May 10, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Scott Gottlieb is returning to the U.S. Food and Drug Administration as its new chief. On Tuesday, the U.S. Senate voted 57 to 42 to confirm Gottlieb, who was selected to helm the regulatory agency by President Donald Trump in March.
For the pharma industry Gottlieb, 44, was the most popular choice to helm the regulatory agency due to his knowledge of the FDA, as well as his understanding of the pharma industry through his professional connections and ties. But, it was those GlaxoSmithKline or consulting work for Daiichi Sankyo and Novo Nordisk that caused some members of the Senate to oppose his nomination. U.S. Sen. Patty Murray, a Washington Democrat, told the Washington Post that his “unprecedented industry ties” will create a bias in the way he runs the administration.
“He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first,” Murray told the Post.
Other Democratic senators, Edward Markey of Massachusetts and Maggie Hassan of New Hampshire, were critical of Gottlieb’s earlier oppositions to risk evaluation and mitigations studies conducted by the FDA, the New York Times reported.
Despite those concerns, Gottlieb had plenty of support from Republican leadership, including Majority Leader Mitch McConnell, R-Ky., who said Gottlieb is committed to the development of groundbreaking treatments in healthcare, the Times said.
Gottlieb served several years at the FDA and has a strong understanding of the agencies role. From 2003 to 2004, Gottlieb was a senior adviser to the FDA commissioner and then the agency’s director of medical policy development. In 2004, Gottlieb took on a role as senior adviser to the Centers for Medicare and Medicaid Services. And then from 2005-2007, he served as the FDA’s deputy commissioner for medical and scientific affairs.
Gottlieb earned his medical degree from Mount Sinai School of Medicine and holds a bachelor’s degree in economics from Wesleyan University. He is currently a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute, a conservative think tank.
In previous writings, Gottlieb has called for reforming the rules for the approval of generic drugs. Based on previous remarks and writings, Gottlieb has called for streamlining the FDA’s process for approving drugs with the FDA’s breakthrough therapy designation. Gottlieb has also been a proponent of publishing Complete Response Letters, which would prevent drug companies from distorting or concealing why a drug was rejected. Gottlieb is expected to encourage increased flexibility in clinical trial development. That will be made easier thanks to the signed into law by former President Barack Obama on Dec. 13. The Cures Act paves the way for streamlining FDA reviews of new medicines.
Additionally, Gottlieb has also been critical of the FDA when it comes to the slowness of approving new drugs, suggesting the agency is overly risk-adverse.
Now that he has been confirmed, Gottlieb will divest himself of holdings in the pharma industry, as well as other businesses the FDA has oversight. Gottlieb’s financial disclosure letter provided to the Health and Human Services counsel for ethics provides a comprehensive look at his role in the pharma industry. In his letter, Gottlieb said he would recuse himself for one year from any decisions the FDA may become involved with that would involve those companies, unless he is provided a waiver.
