By ED SILVERMAN @Pharmalot

A mid growing concerns over the pharmaceutical supply chain, regulators sternly warned the Dollar Tree (DLTR), which runs a vast network of stores serving mostly low-income communities, for selling over-the-counter medicines made by companies that failed to ensure the drugs were safely manufactured and tested.

In a Nov. 6 warning letter, the Food and Drug Administration noted the retailer purchased medicines from foreign companies that failed to follow manufacturing standards and displayed a pattern of serious violations. These included a failure to test raw materials and finished products, and falsifying test results and releasing sub-potent drugs to the U.S. market. One company had rodent feces throughout its facility, according to the letter, which was posted on the FDA website Thursday.

Moreover, the retailer had previously told the FDA that, if it was made aware of any warning letter issued to a supplier or contract manufacturer, it would stop purchasing products made by those companies. But the FDA also noted suppliers and contract manufacturers received warning letters between 2016 and 2019. Dollar Tree made the same commitment concerning any company whose products were placed on an import alert. But the retailer did not always follow through.

“The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a statement. “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans.”

A spokesman for the retailer — which runs nearly 14,900 Dollar Tree and Family Dollar stores in the U.S. — sent us a statement saying “we are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe.” He added the items referenced in the FDA’s letter are topical, and not ingestible, products.

The warning letter was disclosed as the agency grapples with growing anxiety about the quality of medicines entering the U.S. from other countries.

Much of the problem has been blamed on lax production by suppliers of active ingredients and finished medicines that are based in China and India. The number of registered facilities making active pharmaceutical ingredients in China more than doubled between 2010 and 2019, according to the FDA, although this does not address production volumes. At the same time, the agency found quality issues accounted for 62% of 163 drugs that went into shortage between 2013 and 2017.

The issue has occupied a prominent place in the news cycle ever since the FDA last year found contaminated ingredients used to make valsartan, a type of blood pressure medicine that is otherwise known as an angiotensin II receptor blocker. Many of the contaminated ingredients were sold to numerous drug makers, including many in India. The discovery prompted a steady stream of product recalls, which alarmed patients and eventually led to shortages.

The FDA is still looking to explain how traces of a possible carcinogen known as NDMA were detected in so many lots of the medicine sold by different manufacturers. NDMA is an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions. The possible carcinogen has also been detected in heartburn medicines known as ranitidines, such as Zantac, although an online pharmacy claims contamination is not the cause.

About the Author

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical [email protected]@Pharmalot