November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality and reliability of the drug supply that enabled passage of the law:
- Title I, the Compounding Quality Act (CQA), primarily responded to an acute public health crisis that was caused by the distribution of contaminated steroidal injections, compounded without patient prescriptions, which had already claimed the lives of more than 60 Americans.
- Title II, the Drug Supply Chain Security Act (DSCSA), addressed the long-held desire for a federal drug-tracking system to prevent a series of ills, especially the distribution of counterfeit drugs, but the particular timing was motivated by the pending onset of state-level drug tracking requirements that the DSCSA ultimately preempted.
In implementing the DQSA, the Food and Drug Administration (FDA) has made measureable progress since 2013, but it has also experienced implementation challenges. In addition to the concerns that the law was designed to meet, new public health and policy challenges have emerged. The affected industries have also confronted challenges in accommodating the law's new mandates, many of which require implementation steps by FDA. This five-year milestone offers a valuable opportunity to assess the state of the law, what has transpired over the first five years since the law's enactment and what is ahead by analyzing several key themes of the CQA.
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