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STAT – The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy

STAT – The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy

Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic reputation and an outsized personality to match. For years, rumors have swirled: Who could possibly succeed her?


Now, it seems, there’s an answer to that question: The FDA official who has been tapped to step into Woodcock’s role for at least a temporary stint is a relative newcomer — and until now, a relatively quiet, low-profile presence at an agency that has been thrust into the spotlight amid the coronavirus pandemic.


Her name is Patrizia Cavazzoni, and last month she was selected to stand in for Woodcock as head of the Center for Drug Evaluation and Research, the FDA subagency in charge of nearly all drug approvals, while Woodcock takes a leave of absence to focus on a Trump administration coronavirus initiative. It catapults Cavazzoni to the helm of the FDA’s most important office at a time when the agency is under more pressure than ever before in its nearly 114-year existence.


Multiple current and former top FDA officials told STAT that Cavazzoni’s rise is the latest evidence that she is emerging as the clear choice to eventually succeed Woodcock, 71. These officials said Cavazzoni, 57, has gone through an extensive grooming process for the potential permanent post. And Former Commissioner Scott Gottlieb called Cavazzoni the “perfect choice” to run the drug center when Woodcock decides to retire.


Even Woodcock spoke highly of Cavazzoni in an email exchange with STAT, though federal rules bar her from speculating about any potential replacement.


“Patrizia is a better manager than I am and she has executed some complex IT and systems plans that are a real benefit for the center, ” Woodcock wrote.


For now, at least, Woodcock has no immediate plans for retirement, and multiple sources told STAT that she plans to return to leading CDER after she has finished her tenure on the White House’s Warp Speed project.


No matter when Woodcock decides to step away, it is clear that Cavazzoni is rising in influence at a critical time. In nearly a dozen interviews, advocates, colleagues, and three former FDA commissioners described Cavazzoni as a problem-solver, who, despite her low public profile, has repeatedly demonstrated her willingness to take on some of the agency’s most perplexing problems.


“Whenever I have to get clarity on something that both NCI and FDA are working on together, especially when it’s not clear who can help answer my questions, Patrizia is the person I call,” said Ned Sharpless, a former FDA acting commissioner who now leads the National Cancer Institute. “Patrizia always helps come up with a solution and the solution is always reasonable.”


Her allies describe her as someone who will keep the agency on an even keel and carry on the legacy left by Woodcock, who has pushed the FDA to speed up drug approvals, and accept data that strayed from the gold-standard of double-blind placebo controlled trials, particularly for rare diseases with no other treatments. Others caution, however, of her close ties to industry and her history of defending drugs with serious safety problems.


Cavazzoni told STAT in an email that her background in industry is a strength, but she declined to comment on some of the most controversial aspects of her resume, citing the fact that she was involved in litigation. She also confirmed to STAT that she would be an advocate for “continuous improvement” at the agency. The FDA declined multiple requests for a phone interview with Cavazzoni.


Cavazzoni is, in many ways, trying out for a seemingly unfillable position. Woodcock has been at the FDA for 34 years. She’s been credited with everything from creating FDA’s adverse event reporting system to approving some of the world’s most controversial drugs. Her opinion often holds more clout at the agency and on Capitol Hill than even the FDA commissioner’s, given that tenure. She is such a staple that allies have joked that a statue to her should be erected at FDA’s Maryland campus upon her retirement.


By contrast, Cavazzoni, despite being an influential career official at the FDA, has kept a low profile. She has not testified before Congress and has never appeared to have been quoted in the media. Her name rarely appeared in press releases before she took over for Woodcock in May. Many advocacy groups and industry lawyers that STAT contacted for this story said they had never even heard of Cavazzoni.


One advocate told STAT their most striking memory of Cavazzoni was when she quietly sat listening during a meeting with outside stakeholders and helped summarize the findings at the end.


Cavazzoni’s allies insist that her retiring presence is a testament to her dedication to her job at the Center for Drug Evaluation and Research.


“That’s because she’s focused on CDER, and learning CDER, and running CDER, and the operations of CDER and putting her head down and doing the hard work,” said a former senior FDA official, when asked why Cavazzoni had such a low public profile.


It’s an obvious contrast to Woodcock, who is known for her countless public appearances where she is often unwilling to avoid challenging assumptions about the FDA with which she disagrees.


While Cavazzoni isn’t known, like Woodcock, for telling lawmakers when their ideas about the FDA don’t make sense, her allies insist that she is more like Woodcock than one might gather at first glance.


Like Woodcock, they describe Cavazzoni as a truth-teller with a “bias for action.”


Robert Califf, who served as FDA commissioner from February 2016 to January 2017, said she does not “accept sloppy use of words or advocacy of methods.”


Ellen Sigal, founder and chair of Friends of Cancer Research, described both Cavazzoni and Woodcock as “very forceful women.”


“Janet is clear and direct on what she’s thinking, and she is precise and very gifted in telling you where you stand, even when she disagrees with you,” Sigal said.

“Patrizia is a psychiatrist, and maybe that comes into play a little bit. She’s slightly more nuanced, but she still has the same character.”


Cavazzoni’s main preoccupation for the last two years has been making sure that the FDA’s drug center runs smoothly.


The Center for Drug Evaluation and Research, or CDER, as it’s commonly known, is widely regarded as the FDA’s most important office. It employs more than 5,000 people, has a budget of over $1 billion, and regulates everything from blockbuster cancer drugs like Remicade and Revlimid to billions of doses of generic drugs manufactured around the world.


“Running that center is harder than running the agency,” Gottlieb said. “I think Patrizia has a harder job than the commissioner does.”


As the head of CDER, Cavazzoni will be leading the center’s near 24/7 response to Covid-19 and making sure the center still completes its normal work, like reviewing the hundreds of other drug applications that cross the agency’s desk, dealing with drug shortages, and investigating safety issues with factories around the world.


“It’s stepping in to run one and a half centers,” said Susan Winckler, a former FDA chief of staff who now leads the Reagan-Udall Foundation. Winckler compared the new workload to caring for a “family of eight, and then you have the four neighbors move in with you.”


Before her ascension, Cavazonni was the agency’s deputy director for operations, a position she held from January 2018 till this May. The role put her among Woodcock’s top three deputies.


“Janet was instrumental in recruiting her to the agency,” Gottlieb said. “Janet found her … it was Janet’s choice on who that deputy was going to be.”

Cavazzoni is clearly an admirer of Woodcock’s, too. She told STAT that one of her main motivations for joining the FDA was working directly with Woodcock.


“I decided to join FDA because of its mission, what the agency does for the public, and a belief in the importance of the regulatory process,” Cavazzoni wrote. “The icing on the cake was the prospect of working with Janet Woodcock.”


It’s not a job that seems tailor-made for her. Her background isn’t in operations, or human resources: She’s a McGill University-trained psychiatrist with a slew of publications assessing antipsychotic medications.


But Cavazzoni has developed a reputation as somewhat of a fixer in nearly every job she has had.


In nearly eight years at Pfizer, where she held multiple senior vice president roles, Cavazonni shined by fixing the logistical snafus that were seemingly outside her job description. She spearheaded a reorganization of the company’s entire development operations, for example.


Peter Honig, senior vice president of global regulatory affairs at Pfizer, described how she had brought a “harmonized and consistent approach” toward conducting clinical trials by revising some of the arcane but nonetheless central policies, such as its clinical trial protocols and site selection processes.


Honig praised her ability to “create an organization that is both effective and efficient.”


Her time at the FDA has been no different. Several colleagues told STAT she played a central role in averting crisis at the FDA when the government shut down for 35 days in 2018.


“She helped us find available resources to keep critical operations going,” Gottlieb said. “If she hadn’t managed to do that we would have had to shut a lot of things down. A lot of things were kept going because of her creativity.”


She was critical, too, in the FDA’s efforts to staff up following the passage of the 21st Century Cures Act, as well as the agency’s efforts to modernize its woefully antiquated computing systems.


Cavazzoni’s career to date has also put her front and center of the debate raging over whether new forms of data, like so-called real-world evidence that is gathered from sources like electronic medical records, should be used as the basis for regulatory decisions.


At Pfizer, one of Cavazzoni’s main responsibilities was helping the company gather these new forms of evidence.


She also served on the sterling committee of I-MEDS, an FDA-industry partnership which allows drug makers to pay for use of the FDA’s real-world data system known as Sentinel to complete certain safety studies more quickly.


Sigal of Friends of Cancer Research said Cavazzoni understands the need “to do business differently and to embrace innovation.” Sigal added that she believes Cavazzoni is “very aligned with Janet and where the agency is going.”


The FDA has cautiously embraced the use of some of these new technologies, albeit not as quickly as industry has often hoped. Already some are hoping that Cavazzoni’s ascension will also cement the FDA’s embrace of the new standards.


“If anybody can drive change or potential progressive thinking, I think Patrizia is probably as good as any, if not better than most,” Honig said.


Cavazzoni’s backers insisted that she is not an evangelist for these new forms of evidence. Instead, they say, she understands their utility when used responsibility. They say, too, that she won’t lower FDA-approval standards.


Cavazzoni told STAT it’s fair to assume she will drive change at the agency.


“I am a strong proponent of continuous improvement and innovation,” she said. She cautioned however, that she won’t change things “for the sake of change.”


“Particularly when it comes to the complex and high-impact work that we do at FDA, it is important to couple progressive thinking with a thorough understanding of the regulatory framework and regulatory precedents,” she added.


That’s cold comfort for activists and certain public health researchers. They’ve complained for years that the FDA’s embrace of alternative data sources as evidence has lowered the agency’s standards, and they fear Cavazzoni will only represent more of the same.


“The pendulum has swung too far,” said Diana Zuckerman, the president of the think tank, the National Center for Health Research. “FDA leadership needs a greater focus on public health, and less focus on getting drugs to market more quickly based on promising but preliminary data.”


A number of public health advocates STAT spoke to also insisted that Cavazzoni’s industry experience is a liability, if not a disqualification.


“We can do better,” said Peter Lurie, a former associate FDA commissioner who now leads the Center for Science in the Public Interest. “Fundamentally I’m troubled by the idea of someone who has spent their career on the pharma side trying to reduce barriers to entry. That’s the last thing the agency needs, the last thing the American public needs.”


Some of the issues she tackled during her time in the private sector were, in contrast, much more controversial.


In the early 2000s, Cavazzoni, then a director of surveillance and epidemiology at Eli Lilly, played a central role in the legal fight over the company’s top-selling drug, the antipsychotic Zyprexa.


Eli Lilly faced more than 18,000 lawsuits alleging the company downplayed risks that the drug could lead to type 2 diabetes. They eventually paid $500 million to settle many of those lawsuits in 2007.


During one of those lawsuits that went to trial, Eli Lilly’s own lawyers described Cavazzoni as “the chief detective at Lilly when it comes to understanding the safety of Zyprexa.”


Internal Lilly emails and legal filings reviewed by STAT paint Cavazzoni as directly tied to Eli Lilly’s attempts to assuage regulators’ and doctors’ concerns over the risks associated with Zyprexa. A Bloomberg article from 2009 also claims Cavazzoni even ghostwrote an article for the former president of the American Diabetes Association criticizing research published in the Journal of Clinical Epidemiology linking Zyprexa to diabetes.


Cavazzoni declined to comment directly on the lawsuit involving Zyprexa but denied that she ever ghostwrote an article for another author.


“All articles I have authored or co-authored have been published with my name on the authors’ list,” she wrote in the email to STAT.


Six years later, Cavazzoni, as a senior vice president at Pfizer in charge of monitoring safety for all of Pfizer’s portfolio, was again involved in a similar lawsuit alleging that Pfizer downplayed risks of birth defects associated with the depression drug Zoloft.


Pfizer fought to block Cavazzoni from being deposed in the lawsuit, claiming that she had “not worked directly on any issue concerning Zoloft.” The plaintiffs, however, insisted that such an argument was “simply not credible.”


A judge found in 2016 that the plaintiffs had not presented a credible link between birth defects and Zoloft.


It’s not clear exactly when Cavazzoni might permanently replace Woodcock.


The longtime FDA leader has fiercely denied past rumors over her imminent retirement. When Reuters reported in 2013 that fears were swirling over Woodcock’s departure, the longtime regulator personally issued a center-wide memo railing on the “erroneous” reporting.


“The inaccuracy of the media has unnecessarily raise[d] concerns among Center staff, and even among my own family,” Woodcock wrote. “Quite the opposite is true. I am becoming more deeply involved in many of the Center’s issues.”


But multiple sources told STAT that things feel very different this time around. They noted that while they couldn’t imagine anyone replacing Woodcock as recently as 2018, they feel a sense of calm now that Cavazzoni has stepped up.


“If you asked me two years ago would I ever be having an interview about who could succeed Janet Woodcock, I would have said no. I couldn’t even imagine,” said the former senior FDA official. “And now I’m like, yeah Patrizia could totally do it.”


But many still cautioned against any suggestion that Woodcock would retire soon.


Califf, the former FDA commissioner, railed off a number of reasons why Cavazzoni would be a great replacement for Woodcock. He praised her honesty, her management skills, and her industry and FDA experience as reasons why she’d be a great replacement. But he doesn’t anticipate it happening soon.


“Janet is a national treasure. If anyone deserves to be able to retire, it should be Janet,” Califf added.


When STAT asked what Cavazzoni thought of replacing Woodcock, she demurred.


“There have been predictions before about who will serve as successor to Dr. Woodcock and there will be again in the future,” Cavazzoni said in the email. “I am currently serving as Acting Director of CDER until Dr. Woodcock return