The globalization of US medical countermeasure production and its implications for national security

Recent cases of counterfeit and contaminated medications have raised concerns about the integrity of the US supply chain of pharmaceuticals. Moreover, shortages in oncology drugs have highlighted a weak domestic production capacity for essential medications. The FDA and the Pew Charitable Trusts have published analyses of the problems as they relate to the US's regulatory system and healthcare industry.1,2 These issues also represent a potential national security threat. In preparing for and responding to pandemic influenza, US officials realized that a lack of domestic production capacity for flu vaccines and therapeutics heightened political tensions and shook popular confidence when these products became scarce. In 2005, Roche struggled to meet demand for oseltamivir because of a bad harvest of the star anise plant. Star anise is the source of shikimic acid, the backbone of the medication, and grows almost exclusively in 5 provinces of China. As a buffer against future shortages, 50 million doses were acquired for the Strategic National Stockpile (SNS), the federal repository of medical countermeasures (MCMs), to be used in a national emergency. In 2011, to augment domestic influenza vaccine production capacity, Novartis opened the first cell-based vaccine plant in the United States, with nearly $500 million in subsidies from the US government. While these efforts may decrease the chance of dangerous supply shocks, in-fluenza countermeasure supply and production problems, as well as current concerns for other pharmaceutical products, are early warnings of a larger supply chain issue in MCMs and other crucial therapeutics with major implications for public health and national security.