Trump makes choice on new FDA head

pharmafile | March 13, 2017 | News story | Medical Communications, Sales and Marketing FDA, Gottlieb, Trump 

Dr. Scott Gottlieb is Trump’s chosen nominee for the role of commissioner of the FDA. The nomination appeases fears within the pharmaceutical industry and the FDA of an about-turn towards extreme deregulation of the drug approval process. It is expected that Gottlieb will be a moderate force within the FDA, with strong ties to the pharmaceutical industry and experience working as deputy commissioner during the administration of George W. Bush.

Gottlieb has plenty of experience working with the pharmaceutical industry. He has acted as an external consultant to GSK for the last seven years, acted as an Independent Advisor to Vertex Pharmaceuticals for seven years and holds positions as a member of several boards across the industry. These ties will be severed, in the process of becoming the new commissioner, but whether he can be truly independent after working for such a long period with the industry remains to be seen.

It is thought that Gottlieb will push through Trump’s desire to speed up the drug approval process and Gottlieb has already commented previously, in a 2010 piece in The Wall Street Journal, that he was worried at the rate at which the FDA was approving drugs compared with European countries. Later than this, in 2014, he wrote a piece for Forbes that highlighted what he believed to be an unfit process whereby the FDA approached generic approvals.

Gottlieb’s position is likely to be less dramatic than another name that was touted as a possible Trump pick, Jim O’Neill.  O’Neill had suggested that drugs only needed to be tested for safety without considering efficacy; this suggestion raised concerns in the FDA and from within the pharmaceutical industry. This proposed change would have meant drastically changing the way FDA reviews applications for new medicines and would have had dramatic impacts on the entire system.

As it, the first signs of the path likely to be taken by the Trump Administration will be on the bills to charge pharmaceutical companies and medical device makers for approval reviews, whilst allowing the FDA to set the fees. There is a chance among these bills to push through other changes.

Gottlieb’s appointment will still need to be approved by the Senate, though there are no issues expected in this process.

Ben Hargreaves

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