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The generic-drug mess hits home
September 12, 2019, 3:00 PM EDT
The FDA has a rigorous approval process for new drugs. Companies conduct clinical trials in humans over several years to prove a drug is safe and effective.
But there's a big problem: 90% of all medications prescribed to Americans are generics. They're cheaper, they're supposed to work the same way, and they receive less scrutiny.
At least 80% of the active pharmaceutical ingredients for all drugs are made in Chinese and Indian factories that U.S. pharmaceutical companies never have to identify to patients. And the Food and Drug Administration checks less than 1% of drugs for impurities or potency before letting them into the country. Surveillance inspections of overseas factories have declined since 2016, even as the agency is under pressure to get more generics to market more quickly.
In July 2018 the FDA announced that a solvent called NDMA, a probable carcinogen in humans. had been found in the widely used blood-pressure medicine valsartan and started overseeing a recall of drugs from three companies. They'd all bought the active ingredient for their valsartan from one of China's biggest generic companies.
The quality-control problems in the generic drug industry go beyond the visible lapses. The valsartan recall has revealed the once-invisible failures in the chemistry itself, sometimes undetected for months, maybe years.
"The more regulatory agencies look into more generic brands, the more we're going to find," said a U.S. judge involved in dozens of lawsuits against a Chinese drugmaker that produced valsartan. "There's no good way around it. It's a mess."—Mark Schoifet

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