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Industry responses to cargo thefts face greater FDA scrutiny

By Nick Taylor , 02-Apr-2012

The FDA will assess industry responses to drug cargo thefts as part of its fight back against crimes in the pharmaceutical supply chain.

By creating the Cargo Theft Response Team (CTRT) and increasing scrutiny of industry actions the US Food and Drug Administration (FDA) hopes to protect patients from stolen pharmaceutical products.

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”, the FDA wrote in a new standard operating procedure (SOP) file .

In the SOP the FDA outlines how it will respond to thefts of pharmaceutical cargo thefts from now on. Much of the policy focuses on communication between internal units at the FDA, police forces, and the company involved, which will have its response assessed by the CTRT.

The CTRT will determine whether a firm’s action plan adequately addresses the public health risk posed by the cargo theft”, the FDA wrote.In making this assessment the CTRT will consider the threat posed by the theft, looking at storage requirements, tamper protection, and other risk factors.

An area of particular concern for the FDA is the likelihood of the stolen products re-entering the legitimate supply chain. In conjunction the FDA will assess mitigating actions taken by the company to stop the stolen pharmaceuticals from re-entering the legal supply chain and reaching patients.

Taking action

Having evaluated the threat the CRTR will compare this to a company’s response. If a firm refuses to tell the public about the theft or omits information from its press release “the CTRT will develop an appropriate regulatory response”, the FDA wrote.

Possible FDA responses include publication of a consumer alert, a notice to members of the supply chain, or another form of communication. As well sharing information with public the FDA may also direct details specifically at healthcare professionals and other regulators.

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