President Donald Trump wants to remake the Food and Drug Administration. And he happens to have a “fantastic person” in mind to do it, he said Tuesday — someone who will turn the agency into an industry-friendly shop that cranks out new cures on the double.
But does anyone really want a deregulated FDA? STAT canvassed biopharma insiders, physicians, Wall Street analysts, and FDA veterans. Their verdict: Trump’s plan sounds like a solution in search of a problem.
Trump is weighing several candidates for FDA commissioner who would seek to radically change how the agency vets new drugs. One candidate has proposed scaling back the requirements for approval and letting doctors and patients sort out what’s worth trying. Another once claimed a “Yelp for drugs,” posting consumer reviews of medications, would better serve patients than the existing FDA. A third favors approving treatments once they’ve passed an initial safety test, regardless of whether they work.
If Trump can bring sweeping changes in the structure of FDA and a FDA Moderation Act to make medicines available to patients at affordable price, it will be welcome with open arms. Deregulation cannot happen – however, moderation can. Medicines require regulation but with well defined stages of regulation. Drug Development studies should be done with cell lines and not on human beings. Our science has advanced so much that new technologies can be introduced for drug development – cutting development cost and time. FDA should have experts from industry coopted for special task force teams for the Moderation Act.
très bonne chose pour les patients en train de mourir sans aucun espoir, pour ces gens là, un jour compte, une heure même un e minute
Pour des fonctionnaires de la FDA, ils ont tout leur temps, pourquoi prendrait-il me plus petit risque
Trump a de la compassion, formidable président
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