Flu vaccine manufacturer gets warning from US regulator

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creampie
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Flu vaccine manufacturer gets warning from US regulator

Postby creampie » Sat Jun 25, 2011 2:19 am

MARK COLVIN: 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 the vaccine caused fever and convulsions in children.

The US Food and Drug Administration has issued a stern warning to CSL.

It's threatened to withdraw its license if CSL doesn't address a number of significant concerns about its manufacturing practices.

The company withdrew the vaccine for use on children last year, after children given it had seizures.

CSL says it's taking the FDA's warning very seriously, but an Australian infectious diseases expert has questioned the Australian regulator's actions.

Simon Lauder reports.

SIMON LAUDER: 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 the US regulator is now threatening to cut CSL out of the market if it doesn't change its ways.

VOICEOVER: Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions may include licence suspension and/or revocation.

SIMON LAUDER: In March this year the US Food and Drug Administration sent inspectors to CSL's Melbourne headquarters. In a letter sent last week, entitled "Warning Letter" the FDA tells CSL it's not happy with what it found.

VOICEOVER: A number of significant objectionable conditions relating to your facility's compliance with current good manufacturing practice.

SIMON LAUDER: The FDA started paying close attention to CSL after hundreds of Australian children under five had severe reactions to last year's flu vaccine.

More than 20 children were hospitalised in Western Australia with symptoms including seizures and fever.

The Australian Government reacted by withdrawing the flu vaccine for use in children. The FDA says CSL's investigation into the adverse reactions isn't good enough.

JEFF DAVIES: I don't accept that as a stand alone statement. I think our investigations have been comprehensive in looking at our manufacturing process.

SIMON LAUDER: Dr Jeff Davies is the executive vice president of CSL Biotherapies.

JEFF DAVIES: What I do accept and it's .. we appreciate the FDA's feedback and I think it's, 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.

SIMON LAUDER: Is it true that CSL used in its products components which didn't meet appropriate written specifications, namely 15 lots of sodium deoxycholate.

JEFF DAVIES: No. FDA is really questioning the methodology we used around some initial testing that we do on product.

SIMON LAUDER: It says that those products, those components failed tests but were accepted for use anyway.

JEFF DAVIES: No… yes. I mean 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.

SIMON LAUDER: So why do you think that's failed to satisfy the FDA?

JEFF DAVIES: I think they're just concerned about how we documented that process.

SIMON LAUDER: Previous concerns have been raised about dark particles found in multi dose vials of the CSL flu vaccine. The FDA says there's no rationale to CSL's claim that the particles are not foreign matter.

Professor of infectious diseases at the Australian National University Peter Collignon says the FDA's warning letter raises questions about Australia's regulator.

PETER COLLIGNON: The vast majority of vaccines we have are lifesavers. The worry about this, is it undermines people's confidence in vaccines in general when we shouldn't allow that to happen and 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.

SIMON LAUDER: CSL's Dr Jeff Davies.

JEFFDAVIES: There's no question about our products and our safety in the field at present and we continually monitor the products out in the field.

SIMON LAUDER: Professor Collignon says there's a lot at stake for Australia's biggest biotechnology company.

PETER COLLIGNON: This warning letter means they'll either get it right pretty quickly or they won't be making these vaccines anymore.

SIMON LAUDER: Why's that?

PETER COLLIGNON: 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.

SIMON LAUDER: A spokeswoman for the Therapeutic Goods Administration says the Administration 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.

MARK COLVIN: Simon Lauder.


http://www.abc.net.au/pm/content/2011/s3250836.htm
The only thing necessary for evil to triumph, is for good men to stay silent.
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