There was a hint of frustration in a New York Times headline about Scott Gottlieb, the commissioner of the Food and Drug Administration and an appointee of Donald Trump: “F.D.A. Chief Goes Against the Administration Stereotype.” The story’s conclusion that “Dr. Scott Gottlieb isn’t rolling back his agency’s mission” was a lament of sorts, an admission that the “millionaire with a libertarian bent” running the nation’s food and drug safety agency maybe wasn’t so bad. An April piece for Vox, the “explainer” site written by and for earnest, pointy-headed liberals, even conceded that Gottlieb had been “making real progress tackling the most serious health issues in America.”
“I think it is clear that he is someone who believes in the mission of the agency and believes in its functions,” Jeremy Sharp, a deputy commissioner at the FDA during the Obama administration, tells me. Another former deputy commissioner under Obama, Joshua Sharfstein, told Vox, “I think that he’s done a lot for FDA’s morale at a time like this.”
In normal times, it would be notable that Gottlieb, a 45-year-old physician and veteran of the medical venture capital world, is getting this much praise from his ideological opponents. And in Donald Trump’s Washington, it’s just as remarkable the FDA commissioner isn’t among the president’s high-level political appointees embroiled in personal scandal. But none of that is a coincidence. Perhaps more than any other figure in the executive branch, Gottlieb came into his role at the FDA with a fully formed vision for one of the most powerful and influential agencies in the federal government. That vision involves achieving the FDA’s regulatory and public-health goals with a more friendly disposition toward market forces and the need to spur, not discourage, innovation.
Already, Gottlieb has made a serious push to change the FDA’s approach to generic drugs, streamlining the approval process and minimizing advantages for name-brand manufacturers that had been built into the regulatory regime. “The way that we’re going to help lower prices of drugs is . . . more competition,” he says in an interview. “I firmly believe that the best way to create proper incentives for innovation is through market-based pricing.” He’s also taken incremental steps toward opening up the drug and medical device approval process, such as more transparency about clinical trials to help innovators and manufacturers understand the FDA procedures.
It may sound like smart government to conservatives and centrists, but it may also set off alarm bells among market-skeptical regulators like those who fill career positions at the FDA. Unlike other Trump appointees to powerful agencies, however, Gottlieb has approached his job with an eye toward collaboration, not confrontation. It helps that he has served in government before, including at the FDA during the George W. Bush administration. As John Taylor, a friend and former colleague of Gottlieb’s who was acting principal deputy commissioner during the Obama administration, puts it, Gottlieb’s approach is less “disruption” and more “transformation.”
“Anyone who thinks they can come into a regulatory agency and think that they’re going to hire five political people, put them in the front office, and start writing policy, and it’s going to be effective and it’s going to be enduring—that’s never going to happen,” Gottlieb says. “That’s not a way to run an agency.”
“He has effectuated change without hobbling the agency,” Taylor says. Yuval Levin, a top conservative policy thinker, agrees. “Scott’s approach to the role of the FDA has always combined an appreciation for the importance of public confidence in drug safety and in the agency’s judgment with an appreciation for the importance of innovation in medicine,” Levin says. “He sees that it’s on the latter front—the need to allow more innovation to happen—that the FDA has most needed to improve, but also that this can’t be allowed to undermine public confidence, especially at a time when confidence in so many of our institutions is plummeting.”
It doesn’t exactly sound like draining the swamp, but Trump is nonetheless a big fan of Gottlieb. The FDA commissioner was among those who accompanied the president to the World Economic Forum in Davos, Switzerland, this past January. “Scott Gottlieb, as you know, is a star,” Trump boasted at a reception there. The president has name-checked Gottlieb in other settings, including in March at a speech in New Hampshire on the opioid crisis.
Gottlieb’s conservative bona fides on public-health issues are well established. During the Obama administration, his byline was found everywhere from Yuval Levin’s policy journal National Affairs to the op-ed page of the Wall Street Journal. In hundreds of articles, written from his perch at the American Enterprise Institute (where he was a resident fellow from 2007 until his confirmation last spring), Gottlieb was highly critical of what he called “careless policymaking” at the FDA, particularly in generic drug regulations and the drug‑approval process.
In a 2012 National Affairs article, “Changing the FDA’s Culture,” Gottlieb identified “an excessive desire for certainty” among the agency’s drug reviewers. He described a view within the agency that saw the FDA’s role in ensuring drug safety as being in direct conflict with its other role in guiding innovation in medical treatments—and choosing the former. Gottlieb made what he now calls “provocative” recommendations for how to change the review process, siloing off the scientific evaluators of drugs from more senior officials who would make final approval decisions.
Gottlieb says he still believes in the need to accelerate drug approval in ways that increase competition and make drug development more responsive to market forces. “I think it’s the optimal way to send good signals to entrepreneurs and innovators to where they could and should allocate capital in order to underwrite new innovation,” he says, pointing to efforts he has made to improve the existing process. But he’s been less aggressive than his commentary suggested, in part as a recognition of the need to work with, not against, the agency.
Part of that balance means he’s continued to pursue and even expand on certain public-health goals that began under the previous administration, most notably in the area of restricting nicotine in tobacco products. “He has started the FDA down a path to make cigarettes minimally or non-addictive,” says Jeremy Sharp. “If that is implemented it could save millions of lives and have a profound public-health benefit.”
There’s no question Gottlieb is trying to ensure his work and changes at the FDA outlast his tenure there. “If you want to make policy change enduring, you have to do it through processes like developing regulation, developing guidance,” he says. “You have to get broad consensus. I can’t just unilaterally write a guidance document or a regulation. I need my senior career leaders on board and believ[ing] it’s the right direction. You have to build that consensus.”
His friend John Taylor puts it this way: “He wants to leave a positive legacy and he is hellbent on doing so.”
