With 54 major pharmaceutical cargo thefts last year, two of them accounting for over a $10 million loss, the FDA (Food & Drug Association) is seeking more power and stricter regulation in securing the pharmaceutical supply chain.
Feeling that they are unable to fully handle security issues, FDA deputy commissioner Deborah Autor asked that the agency receive “explicit authority to refuse admission of a product into the U.S. if the foreign manufacturer delays, limits or denies inspection of its facilities” as well as new authorities (http://www.procurementleaders.com/news/latestnews/3803-fda-urgent-attention/).
One such authority that Autor seeks is the FDA’s ability to issue mandatory recalls in order to prevent serious health affects, such as those that could be caused during an accident or theft when transported with an unqualified carrier.
Along with tighter regulations, manufacturers could also be facing more responsibility on the quality of their products, an article on ProcurementLeaders.com notes. In return, manufacturers will be less concerned about finding the cheapest way to transport their freight and more concerned about the quality and reputation of the carrier transporting it.
Just last year, the average loss per stolen load amounted to $3.78 million, making pharmaceuticals the most costly stolen commodity.
Stricter pharmaceutical penalties, such as the Safe Doses Act (S.1002) introduced in May, as well as modernized technology, such as a track-and-trace system, are efforts to cut back on thefts.
The FDA is currently in support of a mandatory track-and-trace system on pharmaceuticals which would increase security measures during distribution, while the National Community Pharmacists Association (NCPA) remains skeptical, believing that the system is still unproven and rather expensive, especially for smaller companies, offering a risk-base approach and federal grants for those independent pharmacies to incorporate the system (http://drugtopics.modernmedicine.com/drugtopics/Chains+%26+Business/NCPA-cautions-Congress-about-track-and-trace-bill/ArticleStandard/Article/detail/740090?contextCategoryId=40159).
In the first half of this year alone, there were already 14 pharmaceutical thefts which decreased from the 25 reported during the same period last year, due to effort from groups such as the Pharmaceutical Cargo Security Consortium and secure/knowledgeable trucking companies such as Road Scholar Transport.
Road Scholar Transport has the ability to monitor, timestamp, and log the location of the trailer and your cargo. Need to know where our truck was with your cargo at 11:30 am? No problem, we can verify. What about every time the trailer door was opened or closed with your freight inside? No problem. Road Scholar has electronic door monitoring and can tell you the exact time the door was opened and for how long.
But what about theft? That’s a $4 million shipment in there! Road Scholar not only has satellite tracking but Navalock to ensure that thieves can’t break in. And, in the unfortunate case of a theft, Road Scholar not only can provide you with the route history but a log of the temperature within the trailer so you know whether your freight has been contaminated.
As ProcurementLeaders.com notes, “If Congress accepts the proposals, the provisions would be introduced as part of the legislation to re-authorize the Prescription Drug User Fee Act (PDUFA V) next year.”
On a scale of 1-10, how secure do you believe the pharmaceutical supply chain to be? List your comments below.