The U.S. Senate voted on Tuesday to confirm Dr. Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.
The Senate voted 57-42 in favor of Gottlieb, a conservative physician and former deputy FDA commissioner under George W. Bush, who supporters say is knowledgeable and competent but who critics consider compromised by deep ties to the pharmaceutical industry.
Jeff Allen, president of the patient advocacy group Friends of Cancer Research, welcomed the confirmation, saying Gottlieb’s experience as a cancer survivor, physician and former FDA employee makes him “uniquely qualified to understand the impact the FDA has on the lives of patients.”
Gottlieb, 44, is a longtime healthcare investor and consultant who has sat on multiple company boards. He has agreed to divest his holdings in some two dozen healthcare stocks, though critics argue that will not solve the problem.
“It is inappropriate for the FDA Commissioner to have had such close financial ties with the pharmaceutical industry,” Democratic Senator Joe Manchin of West Virginia said in a statement.
Gottlieb is expected to move quickly to implement FDA mandates in the recently passed 21st Century Cures Act, which is, among other things, designed to speed the drug approval process by relaxing certain clinical trial requirements.
The Act requires the FDA to consider the use of “real world evidence” to support new drug applications, including patient reports, anecdotal data and observational studies.
Such trials are less rigorous than the gold standard randomized clinical trial but quicker and cheaper to conduct.
Jim Greenwood, chief executive of the Biotechnology Innovation Organization, said the trade association was confident Gottlieb’s confirmation would help the agency “better incorporate patients’ perspectives into the agency’s regulatory process.”
Gottlieb is also expected to quickly act to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics.
