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I always thought generic drugs were the best choice. They were tested and proven to be equivalent to the brand name originals and cost much less. But I never imagined that some of the data the FDA relied on had been doctored as part of a global pattern of deception. The book Bottle of Lies: The Inside Story of the Generic Drug Boom by investigative journalist Katherine Eban is an eye-opener. The unfortunate truth is that generic drugs can’t always be trusted: some of them are ineffective or even deadly.
When brand-name drugs come off patent, less expensive generic equivalents can be marketed. Prior to 1984, there was no clear pathway for a generic drug to be approved in the US. Senator Orrin Hatch sponsored legislation to get generics approved through an Abbreviated New Drug Application. All the company had to do was show that the generic was bioequivalent and performed similarly in the body. The first company to file its generic application would win the right to market its product exclusively for 6 months at close to the brand-name price before competitors could jump in and slash the price.
The FDA has a worldwide reputation as the “gold standard” for regulatory bodies. It regulates about one-fifth of the US economy, safeguarding public health by ensuring the safety of food, drugs, medical devices, pet food, and veterinary supplies. It has had an admirable track record, for instance when it refused to approve thalidomide. But the generic drug revolution exposed some serious flaws in the system. By 2005, the number of foreign manufacturing sites regulated by the FDA exceeded the number of sites in the US. American drugs are no longer made in America, and the FDA lacks the resources to properly regulate them.
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