New Law Protects Patients from Unsafe Medicines


Alisha Martin

While the U.S. pharmaceutical distribution supply chain is considered among the safest and strongest in the world, public health experts agree it is critical to remain vigilant in protecting it against infiltration and unsafe medicines.  In an effort to safeguard this complex and critical system and ensure Americans receive safe medications, President Obama has signed into law the Drug Quality and Security Act.

The new law enhances the security of the U.S. supply chain by establishing one uniform, federal standard for drug traceability.  Its enactment prevents the development of a patchwork of potentially conflicting state laws that would make manufacturer compliance difficult, and that would not adequately protect patients in all fifty states.

This law’s enactment is a significant and long awaited achievement.  It provides patient safety benefits through provisions based on the strongest state models.  The law also grants the Food and Drug Administration (FDA) new authorities and enhanced oversight to minimize the risk of illicit trade in the U.S. distribution network.  It requires that prescription drug packaging utilize serialization and advanced technologies to trace the source of prescription products and their distribution histories from the manufacturer to the pharmacy counter.  Further, it will institute an unprecedented accountability system that significantly improves the ability of the FDA and the industry to promptly recall products.

Working collaboratively and developing strategic alliances is an integral part of AstraZeneca’s global product strategy.  The company supported this legislation in Congress,  actively  working with legislators, industry groups and other stakeholders to ensure its passage.  AstraZeneca appreciates Congressional members’ commitment to this issue, and looks forward to continued efforts to implement this law which will help to make certain that the drugs patients receive are safe and effective as they travel through the U.S. supply chain.