Letter from Pew and The Pharmaceutical Distribution Security Alliance to Senate Leadership Calling for Passage of Track and Trace Legislation


The Pew Charitable Trusts continues to call for passage of The Drug Quality and Security Act (HR 3204), which would implement a “track and trace” system for the U.S. pharmaceutical distribution supply chain and enhanced federal oversight of compounding pharmacies to safeguard the nation's drug supply against counterfeit and contaminated medicines.

Pew and the Pharmaceutical Distribution Security Alliance, or PDSA, PDSA have co-signed a letter asking Majority Leader Harry Reid (D-NV) and Republican Leader Mitch McConnell (R-KY) to move this bipartisan, bicameral legislation forward.  The two organizations advocate the establishment of a single rigorous and uniform supply chain standard for all supply chain participants. The bill would set up a system to govern all participants: product manufacturers, primary and secondary wholesale distributors, logistics providers and pharmacies.

October 23, 2013

The Honorable Harry Reid
Majority Leader
United States Senate
Washington, DC 20510

The Honorable Mitch McConnell
Republican Leader
United States Senate
Washington, DC 20510

Dear Majority Leader Reid and Republican Leader McConnell:

The Senate Health, Education, Labor and Pensions committee, along with colleagues in the House, worked long hours over many days to produce the Drug Quality and Security Act (HR.3204) — significant bipartisan legislation that would address two patient safety issues: pharmaceutical compounding and drug distribution security.

Both of these issues are important to the safety of our drug supply. However this letter focuses on measures to safeguard the nation's pharmaceutical distribution system – policy our two organizations have worked on for close to two years. HR.3204 is carefully negotiated legislation that has significant support from a broad range of stakeholders. It creates a single, national drug traceability system that will extend from coast to coast, and sets uniform standards for all supply chain partners. We urge you to take up this legislation and pass it without delay.

The United States has one of the safest pharmaceutical supply chains in the world, but the risk to consumers when the supply chain is porous is significant. A hole in the system could permit illicit, counterfeit, stolen, and life-threatening products to enter the legitimate supply chain.

These challenges make clear the benefit of a national solution that increases patient safety by placing unique serial numbers on each drug package, and tracking them as they move through the distribution system. Because a product may travel through multiple states before arriving at a pharmacy, the most effective solution is a single, federal system so all healthcare consumers receive the same level of protection regardless of where they live, and industry has a single standard with which to comply.

As representatives of multiple stakeholders deeply committed to the goal of a stronger supply chain, we urge you to act as quickly as possible and send HR.3204 to the President for his signature.


Vince Ventimiglia
Pharmaceutical Distribution Security Alliance

Allan Coukell
The Pew Charitable Trusts