Scott Gottlieb, who has been nominated by US President Donald Trump to head the FDA, said that if he is confirmed as commissioner, he will recuse himself for a year from FDA decisions on 20 or more companies in which he has held financial interest or worked as a consultant. According to an ethics agreement with the Department of Health and Human Services, Gottlieb agreed to recuse himself from decisions concerning drugmakers such as Bristol-Myers Squibb, GlaxoSmithKline and Vertex Pharmaceuticals, which previously hired him as a consultant.
In addition, the nominee stated that he plans to step down from his position at venture capital firm New Enterprise Associates and recuse himself from decisions involving other client companies in which he has invested through the venture firm, including Cell Biotherapy, where he serves as acting CEO. Gottlieb also vowed to leave his position with T.R. Winston & Co., untie his financial investments in more than a dozen companies and recuse himself from decisions regarding the companies until the divestitures are completed.
According to the filing, from January 2016 through March 1, 2017, Gottlieb received an income of more than $3 million, including nearly $1.9 million in total from T.R. Winston and $280 000 from New Enterprise. Moreover, according to other data in a federal database, between 2013 and 2015, Gottlieb reportedly received $413 000 in various fees from medical companies, in addition to more than $200 000 in speaking honoraria from drugmakers from January 2016 to February 2017.
Commenting on the news, Susan Wood, former director of the FDA's office of women's health, remarked "if you have a commissioner who is that conflicted, recusal is a tricky business." Wood added "Gottlieb's obviously well trained, he has experience, but my concern is whether he has the strength of will and the commitment to ensuring that actually the best science and the best medicine drives the decisions of the FDA."
Conversely, Leslie Kiernan, a lawyer representing Gottlieb, countered "every individual who goes into government from the private sector with experience in the industry is going to have some recusals," noting that agency commissioners do not typically participate in matters involving individual companies." Kiernan continued "the key role of the commissioner is to set broad policies for the agency."
For related analysis, read ViewPoints: Trump eschews unpredictability by tapping Gottlieb to head FDA.
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