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Viewpoint: To fix the FDA, we need these qualities—including a commitment to regulatory reform — in its new leader

| | March 15, 2019
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Image credit: FDA photo by Michael J. Ermarth
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

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.

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

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