On Tuesday May 9, 2017 the Senate confirmed Scott Gottlieb to be the next head of the FDA. In order to provide a well rounded view of our new FDA Commissioner, we’ve provided excerpts and links to a diverse variety of stories as reported by FDA, Reuters, The New York Times, and RAPS Regulatory Focus:
“Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. Dr. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner.” –FDA
“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.
Gottlieb is also expected to quickly act to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics.” –Reuters
“To the drug and biotech industries, Dr. Gottlieb is a known quantity, both because he has written prolifically on F.D.A. policy as a fellow at the conservative American Enterprise Institute and because he often worked for those industries. Over the years, Dr. Gottlieb has been a frequent consultant to drug companies, serving on advisory boards for large pharmaceutical companies like GlaxoSmithKline and Daiichi Sankyo.” –NY Times
“In his confirmation hearing, and unlike several other Trump nominees, Gottlieb made clear that he would not be afraid to offer conflicting views with the administration…. ‘There is one standard for safety and effectiveness, and no commissioner can change that’…Gottlieb, a cancer survivor who received his doctor of medicine at Mount Sinai School of Medicine of New York University in 2002, is a former resident fellow at the conservative American Enterprise Institute and assistant professor at New York University School of Medicine” –RAPS Regulatory Focus
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