They're the FDA, not the FBI. But the agency that regulates drugs and devices in the U.S. is cracking down on thefts of medical products through its Office of Criminal Investigations.
FDA has sent a letter to key stakeholders in the medical supply chain to be wary of cargo thefts of drugs and devices. The April 28, 2010 letter expresses concern over increasing cargo and warehouse thefts.
Improper storage of stolen drugs poses an immediate public health danger.
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"There have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling. We do not want to see this increase in thefts continue," said FDA's Michael A. Chappell, acting assistant commissioner for regulatory affairs, in the letter. In addition to medications and vaccines, devices and infant formula are often targets of the crimes.
Chappell warned that recalls of products may be necessary if drugs are stolen and the affected lots can't be identified.
"We recognize the impact that such a withdrawal may have on consumers, the supply chain, and a firm's business operations, and the agency is ready to work closely with firms to determine the appropriate steps to consider in order to protect the public. Depending on the circumstances, a prompt and effective response to a theft will reduce the need for such a market withdrawal," he wrote.
Proper custody and reporting should prevent or mitigate the problem.
Specifically, the agency admonishes companies to review their warehouse physical security and other security practices and procedures for storing and transporting products, to ensure that measures are in place to minimize the risk of warehouse and cargo theft. Care should be taken all along the supply chain from manufacturing, distribution, through storage and sale in retail or wholesale settings.
In the event of a theft, it's the manufacturers or holding company's responsibility to notify FDA's Office of Criminal Investigations (OCI) at 800-551-3989 or by accessing the OCI web site (www.fda.gov/oci).
Read the letter and more details about this important emerging problem, including reporting procedures.