Beyond the seal

Six months after recalling two lots of its immune deficiency drug because of tampering, Bayer Biological Products (BP) is now trying to stamp out future incidents with a seal. In September the firm rolled out new secondary packaging with branded seal tabs on all boxes for Gamimune N, 10%, Immune Globulin Intravenous (Human), 10%, a therapy used to treat patients with compromised immune systems. But will a seal be enough?

While researching this story on the Internet, I came across the site of a Scranton, PA, law firm. The site features a story detailing the recall and referring to another recall and another instance of tampering. The story concludes with the statement, "Contact us if you believe you may have a claim for damages."

The site doesn't blame Bayer BP or the other two mentioned companies, Eli Lilly and Co. and Bristol-Myers Squibb, for the product tampering. But the invitation to file a claim encourages a new area of litigation, one that all drug manufacturers and packagers should monitor. If such claims are filed, these drug manufacturers may need to prove that they took every step to protect their products from tampering.

Bayer BP's original packaging for Gamimune did feature other protective measures, such as an overseal and a flip-top covering for the vial stopper. While these were intended to demonstrate package security, it appears as though tampering with them wasn't enough to alarm users. Instead, the presence of an unusual white precipitate prompted a customer, presumably a healthcare practitioner, to report a questionable product. Bayer needed to provide more tampering signals on its products.

After the report, Bayer BP set out to develop tamper-evident packaging for its biological products. It aided investigators and partnered with the Immune Deficiency Foundation to provide information to the immune deficiency community. Additionally, Bayer BP worked to educate patients and professionals on how to identify products that may have been altered.

And Bayer did add the safety seal on all boxes. According to Bayer BP, any tampering with them will show users that product integrity may be compromised and that the product should not be used. "While all of us at Bayer were disturbed by the tampering incident with Gamimune N, 10%, we felt we must do more than simply express our indignation," said Gunnar Riemann, executive vice president, Bayer Corp., and president, Bayer BP division. "The enhanced tamper-resistant packaging program we have initiated with Gamimune N, 10%, is an example of our ongoing commitment to enhance product safety for our patients." The seal tab features the Bayer name printed in blue in diagonal strips.

But Bayer BP isn't sticking with just a seal. The company seems to understand that product protection must evolve to outpace the constant threat of tampering: its public relations firm reports that Bayer BP is currently conducting market research to determine other steps for a multiphase program to ensure product and package safety. It is also considering extending the seals and other protective measures to other products.

Bayer BP, Eli Lilly, Bristol-Myers Squibb, and every other drug manufacturer must be vigilant and continue such research to foil criminals, who are likely increasing their own sophistication. Companies must use obvious packaging features to signal product authentication. And they must periodically revise those features to ensure that criminals cannot use similar materials to duplicate authentic ones. Otherwise, law firms like the one in Scranton, PA, may build a booming business by arguing that manufacturers—whose pockets may be deeper than those of any rogue operation—failed to adequately protect its products.