U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, a White House official said Friday.
If confirmed by the Senate, Gottlieb would be in charge of implementing Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.
Gottlieb is well-known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. A former FDA official, Gottlieb also sits on the boards of pharmaceutical companies.
"Thank God it's Gottlieb," Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. "We view this as a favorable development for the sector."
Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products.
"Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with," said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner.
Picked over O'Neill
Gottlieb was chosen over Jim O'Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O'Neill's stated view that drugs should be approved before being proven effective generated widespread alarm.
Gottlieb, who declined to comment on the nomination, is unlikely to upend the FDA in the way O'Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.
In this he will be supported by the recently passed 21st Century Cures Act, which instructs the FDA among other things to consider the use of "real world evidence" to support new drug applications. This could include anecdotal data, observational studies and patient reports.
"People don't want to take chances with safety, but there's increasingly some clamor to be more flexible on the efficacy side," said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. "You need to have some signal of efficacy. The question is: How much?"
Generic therapeutics
One of Gottlieb's priorities will most likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.
A survey conducted by Mizuho Securities USA Inc. of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.
"He will be a pragmatic leader with an eye toward both expedited approvals and safety," one executive wrote.
Others were less sanguine, citing his deep ties to industry, including his seat on multiple pharmaceutical company boards, as potential conflicts of interest.
Dr. Michael Carome, director of Public Citizen's Health Research Group, said Gottlieb "has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry." If confirmed, he added, "he will have to be recused from key decisions time and time again."
