going back 14 years that it promoted its big-selling medicines Advair, Paxil and Wellbutrin for unapproved uses. The £1.9bn Federal fine from the FDA for mis-selling drugs also related to anti-depressents Paxil and Wellbutrin as well as Avandia, once the world’s most popular type-2 diabetes drug, until it was found to have potential serious side effects, including heart attacks.


Remembering GSK’s Cidra Disaster, Ian Mc Cubbin and Courageous Whistleblower Cheryl Eckard



GSK whistleblower Cheryl Eckard vs GSK’s Ian McCubbin on 60 Minutes

Back story here and here.

So. How does one defend the indefensible?

Here’s GSK’s Ian McCubbin’s (pic) attempt:

Ian McCubbin is a senior vice president from Glaxo headquarters in London.

“We regret what happened in Cidra. But we’ve worked really, really hard to resolve those issues. We spend $600 million every year on make sure that our plant and equipment is state of the art,” McCubbin said.

“Would you say that the company was chastened by all of this?” Pelley asked.

“No, I’d say the company was very disappointed that this occurred and that we regret that this occurred. But we’ve learned from it. And what you learn from, you become stronger,” McCubbin replied.

McCubbin told Pelley the company has about 80 plants around the world. When asked if any of them operate the way Cidra did, he said, “Absolutely not.”

“So how did Cidra go wrong?” Pelley asked.

“They all operated to the same standard, to the same quality system that we had in place. The difference between Cidra and all the rest of the plants is the effectiveness with which that quality system was implemented it was much weaker and that resulted in the compliance issues that occurred,” McCubbin said.

“Cheryl Eckard says that she was issuing warnings and no one was listening,” Pelley remarked.

“I don’t know Cheryl Eckard. And I don’t know all the details of her accusations. What I do know is that we were working with the FDA before Cheryl went to that plant,” McCubbin said.


Nice try Ian!

But who is Ian McCubbin? And why did GSK have him speak on their behalf if he didn’t know Cheryl Eckard or all of the details of her accusations?

Ian is currently responsible for strategy development and execution within GSK’s Global Manufacturing & Supply organisation. In addition he holds responsibility for the Global Logistics organisation which delivers supply chain processes connecting the Manufacturing and Commercial organisation. Prior to rejoining GSK in July 2006 Ian undertook significant Global Operations roles in the generic Pharmaceutical sector with two of the top 10 Global generic companies. Ian is a pharmacy graduate with additional management qualifications.


Glaxo pleaded guilty to a felony. It admitted it distributed “adulterated drugs Paxil CR, Avandamet (a diabetes drug), Kytril (a drug given to cancer patients), and Bactroban.” All together, the company paid $750 million to settle the criminal conviction and Eckard’s suit.

“Can anything like this happen at Glaxo again?” Pelley asked Glaxo’s Ian McCubbin.

“I absolutely hope not. We will work really hard to resolve these issues and make sure that our quality management system is in place and robust,” he replied.


Well done Ian!

Now – how many senior execs who ignored Cheryl Eckard’s pleas and tears still have jobs at GSK?

Posted by at 12:54 pm


Anonymous said…

According to The Guardian, there were still quite a few such execs there as late as Oct 2010: http://www.guardian.co.uk/business/2010/oct/28/glaxosmithkline-executives-allegedly-ignored-eckardSurprised? Not me!

4:25 pm

AJ said…

…Now – how many senior execs who ignored Cheryl Eckard’s pleas and tears still have jobs at GSK?…I detect a trick question.

9:42 pm

Bernard Carroll said…

Dr. Jerry Avorn also delivered a body blow to GSK’s obfuscations. In the piece that ran on 60 Minutes, he dismissed talk like “… We will work really hard to resolve these issues and make sure that our quality management system is in place and robust…” Dr. Avorn reminded viewers that in medicine the standard is we get it right, as in brain surgery. Glaxo’s lame excuse that drug manufacturing is a complicated process does not hold water.And then, as so often, the subsequent coverup deepened the ethical failure.

12:43 pm