This article is part of PharmTech's supplement on Ingredients, Excipients, and Manufacturing 2011.
PharmTech: Issues such as product theft, product diversion, economic adulteration, and counterfeit goods are areas of concern for pharmaceutical companies. On an industry wide basis, what would you identify as the significant initiatives or programs in place or under consideration to address supply-chain security, first looking at the United States?
Johnson: There is a lot of work being done by pharmaceutical companies, suppliers, government, law enforcement, and distributors to address supply-chain security threats in the US market. It is going to take cooperation by all components of the supply chain to be successful. The weakest link in the supply chain will be exploited by the criminals.
FDA recently published a strategic plan, "Pathway to Global Product Safety and Quality" (1). It outlines four FDA focus areas that include: increased global regulatory cooperation, improved information sharing, improved intelligence and information-technology capability, and allocating agency resource using risk-management principles. Foundational to these efforts is engagement and cooperation with all supply-chain stakeholders. FDA recognizes that we are in this together.
There also are a number of trade organizations, consortiums, and coalitions working on various aspects of this global problem. Many of these are cooperative efforts between industry, government, and law enforcement. Some examples are: the Pharmaceutical Security Institute (PSI) and the Partnership for Safe Medicines (PSM) , which are working on counterfeiting; the Pharmaceutical Cargo Safety Coalition (PCSC), which is working on cargo theft; and the recently formed Supply Chain Safety Consortium, which is working on track and trace. Rx–360, an international pharmaceutical supply-chain consortium, is a great example of a consortium where these efforts are coming together to look at supply-chain security holistically. All of these organizations are doing great work.