Former Deputy Commissioner for Medical and Scientific Affairs of the US Food and Drug Administration (FDA), Scott Gottlieb, has been nominated by President Donald Trump to be the next head of the agency. As someone who has a number of years of policy-making experience, Gottlieb is considered to be the least-controversial pick for the position.
The FDA is tasked with regulating a plethora of consumer products, from prescription drugs and food, to cosmetics and tobacco products. Trump has spoken openly about cutting regulations at the FDA – a move he believes will help to accelerate new drug approvals and get treatments into the hands of patients who need them most.
Between 2005 and 2007, Gottlieb served under President George Bush as Deputy Commissioner for Medical and Scientific Affairs for the FDA. He has also filled other positions within the regulatory agency, as well as worked for the Centers for Medicare and Medicaid Services.
While Gottlieb is considered to be the least radical choice for the appointment – especially when compared to rumored nominees such as Jim O’Neill who sought to have the FDA approve drugs based only on safety data – some are critical of his relation to the industry. According to a federal database, between 2013 and 2015, Gottlieb received more than $413,000 in consulting fees from biopharmaceutical companies.
“President Trump’s FDA pick Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties,” said a statement written by Dr. Michael Carome, Director, Public Citizen’s Health Research Group. “Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients.”
In contrast, industry trade association, PhRMA, released a statement in favour of the nomination. If Gottlieb is able to make Trump’s desired changes to the review process, the accelerated drug approvals would be a boon to the pharmaceutical industry.
“His extensive experience as a physician and breadth of health care knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation in the Agency’s review and approval of new medicines for patients in need,” said PhRMA CEO Stephen J. Ubl. “We look forward to working with Dr. Gottlieb in his new role and engaging with him and the Agency as they seek to modernize the drug discovery and review process and advance competition in the biopharmaceutical market.”