March 13, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Hours after BioSpace reported Dr. Scott Gottlieb was President Donald Trump’s likely nominee to helm the U.S. Food and Drug Administration, the president pulled the trigger Friday night and tapped the former deputy commissioner of the regulatory agency. The move has bolstered shares of biotech stocks in early morning trading today.
Although Gottlieb will likely implement reforms Trump has called for at the regulatory agency, his nomination is considered palatable to industry leaders as he is not expected to dismantle the agency. Brian Skorney, an investment analyst at Robert W. Baird, praised the selection in a research note, saying “Thank God it’s Gottlieb,” Reuters reported.
If confirmed by the U.S. Senate, Gottlieb is expected to encourage increased flexibility in clinical trial development. That will be made easier thanks to the 21st Century Cures Act, which was overwhelmingly passed by Congress earlier in December and signed into law by former President Barack Obama on Dec. 13. The Cures Act paves the way for streamlining FDA reviews of new medicines. In published opinion pieces, Gottlieb has also talked about overhauling rules for approval of generic drugs as well as “injecting competition” into the market concerning situations where older drugs are controlled by one manufacturer and allowed to set the price at high levels.
In a recent survey of 53 drug companies conducted by Mizuho Securities USA of Trump’s potential FDA choices, Gottlieb was the overwhelming favorite, garnering 72 percent of the vote.
Gottlieb was selected over candidates such as Jim O’Neill, who has a history of calling for reforms at the FDA, including allowing for the approval of drugs after they have been proven safe, but have not yet necessarily proven efficacy.
Trump has criticized the FDA, particularly what he called a “slow and burdensome” process of drug approval in the United States. According to Trump’s 100 Day Plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Trump has also called for easing restrictions for drugs that have been approved by foreign regulatory agencies to be available in the United States, which would bypass the FDA’s regulatory authority over drugs available in the U.S.
While considered someone who will implement reforms at the FDA, Gottlieb has a long history with the agency. Gottlieb served several years at the FDA and has a strong understanding of the agency’s role. From 2003 to 2004, Gottlieb was a senior adviser to the FDA commissioner and then the agency’s director of medical policy development. In 2004, Gottlieb took on a role as senior adviser to the Centers for Medicare and Medicaid Services. And then from 2005-2007, he served as the FDA’s deputy commissioner for medical and scientific affairs.
Gottlieb earned his medical degree from Mount Sinai School of Medicine and holds a bachelor’s degree in economics from Wesleyan University. He is currently a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute, a conservative think tank. Gottlieb has strong ties to the pharmaceutical industry and currently serves as an adviser to several companies, including GlaxoSmithKline .
While Gottlieb is considered palatable by pharmaceutical and biotech industry leaders, it’s his long history within the sector that has some watchdog groups concerned. Michael Carome, director of the health research group of watchdog Public Citizen, said in a statement that Gottlieb is “entangled in an unprecedented web of Big Pharma ties,” which includes his advisory role with GSK. Because of those ties, Carome called for the Senate to reject his nomination.
“Aside from the tangle of industry ties, Gottlieb has advocated dangerous deregulatory approaches to the review process for new medications. In exchange for getting medications to the market faster, Gottlieb is willing to accept a greater degree of uncertainty about safety and effectiveness at the time of approval. He also has favored looser restrictions on off-label promotion,” Carome said in his statement.
