SILVER SPRING, Md., April 28 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today sent a letter to companies and a wide range of other key stakeholders detailing the agency's concern over cargo and warehouse thefts of FDA-regulated products.
The products stolen have included prescription and over-the counter medicines, medical devices, and infant formula.
In its letter, the FDA seeks to:
The FDA believes every company should have a clear plan developed on how to respond to these incidents, since swift action is essential.
The agency believes prevention of cargo theft is critical. To help achieve that goal, the FDA will continue to work closely with manufacturers and wholesalers to find ways to better secure the nation's supply chain, which protects the public health.
Here is the full text of the letter:
To [manufacturer, wholesaler, pharmacy, device, and infant formula trade associations]
April 28, 2010
FDA is very concerned about the increase in cargo and warehouse thefts of FDA-regulated products, including prescription and over-the-counter medicines, vaccines, medical devices, and infant formula. These crimes threaten the public health because product that has left the legitimate supply chain poses potential safety risks to consumers.
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. We would like to share our thoughts on steps that your members should take to minimize the risk of such thefts, as well as how FDA can work together with your members when a theft has occurred to address the public health risks associated with the stolen products.
Of course, the best intervention is to prevent these thefts from occurring in the first place. 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 to ensure that measures are in place to minimize the risk of warehouse and cargo theft. These measures are important throughout the supply chain -- starting from the point of manufacturing, continuing through the distribution of the product and to the retail outlet or other point where the product will be sold. Your members should ensure that their business partners and carriers review and have strengthened their storage and in-transit security practices as well. Your members need to be one-step ahead of thieves in securing their warehouses and product transport.
When a theft occurs, FDA is committed to work with the affected firm to minimize the public health risks and ensure an appropriate public health response. The agency has developed streamlined procedures to rapidly respond to reports of theft and ensure consistency as we work with firms that have experienced a cargo or warehouse theft.
We would like your members to promptly notify FDA's Office of Criminal Investigations (OCI) as soon as possible when a theft has occurred by contacting OCI's Headquarters office at 800-551-3989 or by accessing the OCI web site (www.fda.gov/oci). OCI will ask for information about the theft to assist FDA in evaluating an appropriate regulatory response. In the attached Appendix A to this letter, we have listed the types of questions that an FDA District Office may ask about the incident. FDA also encourages prompt reporting to law enforcement agencies.