Even though pharmaceutical cargo theft has fallen dramatically in the U.S. the last couple of years, the FDA is displaying rising concern about the health risks stolen drugs can pose. It has a new standard operating procedure in the case of pharmaceutical cargo theft, and it comes with a stick and no carrot.
Basically, it says that the FDA is going to expect most companies to notify the public if their products have been stolen. The idea is that thieves are not likely to care if drugs have been properly transported or carefully stored, and so the drugs could pose a health risk.
And if the companies don't want to disclose the information? Doesn't matter. The SOP, which became effective when the agency posted it in late March, says that if a company is "unwilling or reluctant to alert the public to the cargo theft," the agency's Cargo Theft Response Team (CTRT) will take it upon itself to send out a release and perhaps a health alert.
Of course, this is likely to upset some in the industry, points out Pharmalot. Some companies are not much for making a big, public deal about the fact that their drugs have gotten ripped off, because it can mean bad publicity.
Pharmaceutical cargo theft in the U.S. has dramatically decreased in the last couple of years. Charles Forsaith, who coordinates the Pharmaceutical Cargo Security Coalition, recently said a better-educated industry, new technologies and new approaches had made the difference. Forsaith, who is also director of supply chain security for Purdue Pharma Technologies, said the industry has done as much as it reasonably can to deter theft and to make it easier to recover loads when it happens.
Coalition statistics tell the story: In 2011, there were 5 stolen shipments worth more than $500,000 and three worth more than $1 million. That compares with 2009 in which there were 15 stolen shipments in the half-million-plus category, and 11 of those topped $1 million.
The new SOP lays out all of the expectations for industry and agency responses. The FDA expects to be immediately notified when there is a theft, and it wants lots of details, including the quantities, lot numbers, dosages, strengths, expiration dates and storage needs for the hijacked goods.
- check out the FDA SOP
- get Pharmalot's read on it