As Covid-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege

WASHINGTON — Stephen Hahn, a political novice who moved here in December to take over the Food and Drug Administration, has found himself steering his agency through the most tumultuous time in its history.

But with almost no institutional knowledge behind him, FDA experts worry he’s flying blind, leaving the agency flailing despite its vital role in the effort to control the spread of Covid-19.

Hahn, a career cancer doctor, is suddenly at the center of a fight for his agency’s integrity — and for his own. That could have not been more clear than late Monday night, when in an extraordinary series of tweets, Hahn himself seemed to acknowledge his embattled position. He said criticism about his effusive blood plasma statements was “entirely justified,” and he sought to “reassure the American public” that the FDA “will remain data driven.”

Hahn was trying to dampen an outcry from Sunday evening, when, flanked by President Trump during a primetime White House briefing, he alarmed former FDA officials and outside scientific experts by spouting nonsensical statistics about the benefits of blood plasma from recovered Covid-19 patients. At one point, he falsely claimed that the treatment, which the FDA authorized Sunday on an emergency basis, would save the lives of 35 in 100 coronavirus patients. (No available data supports his claim, which also dramatically inflates Covid-19 mortality.)

According to interviews with current and former agency officials, the challenge has been especially complicated because more than any recent commissioner, Hahn has surrounded himself with an insular cadre of advisers, none of whom has significant experience in FDA leadership. A slew of high-level FDA experts have also departed the agency since its former commissioner, Scott Gottlieb, left in early 2019.

Hahn, moreover, doesn’t have relationships with the small group of former FDA commissioners who often support one another with policy and other advice: The three most recent FDA commissioners told STAT that they have had only passing conversations with Hahn since he was confirmed.

Hahn’s verbal blunder on Sunday, and the contrast between his enthusiasm and the FDA’s markedly cautious press releases, have raised questions about Hahn’s ability to navigate the agency through the president’s impulses — and whether Hahn’s supporting cast at FDA is capable of guiding him.

“It would be hard to have faith in his ability to push back [against political interference], given what we saw yesterday,” said Joshua Sharfstein, an Obama appointee who served as the FDA’s principal deputy commissioner from 2009 to 2011. “Either he is a cheerleader for the president … or he’s doing his best impression of one, and that’s not the job of the FDA commissioner.”

While Hahn’s allies acknowledge his outsider status, they argue it’s an inevitable reflection of his career outside government as well as rules of decorum that prevent sitting officials from discussing decisions with people no longer among the agency’s ranks. They also noted Hahn’s tenure as commissioner has been defined — and derailed — by Covid-19, leaving little opportunity for relationship-building.

“The commissioner is a gregarious person,” said Bill Pierce, a senior director at APCO Worldwide, a communications firm, who served a top health policy spokesman during the George W. Bush administration. “The forced physical distancing prevented him from getting together with anyone, and he walked into an unprecedented circumstance that other commissioners didn’t face. That’s why we are where we are.”

The FDA did not immediately respond to a request for comment.

But despite the public health crisis, the FDA has been buffeted more than most agencies. The press conference on Sunday, at which Hahn spoke alongside the president and health secretary Alex Azar, came just a day after Trump singled out Hahn in a tweet that suggested the FDA was part of a “deep state” conspiracy to sabotage his reelection bid. The week before, the Trump administration installed Emily Miller, a former reporter for the far-right, conspiracy-heavy cable channel One America News Network, as the FDA’s top spokesperson — a role typically filled by nonpolitical civil servants.

As drug companies edge closer to submitting the data that could demonstrate they’ve developed an effective Covid-19 vaccine, those moves have generated intense scrutiny surrounding the agency’s independence and its fidelity to rigorous science.

“The way the public part [of the plasma announcement] was handled will erode precious public confidence,” Gottlieb said Sunday on Twitter, in a reply to Yale epidemiologist Gregg Gonsalves. “You earn public confidence in small drops and you [sic] loose it in buckets.”

Hahn relies on a small circle of advisers at the FDA, all of whom are as new to the agency as he is.

Anand Shah is Hahn’s closest ally at the agency. He joined the FDA in January as deputy commissioner for medical and scientific affairs, a position that hadn’t been filled since Scott Gottlieb held it during the George W. Bush administration. Shah had one prior stint at the FDA, serving as an adviser to the FDA Oncology Center of Excellence. He most recently served as a senior adviser in the Centers for Medicare and Medicaid Services.

Though Amy Abernethy, the principal deputy commissioner, technically outranks him, Shah has emerged as the linchpin of Hahn’s FDA. Shah describes his role as “developing and leading high-priority FDA policy initiatives and oversee cross-agency teams,” as well as spearheading “Hahn’s agency-wide strategic planning process.”

Hahn has also tapped three appointees to serve as advisers: Jeet Guram, Colin Rom, and Lowell Zeta.

Rom started at the FDA roughly six months before Hahn, first serving as an adviser to the deputy commissioner for policy before being tapped by Hahn’s office. Rom has worked in Washington health policy for roughly five years, largely in low-level positions: He recently served as an assistant in the Office of Management and Budget. Before that, he was a researcher for Sen. Richard Burr (R-N.C.), focused on issues pertaining to Burr’s seat on the Health, Education, Labor, and Pensions Committee.

Zeta, a former senior associate at the law firm Hogan Lovells, has been with the FDA for just six months and, according to his LinkedIn profile, has never served in government.

Guram was hired at the FDA in February 2020. He is a Havard-educated doctor who spent nearly three years as a senior adviser to CMS Administrator Seema Verma, according to his LinkedIn profile.

Combined, the three advisers have roughly 3 1/2 years of experience working at the FDA.

It’s a striking contrast from commissioners in the past. The agency’s most recent commissioner, Gottlieb, staffed his inner circle with agency veterans and longtime Capitol Hill staffers.

One of Gottlieb’s closest advisers, Kathleen Quinn, had worked at the agency since 1995. Lauren Silvis, Gottlieb’s chief of staff, worked for roughly nine years at the law firm Sidley Austin, where she was a partner, and spent two years in FDA’s device center before being elevated to chief of staff.

Gottlieb also tapped FDA career staff to direct various policy initiatives he championed as commissioner. Lauren Roth, then associate director for strategy and regulatory operations at FDA’s device center, was tapped to lead Gottlieb’s device work; Maarika Kimbrell, then division director in the FDA’s office of generic drugs, was tapped to lead Gottlieb’s drug pricing initiatives; and Caitlin Boon, then a senior adviser to the FDA’s food center director, was tapped to handle food policy.

Gottlieb also recruited a slew of Capitol Hill veterans. They included Anna Abram, who had spent more than a decade on Capitol Hill and served as associate director of the White House Domestic Policy Council under George W. Bush; Carly McWilliams, who served on the House Energy and Commerce Committee for six years; Lowell Schiller, who served as senior counsel on the Senate HELP Committee; and John Martin, who previously served as legislative director for Sen. Tom Cotton (R-Ark.). The FDA’s media office was helmed by a longtime FDA career official, Jennifer Rodriguez, who had been with the agency since 2012.

Many of those close to Gottlieb have left the agency, including Quinn, Silvis, and Rodriguez, all of whom departed in 2019. More recently, McWilliams resigned, according to three sources familiar with the move. The move has not been announced publicly and McWilliams couldn’t be reached for comment. Karas Gross, who served as associate commissioner for legislative affairs since February 2019, also recently resigned.

For some newly minted FDA leaders in the past, the group of former commissioners are a support system and a sounding board. Hahn hasn’t taken advantage of that resource.

Gottlieb, Hahn’s immediate predecessor, counts former FDA commissioner Mark McClellan as one of his closest mentors and friends. Robert Califf, who served as FDA commissioner under Barack Obama from 2016 to 2017, had frequent coffees with his predecessor, Peggy Hamburg.

Gottlieb, Califf, and Hamburg, the three most recent FDA commissioners, all told STAT they have had only passing conversations with Hahn since his confirmation last year.

While some had numerous conversations with Hahn leading up to his confirmation, they’ve hardly spoken to him since.

Hamburg told STAT that early on in the pandemic, she and Hahn would trade emails, but “communications have fallen off.” Even a recent email relaying warm wishes from a friend who Hahn had helped as a cancer doctor went unanswered, she said.

“He did not respond, which surprised me,” Hamburg wrote in an email. “But [I] can understand that he has been busy!”