FDA urges increase in security to thwart cargo theft

Agency expresses concern over theft of regulated products


Typically, FDA's District Office closest to a firm's corporate headquarters will follow up with their regulatory contact. The District Office will request that the firm provide information pertaining to the stolen products, including a risk assessment and an action plan, as expeditiously as possible.

In some cases, the appropriate public health response may be a market withdrawal for product already in the supply chain with the same lot numbers as the stolen product.

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.

Prompt public notification of the theft is a critical step in protecting the public health because it alerts others in the supply chain and the public to look out for the stolen products and to be skeptical of offers for these products at unusually low prices or from a person outside the legitimate distribution chain. In addition, if persons in the supply chain are looking out for these products, it becomes more difficult for the thieves to sell the products back into the legitimate supply chain. If a firm experiences a cargo or warehouse theft, we strongly encourage it to prepare a public notice for posting on its website or as a press release as soon as possible after the theft. FDA is ready to provide comment on the public notice in an expeditious manner if the firm would like to share it with the agency before release. FDA's District Office will coordinate this review with the firm. FDA will typically provide a link to the firm's public notification on FDA's new Cargo Theft website. http://www.fda.gov/ICECI/CriminalInvestigations/ucm182888.htm

As you may know, FDA has been working with manufacturers, wholesalers, and retailers on ways to further secure our nation's supply chain from counterfeit, diverted, unapproved, and otherwise misbranded or adulterated products. We have now added stolen products to this effort. FDA is working with the medical products and infant formula supply chain to identify best practices and provide other guidance on how to prevent and respond to cargo/warehouse thefts.

FDA hopes and expects that your members and others in the supply chain will immediately review their in-transit and warehouse security practices and take proactive measures to prevent opportunities for theft. It is also prudent for your members to plan in advance, for how they would respond to such an incident, since swift action is essential.

We look forward to continued dialogue with participants in the supply chain to identify best practices and other steps that can be taken to further ensure that American consumers can be confident about the safety and quality of medical products and infant formula sold in the U.S.

If you have any questions related to this letter or cargo theft generally, please contact Dr. Ilisa Bernstein, Director of Pharmacy Affairs, FDA, Office of the Commissioner, Office of Policy at 301-796-4723 or ilisa.bernstein@fda.hhs.gov.

Sincerely,

Michael A. Chappell

Acting Assistant Commissioner for Regulatory Affairs

Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA