Recently, a senior FDA official dismissed advisory committees (AdComs) as “costly,” “slow,” and defined by “pomp and flash.” The unnamed official suggested that the pharmaceutical industry uses “slick presentations” to obscure facts and cast doubt on the integrity of the independent panelists themselves.
Having spent the past 25 years working alongside scientists, statisticians, and clinicians preparing programs for health authority review, with the explicit aim of bringing safe, effective treatments to patients, I respectfully but strongly disagree.
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