Title VII of the U.S. Food and Drug Administration’s Safety and Innovation Act (FDASIA) of 2012 seeks to quell the invisible hand that until now has guided sourcing and supply of raw ingredients and drug substances. The law, which is based on the European Union’s Falsified Medicines Directive, seeks to tame and modernize an increasingly global network through which the substances that make up drugs funnel into the smaller but still vast global network of manufacturers and suppliers.
Through Title VII, the FDA acknowledges that national borders prove insufficient to the entry of ingredients and drugs that are adulterated, misbranded, or counterfeit, and that patrolling the global supply chain is beyond the capabilities of any one regulatory body. The diverse, disjointed overseas supply chain has forced FDA to step up inspections from around 700 per year in 2008 to 2,700 in 2013. A further anticipated increase would be impossible without assistance from overseas regulators.
The most far-reaching—and controversial—component of Title VII is the Agency’s assumption of legal and enforcement capabilities beyond U.S. borders—powers whose legal status (and justification) remain to be settled.
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