FDA warns of cargo theft risk
The Food and Drug Administration last Wednesday strongly urged pharmaceutical companies, wholesalers, retailers and transportation providers to tighten security following a string of cargo thefts during the past year, capped by the heist of $76 million worth of drugs from an Eli Lilly warehouse in March.
Among the products targeted by criminals are vaccines, prescription and over-the-counter medicines, medical devices and infant formula. FDA officials are concerned that stolen products may be resold in the marketplace and cause patients to have adverse reactions because the drugs went bad from improper storage and handling.
'Your members need to be one step ahead of thieves in securing their warehouses and product transport,' Michael A. Chappell, acting assistant commissioner for regulatory affairs, said in a letter to industry trade associations.
He said companies engaged in selling and distributing medicine and infant formula 'have a fundamental responsibility to continuously review their' supply chain security plans and make sure their customers and transportation providers also have strong storage and in-transit security practices in place.
Companies that are victimized by theft are asked to immediately contact the FDA's Office of Criminal Investigations and local law enforcement, as well as issue a prompt notice to the public to be aware of products sold at unusually low prices or from a person outside normal distribution channels.
Chappell said public health concerns sometimes dictate that drugs from the same production lot be recalled to eliminate confusion between legitimate and illegitimate products, even though it may result in significant additional cost to the drug maker.
'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 said.
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The FDA is adding cargo theft to its list of high-priority prevention efforts, which include securing the pharmaceutical supply chain from counterfeit, diverted, unapproved and otherwise misbranded or adulterated products. The agency is collaborating with the drug and infant formula makers to identify best practices and issue guidance for how to prevent and respond to cargo thefts from trucks and warehouses, according to the letter.
American Shipper's May cover story, 'Ripped off,' details how companies are dealing with the increase in cargo theft. The pharmaceutical industry's reaction is explored in a 'Bitter pill,' May Web-only content. ' Eric Kulisch