Scott Gottlieb confirmed as FDA commissioner

Scott Gottlieb has been confirmed as the next FDA commissioner after Senators voted in favour of president Donald Trump’s pick to run the world’s most influential regulator.

Senators voted 57-42 to ratify Gottlieb’s appointment, seen as the best of a bad bunch that Trump was reportedly considering for the job.

A former deputy commissioner under the George W Bush administration, the main issue with Gottlieb’s appointment is a network of business dealings with various drug companies and biotechs that has led him to recuse himself from a raft of regulatory decisions during his first two years in office.

During a hearing with Senators before the vote, Gottlieb revealed a long list of links with pharma including as a consultant for GlaxoSmithKline, Bristol-Myers Squibb and Vertex.

Womens’ rights campaigners are also concerned about Scott Gottlieb’s record on birth control, saying he opposes policies such as contraceptive coverage under former president Barack Obama’s Affordable Care Act.

 

Nevertheless, the pharma industry has backed Gottlieb, a well-respected doctor who Trump chose over the more radical choice of Jim O’Neill, a Silicon Valley investor who advocated a radical reduction of FDA regulations.

In the past, Gottlieb has written several columns outlining his ideas for the future of US drug regulation, such as faster approvals, a special unit focusing on development and review of orphan therapies, and publication of FDA rejection letters.

Although Gottlieb has kept his counsel during the build-up to his appointment, the direction of travel for the FDA under Trump will be a reduction in regulation and red tape, and industry is keen to see what Gottlieb will propose when he takes office.

There are also suggestions that Gottlieb will become involved with Health and Human Services secretary Tom Price’s efforts to reduce drug prices in the US.

While this is not an area covered by the FDA, Gottlieb could end up making policies that tie in with the Trump administration’s promised clamp down on high prices.

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