Does The FDA Have A High Enough Standard For Drug Approvals?

Is the Food and Drug Administration’s approval process broken? At a HUBweek panel hosted by STAT, experts explored that question in light of the FDA’s decision last week to approve a controversial drug for Duchenne muscular dystrophy, a rare disease.

The decision reflected the power of patient lobbying and raised questions about the standards for drug approval, as the FDA’s own medical staffers earlier this year questioned the effectiveness of the drug, which was tested in a small clinical trial. STAT senior writer and Pharmalot columnist Ed Silverman led the panel, calling the Duchenne drug a “litmus test” for the FDA.

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