During PSM’s 2014 Interchange, Howard Sklamberg, the FDA’s Deputy Commissioner for Global Regulatory Operations and Policy gave an overview of the FDA’s work in protecting the safe drug supply chain and of legislation enacted in 2012 and 2013.
During PSM’s 2014 Interchange, Howard Sklamberg, the Food and Drug Administration’s Deputy Commissioner for Global Regulatory Operations and Policy and the conference’s second keynote speaker, gave an overview of the FDA’s work in protecting the safe drug supply chain. He introduced the audience to the CD3, a portable device which will be used by FDA investigators to detect counterfeit products, spoke about the agency’s participation in Operation Pangea and mentioned the BeSafeRx campaign, an education effort that teaches Americans how to safely source their medicines.
Sklamberg also spoke about legislation enacted in 2012 and 2013 which provides the FDA with greater power to protect the American public from fake medicines. The Food and Drug Administration Safety and Innovation Act (FDASIA) expands FDA’s authority to confiscate and destroy adulterated, misbranded or counterfeit drugs and requires companies working in the drug supply chain to communicate with the FDA about threats to supply chain security. A second law, the Drug Quality and Security Act (DQSA), outlines steps to build an electronic system that will allow pharmaceutical companies, law enforcement and regulatory agencies to exchange information at the individual package level about where a drug has been in the supply chain. That specificity will enable supply chain actors to better check the legitimacy of medicines and make warnings and recalls more efficient.
FDA’s ongoing work, public education and improved regulation are “real successes, real skirmishes won in this overall battle,” Sklamberg stated, but the challenge continues:
The bad actors are all over the globe. They can get to our shores in numerous and devious ways and they can operate like ghosts, from a single computer terminal which a reach to millions of individuals, from every point of the compass…It’s difficult because what we’re dealing with here in many instances is international organized crime…and when you look at the cases we work on, you see actors in countries all over the globe involved in money moving around using the most sophisticated techniques that international organized crime uses.
Watch Deputy Commissioner Sklamberg’s speech in its entirety: