This shows that the FDA is more interested in protecting pharmaceutical companies than patients. Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk. A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug. And allowing any American to use the untested drug carries more risk than the dozens or hundreds of people who would be in a test.
Also, note that some of these drugs are generics. Which means that individuals injured by drugs that weren’t even tested still can’t sue the manufacturer. And of course, there is no “fraud on the FDA” claim available…
In 2011, the FDA announced years’ worth of studies from a major drug research lab were potentially worthless. About 100 drugs were on the U.S. market based in part on these tests. The FDA let the drugs stay on pharmacy shelves with no new testing (in some cases until now). As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market. The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed. The FDA has never named the drugs, saying to do so would reveal trade secrets.
FDA Let Drugs Approved on Fraudulent Research Stay on the Market – ProPublica