The FDA has issued a letter to stakeholders detailing best practices for preventing and responding to theft of pharma products.
In recent months there have been a number of high profile thefts from pharma facilities, such as the $75m (€57m) heist from Eli Lilly, and this has prompted the US Food and Drug Administration (FDA) to contact stakeholders.
A central message of the FDA letter is that “the best intervention is to prevent these thefts from occurring in the first place”. Consequently, the agency believes companies must “continuously review” physical warehouse security, onsite practices and transport procedures.
Security review and improvement should occur across the supply chain, from the point of manufacturing through to the location where the product is sold, added the agency.
Furthermore, the letter recommends companies check that their business partners and carriers are also reviewing and strengthening security practices. By remaining vigilant across the supply chain the FDA believes companies can stay “one-step ahead of thieves”.
In the event of a theft
Following a theft the primary concern for the FDA is how to minimise the risk to public health. Improper handling and storage of stolen drugs is believed to have led to adverse events and consequently the agency has “developed streamlined procedures” to help it respond quickly.
In the event of a theft the company should promptly notify the FDA and issue a public notification. Alerting the public is intended to make people wary of products being sold at unusually low prices and make it more difficult for thieves the sell the drugs back into the legitimate supply chain.
The agency added that in some cases it may be necessary to withdraw the product already in the supply chain with the same lot numbers as the stolen goods. This is intended to protect the public and the FDA works closely with businesses to determine the appropriate actions.