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By Toni Clarke
May 9 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
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
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
Gottlieb is also expected to quickly act to streamline the
process for approving generic versions of complex,
(Reporting by Toni Clarke in Washington, additional reporting
by Amanda Becker; Editing by Dan Grebler and Tom Brown)