With another quality scandal on its hands with diabetes drug metformin, the FDA could be looking at another global recall of a commonly used med. With COVID-19 challenging the FDA's ability to keep up with inspections––and potentially putting dangerous drugs in U.S. patients' hands––is metformin just the beginning?
The COVID-19 pandemic has exposed significant flaws in the FDA's ability to adequately inspect drugs produced by foreign manufacturers and might cause quality concerns in the U.S. supply for years to come, Valisure CEO David Light testified Tuesday during a Senate Finance Committee hearing.
With COVID-19 freezing FDA inspections of foreign plants since March, Light warned senators that the combination of a strained global supply chain and structural issues in the FDA's testing of foreign drugs could damage consumer confidence.
"Manufacturing problems that arise from the escalated production of drugs [tied to COVID-19] and a lack of FDA inspectors on the ground at foreign plants could produce a domino effect for years to come," Light said. "The lifecycle of a drug in the supply chain is many years, and it could be many more before significant and serious issues are found, let alone addressed."
Light's testimony comes just days after the FDA asked five metformin manufacturers to pull their extended-release metformin products. The agency had found high levels of N-Nitrosodimethylamine (NDMA), a likely human carcinogen, in tested lots.
Valisure, an independent testing laboratory, helped drive those voluntary recalls after discovering contaminated lots of metformin in March, calling the FDA's prior findings into question.
The FDA said it was working with drugmakers to determine whether the recommended recalls would cause a shortage in the U.S. The move doesn't apply to metformin's immediate-release formulation, and the FDA specified that "there are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled."