In a cautiously worded essay, the Food and Drug Administration commissioner and more than a dozen other agency officials are trying to temper enthusiasm for a controversial provision in the 21st Century Cures Act, which was signed into law on Tuesday by President Obama.
The subject of their treatise is real-world evidence, a euphemism for various sorts of data that the law would allow the agency to use for approving additional uses of medicines, as well as for any follow-up studies that may be required. Such evidence could include electronic health records, observational studies, ongoing safety monitoring, claims data, and patient registries, among other things.
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Skip this whole “efficacy” nonsense for drug approval, “safety” (doesn’t kill you within, let’s say, 3 weeks) is good enough! GREAT! again…