Advice For The Next US FDA Commissioner: Grow A ‘Thick Skin’ Against Political Pressure

The next US FDA commissioner needs the ability to maintain a focus on long-term policy priorities while managing the inevitable daily crises, a willingness to act as a “human heat shield” for career staff against political pressure from Capitol Hill and the White House, and, generally, a “thick skin and a strong stomach,” a panel of former commissioners said.

Four former commissioners (Mark McClellan, Andy von Eschenbach, Peggy Hamburg and Scott Gottlieb) joined current FDA chief Rob Califf in an Oncology Center of Excellence-sponsored “Conversations on Cancer” webinar October 23. The webinar was one of several events held to celebrate OCE Director Rick Pazdur’s 25th anniversary at the agency; Pazdur served at FDA under all five chiefs.

The forum became an opportunity for five of FDA’s six most recent commissioners to deliver a message about the importance of preserving the independent decision-making of the career staff. It also presented Pazdur in the role of a peer with his current and former bosses.

The event included all but two of the commissioners who served during Pazdur’s tenure at FDA: Jane Henney, a Bill Clinton nominee who was commissioner when Pazdur joined the agency in 1999 but left with the transition to George W. Bush in 2001; and Steven Hahn, a Donald Trump nominee who served in 2020 until the start of the Biden Administration in 2021. Hahn’s absence was notable, as there is speculation that he could be open to a return to FDA if Donald Trump prevails in the upcoming election.

The commissioners’ discussion with Pazdur was lively and congenial, and the oncology chief quickly took over as an enthusiastic moderator. Under questioning from Pazdur, the group discussed the political challenges with the job, what they each found most surprising when they arrived at FDA and the “most memorable” controversy they faced while in office.

The political attention on FDA business was surprising to most of the commissioners. “You get to get pushed around a lot in this job,” Califf said. “I’ve never had anyone interfere with an individual product decision” in either of the two terms he has held as commissioner, but “there are many, many calls from politicians wanting to interfere. You’ve got to be tough and be willing to take the consequences and be a human heat shield” for the staff.

“Before you take this job, you better examine your internal compass and make sure that you really know what it tells you, and you’d better stick to it,” Califf declared.

Pazdur later jumped in to affirm that the commissioners he has served under have indeed served as the “heat shield” as far as he is concerned: “I’ve never had a call from anybody about a specific product to do something about it.”

Any commissioner needs to “maintain thick skin and keep your bearings,” McClellan agreed. But he also reflected on the joy of the job: “Just remember to appreciate what a privilege this job is. There’s no other job on the planet where you get [exposed to] so much science” and the ability to “potentially impact human and animal health.”

“It’s easy to forget that: the days are really long – especially if there’s an oversight hearing or two – but the weeks and the years go by quickly, and there’s so much that changes” with new scientific advances and evolving regulatory approaches for FDA to explore, McClellan said. “I think it’s a lot of fun.”

Hamburg agreed. “The critical thing for me was learning how important listening was, bringing the right people to the table, asking for help when you need it, and never forget the critical and unique mission of the FDA to protect and promote” the public health. She joked that she also quickly learned to “develop a thick skin and a strong stomach.”

A Little Help From My Friends

“It’s also really important to make a lot of friends,” von Eschenbach added. He noted Gottlieb’s decision to testify frequently on Capitol Hill (20 times during his two years as commissioner) but also Gottlieb’s strategy of meeting informally with legislators on a weekly basis (usually on Fridays before representatives returned to their districts) to build comradery and trust. “Scott made a lot of friends for the agency,” von Eschenbach said.

In explaining his Hill strategy, Gottlieb said every time FDA delivered a major policy announcement, he would call four or five members who would be affected by it. He pointed to the 2018 recall of romaine lettuce right before Thanksgiving as an example: knowing the crops would be harvested in the Salinas Valley, he reached out to Rep. Jimmy Panetta (D-Calif.) to brief him on the recall.

“Right after we notified the public, I called him personally,” Gottlieb said. “Those personal touches became very important – building relationships so that then when you went back to the Hill to try to talk about your [priorities], you had those relationships. It’s also why I tried to testify a lot on Capitol Hill, because I felt by putting myself in front of the members, it would build credibility that I could then bank and use on the agency’s behalf.”

Gottlieb said he was surprised at how political the job became between working at FDA under McClellan and von Eschenbach in the early 2000s and returning to the agency as commissioner in 2017.

“Peggy and Rob had been there in the intervening years and may have a different perspective about how much that evolution had taken place,” Gottlieb said. “But when I think back to the early 2000s versus my tenure, I felt that a lot more of the time was spent defending and advancing the agency’s prerogatives in the broader political sphere.”

Hamburg also “felt that the pressures of politics bearing down,” due in some part to the stand up of the tobacco center and the initial implementation of the Food Safety Modernization Act. She acknowledged the challenges of “defending the autonomy of the FDA” while “being able to engage day in/day out without interference in the important tasks at hand.”

Califf noted that both he and Gottlieb had the experience of serving at FDA in non-political posts – Califf was deputy commissioner of medical products under Hamburg, and Gottlieb served as deputy commissioner for medical and scientific affairs under McClellan and deputy commissioner for policy under von Eschenbach. “I had a great year as a civil servant,” Califf said. “I got to learn a lot and people treated me quite well.”

While Gottlieb arguably had the most previous agency experience before becoming the head of FDA among the modern commissioners, Hamburg acknowledged that she did not.

Hamburg interacted with FDA early in her career as an HIV researcher, and had some exposure to the agency as health commissioner for New York City on counterfeit products and food borne outbreaks.

“But I didn’t really know FDA well,” Hamburg acknowledged, “and I’ll be honest: it wasn’t my first choice for a job in the Obama Administration.” Hamburg initially agreed to be deputy director of the White House’s Office of Science and Technology Policy, but joked that she was encouraged by her daughter to accept the FDA post, because it was a “real job. And she was right.”

She now looks back on her tenure with pride, noting her six years was “one of the longer FDA terms in modern history.”

Hamburg said she was quickly impressed upon arriving at FDA. “I had no idea the depth and breadth with the science at FDA. I really thought it was sort of a ‘checklist science’-kind of a place,” Hamburg said. “I thought that at the end of every day at the FDA, there’d be a stack of things for me to sign off on approvals. That was part of why I didn’t think it would be the most exciting job in the world, because I’d be spending hours just signing off on stuff.”

“I didn’t really understand the caliber of the people that I’d be working with, the cutting-edge nature of the discussions around science and medicine, and the compassion that people were there because they really wanted to see these new discoveries and these new products that were being developed translate into products that would make a difference in people’s lives. I was just bowled over.”

Praise For Pazdur

The commissioners also heaped praise on Pazdur for his accomplishments at FDA: if the OCE director were to launch a campaign for commissioner himself, there would be plenty of strong endorsements to cull from the recording. Pazdur also recognized a potentially valedictory tone to the event, and made clear that he has no plans to leave the agency.

Pazdur acknowledged there was confusion among his staff about the reason behind the celebrations. “I just had to laugh, because some people said, ‘is this your retirement party’? And I said, ‘no, no, no, no, no. I’m not retiring. I want to make that real clear, this is not a retirement party.’ I’m just beginning here.”

“Rick’s personality is the mission of the FDA,” Califf said. “You can call him any hour of the day or night. He has opinions on everything about the future of what needs to be done.” But most importantly, “he’s always in touch with the patients, always in touch with the clinical community, and he has a really good sense of what the industry is doing.”

Califf also praised Pazdur for his past (and continued) arm-twisting to get drug sponsors to agree with him on policies that he feels are in the best interests of patients.

He has the “courage to force the industry sometimes to do things that they didn’t want to do in the interest of patients,” Califf said. “This is what he’s all about. So where else could he go?” Pazdur broke in at that point to quip: “I’m unemployable.”

Von Eschenbach agreed: “You’ve been an example to others at the FDA to emulate you. And I think that you’re never going to leave FDA, even the day you walk out the door, because FDA is never going to leave you.”

The Most Memorable Controversies

When asked by Pazdur, the commissioners also reflected on their “most memorable” controversies. Califf answered first: “there are so many to choose from,” but settled on infant formula as an issue that “ate up a large segment of my time.”

Califf said he arrived at the office the first day following his Senate confirmation, and then-Acting Commissioner Janet Woodcock told him, “‘by the way, we’re shutting down the biggest infant formula plant in the country, and it’s probably going to create a shortage.’ Well, yes, it certainly did.” Califf noted the lessons learned from the experience, including the largest reorganization in the history of FDA.

McClellan named several controversies during his time as commissioner: mad cow disease, drug reimportation, and the transfer of most therapeutic biologic reviews to the Center for Drugs Evaluation & Research. Gottlieb noted the shortages from Hurricane Maria in 2017 and the concern that as a Republican appointee he would delay implementation of regulations related to the Food Safety Modernization Act and the final deeming rule for tobacco.

For Hamburg, easily the most controversial issue was the controversy around bringing Teva’s Plan B One Step emergency contraception over the counter. The OTC version of the morning-after pill was originally approved in 2009 as a nonprescription product for women ages 17 and older, and as a prescription-only product for younger women.

In 2011, Teva applied for full OTC status and the CDER review team agreed to drop the age restrictions for the OTC product. Hamburg signed off on that decision, but she was ultimately overruled by the White House and HHS Secretary Kathleen Sebelius.

“It was a political hot potato, and the White House was not eager to proceed with this approval,” Hamburg said. She remembers it as a “stark moment” in her career. “Many people thought I should quit. Many people thought I should take the heat.”

Instead, she told the White House “that I wanted to be able to be clear about the FDA decision, the science on which it was based … and I wasn’t going to be quiet about it.”

“I, in turn, respected their request that I didn’t go out and paper the world with our disagreement and do a million talk shows,” but her opinion was very clearly on the record.

“At the end of the day, the people within FDA felt supported, but understood that this was the decision,” she said. “Ultimately, the courts found in support of FDA, but it was a very difficult time to have such a visible conflict with the White House and such a visible need to really search within about my values, my commitments and when to fall on the sword.”

Plan B eventually went OTC in 2013, after Obama’s reelection.

Camaraderie Among The Commissioners

The former commissioners are a tight-knit group, despite coming from different political backgrounds.

Von Eschenbach reflected on that point. “One of the important things to come out of this conversation which most people don’t appreciate is how much camaraderie there is among us who are former commissioners and with the current commissioner. We may have come from different political backgrounds and appointments, but there’s a cohesiveness and a commitment to the agency that transcends one commissioner after another after another.”

Pazdur agreed. “That’s exactly why I wanted this for my anniversary, because I worked with all of you, and I’ve seen the camaraderie and the relationships that we have developed over the years, and it does transcend politics. … Let’s just face it: this is a science-based agency, and despite political differences, we have to move the agenda forward for the health and safety of the American public.”