On 10 March, the White House announced that President Donald Trump will nominate Scott Gottlieb to lead the Food and Drug Administration (FDA) - a doctor and a pharmaceutical industry favourite.

Gottlieb, a former deputy commissioner of the FDA under former president George W. Bush in 2005, was rumoured to be on Trump's shortlist including potential candidates such as Joseph Gulfo, Jim O'Neill and Balaji Srinivasan - with the latter two having no medical background or appreciation for how medical regulation works.

Rumours were also rife two months ago that Jim O'Neill was Trump's pick, probably due to Peter Thiel's - an iconoclastic Silicon Valley mogul - influence. As a libertarian, O'Neill advocated some outlandish ideas including paying organ donors and supporting the Seasteading movement.

So Gottlieb, who promises to attend the post with clearly defined views about what FDA reform might look like, might just be "the least problematic of a very sorry pool of candidates," by Daniel Carpenter, a professor at Harvard University who studies the FDA.

Gottlieb: A man with too many conflicts of interest

However he also said that if Gottlieb was confirmed, "he would be the most interest-conflicted commissioner in American history, by far." Many critics have highlighted his multiple ties with pharmaceutical companies, which might compromise his ability to direct the FDA independently.

Gottlieb often served as a consultant or board member for several companies, including GlaxoSmithKline currently, and Vertex Pharmaceuticals. According to a federal database, he has reportedly received at least USD413,000 in payments from the pharmaceutical and medical device companies between 2013 and 2015, mostly for consulting and speaking fees.

He is also a partner at a large venture capital firm, New Enterprise Associates, a senior principal at the investment bank TR Winston, and partner at the hedge find Arcoda Capital Management centric finance groups.

Carpenter added, “These are not relationships whose influence just disappears once he resigns from a corporate board. The Senate should scrutinize the conflicts of interest carefully.”

Industry connections do not mean anything, supporters say

Industry executives like Steve Holtzman, president and CEO of Decibel Therapeutics in Massachusetts, advise the public not to read too much into his industry connections.

"People have sought Scott's advice because they want to understand what the agency, is looking for. It doesn't mean that he's been bought and sold. I think that's a naive view," he added.

Erik Gordon, a business professor at the University of Michigan, agreed and added that a commissioner with ties to the drug industry is suspected of prioritising profits instead of patient safety, "but one with no ties is suspected of not understanding how to get drugs to patients who need them."

So far, Gottlieb has called for the loosening of the rules that govern generic drugs and streamlining the process for their approval. This worries consumer advocates as tipping the pendulum too far in favour of drug approvals only, may compromise on patient safety.

Gottlieb is a consolation out of Trump's picks

But the drugs are only part of the agency. Gottlieb would be heading an extensive agency that oversees everything from drugs and medical devices to tobacco, food and cosmetics. To put it on a scale, the products regulated by the agency account for 20 cents of every dollar spent by American consumers each year. It's a big business.

"This is a vast agency with very important responsibilities, and does many things every day that matter for millions of Americans," said Dr. Mark McClellan, the former FDA commissioner during the Bush administration, who also hired Gottlieb.

But when compared with Trump's other picks, Gottlieb - with his experience in the FDA and medical background - seems like a better choice, which may be why the administration suggested the other names.

"It could have been worse," said Gregg Gonsalves, a Yale research scholar. "We could have had a sabre-toothed tiger guarding the henhouse like Jim O'Neill, and instead we [may get] a garden-variety fox at the helm."

Gonsalves was also very certain about one thing: "Unlike many Trump nominees, he's actually highly qualified to destroy the agency he's meant to lead." MIMS

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Sources:
http://www.vox.com/2017/3/10/14887290/scott-gottlieb-fda-trump
https://www.nytimes.com/2017/03/10/health/fda-scott-gottlieb.html?_r=0
https://www.statnews.com/2017/03/10/scott-gottlieb-fda-donald-trump/
https://www.statnews.com/2016/12/07/trump-fda-oneill/