Few products have a greater effect on the health of American families than pharmaceuticals.
Most consumers give little thought to the many entities that handle a product before it finds its way into their medicine cabinets or their doctors’ offices. But when one link in the vast distribution supply chain breaks down, patient health is at risk.
For the first time, all stakeholders in this supply chain have coalesced behind one proposal to give the Food and Drug Administration the tools it needs to enhance the integrity of the system throughout the nation.
Twice this year, the FDA issued warnings that a counterfeit version of a drug to treat cancer patients entered the U.S. distribution system through purchases by doctors’ offices. Originating in the Middle East, the counterfeit products passed through several intermediaries before finally entering the U.S. market.
Like any chain, the pharmaceutical distribution supply chain is only as strong as its weakest link. When it comes to safeguarding the public’s health, every link must be as strong as possible.
With more than 2,000 authorized suppliers of drugs to the U.S. market and products traveling great distances and through many hands, weak links cause vulnerabilities that can be exploited by bad actors to the detriment of patients. While incidents of counterfeiting and patient harm are rare in the United States, public health experts agree we should do everything possible provide greater levels of protection.
Unfortunately, the FDA lacks the authority to establish a uniform national system to help prevent dangerous products from entering the supply chain and to quickly and efficiently identify, trace and remove suspect products before they reach a patient.
About 30 states have stepped in to fill the void by enacting assorted laws of their own, but the technology required to support many of these laws is unreliable and underdeveloped. A system that varies widely by state results in a patchwork quilt of conflicting rules, laws and regulations that creates opportunities for bad actors to shop for locales with the lowest safety requirements to inject unsafe products into the supply chain.
Recognizing the need for a nationwide system, Congress is considering a drug traceability solution that would provide the American public with the single, comprehensive, uniform, comprehensive and immediate nationwide protection it needs.
Legislation spearheaded by Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) and Reps. Brian Bilbray (R-Calif.) and Jim Matheson (D-Utah) would:
• Provide immediate patient safety benefits based on the strongest state models and build a foundation that can be expanded over time as technology and practices evolve. This building block or stepwise approach will protect American patients today and tomorrow.
• Require the serialization of prescription drug products and establish a lot-based tracing system that would provide mechanisms for stakeholders and the FDA to access unit-level data.
• Provide the FDA with the legal authority and tools it needs to keep counterfeiters and other bad actors out of the system and institute an unprecedented accountability system that improves significantly the ability of the FDA or industry to recall products promptly.
By establishing a uniform national tracing system that uses proven technologies, Congress can provide immediate and robust protections to the American consumer. If Congress fails to act, the consequences will be a patchwork quilt of inconsistent, incomplete and contradictory state laws, rules and regulations that will fail to strengthen the distribution supply chain.
With all components of the supply chain — pharmaceutical and biologics manufacturers, wholesalers and distributors, logistics providers and chain and community pharmacists — coming together to support a bipartisan solution, Congress can strengthen the integrity of our pharmaceutical supply chain right now by including an effective drug traceability solution within the user fee legislation.
Vince Ventimiglia, a principal of FaegreBD Consulting and former assistant secretary for legislation at the Department of Health and Human Services, serves as adviser to the Pharmaceutical Distribution Security Alliance.