ARMSRx Comment:

The U.S. Drug Supply Chain has been the safest in the world, but it is threatened on multiple fronts as never before by tainted, ineffective, dangerous and illegal drugs.

A prior newsletter discussed the risks of legally imported generics due to, in part, inadequate FDA monitoring of foreign manufacturers. Importing drugs from Canada carries risks as well. Over-the-counter products have been tainted. And now, illegal pill presses enter the equation.

The articles summarized in this issue discuss some of these threats.


Carcinogen in Zantac and Generics Triggers FDA, EU Probes

Global health regulators sounded a coordinated alarm about the possibility that a stomach drug taken by millions of people could be tainted with the same cancer-causing agent that has sparked a worldwide recall of blood-pressure pills.

Drug-safety officials in the U.S. and Europe said Friday that they were looking into whether Sanofi heartburn medication Zantac and generic versions made by numerous manufacturers contain levels of the probable carcinogen NDMA that could pose a danger to patients.

The discovery further underscores the challenge pharmaceutical-industry regulators face in overseeing a vast global supply chain of drugs, drug ingredients and factory processes.

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State Drug Importation Laws Undermine the Process That Keeps Our Supply Chain Safe

Three states – Vermont, Florida, and Colorado – recently passed laws that legalize the importation of prescription drugs. Other states are considering similar legislation. Legislators in those states believe that drugs can be safely sourced from Canada at costs lower than U.S. prices.

These new state laws conflict with and undermine our country’s in-progress national legislative and regulatory system for tracking and tracing drugs.
The U.S. track-and-trace system is designed to prevent the very problems that misguided state importation laws will create.

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Broad Availability of Illegal Pill Presses Creates Unprecedented Threat to America’s Communities, Patients and Law Enforcement

The supply and demand of dangerous counterfeit and illegally-imported medications is posing one of our country’s most serious health challenges, and illegal pill presses are directly contributing to this crisis, a new report jointly recently released by The National Association of Boards of Pharmacy, National Association of Drug Diversion Investigators, and The Partnership for Safe Medicines has found.

The report, “Pill Presses: An Overlooked Threat to American Patients,” examines the devastating impact of counterfeit medicines, the significant role of illegal pill presses, and challenges facing law enforcement and other government agencies.

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