Mar 7, 2019
Scott Gottlieb's legacy of experimental drug approvals
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Outgoing Food and Drug Administration Commissioner Scott Gottlieb presided over 2 years of relative leniency toward novel drug therapies, according to an Evaluate analysis.
Why it matters: While this was good for investors and drug companies, the impact on patients isn't yet clear. Most of these experimental approvals were for cancer drugs, which can get approved quickly for end-of-life care when a patient is out of options.
Details: In 2017 and 2018, there were record numbers of accelerated drug approvals based on early signs that the drug was effective, rather than the full approval process.
- Most of these accelerated approvals were based on information from small clinical trials, without concrete evidence of drugs' effectiveness, Evaluate notes.
- And most of these approvals have not yet been converted into full approvals based on more rigorous conditions.
- "Mr. Gottlieb was considered a friendly face by drug developers and investors, a safe pair of hands in an administration rife with unpredictability," the authors of the analysis write.
