How Did Carcinogenic Generic Pill Get Past the FDA?

STORY AT-A-GLANCE

  • Since 2018, the carcinogenic compound NDMA has been found in several different drugs, including three blood pressure medications (valsartan, losartan and irbesartan), two heartburn medications (Zantac and Axid) and the diabetes drug metformin
  • In the case of valsartan, three companies whose drugs were recalled in 2018 had all purchased the active ingredient from a Chinese manufacturer called Zhejiang Huahai Pharmaceutical Co.
  • The U.S. Food and Drug Administration checks less than 1% of imported drugs for impurities or potency, and in the past five years have sent warning letters to only 25% of companies suspected of faking quality data
  • While generics are a boon to patients in that they’re far less expensive while still providing the same benefits, there’s more room for error as they also receive far less scrutiny by regulators, and manufacturers are trusted to regulate themselves
  • An estimated 80% of all active drug ingredients are manufactured in China and India, and overseas plants are rarely inspected by U.S. authorities

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