Bayer responds to fake drug drive
drugs produced in vials, starting with its Gamunex IGIV product, to
make them more tamper-evident and improve their safety. The move
follows an FDA initiative on counterfeiting.
Bayer Biological Products has unveiled plans to introduce shrink-banding across the entire range of liquid products in vials made at its facility in Clayton, North Carolina, to make them more tamper-evident and improve their safety.
The shrink-band is designed as a clear plastic wrap, covering the neck and lid of the bottle. The shrink-band comes with a pull-tab for easy removal and, if tampering has occurred, the shrink-band will be broken or loosened and the disruption will be obvious to the naked eye.
Additionally, the shrink-band contains the Bayer BP logo, making it difficult to duplicate and providing an anti-counterfeiting function. If a disruption in packaging is identified, the product should not be opened or used. The company said it is also looking into alternative packaging safety innovations for other Bayer BP products.
Bayer BP's move comes as the US Food and Drug Administration (FDA) is gearing up to implement new guidelines for industry on how drug counterfeiting can be fought. The agency set up a task force earlier this year that is scheduled to issue an initial report later this week.
The first product to bear the new packaging is Gamunex (immune globulin intravenous (human), 10% caprylate/chromatography purified), Bayer BP's next-generation IGIV product that was approved in the US and Canada last month. The drug is used for idiopathic thrombocytopenic purpura, primary immune deficiencies, allogeneic bone marrow transplantation, and paediatric HIV infection.
Last year, Bayer BP became the first company in the biological products industry to introduce enhanced packaging safety innovations in response to tampering concerns.
"It is fitting that Gamunex becomes the first product to feature our latest enhanced tamper-evident packaging feature," said Dr Gunnar Riemann, president of Bayer BP. He noted that the product is the first completely new IGIV product development in more than a decade, with advantages such as a rapid infusion time, storage at room temperature and excellent tolerability.
Although not an issue with Gamunex, which will include shrink-banding from the time of launch, inventory of other products may lead to a period of time during which both shrink-banded and non-shrink- banded product is present in the market, said Bayer BP.
