April 5, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Scott Gottlieb and his long-time ties to the pharmaceutical industry, including $400,000 in various earnings from pharma companies, will be on display today as he seeks to be confirmed by the U.S. Senate as the next commissioner of the U.S. Food and Drug Administration.
Gottlieb has a history with the regulatory agency, having served as a senior adviser to the FDA commissioner and director of medical policy development. He also served as the FDA’s deputy commissioner for medical and scientific affairs. However, outside of his public service, Gottlieb has also served on the boards of pharma companies, or as advisers to boards, such as his relationship with GlaxoSmithKline , where he holds a position on the company’s product investment board. Gottlieb has also served on the boards of Gradalis Inc., CombiMatrix Corp. and Aptiv Solutions.
Marketwatch reported that Gottlieb has received consulting fees of about $155,000 from 2013 to 2016. He has also received fees from Daiichi Sankyo and Novo Nordisk . Gottlieb has also collected earnings from embattled Valeant Pharmaceuticals and Bristol-Myers Squibb . Marketwatch also noted that he earned fees from Pfizer , AstraZeneca , Takeda Pharmaceuticals and Millennium Pharmaceuticals.
Gottlieb, who is also a venture capitalist with New Enterprise Associates, has holdings in multiple pharmaceutical companies. Through NEA, Gottlieb has holdings in companies such as Clovis Oncology , Loxo Oncology, BioMarin Pharmaceuticals and Tesaro Inc. , Marketwatch reported.
Gottlieb also served as a managing director for T.R. Winston, an organization that invests in health care, among other sectors.
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. His disclosure lays out the numerous investments he has in the healthcare industry. In his letter, Gottlieb said he would resign from any board or position he holds within 90 days of confirmation. He said he would also divest himself of his stock holdings and 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.
Recusal from a decision at the FDA would not be new to Gottlieb. CNN reported that while he served as deputy FDA commissioner in 2005, he had to recuse himself from decisions regarding nine companies, including Roche , Sanofi , Eli Lilly , VaxGen and Inamed.
Although Gottlieb has deep ties to the industry, it will probably not be a hindrance to his confirmation, given that other picks for federal positions have been confirmed by the Senate. Case in point, Tom Price, now the U.S. Secretary of Health and Human Services, had multiple holdings in the pharma industry, including Biogen , Bristol Myers Squibb, Eli Lilly, Innate Immunotherapies, Jazz Pharmaceuticals , McKesson Corp. , Pfizer and Thermo Fisher Scientific .
Because Gottlieb has had such a long role in the pharma industry, some critics believe he is a poor choice to helm the FDA. Michael Carome, director of watchdog group Public Citizen,” told CNN that Gottlieb has been “a shill for pharmaceutical corporations for much of his career,” which he said has framed the way Gottlieb thinks.
On the other hand, Gottlieb was the top choice of the candidates President Donald Trump was considering for the FDA role. In a survey of 53 drug companies conducted by Mizuho Securities USA of Trump’s potential FDA choices, Gottlieb was the overwhelming favorite, garnering 72 percent of the vote.
If confirmed by the U.S. Senate, Gottlieb is expected to encourage increased flexibility in clinical trial development. That will be made easier thanks to the 53 drug companies, which was overwhelmingly passed by Congress earlier in December and signed into law by former President Barack Obama on Dec. 13. The Cures Act paves the way for streamlining FDA reviews of new medicines. In published opinion pieces, Gottlieb has also talked about overhauling rules for approval of generic drugs as well as “injecting competition” into the market concerning situations where older drugs are controlled by one manufacturer and allowed to set the price at high levels.
