Generic Drugs May Not Be As Safe Or Effective As You Think

An anonymous reader quotes a report from NPR: As the cost of prescription medication soars, consumers are increasingly taking generic drugs: low-cost alternatives to brand-name medicines. Often health insurance plans require patients to switch to generics as a way of controlling costs. But journalist Katherine Eban warns that some of these medications might not be as safe, or effective, as we think. Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban’s new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results.

“These plants know that [the FDA inspectors are] coming,” Eban says. “I discovered [some overseas drug companies] would actually … alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old.” As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as “overwhelmed and underresourced” in its efforts to ensure the safety of overseas drug production. Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives, because of cost. In a statement to NPR, the FDA said that Americans “can be confident in the quality of the products the FDA approves” and notes it has “conducted a number of unannounced inspections” at foreign plants over the past several years.

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