The U.S. Senate voted on May 9 to confirm Dr. Scott Gottlieb, a conservative health policy expert and venture capitalist, as commissioner of the FDA.
Dr. Gottlieb, a physician and former deputy FDA commissioner during the George W. Bush administration, is seen as competent and knowledgeable. But critics worry about his ties to the pharmaceutical industry. Dr. Gottlieb 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.
Dr. 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.
Dr. Gottlieb is also expected to quickly act to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics.