With the just-announced resignation of FDA Commissioner Dr. Scott Gottlieb, the White House and Health and Human Services Secretary Alex Azar will begin a search to replace him. We need someone who will deregulate aggressively in order to stimulate innovation, get more products on the market, and put downward pressure on drug prices.
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While he did a lot of chest-thumping on easier issues, Dr. Gottlieb shied away from or stumbled over many tough ones. The FDA’s current dysfunctional regulation of animals made with modern genetic engineering … and the permissiveness toward illegal claims by the organic food industry are good examples.
Several characteristics will be essential in Gottlieb’s replacement.
… The agency’s scope is so sweeping – encompassing cardiac pacemakers, x-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, genetically engineered animals, artificial sweeteners and fat substitutes – that a single person cannot be expected to master the body of science, medicine, pharmacology and engineering (to say nothing of the law and “regulatory science”) involved. …
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In addition, FDA’s senior and mid-level managers must be made more accountable for their decisions – especially those that delay the availability of new drugs, vaccines and medical devices to patients in need of them.
Read full, original post: The FDA has problems — Here are the qualities the next commissioner must have to fix them