Tag Archives: FDA commissioner

FDA’s agenda in limbo as Biden’s nominee stalls in Senate

Published Newspaper or Magazine Articles, Uncategorized, We Are Quoted,

Matthew Perrone, Fox13: February 08, 2022

WASHINGTON — (AP) — President Joe Biden’s pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and a raft of other high-profile health issues pending at the agency.

Biden nominated Dr. Robert Califf for the job in November after a 10-month search that critics complained left a leadership vacuum at the powerful regulatory agency, which has played a central role in the COVID-19 response effort.

Califf, a cardiologist who was an FDA commissioner under President Barack Obama, was viewed as a safe choice who could easily clear the Senate, given his 2016 confirmation by an overwhelming vote, 89-4.

But his latest Senate bid has been snared by political controversies on both the left and right that threaten to sink his nomination and leave the FDA in limbo for months — possibly even until a new Congress convenes next year.

No vote has been set on Califf’s nomination as Senate Democrats, the White House and other administration officials make a full-court press to lock up the votes needed to pass the 50-50 chamber. Former FDA officials warn that failure to move on Califf’s nomination will make it even harder to find and confirm future nominees.

“If he can’t get confirmed it bodes poorly for almost anyone else who could be nominated,” said Dr. Stephen Ostroff, who twice served as acting FDA commissioner. “What you’re seeing here is a lot of extraneous issues inserting themselves into the confirmation process and the same thing would happen to virtually anyone else nominated.”

Five Senate Democrats are opposing Califf due to his consulting work for drugmakers and the FDA’s track record of overseeing addictive painkillers that contributed to the U.S. opioid epidemic. That group includes Sens. Joe Manchin of West Virginia and Maggie Hassan of New Hampshire, both from Republican-controlled states ravaged by the epidemic.

With Sen. Ben Ray Luján of New Mexico absent and recovering from a stroke, Democrats need the support of six Republicans to confirm Califf.

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The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from the pharmaceutical lobby. Indeed, Califf seemed to be cruising toward confirmation after a cordial hearing before the Senate’s health committee in December, which included friendly exchanges with most of its Republican members.

But two days after his appearance the FDA eased longstanding restrictions on abortion pills that allowed women to order them through the mail. Although Califf had no role in that decision, dozens of anti-abortion groups lobbied Republicans to vote against him based on earlier changes impacting the medications while he was at the FDA.

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“It is troubling to see Dr. Califf judged on issues that are a very small part of the FDA’s responsibilities,” said Steven Grossman of the Alliance for a Stronger FDA, which represents industry, patient and consumer groups that interact with the agency. “This narrow focus increases the likelihood there will be more and longer periods when FDA is without permanent leadership.”

The White House is unlikely to send another FDA nominee to Capitol Hill if Califf can’t clinch 50 votes, noted Grossman, a former HHS and Senate staffer.

In that scenario, the current acting FDA chief, Dr. Janet Woodcock, could continue leading the agency for months to come — potentially into next year. She can serve as acting commissioner as long as Califf’s nomination is pending, followed by another 210 days after it is withdrawn or expires, under federal law.

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Last week Sen. Elizabeth Warren, D-Mass., announced her support for Califf after he agreed to not work for any pharmaceutical company for at least four years after leaving the FDA. Califf has recently served as a board director or adviser to more than a half-dozen drug and biotech companies, according to his ethics disclosure form.

“I think all this publicity that ‘maybe Califf isn’t going to make it’ is going to get people more focused on why they want Califf there,” said Diana Zuckerman, of the nonprofit National Center for Health Research. “I think he still has a very good chance.”

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Biden’s Drug Agency Nominee Returns With Deeper Industry Ties

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Alex Ruoff, Jeannie Baumann and Celine Castronuovo, Bloomberg Business: November 23, 2021

President Joe Biden’s choice to lead the Food and Drug Administration made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.

Robert Califf was paid $2.7 million by Verily Life Sciences, the biomedical research organization operated by Alphabet Inc., and sits on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals PLC. He also reported ties to 16 other research organizations and biotech companies, ethics and financial disclosure documents show.

Califf’s deep industry ties have prompted at least two Democratic senators to oppose his nomination, complicating his path to confirmation and echoing concerns that emerged when he was last nominated. While Califf previously was paid largely as a consultant for drugmakers before, in recent years he’s been hired as a top adviser and board member to major health-care companies creating innovative technologies and medicines.

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Consulting, Stock Options

Califf’s reported income from the health industry skyrocketed between stints at the FDA.

Califf was a paid consultant for Johnson & Johnson, GlaxoSmithKline PLC, AstraZeneca PLC, and Eli Lilly from 2009 to 2016, according to disclosures compiled by ProPublica. During this time he collected fees ranging from $2,160 to $9,000. Califf had also disclosed accepting consulting fees from drugmakers Amgen Inc., Eli Lilly & Co., and Merck & Co.

After his time leading the FDA, Califf earned $56,299 in fees from the biopharmaceutical firm Cytokinestics Inc. and unvested stock options worth as much as $5 million from Centessa Pharmaceuticals.

Califf is an expert in clinical trial research and cardiovascular medicine and founded the Duke Clinical Research Institute, a large academic center that received more than half its funding from the drug industry.

This kind of expertise is almost impossible to acquire without working with or for the pharmaceutical industry, David Magnus, director Stanford Center for Biomedical Ethics, said. Drugmakers have historically provided the funding for most clinical trials, he said.

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During his first tour at the FDA, Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, Howard Sklamberg, who was a deputy commissioner under Califf, said.

“He was very, very, very careful,” Sklamberg, who’s now an attorney at Arnold & Porter LLP, said.

He may have more ties to track this time.

“It seems he would have to recuse himself from a large number of decisions,” Lisa Bero, chief scientist for the University of Colorado Center for Bioethics and Humanities, said.

Califf’s years of ties to the pharmaceutical industry don’t seem to have been “a deciding factor” in the White House’s nomination decision, Diana Zuckerman, president of the National Center for Health Research, said in an interview with Bloomberg Law.

“Dr. Califf has these other very important, positive attributes of having been FDA commissioner, having been a high-level person at FDA even before he was commissioner, and having a track record of showing his commitment to scientific evidence,” Zuckerman said.

The plan offered by Califf to manage his financial interest appears to fairly standard and routine, New York University bioethicist Arthur Caplan said. “I don’t find it disqualifying that he has industry ties,” he said, adding that he’s breaking ties with for-profit, academia, and other think tank types of organizations. Califf “showed himself to be independent and fair” when he was last at the agency, Caplan said.

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Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties

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Sheryl Gay Stolberg and Sheila Kaplan, The New York Times: November 12, 2021

WASHINGTON — President Biden on Friday is expected to nominate Dr. Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, several people familiar with the planning said. The move would end nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry.

In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry.

During his previous stint as commissioner, Dr. Califf sought to permit pharmaceutical companies to advertise off-label uses for F.D.A.-approved products, a practice that is not permitted under the strict regulations governing drug advertising. But the proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration, according to a person familiar with it.

A cardiologist who has seen the harmful effects of smoking on the heart, Dr. Califf has been a forceful advocate for tobacco control; before he was the F.D.A. commissioner, he was the agency’s deputy commissioner for medical products and tobacco. In an appearance with other former commissioners this year, he said, “I have never seen more capable or nastier lawyers than what I experienced in trying to deal with the tobacco industry.”

He added, “It was awesome and quite frightening for public health.”

For the past two years, after stepping down as the vice chancellor for clinical and translational health at Duke University, Dr. Califf has worked as senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. He has encouraged Verily to focus on addiction, cardiovascular health and management of chronic diseases, according to a person at the company who spoke on the condition of anonymity.

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Dr. Califf’s relationships with pharmaceutical companies as a clinical trials researcher proved to be a liability during his Senate confirmation process in 2016. Mr. Manchin blasted him for “big pharma ties” and voted against him.

Dr. Califf was confirmed for the job in a vote of 89 to 4; in addition to Mr. Manchin, Senators Edward J. Markey, Democrat of Massachusetts; Richard Blumenthal, Democrat of Connecticut; and Kelly Ayotte, Republican of New Hampshire, voted against him. But other Republicans, led by Senator Mitch McConnell of Kentucky, then the majority leader, voted in favor.

That support may be one reason Mr. Biden picked Mr. Califf: His selection drew mixed reaction.

“It is surprising that the White House has seemed really tone-deaf on conflicts of interest and very close ties to the industry,” said Diana Zuckerman, the president of the National Center for Health Research, a nonprofit think tank.

But others said they believed that Dr. Califf’s industry experience should not bar him from the job, noting that he has disclosed his ties in publishing the results of clinical trials.

“The truth of the matter is industry develops drugs — you have to work with industry. The issue is disclosure in publication,” said Ellen V. Sigal, the founder and chairwoman of the nonprofit Friends of Cancer Research, which accepts industry funding. “Rob has done many, many clinical trials with industry, but he has not been a pawn of industry. He’s completely committed to transparency, integrity and science.”

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But Dr. [Aaron] Kesselheim objected to Dr. Califf’s efforts, when he was the commissioner, to allow drug companies to advertise off-label uses for their products, noting that patients can be endangered by drugs that are prescribed for uses that the F.D.A. has not approved. “That to me is a red flag,” Dr. Kesselheim said. “Hopefully, he’s moved past that as an idea, because it would be a terrible idea.”

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Biden picks ex-FDA chief Robert Califf to again lead agency

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Matthew Perrone and Zeke Miller, AP News: November 12, 2021

WASHINGTON (AP) — President Joe Biden on Friday is tapping Dr. Robert Califf, a former Food and Drug Administration commissioner, to again lead the powerful regulatory agency, according to a person familiar with the decision.

Califf’s nomination comes after months of the concern that the agency near the center of the government’s COVID-19 response has lacked a permanent leader. More than a half-dozen names were floated for the job before the White House settled on Califf.

Biden is to make the formal announcement later Friday, said the person familiar, who spoke on the condition of anonymity to preview the announcement.

A cardiologist and clinical trial specialist, Califf, 70, served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent one year as the agency’s No. 2 official after more than 35 years as a prominent researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.

Since leaving the government, he has worked as a policy adviser to tech giant Google, in addition to his ongoing academic work at Duke.

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Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data. But his brief time as commissioner was dominated by unrelated pharmaceutical controversies, including the surging epidemic of opioid addiction and overdoses.

He was among the first FDA officials to publicly acknowledge missteps in the agency’s oversight of painkillers like OxyContin, which is widely blamed for sparking the ongoing opioid epidemic, now driven by heroin and fentanyl.

“If addiction to opioids and misuse of opioids is an enemy then we at the FDA — like every other part of society — underestimated the tenacity of the enemy,” Califf told The Associated Press in a 2016 interview. “So we’ve got to adjust.”

Califf’s extensive work with the drug industry drew scrutiny during his Senate confirmation hearing, though he was ultimately confirmed by an overwhelming margin. Given the pressing need for a permanent commissioner, he is expected to again win bipartisan confirmation. He also has the backing of the powerful pharmaceutical and medical device lobbying groups in Washington.

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FDA watchers said Califf had several key advantages over other candidates vetted for the job, several of whom would have faced more scrutiny in the Senate.

“He knows how the FDA works, and he avoided making any outrageous decisions as commissioner,” said Diana Zuckerman of the non-profit National Center for Health Research. “Those are essential if the FDA is going to regain the public trust.”

His first tasks would include easing burnout and boosting morale among the FDA’s 18,000 employees. The agency’s medical reviewers have been straining for months under a crushing coronavirus pandemic workload, while the agency’s reputation for scientific independence has been battered by a string of public controversies.

Two congressional committees are investigating the agency’s June approval of the much-debated Alzheimer’s drug Aduhelm against the recommendation of its outside experts, three of whom resigned over the decision. Then in September, two top FDA vaccine regulators announced they would leave the agency after disagreeing with the Biden administration plan to make COVID-19 vaccines boosters widely available.

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Biden expected to tap Califf as FDA commissioner

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Emily Kopp, Roll Call: November 12, 2021

President Joe Biden is expected to tap Robert Califf to again serve as commissioner of the Food and Drug Administration.

Califf, who previously helmed the FDA in the final year of the Obama administration, is seen as a status quo choice.

Independent experts say Califf has decades of experience in the development and conduct of clinical trials. That resume has brought Califf in frequent contact with both the FDA and the pharmaceutical industry he would be charged with regulating.

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Califf had such strong bipartisan support that when Trump took office in early 2017, many pharmaceutical and medical device industry officials expressed hope he would continue on as the FDA’s leader.

“My feeling about Califf is that he’s a political compromise. His nomination shows the power of pharma. But despite his close ties to pharma, he has always talked about the importance of solid scientific evidence.” said Diana Zuckerman, president of the National Center for Health Research, a think tank in Washington, D.C. “I have some confidence that Dr. Califf is not someone who likes controversy. That is different than Dr. Woodcock who doesn’t seem to mind controversy at all. I’m hopeful he will really focus on the science in a way that has been missing lately at FDA.”

Califf’s background

Califf is a longtime cardiologist and a professor in the school of medicine at Duke University. Califf also served as founding director of the Duke Clinical Research Institute, a partnership between the university and pharmaceutical companies with the goal of innovating clinical trial design. He led it for a decade. The research institute receives about half of its funding from the pharmaceutical industry and half from the government, according to a 2020 report. He founded the Clinical Trials Transformation Initiative, a collaboration between the FDA and Duke on improving the speed and reducing the cost of clinical trials, which collaborates with pharmaceutical companies.

Califf is also an executive at Verily Life Sciences, formerly Google Life Sciences, an Alphabet Inc. company.

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But Califf has in several public statements voiced support for more patient input at the FDA.

Critics say this advocacy is often financed by the pharmaceutical industry, and the FDA often does not distinguish between authentic advocacy and these conflicts of interest.

Califf has also called for other changes to clinical trials supported by the pharmaceutical company, including greater reliance on real-world evidence pulled from electronic health records outside of a clinical trial and on biomarkers, biological signals a drug is working before it shows a clinical benefit.

“Of course, the devil’s always in the details. It’s fine to be supportive, for example, of biomarkers as a way to get information about potential benefits but it needs to be backed up by solid science,” said Zuckerman.

At the FDA, Califf would likely have to respond to an ongoing investigation by the Health and Human Services inspector general into the approval of the Alzheimer’s drug aducanumab. It was approved through FDA’s accelerated approval pathway based on the difference it made with a controversial biomarker, amyloid plaques.

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Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner

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Laurie McGinley, Washington Post: November 12, 2021

President Biden is expected Friday to nominate former Food and Drug Administration commissioner Robert M. Califf to return as the agency’s head, ending a difficult, months-long search to find a leader for the sprawling bureaucracy on the front lines of the coronavirus pandemic.

The announcement is expected later in the day, according to people familiar with the decision who spoke on the condition of anonymity because they were not authorized to discuss the issue.

Califf, 70, a renowned cardiologist and researcher, is senior adviser for Verily, a research organization devoted to the life sciences, and Google Health. He served as FDA commissioner during the last year of the Obama administration. Before that, he had a long career at Duke University School of Medicine, where he founded the Duke Clinical Research Institute, one of the largest academic clinical trial operations in the world.

Many FDA experts see Califf as a safe choice — an experienced hand who is unlikely to make abrupt changes as the agency navigates a tumultuous period marked by high-pressure reviews of coronavirus vaccines and therapies and hot-button issues involving Alzheimer’s treatments, opioids and tobacco products. An expert on clinical trials and other types of health data, Califf is likely to press for better evidence in assessing drugs and devices.

But others hoping for fresh leadership see Califf’s nomination as a missed opportunity. Some are uncomfortable with his longtime relationships with the pharmaceutical industry.

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“I think he would be terrific,” said Harlan Krumholz, a cardiologist at Yale School of Medicine. “It is critically important to have a commissioner who can step in and knows the job and knows how to make policy decisions.”

Even some of the agency’s toughest critics say Califf is acceptable.

“Rob Califf is a good choice,” said Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who has faulted the FDA for approving drugs on what he considers flimsy evidence. “Califf certainly spent the vast majority of his early career working on clinical trials … and understands the value of rigorous data.”

But Califf’s longtime industry relationships have drawn criticism from some who argue the agency already is too close to the companies it regulates.

“Califf has a long history of extensive financial ties to Big Pharma, most significantly through pharmaceutical industry funding of the Duke Clinical Research Institute,” said Michael Carome, director of nonprofit Public Citizen’s Health Research Group, a consumer advocacy organization. “We need someone to tilt in the opposite direction and be more pro-public health and less pro-regulated industry.”

Some past critics, however, have softened their views of Califf. Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank, said that while she still considers Califf’s industry ties to be a shortcoming, “He has certain qualities that are very good for the position. He has experience at the FDA and a commitment to science. That’s very important.”

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FDA continues operating without a Senate-confirmed, permanent leader

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Kim Riley, Homeland Preparedness News: September 28, 2021

The U.S. Food and Drug Administration (FDA) remains without permanent leadership during the nation’s ongoing battle against the COVID-19 pandemic.

“It’s of top concern that President Biden still has not nominated someone to serve as permanent FDA commissioner,” a House Energy and Commerce Republican aide told Homeland Preparedness News. “Why hasn’t this been a priority after more than eight months into his presidency, especially to ensure public confidence in vaccine approvals?”

Pressure on the president to make an FDA nomination is mounting as the current Acting FDA Commissioner Janet Woodcock’s term ends on Nov. 15. People want to know: What’s the plan?

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The FDA plays a major role in the federal government’s preparedness and response to the pandemic, such as by expediting access to COVID-19 medical countermeasures for the detection, protection against, and treatment of COVID-19, according to agency staff.

The FDA also is supporting the stability and quality of medical product and food supply chains, and ensuring that its decisions are guided by science using an open and transparent process, agency staff say.

Acting FDA Commissioner Woodcock, who has served in the position since Biden took office in January, began her career with the agency in 1986. This year she has faced opposition from lawmakers on Capitol Hill who oppose her taking over as the permanent FDA chief.

U.S. Sen. Joe Manchin (D-WV), for instance — who holds a key swing vote in the evenly divided chamber — this summer voiced concerns to Biden about “the continued tenure of Dr. Janet Woodcock as interim commissioner.”

In a June 17 letter Manchin sent to the president, the lawmaker specifically took issue with the FDA’s approval for Aduhelm, a treatment for Alzheimer’s disease, despite its advisory panel voting nearly unanimously against its approval, with no panel member voting in favor of approval.

“The FDA’s, and in particular Dr. Woodcock’s decision to go against its advisory committee’s decision, yet again has resulted in at least three scientists resigning from the committee,” Manchin wrote. “This brings into question the current interim leadership of Dr. Woodcock, at a time when strong, trusted leadership at our health agencies is most important.”

The senator noted that having a permanent agency head in charge to answer questions from patients and doctors on this approval, and to assure the general public of the FDA’s commitment to public health, “is imperative, and Dr. Woodcock is not the right person to lead the FDA.”

Other experts pointed out similar issues under Woodcock’s leadership.

Diana Zuckerman, president of the National Center for Health Research, told Homeland Preparedness News in an email that a negotiation the FDA recently completed with industry regarding drug user fees “is entirely focused on pleasing industry with quicker approvals, and all but ignores whether the new drugs being approved are proven safe or effective.”

“What is critical is to have a permanent, Senate-confirmed FDA commissioner who understands that the American taxpayer is their customer, not the companies that make the products that the FDA regulates,” Zuckerman wrote. “Unfortunately, recent commissioners, including the current acting commissioner, have repeatedly referred to their goal of providing good customer service to industry.”

Zuckerman also said that while the FDA doesn’t have the authority to make decisions about vaccine or mask mandates, the agency does, for example, have the authority to ensure that the masks being sold to prevent COVID transmission are as effective as possible.  

“The FDA has failed to do that under the acting commissioner, and there really is no excuse for that,” said Zuckerman. 

And “while it has been obvious that the White House has made decisions that were supposed to be made by the FDA,” according to Zuckerman, she doesn’t think having a confirmed FDA commissioner will necessarily improve that situation.   

“It would be improved, however, by a commissioner who is dedicated to public health, knows FDA and the federal government well, and is not afraid to stand up for FDA’s public health mission,” she said.

Steven Grossman, executive director of the Alliance for a Stronger FDA, took a similar stance.

“As is the case now, FDA has been blessed with very strong interim leadership that has served the agency well,” Grossman wrote in an email to Homeland Preparedness News. “However, only a Senate-confirmed commissioner can make — and stand behind — long-term commitments on behalf of the agency.”

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