- President Donald Trump on Friday nominated Scott Gottlieb to head the Food and Drug Administration, tapping the former FDA deputy commissioner and noted conservative health policy expert to oversee the important regulator.
- As FDA commissioner, Gottlieb will oversee an agency that regulates a broad swath of commerce, ranging from drugs and food to cosmetics and tobacco. He will also be tasked with carrying out the President's desire to dramatically cut regulations at the FDA and speed up the approval process for drugs and devices.
- Gottlieb was widely considered the most traditionally experienced candidate for the post, compared to other more controversial names floated as possible picks. Jim O'Neill and Balaji Srinivasan, two associates of the Silicon Valley and Trump insider Peter Thiel, had both expressed more radical ideas for reforming the FDA.
Unlike some of the lesser-known names which were reported to be in the running for FDA chief, Gottlieb has a track record of policy-making experience and familiarity with the agency's workings.
From 2005 to 2007, he served as Deputy Commissioner for Medical and Scientific Affairs under President George Bush after having held other roles within the FDA and the Centers for Medicare and Medicaid Services.
Since leaving the FDA, Gottlieb has served as a resident fellow at American Enterprise Institute, a conservative-leaning think tank, and is a venture partner at New Entreprise Associates.
By choosing Gottlieb, Trump eased worries that he would select a radical reformer to head the agency. Jim O'Neill, who was considered a potential choice, had suggested in the past that the FDA should approve drugs on safety and preliminary efficacy alone, letting drugmakers prove efficacy post-approval. Similarly, Balaji Srinivasan, another reported candidate, had accused the agency of slowing new medicines from reaching patients.
Even so, Gottlieb's close ties to industry could put him in a tough spot during confirmation hearings. He received over $413,000 in consulting fees and other payments from biopharma companies between 2013 and 2015, including over $150,000 from both GlaxoSmithKline and Vertex Pharmaceuticals, data from a federal database shows.
"President Trump’s FDA pick Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties," wrote Public Citzen, a non-profit watchdog group, in a statement. "He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry and the U.S. Senate must reject him."
Industry trade association PhRMA, on the other hand, praised Gottlieb's extensive experience, saying the group hoped to work with him on modernizing the review process and boost competition.
Not a radical, but a deregulator still
While Gottlieb may have a more traditional background, his public positions indicate he will also likely push to trim regulations and push the FDA to move faster.
In an August 2016 op-ed published by The Wall Street Journal, Gottlieb argued the FDA's imposition of new regulations and standards on generic drugmakers had slowed entry of cheaper medicines and reduced competition.
Rising costs for submitting an abbreviated new drug application for generic drugs plus lengthening review times, Gottlieb wrote, means an economic model that no longer delivers lower prices for consumers.
"The FDA should prioritize applications for generic categories where competitors are exiting," Gottlieb proposed. "Companies that pursue copies of 'abandoned' generics could receive a voucher that gives them expedited review of another generic drug."
A similar system is already in place for neglected tropical or rare pediatric diseases.
Speeding drugs to market
Gottlieb favors the FDA's breakthrough designation program, which was set up in 2012 to expedite review of promising therapies, and has applauded the agency's oncology unit for tapping this process to approve new cancer meds.
Yet, in a speech to the International Society for Pharmacoeconomics and Outcomes Research last year, he noted much of the FDA hasn't been as quick to adapt their decision making process. Further encouragement along this pathway could be one direction Gottlieb takes as commissioner.
In the same speech, Gottlieb argued for the FDA to more fully consider the role of biomarkers and other surrogates as basis of approvals.
Trump has promised a quicker process for FDA approvals and looks to be serious about making an effort to bring down drug prices in the U.S. With Gottlieb, he'll have a commissioner eager to push his agenda forward, but one that appears to support the overall regulatory framework.