Novartis Tricked Into Buying Anti-Counterfeiting Technology!?

Novartis Tricked Into Buying Anti-Counterfeiting Technology!?

April 12th, 2013 // 2:46 pm @

Exclusive cGMP and FDA Compliance News

In one of the more embarrassing gaffes, Novartis was fooled into purchasing an anti-counterfeiting technology from Australia’s science agency and a marketing partner, which reportedly knew could be compromised. As a result, the drugmaker is now conducting an internal probe into the $2.5 million deal, a spokesman confirms.

At issue is a ‘tracer’ that was supposed to protect millions of vials of Voltaren, an injectable medication used to treat osteoarthritis, from being duplicated by counterfeiters, according to The Sydney Morning Herald. The drugmaker signed a deal two years ago with DataTrace DNA, a joint venture between Australia’s Commonwealth Scientific and Industrial Research Organization, or CSIRO, and DataDot Technology.

Instead of receiving a custom-designed solution, Novartis was apparently sold tracer material that had been purchased from China, although the joint venture was reportedly made aware that the material was insufficient for pharmaceutical application, the paper writes. DataTrace, however, repeatedly assured Novartis the tracer was made under secure conditions at a CSIRO facility, the Herald continues.

A former CSIRO employee and chief scientist for the project, Gerry Swjegers, had reportedly warned months before the deal was announced that the tracer was problematic. “The code which has been offered to Novartis may not be for purpose… because the code material is commercially available from a variety of vendors,” he wrote to DataTrace in 2010, according to the paper.

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“If there is a serious counterfeiting threat to the Novartis (vials), then this code risks being quickly and easily cracked,” he continued. “Serious questions could then be raised, especially if the successful counterfeiting attack resulted in injury or death.” He later left CSIRO after a falling out, according to the paper, and joined DataDot.

Moreover, the DataTrace manager who negotiated the deal with Novartis, emailed CSIRO managers that “there may well be a possibility that aspects of the code could be simulated with commercially available products.” And in a January 2010 memo prepared for a meeting attended by CSIRO officials, he wrote that “we currently source end-product, ie we deploy the product as purchased by us for our clients.”

The revelation has alarmed Novartis, which scrambled to assure the public that Voltaren supplies have not been compromised. “The product verification feature… is used as an additional verification feature and does not affect product quality or the safety and efficacy profile of the product. It is neither used for product identification nor quality determination,” according to a statement sent us.

“Novartis uses several verification features on our products. If one verification feature were compromised, this would not prevent us from being able to clearly determine the origin and authenticity of our products. Novartis is taking any matters related to its products very seriously and is therefore investigating on this matter, in full collaboration with the appropriate authorities.”

CSIRO, meanwhile, attributed the allegations to a former employee who left the agency four years ago and maintains the “substance” of the claims were not raised before appearing in the media. The agency notes the charges do not relate “solely, or even primarly” to CSIRO, but is urgently “making inquiries” to establish facts and verify the claims.

As for DataDot, the company has not posted any notice on its web site concerning these developments, but trading in its stock was halted yesterday in response to the coverage.

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