Protect Patients by Strengthening Supply Chain

Article excerpt

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. …