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Gottlieb for Deregulation

Scott Gottlieb, President Donald Trump's pick to lead the US Food and Drug Administration, has long favored deregulating medical devices and drugs, write Judith Garber and Shannon Brownlee from the Lown Institute in an opinion piece at Stat News.

"We believe his confirmation will lead to the demise of some FDA rules that are already barely keeping a lid on useless or dangerous medical products," they say.

Gottlieb, a physician and fellow at the conservative American Enterprise Institute, supports off-label marketing of medical devices and has said FDA is too slow to approve new drugs. To speed that process up, he's promoted the use of secondary markers, as this would allow drug developers to conduct smaller and shorter trials.

However, Garber and Brownlee argue that such an approach would help companies' profits and not patients. In particular, they point to a tuberculosis drug whose effectiveness was gauged by measuring the levels of tuberculosis bacterium in patients' sputum. A later study found that patients on the drug were five times more likely to die, they add.

Garber and Brownlee also wonder how Gottlieb would handle his conflicts of interest — he's also a partner at a venture capital firm and received more than $400,000 in fees and honoraria from drug and device companies between 2013 and 2015.