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.