FDA gives advice on cargo, warehouse thefts

The US Food and Drug Administration has offered advice to industry on how to handle what it describes as an "increase in cargo and warehouse thefts."

In a letter to pharmaceutical companies and other key stakeholders, the FDA points out that this is crime that has serious consequences, not only for the companies involved but also for patients.

Without divulging details, the FDA notes that there have been "several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling."

Products stolen in recent months have included prescription and over-the counter medicines, medical devices and infant formula.

"Firms engaged in providing medical products and infant formula to the public have a fundamental responsibility to continuously review their warehouse physical security and security practices and procedures for transporting products," says the FDA in the letter, which can be viewed here.

The agency also provides information on the actions it will take when a major theft is reported, and gives guidance on the steps companies should take with regard to notification of regulators, police and other supply chain stakeholders. It asks that companies suffering a large-scale theft notify the FDA's Office of Criminal Investigations (OCI) "as soon as possible."

"Prompt public notification of the theft is a critical step in protecting the public health," says the latter, which is signed by Michael Chappell, the FDA's acting Assistant Commissioner for Regulatory Affairs.

Doing so "alerts others in the supply chain and the public to look out for the stolen products and to be sceptical of offers for these products at unusually low prices or from a person outside the legitimate distribution chain."

The FDA also points out that companies need to review their own storage and in-transit security procedures, and those of their business partners, on a regular basis and to plan in advance their response to an incident.

"We look forward to continued dialogue with participants in the supply chain to identify best practices," said Chappell in the letter.

Freightwatch data

The official recognition comes shortly after security specialist Freightwatch published its report on cargo theft activities for February and March 2010, which indicates that of 65 thefts recorded in the month, five were of pharmaceuticals and one concerned consumer care products.

The total value of pharmaceutical thefts in the period was around $77.5m, but of course almost all of that came from the $76m burglary at Eli Lilly's warehouse facility in Connecticut in March.

The report also included four full truckload (FTL) robberies - one valued at $400,000, two others at approximately $350,000 apiece, and one where the value has not been disclosed. Two took place at truck stops, one from a public parking lot and another from a warehouse facility.

- Meanwhile, on the other side of the Atlantic the UK's Chemical Business Association also has security in its sights, having just published a code of practice for its members in a bid to improve supply chain security. In addition to theft, the Security Code document is designed to improve security against terrorist incidents.

The five-stage risk assessment required for CBA members involves: identifying potential security threats; identifying the nature of the vulnerability involved; implementing risk reduction measures; documenting the assessment; and subsequent monitoring and review. In parallel with the Security Code, the CBA has also issued voluntary Security Guidelines to establish best practice for the chemical supply chain.


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