FDA scathing of Australian vaccine maker
June 22nd, 2011 // 12:53 pm @ jmpickett
The world’s most powerful drugs industry regulator has accused the Australian company that makes the flu vaccine of not doing enough to find out why it caused fever and convulsions in children.
The US Food and Drug Administration (FDA) has issued a stern warning to CSL and threatened to withdraw its license if the company does not address a number of significant concerns about its manufacturing practices.
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The FDA started paying close attention to CSL after hundreds of Australian children under five had severe reactions to last year’s flu vaccine, prompting CSL to withdraw the vaccine for use on children.
The FDA says CSL’s investigation into the adverse reactions is not good enough.
In March this year the FDA sent inspectors to CSL’s Melbourne headquarters. In a letter sent last week the FDA told CSL it is not happy with what it found.
“Failure to promptly correct these deviations may result in regulatory action without further notice,” it said.
“Such actions may include licence suspension and/or revocation. A number of significant objectionable conditions relating to your facility’s compliance with current good manufacturing practice.”
But CSL Biotherapies executive vice-president Dr Jeff Davies disagrees.
“I think our investigations have been comprehensive in looking at our manufacturing process,” he said.
“What I do accept – and we appreciate the FDA’s feedback, and I think we really take their feedback very seriously – the FDA has identified flaws in the methodology we use to look at these investigations and I think we’re working with them to address that.”
Dr Davies denies CSL uses in its products components which do not meet appropriate written specifications – namely 15 lots of sodium torodeoxecolate.
“FDA is really questioning the methodology we used around some initial testing that we do on product,” he said.
“Basically they were tested for a simple identity test, when they fail that identity test they go to a more comprehensive test; they passed that test.
“So what I’m telling you, is that there was no raw material that went into that product that was not tested and hadn’t passed the test.”
He believes the FDA is concerned about how the company documented that process.
Previous concerns have been raised about dark particles found in multi-dose vials of the CSL flu vaccine. The FDA says there is no rationale to CSL’s claim that the particles are not foreign matter.
Australian National University Professor Peter Collignon says the FDA’s warning letter raises questions about Australia’s regulator.
“The vast majority of vaccines we have are lifesavers,” he said.
“The worry about this is it undermines people’s confidence in vaccines in general when we shouldn’t allow that to happen, particularly not because the manufacturing process hasn’t been followed properly.
“And that’s why it’s vital that regulators like the FDA and the TGA come down very hard on these companies by having continuous inspections of them and making sure they are always following appropriate practices.”
Dr Davies says there is “no question about our products and our safety in the field at present” and that products are continually monitored.
Last year CSL Biotherapies sold $124 million worth of its influenza vaccine in countries around the world, including $53 million worth in the US.
But Professor Collignon says CSL has a lot at stake for Australia’s biggest biotechnology company.
“This warning letter means they’ll either get it right pretty quickly or they won’t be making these vaccines any more,” he said.
“Because the Americans, the FDA, whatever their next after a warning letter is, you can’t market your product and if you can’t market in the US because it’s not safe enough then it’s not going to be very satisfactory for Australia either.”
A spokeswoman for the Therapeutic Goods Administration (TGA) says it concurs with the FDA’s findings.
She says the TGA audits CSL annually and has conducted a number of special audits of the facility as part of its investigation into the adverse reactions to the flu vaccine last year.
Its most recent audit was last week.
