WASHINGTON — President Biden will soon have to nominate someone to helm the Food and Drug Administration. His two top contenders couldn’t have more divergent visions for how to lead that agency.
His decision comes at a crucial moment for an agency that has been, at least at times, overlooked by past presidents: The FDA is still in the throes of the Covid-19 pandemic, and regulators are working around the clock to review the new application for what is likely to be the third Covid-19 vaccine authorized for use in the United States. Meanwhile, the agency is facing renewed criticism of its speed, and there are early signs that the FDA is beginning to review some of the questionable scientific decisions made under the tutelage of former Commissioner Stephen Hahn.
The top contenders for the job are Janet Woodcock, the agency’s longtime drug center director, and Josh Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health who served as the FDA’s second-in-command during the Obama administration, although additional candidates could emerge in the coming weeks.
Already, backers of both candidates are waging campaigns boosting their preferred candidate. Woodcock has been widely branded the establishment candidate who will keep the agency on an even keel, Sharfstein as the reformer who will up the agency’s standards. But the differences between the candidates are much greater, and cut to the central question of what the agency’s raison d’être should be.
Below, STAT examines each official’s track record in public policy so far — and the issues they have already made it clear they will focus on if they are nominated and confirmed.
Woodcock’s vision: an FDA that pushes the scientific envelope
Janet Woodcock has been at the FDA for 37 years, but her supporters say she will be a voice for change.
“Janet Woodcock being the voice of the status quo is totally inaccurate,”
said Ellen Sigal, the founder of Friends of Cancer Research, which has publicly backed Woodcock for commissioner.
Woodcock’s spent the majority of her career at the FDA’s Center for Drug Evaluation and Research, the branch of the FDA that handles nearly all of the prescription medicine review process and applications that most people think of when they think of “FDA approval.”
But her passion is changing clinical trials.
Woodcock has publicly proclaimed, on multiple occasions, that “the clinical trial system is broken.” The Covid-19 pandemic, it seems, has only strengthened that belief.
Woodcock has repeatedly railed against the quality of the clinical trials produced during the pandemic, which she has argued were often duplicative and so poorly designed that they did not provide useful data to regulators.
“We all have to acknowledge that the U.S. clinical trial ecosystem did not have an optimal response to the pandemic,” Woodcock said late last month at an event hosted by the National Academies of Sciences, Engineering, and Medicine. “We are left with a lot less evidence than we could have had.”
It’s not immediately clear how Woodcock will channel her frustrations about Covid-19 trials into her policy priorities as commissioner, but already she is pitching a “national clinical trial capacity stockpile,” a government-supported, community-based clinical trial network that can help coordinate research around the country and will allow patients to participate in trials even if they don’t live near a big academic medical center.
A Woodcock-led FDA will be good news too, for patient advocates, scientists, and drug makers that want to see the FDA embrace controversial, cutting-edge topics in drug development, like bespoke drugs for rare conditions and new types of clinical trials, like so-called adaptive platform trials, which study multiple potential treatments for a disease simultaneously.
“She is a hero to so many of us who have benefitted from her vision, innovation and consistently excellent management during her many years at the FDA,” said Anna Barker, a former deputy director of the National Cancer Institute who has worked directly with Woodcock on platform trials.
“She will move the field as far as the science will let us go,” said Sigal. “She sees major changes that she has never had a chance to fully implement that will happen.”
Sharfstein’s vision: an FDA that finally prioritizes public health
It is public health, meanwhile, that will get a very big boost if Josh Sharfstein becomes head of the FDA.
Sharfstein would be only the second FDA commissioner in modern history to serve as a local public health official. While most FDA commissioners typically come from backgrounds in academic medicine or from other federal agencies, and thus tend to focus primarily on the regulation of drugs, Sharfstein has been far more outspoken about the FDA’s lesser known responsibilities, like regulating cigarettes and food.
“Somebody like Josh comes in with a much bigger picture and understands the way the agency can be a positive force for public health,” said Peter Lurie, a former FDA official who worked directly with Sharfstein and is now the president of the Center for Science in the Public Interest.
Sharfstein has argued publicly that the FDA must be seen as a “public health agency,” and that its success should be measured not just on “intermediate measures” like “the number of facilities inspected or drugs approved,” but on its ability to “promote health, prevent illness, and prolong life.”
“The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food — even if those opportunities and threats lie outside the realm of the agency’s usual routines,” Sharfstein wrote in 2009 alongside his boss, former FDA Commissioner Peggy Hamburg, in an op-ed.
Sharfstein’s public statements on hot topics in drug development are few and far between, although earlier in his career he did work at Public Citizen, the advocacy group that has repeatedly complained that the FDA drug center, under Woodcock’s tenure, has lowered its approval standards.
He’s got lots to say, however, about seemingly every public health issue under the sun.
No issue is too small: He once co-authored an article railing about the FDA’s lax regulation of infant formula, and proposed various policy fixes.
He’s perhaps most vocal on the issue of tobacco. There he has asserted that an FDA crackdown on flavors that appeal to youth was overdue and that tobacco companies that can’t reduce youth use to a certain benchmark should pay substantial fines. He’s also railed on the industry for using its influence to stymie FDA regulation, and insisted that it can’t be trusted to regulate itself.
If named, Sharfstein is also all but guaranteed to push the FDA to be more transparent.
It’s been an obsession throughout his career. He chaired an FDA task force on the issue in 2009 and another, supported by the Laura and John Arnold Foundation, in 2017, both of which concluded that the agency should disclose slews of information about its interactions with drug makers, including the letters the agency sends when drug applications are rejected. During the pandemic, he’s renewed calls for increasing transparency, arguing that the reforms will help rebuild trust in the agency.
Sharfstein is also unlikely to shy away from conflict with the drug industry. Pharmaceutical companies have spoken out vociferously against his transparency ideas, arguing they would “increase confusion among patients and healthcare providers and undermine the environment for new medical product research and development in the United States, thereby harming patients throughout the world.”
“Unfortunately there are some times when being pro-public health is being adverse to the interests of industry,” said Aaron Kesselheim, a Harvard professor that has publicly backed Sharfstein. “You can’t shy away from those type of things, but that doesn’t make you anti-industry.”
“He may be tough on them — but that’s OK,” said Georges Benjamin, the executive director of the American Public Health Association, regarding Sharfstein’s likely approach toward drug makers. “They’re big boys, they’ve got great lawyers and they’ve got big budgets. And if they can’t make their case about their products: Shame on them.”
One commonality: a lack of patience for meddling
Sharfstein and Woodcock have one major thing in common: Neither is going to let the FDA get steamrolled the way it did throughout the last year of the Trump administration.
Woodcock has a storied reputation in Washington for telling people, no matter how powerful or passionate, when she thinks they’re wrong. She’s unlikely to bite her tongue just because she is named commissioner.
And don’t expect her to bow to congressional pressure either: She’s plenty used to withstanding a congressional tongue-lashing. Woodcock has testified before Congress more than 50 times.
Sharfstein has also made it clear he won’t stand for political interference at the FDA, and he’s shown himself to have little patience when politicking gets in the way of public health. He has insisted that the purpose of good health policy “is not to make the stakeholders happy.”
He has also railed against political interference at the FDA, once going so far as to argue that White House staffers should “sign their names to decisions that stop the actions of FDA and other agencies that are intended to save lives.”