By Toni Clarke
WASHINGTON (Reuters) – US President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to head the US Food and Drug Administration, said the Friday a White House official.
If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to slash regulations governing food, drugs, cosmetics, dietary supplements and tobacco.
Gottlieb is well known on Capitol Hill, where he has testified multiple times on burning health issues, including complex drug pricing issues, and is frowned upon by drug companies and pharmaceutical investors. Gottlieb, a former FDA official, is also on the board of drug companies.
“Thank goodness it’s Gottlieb,” wrote Brian Skorney, investment analyst at Robert W. Baird, in a research note. “We see this as a favorable development for the sector.”
Gottlieb, 44, is a resident fellow of the conservative think tank American Enterprise Institute and a partner in a large venture capital fund. He is a former deputy commissioner of the FDA who has frequently advocated for relaxation of the requirements necessary for the approval of new medical products.
“Scott knows how the agency works and will move it forward, although perhaps not always in the way the agency feels comfortable,” said John Taylor, attorney and president of regulatory and compliance affairs at consulting firm Greenleaf Health and former interim. Deputy Commissioner of the FDA.
Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a co-founder of PayPal who now advises Trump on science and technology matters. O’Neill’s opinion that the drugs should be approved before they can be proven effective raised widespread alarm.
Gottlieb, who declined to comment on the nomination, is unlikely to improve the FDA the way O’Neill would have, but is nonetheless expected to bring significant change, including changing the agency to increase flexibility in the clinical trial development process.
In this, it will be backed by the recently passed 21st Century Cures Act, which instructs the FDA, among other things, to consider using “real-world evidence” to support new drug applications. This could include anecdotal data, observational studies, and patient reports.
“People don’t want to take risks with safety, but there is a growing 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 sign of effectiveness. The question is, how much?”
One of Gottlieb’s priorities is likely to be expediting the process for approving generic versions of complex and difficult-to-copy therapies. He has publicly stated that he does not believe the FDA has good tools or policies for moving such products and has advocated for the creation of different approval standards.
A Mizuho Securities USA Inc poll 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 expedited approvals and security,” wrote one executive.
Others were less optimistic, citing his deep ties to the industry, including his position on various boards of pharmaceutical companies, as potential conflicts of interest.
Dr. Michael Carome, director of the Public Citizen’s Health Research Group, said Gottlieb “has spent the majority of his career dedicated to advancing the financial interests of the pharmaceutical industry.” If confirmed, he added, “he will have to be excluded from key decisions again and again.”
FLEXIBILITY OF THE CLINICAL TRIAL
The FDA has tried to reject moves to sideline randomized clinical trials, long considered the gold standard. In January, it issued a report documenting 22 cases in which drugs that seemed promising in early trials were found to be ineffective or unsafe, or both in larger trials.
But it has already moved to lower the requirements to show that a drug works.
Last year, Dr. Janet Woodcock, the agency’s powerful director of pharmaceuticals, ordered approval of the drug from Sarepta Therapeutics Inc (O 🙂 to treat Duchenne muscular dystrophy based on little more than an indication of efficacy.
In doing so, he overruled the recommendation of a panel of external advisers and senior scientists at the agency and set what some say is a precedent for the approval of drugs based on minimal data.
“How can you say it’s okay for this company but not for that company?” Mark Mansour, a partner at the Mayer Brown LLP law firm, said. “The administration is going to push for faster approval of drugs for all types of diseases with similar and vociferous patient populations clamoring for a solution.”
Other companies that can benefit from Gottlieb’s presence are manufacturers of electronic nicotine delivery systems, such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence to show that the risk of vaping approaches the risk of smoking.
Between 2005 and 2007, he was the FDA’s deputy commissioner for medical and scientific affairs. Previously, he was a senior advisor to the commissioner and served as the agency’s director of medical policy development.