FDA Finally Toughens Up On Drug Cargo Thefts

On March 23, 2012 the FDA issued a new Standard Operating Procedure (SOP) on Cargo Thefts. We have previously addressed this issue back in May of 2010 when the federal agency issued a warning letter alerting stakeholders in the increasing incidence of these thefts.

As a result of the spectacular March 2010 break-in and theft of over $75 million in drug products from an Eli Lilly warehouse in Enfield, CT most drug manufacturers and wholesale distributors beefed up security to help prevent future occurrences.

In the release of these new SOP's, the FDA wants to ensure that the industry is aware of the reporting obligations when a theft occurs, not only from a licensed warehouse facility but also when prescription drug products are being shipped. It is during the shipping process that these cargos are at their most vulnerable.

The SOP states that "if a firm is non-responsive to FDA's request for information related to the cargo theft or if the firm's action plan is inadequate, or if the firm is unwilling or reluctant to alert the public to the cargo theft, the [FDA's] Cargo Theft Response Team will consider the option of providing the public with the relevant facts about the cargo theft and to address the public health risk associated with that theft".

In other words...they are going to publicly embarrass you. Since the FDA doesn't really have specific licensing jurisdiction over most wholesalers (that is handled by the states), that's about all they can do. But if you don't think that they will notify YOUR licensing agency when you report a theft to them...have some more coffee, you might not be awake yet.

Take steps to secure your product TODAY! Protect that which is in your building, and that which is on the road, either on your own vehicles or with a 3rd party shipper. Have talks with your shippers about security, review your contracts with them to see how they handle a security breach. Are you financially liable, or are they?

There is a great deal of valuable information from FreightWatch International about pharmaceutical cargo thefts at:
http://www.freightwatchintl.com

And, you may read this FDA SOP about Cargo Theft at this link:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM297208.pdf

Until next time...be safe and keep your drugs safe!
Greg Evans, Pharm.D.