Category Archives: News Stories & Editorials

In Vague Announcement, FDA Says It Will Cut Ad Comm Conflicts

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Jessica Karins and Maaisha Osman, Inside Health Policy News, April 17, 2025

FDA will not allow experts who are employed by regulated industry to serve on advisory committees, the agency said in an announcement Thursday (April 17), but though the statement was framed as a change in policy, one expert said it was similar to FDA’s existing policy and so vague as to be “an announcement of nothing.” Another researcher, however, said the move come signal an attempt to add voices to advisory committees who are less qualified but ideologically aligned with the Trump administration.

In its Thursday statement, FDA said it was announcing “a policy directive that limits individuals employed at companies regulated by the U.S. Food and Drug Administration, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed.” The statement also said FDA will “prioritize and elevate the role of patients and caregivers, strengthening the voices of their communities.”

“Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans,” FDA Commissioner Marty Makary wrote. “In fact, the FDA has a history of being influenced unduly by corporate interests.”

The announcement said employees of regulated industry can still serve on advisory committees when required by statute, and that “exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official strictly complies with the applicable ethics requirements.”

To Diana Zuckerman, president of the National Center for Health Research — an organization that has been critical of FDA advisory committees–the new policy sounded much like the existing policy.

Zuckerman said she’d like to see less industry influence on advisory committees. “It would be great if this is a new day, but it’s just not clear,” she said.

FDA advisory panel members are typically not employees of regulated companies, with the exception of industry representatives, who do not vote. Most expert members are physicians and academics, and most panels include at least one patient, consumer or caregiver representative; these members typically do not vote.

[….]

Zuckerman said the impact of the policy will depend on multiple factors not made clear in the announcement, including whether FDA will also exclude from committees experts who have non-employment relationships with regulated companies. Those relationships, such as past consulting work, research funding or payments for licensed inventions, have been frequently criticized by Kennedy in the past.

At press time, HHS had not responded to Inside Health Policy’s questions on whether these relationships will be included.

Zuckerman also said the allowance for employees of regulated companies to serve on an advisory committee if deemed necessary makes the implications of the announcement more unclear.

Additionally, Zuckerman said, the announcement doesn’t mention other conflicts of interest FDA traditionally hasn’t recognized — such as cases in which a physician has prescribed a product in the past for which safety is now being reevaluated and is worried about being sued, or a physician whose livelihood depends in part on a medical product being examined, such as a plastic surgeon who frequently provides breast implants.

Patients can also have conflicts of interest, Zuckerman said, and the patients FDA typically hears from — whether as patient representatives, consumer representatives or speakers during public comment periods — tend not to be those who have been harmed by medical products.

Michael Abrams, a senior researcher at Public Citizen Health Research Group, said the shift from FDA is opaque but potentially dangerous.

“I think it may be a veiled pretext for RFK Jr. to dissolve existing advisory committees, regardless of membership conflicts, and replace them with individuals who are less scientifically accomplished and adept, but who share the new HHS Secretary’s . . . world view,” he told IHP.

[….]

Abrams also pointed to the practical implications of dismantling or overhauling the current committee system, especially amid recent FDA staffing and budget cuts.

[….]

— Jessica Karins (jkarins@iwpnews.com), Maaisha Osman (mosman@iwpnews.com

To read the entire article, click here.

Canadians could lose vital safety information amid deep cuts to the U.S. FDA, experts warn

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Annie Burns-Pieper, CTV News, April 13, 2025

Canadian health experts warn the fallout from thousands of job cuts at the U.S. Food and Drug Administration on April 1 could disrupt the flow of safety information on drugs, medical devices, and food to Canada.

For years, Canadian agencies responsible for monitoring food and pharmaceutical safety have worked closely with regulators around the world. The U.S. Food and Drug Administration’s (FDA) vast resources and global influence have played a role in informing decisions in Canada on issues such as safety warnings and recalls of dangerous foods and drugs from the market.

However, sweeping changes to the FDA since U.S. President Donald Trump took office could impact the benefits Canada derives from this historic collaboration, reducing the quality and availability of information about harmful drugs and food products—potentially allowing serious health risks to go undetected and products to remain on the market longer.

The U.S. Department of Health and Human Services (HHS), now headed by Robert F. Kennedy Jr., laid off 10,000 workers as part of Elon Musk’s Department of Government Efficiency task force. The department plans to cut 3,500 jobs directly from the FDA.

A ‘huge problem’

While a memo on the restructuring claimed that layoffs wouldn’t affect reviewers or inspectors of drugs, medical devices, or food, reporting in the U.S. revealed that these areas are being impacted. Reported job losses include lab scientists who tested food for contaminants including deadly bacteria, scientists at drug safety labs, and staff in the drug inspections and investigations office, among many others.

“I think this is a huge, huge problem,” said Matthew Herder, a professor of law and medicine at Dalhousie University who specializes in regulation of pharmaceuticals. He told CTVNews.ca in an interview that Canada has long benefited from the FDA’s size and reach.

[….]

Canada has historically benefited from U.S. post-market surveillance—the ongoing monitoring of drugs and medical devices after they’ve been approved—to detect safety issues that may not have surfaced during clinical trials. “They just have vastly more resources,” said Herder. “The chances of us picking up something before the U.S. are very slim.”

For example, in 2017, Health Canada issued a safety review and letter to health professionals for commonly used antibiotics, fluoroquinolones, following a review by the FDA, warning of a potential risk of “disabling side effects” from tendonitis or nerve damage.

In 2019, Health Canada recalled surgical mesh for transvaginal repair of pelvic organ prolapse following a U.S. recall. Canadian women had reported debilitating side effects, including urinary problems, mobility challenges, emotional distress, and discomfort during sex associated with this medical device.

Diana Zuckerman, the president of The National Center for Health Research in Washington, D.C, called the staff cuts at the FDA a disaster: “you can’t cut 20% of their staff and think it’s not going to have a tremendous impact.”

She said in an interview with CTVNews.ca that post-market surveillance is already under-resourced and worries it will be weakened further by the cuts.

Herder said less surveillance of approved drugs is particularly concerning given the trend in recent years of letting more drugs into the market with less evidence. “If we’re losing the oversight that the FDA offers globally or losing even the percentage of it, that is really terrifying.”

CTVNews.ca asked Health Canada, responsible for drug and medical device safety, about the concerns raised by experts that a diminished FDA could pose risks to Canadians, but the agency declined to comment.

Canadian outbreaks could ‘go totally unnoticed’

Canada has also long collaborated with American agencies for food safety. Keith Warriner is a food safety professor in the Department of Food Science at the University of Guelph. Despite the Buy Canadian movement, he believes imports from the U.S. will continue to be a significant source of food in Canada.

He said American agencies, including the FDA, Centers for Disease Control and Prevention, and the United States Department of Agriculture, have been particularly good at surveillance, and Canadians have benefited from information sharing.

“When an outbreak occurs, they’re pretty hot on it. In Canada, we could get outbreaks that go totally unnoticed,” Warriner told CTVNews.ca. Often recalls and alerts originate with American products and are adopted in Canada, meaning that a delayed response in the U.S. could also impact Canadian consumers.

His biggest concern about the changes to the FDA is that the U.S. might reduce food safety surveillance, and “if they cut back on that, then it’d be outbreaks running rampant.” He suspects the deep cuts will lead to fewer recalls due to a decrease in outbreak detection.

[….]

Dr. Joel Lexchin is concerned that, given the climate of U.S.-Canada relations, pharmaceutical information sharing could be reduced. The retired emergency room doctor and a former professor at York University who has been researching pharmaceutical policy in Canada for more than 40 years told CTVNews.ca, “if the FDA keeps data to itself, unsafe products may remain on the Canadian market for longer than they currently do.”

He would like to know how the historically collaborative relationship between the FDA and Health Canada is currently operating and how Health Canada plans to fill in any gaps left by potential changes in information sharing.

[….]

To read the entire article in CTV News, click here https://www.ctvnews.ca/health/article/amid-deep-cuts-to-the-us-fda-experts-warn-canadians-could-lose-vital-safety-information/

RFK Jr. brings FDA under tighter control with HHS workforce cuts

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Lizzy Lawrence, Sarah Todd, and Matthew Herper, STAT News, March 27, 2025

WASHINGTON — Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.

The Health and Human Services Department on Thursday announced a sweeping plan to cut 10,000 jobs and consolidate operations across its sub-agencies. FDA drug, medical device, or food reviewers and inspectors will not be among those fired, according to an HHS fact sheet. Instead, the cuts will target employees working on policy, human resources, information technology, procurement, and communications. The administration will start sending notices to employees on Friday, with the terminations coming into effect on May 27.

The sparing of FDA reviewers may put some industry leaders at ease, but other FDA experts are concerned that firing the thousands of employees supporting their work will make it more difficult for the agency to promote innovation and protect public health. The layoffs will shrink the FDA by almost 20%.

“Even though the intent is not to affect product reviews or or inspections, inevitably, by cutting back on services, there will be an impact,” said Wayne Pines, former associate commissioner for public affairs for the FDA.

The cuts align with Elon Musk and the U.S. DOGE Service’s mission to trim the workforce. But they also represent HHS Secretary Robert F. Kennedy Jr.’s goal to exert more control over the sub-agencies he oversees. Even high-level FDA officials appear not to have been briefed on the cuts, sources told STAT, indicating a tightening of command within HHS. The power shift is clear on the media side, as STAT’s media requests continue to be redirected from FDA to the HHS press tea

[….]

This is not the administration’s first attempt to shrink HHS. In February, Musk laid off thousands of probationary workers, including people working on food safety, AI regulation, and preventing the spread of infectious diseases. After pushback from the device industry, the administration rehired some FDA reviewers a week later. A federal judge has since paused all the probationary layoffs. The administration has also offered civil servants $25,000 to leave their posts, and instated a strict work-in-office work policy that has alienated some employees.

Several employees at FDA have told STAT that morale is extremely low, particularly given the agency’s leadership vacuum. The Senate on Tuesday confirmed Marty Makary as FDA commissioner, but he hasn’t yet been sworn into the role. Lawmakers pressed Makary at his confirmation hearing about the DOGE cuts at the FDA, urging him to personally assess personnel before any major culling of the agency.

“If confirmed as commissioner, you have my commitment that I will do an assessment of the staffing and personnel at the agency,” Makary said. It is unclear if he will get the chance.

[….]

Pines noted that efforts to consolidate HHS and FDA are not new; as the former head of communications, he’s witnessed several reorganizations. But he said the level of consolidation is unprecedented, and could significantly impact the way FDA operates.

“The concept of consolidation, every secretary has had their point of view about that,” Pines said. “But there’s never been a change like this at FDA anywhere near this scale.”

The cuts seem “too big, too fast. I agree with RFK Jr., who says this is going to be painful, and I’m not sure what the rewards are going to be,” said Diana Zuckerman, a former congressional investigator for FDA approval standards and president of the nonprofit think tank National Center for Health Research. “These kinds of changes usually are extremely disruptive and not productive for at least a few years.”

Zuckerman wondered whether the cuts will ultimately impede Kennedy’s ambitions to reshape U.S. regulation of food. Kennedy has said he wants to focus on food labeling and fixing the “generally recognized as safe,” or GRAS, loophole in FDA review of food ingredients, as well as improving the quality and supply of infant formula. 

“I think those are important,” Zuckerman said. “Who’s going to do that?” Even if the people working on those specific issues are not affected by the cuts, “usually you’d need more people working on those kinds of issues.” 

Around 46% of the FDA’s total budget comes from “user fees” paid by industry to speed up product reviews. The FDA can use this money to fund employees who review medical product applications, conduct research to speed up regulatory decisions, inspect facilities, and evaluate products’ safety after they hit the market. The HHS reduction in force will likely spare most of these employees.

But the cuts won’t make their lives any easier. One FDA employee told STAT they are starting to lose access to medical journals they rely on for regulatory research. Gutting administrative personnel and cutting down on agency resources may slow down reviewers and worsen morale.

“Eliminating those people, it’s just going to be more difficult from a personnel perspective,” said Brian Ravitch, a regulatory consultant at Olsson Frank Weeda who worked for the FDA for 25 years.

To read the entire article, click here https://www.wsj.com/politics/policy/rfk-jr-plans-10-000-job-cuts-in-major-restructuring-of-health-department-bdec28b0

Pfizer hires FDA drug regulator Cavazzoni, sparking revolving door debate

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David Lim, Politico, February 24, 2025

Pfizer has tapped the FDA’s former top drug regulator, Dr. Patrizia Cavazzoni, as its chief medical officer, the pharmaceutical company announced on Monday.

Allies of the new health secretary, Robert F. Kennedy Jr., seized on the news, pointing to Cavazzoni’s hire as proof of the revolving door with industry that Kennedy has long alleged is corrupting the FDA’s priorities and preventing it from taking a more skeptical view toward vaccines and other drugs.

“This is the core rot in American regulation,” Dr. Vinay Prasad, a professor at the University of California, San Francisco who is in the running for a job in Kennedy’s department, wrote in a blog post. “I find this behavior abhorrent, and it should be criminal. Mr. Kennedy has vowed to stop this, and I welcome that.”

The hire also drew criticism from public health advocacy groups that aren’t aligned with Kennedy.

“Cavazzoni’s move demonstrates that the revolving door between the FDA and the industries it regulates is alive and well,” said Dr. Robert Steinbrook, the director of Public Citizen’s Health Research Group.

Before joining the FDA in January 2018 as the deputy director of operations in the agency’s Center for Drug Evaluation and Research, Cavazzoni worked at Pfizer leading clinical sciences and development operations.

[…]

Cavazzoni will formally start the new role on March 1, according to Pfizer spokesperson Amy Rose. She will report to Dr. Chris Boshoff, Pfizer’s chief scientific officer and president of its research and development arm. Endpoints News and STAT first reported news of Cavazzoni’s new job.

Diana Zuckerman, the president of the National Center for Health Research, a nonprofit, said she’s watching to see who chooses Cavazzoni’s permanent replacement as the nation’s top drug regulator: Trump’s pick to lead the FDA, the as-yet-unconfirmed Johns Hopkins University surgeon Dr. Marty Makary, or Kennedy, a longtime critic of vaccination, or someone else in the administration.

“This is the problem with this revolving door at FDA, people go from industry to FDA and then while they are at FDA they still seem to be strongly aligned with industry and then when they leave FDA they go back to industry,” Zuckerman said. “It raises a lot of questions about how objective they are when they are supposed to be working for the public at the FDA.”

 

Read the article in Politico here: https://subscriber.politicopro.com/article/2025/02/pfizer-hires-fda-drug-regulator-cavazzoni-sparking-revolving-door-debate-00205735?site=pro&prod=alert&prodname=alertmail&linktype=article&source=email.

FDA webpages on clinical trial diversity removed after Trump orders

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Elise Reuter, MedTech Dive, Jan. 27, 2025

Two days into the Trump administration, several webpages covering diversity in clinical trials, annual medical device reports and LGBTQ+ information were removed from the Food and Drug Administration’s website. It’s not clear if the changes are temporary or if the pages will be restored.

When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and Human Services. The HHS did not respond to multiple requests for comment.

“It is definitely not typical,” said Diana Zuckerman, president of the National Center for Health Research. “From one administration to another, certain things are reviewed and taken down. I don’t think ever [in] the first week of the administration.” 

Other federal websites have scrubbed pages on diversity, equity and inclusion; mentions of the acronym LGBTQ+; federal policies on people with disabilities and abortion search results, according to reporting by Politico, NBC News, the Washington Post and NPR. The Trump administration has also frozen health research grants, according to STAT News.

Some of the removed FDA pages related to efforts around diversity, gender and health equity.

“Surely there’s someone who’s knowledgeable enough about science to understand the importance of diversity in clinical trials,” Zuckerman said of the Trump administration. 

A recent draft guidance from the FDA’s Center for Devices and Radiological Health providing recommendations for medical device sponsors to consider sex- and gender-specific data in clinical studies was removed. The guidance was released on Jan. 6, and the page was last archived to the Internet Archive’s Wayback Machine on Jan. 14. As of Monday, the guidance was available through the Federal Register’s website.

Last week, President Donald Trump issued a raft of executive orders targeting DEI programs. One order called for the removal of federal DEI mandates, policies, programs, preferences and activities “under whatever name they appear.” Trump also issued an order stating that official U.S. policy recognizes two sexes as assigned at birth, male or female. The order contradicts medical groups, including the American Medical Association, that recognize sex and gender identity as a spectrum.

Although guidances are not legally enforceable, “it is troubling that this is happening,” said Michael Abrams, a senior health researcher at consumer advocacy nonprofit Public Citizen.

Most of the information in the guidance was “common sense,” said Madris Kinard, CEO of Device Events, a company that tracks the FDA’s adverse event reports and recalls.  “This is research on making sure you include the right populations that are relevant to the device that you’re approving or clearing,” Kinard added.

Several of the CDRH’s annual reports were also pulled from the center’s site Wednesday afternoon. CDRH released and posted its 2024 report Jan. 17.

Meanwhile, Dorothy Fink, the HHS’ acting secretary, ordered a pause on Jan. 21 on communications from health agencies, according to the Associated Press.

“We count on the HHS especially to be transparent and a scientific voice so doctors and patients are informed about emerging and existing prevailing health trends,” Public Citizen’s Abrams said.

A page on increasing clinical trial participation for the LGBTQ+ community was removed as of Monday. It was last archived on Jan. 18

[….]

A page for the CDRH’s Health of Women Program was also removed as of Monday. It was last archived on Dec. 24, 2024. The program was started in 2016 to address sex- and gender-specific issues in medical technology design and performance.

Eileen Barrett, a hospitalist and president-elect of the American Medical Women’s Association, said having women and LGBTQ+ people represented in clinical trials “should be apolitical.”

“Nobody wants the patients to get worse care because we aren’t acknowledging the entire context in which they’re experiencing their health and also the way they experience healthcare delivery,” Barrett said.

Webpages were also down on the CDRH’s recent Home as a Health Care Hub initiative, including an announcement for the program and a listening session the agency held last year. The program was launched in April by Michelle Tarver, who was named CDRH director in October. The program is intended to provide resources for devices to be designed with a home environment in mind, starting with a focus on diabetes.

Another removed page referenced a virtual public meeting on real-world evidence slated for Jan. 30.

[….]

Zuckerman said the communications blackout makes a “bad impression,” raising questions about whether the public will be notified about important recalls or product approvals.

“I think there’s so much that needs to improve with transparency, and I see things going backwards,” Device Events’ Kinard added

To read the entire article in MedTech Dive, click here.

Trump’s pick for FDA to test ‘due diligence’ of Agency’s science

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Nyah Phengsitthy, Bloomberg Law, November 25, 2024

Marty Makary, an outspoken critic of the nation’s food and drug regulator, stands to shake up the FDA’s standards in science and decision-making under President-elect Donald Trump.

The Johns Hopkins surgeon selected Nov. 22 by Trump to lead the US Food and Drug Administration may have laid out his blueprint for a potential agency overhaul if confirmed as commissioner—and it starts with his criticisms over vaccine policy, food safety, and the pharmaceutical industry.

Makary has taken numerous shots at FDA decisions, including the agency’s approval of Covid-19 vaccines by Moderna Inc. and Pfizer Inc., its “cozy relationship” with drug manufacturers, and the approval of a drug to treat Alzheimer’s. He’s also offered judgment on the nation’s food supply, questioning the various chemicals in foods and infant formula.

While some of his opinions have drawn opposition, his critiques put to practice could reshape areas of the agency that have come under scrutiny, health policy experts say. His challenge on vaccine approvals, food safety, and the status quo ideas in the medical establishment signal a commissioner who won’t allow the agency to lower its standards and will tap more into science and decision-making.

“A lot of what he’s been talking about are things we need to be thinking about,” said Diana Zuckerman, president of the National Center for Health Research. “When you have somebody who’s outspoken on the side of public health, I think that’s something we should hear.”

[….]

“Dr. Makary seems like a person who could be persuadable by an evidence-based argument,” said Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.

“But the most consistent through-line between the HHS, CDC, and FDA nominees seems to be being vaccine-skeptical or worse.”

‘Sticking to the Science’

Though it’s unclear how Makary’s concerns will play out as chief, he could demand the agency carry out deeper examinations and assessments in its everyday decisions.

The FDA in recent years has come under fire for some scientific conclusions and the information used to back its regulatory decisions. This includes its authority over e-cigarettes, the abortion pill mifepristone, laboratory-developed tests, and major drug approvals.

“You want to have that person very much sticking to the science, so that we know that these new medicines, medical devices, whatever comes to the market, is truly safe and effective,” said Reshma Ramachandran, an assistant professor at Yale School of Medicine.

“He has a pretty profound background in research, so that gives me some comfort knowing he will hopefully continue to follow the science in making decisions.”

Makary also “recognizes the value of not letting approval standards dip dangerously low,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. She pointed to when he criticized the FDA for approving Alzheimer’s drug aducanumab despite safety concerns.

The author and professor has taken issue with the lack of transparency between the agency and pharmaceutical industry. He’s also a critic of the Orphan Drug Act, which allows manufactures to secure protections for rare disease drugs when they hit the market.

“He wants to make sure that the agency’s decisions are being made from a scientific perspective, and not being unduly influenced by the sponsors who are bringing forward the products,” Ramachandran said. “I’m hoping he’ll maintain that thinking to make sure the agency is doing its due diligence in its work.”

[….]

Food Safety

Makary’s agenda may test the FDA’s oversight on food safety—another area that has been scrutinized in recent years.

He has called the food supply “poisoned” with “highly addictive chemicals.” He’s also scrutinized the amount of seed oils in infant formula, and questioned why Froot Loops are sold with different food dyes in the US than in Canada.

His appointment would come as the FDA rolls out its Human Foods Program, which was created under the agency’s largest reorganization.

Notably, the program is in the midst of establishing a framework to assess chemicals in food already on the market—a move that was criticized for being conducted through an ad hoc basis and largely behind closed doors.

Makary could take “positive steps” in regulating and eliminating “harmful components that are still allowed in food, supplements, food containers and packaging,” according to Ana Santos Rutschman, professor at the Charles Widger School of Law at Villanova University.

“Among all the nominations so far in the public health space, this is the candidate with the strongest credentials,” Rutschman said. “And I think that there is, at least for now and in theory, room for some positive developments at the FDA.”

To read the entire article in Bloomberg Law, click here.

Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself

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Daniel Gilbert, The Washington Post, November 25, 2024

Vivek Ramaswamy, an outspoken ex-biotech executive turned fierce critic of the industry’s main regulator, is now in a position to reshape the agency he derides as the “Failed Drug Administration” in ways that could benefit him personally.

Newly tapped by President-elect Donald Trump to co-lead an initiative to slash the federal bureaucracy, Ramaswamy has heaped criticism on the Food and Drug Administration for “unnecessary barriers to innovation.” At the same time, the company he founded, Roivant Sciences, is pursuing studies for three drugs that, if positive, could land before the FDA during Trump’s second term. His stock in Roivant is worth about $670 million.

Ramaswamy argues that the FDA should err on the side of approving promising therapies faster and then monitoring their effects after doctors start prescribing them. The agency should place “greater emphasis on post-approval surveillance for safety issues to protect patients, rather than adding time and cost to innovative development,” he said in a statement. He highlighted the FDA’s standard requirement of two trials for approval and suggested a single trial — which would generally save biotech firms time and money — would be adequate.

Ramaswamy, with billionaire Trump adviser Elon Musk, is spearheading the “Department of Government Efficiency,” an outside-government project to streamline bureaucracy and carry out “mass head-count reductions,” the two wrote in a Wednesday op-ed. Ramaswamy left Roivant’s board in February 2023 when he launched his presidential campaign but is still one of its largest shareholders.

“It’s an obvious conflict of interest,” said Diana Zuckerman, president of the nonpartisan think tank National Center for Health Research, who points out that the FDA has already lowered its standards considerably to speed novel drugs to market. “Some people might think, ‘He’s a knowledgeable person.’ He’s a knowledgeable person with a vested financial interest in what he’s saying.”

In an interview, FDA Commissioner Robert Califf said he knows and respects Ramaswamy but pushed back on some of the entrepreneur’s harshest criticisms, such as once questioning the need for the agency. “We tried that,” he said, pointing as an example to the drug thalidomide that caused birth defects in babies in the 1960s, “which is why the FDA exists in its current form.”

“Almost every additional authority at FDA has been because of a catastrophic public health event that harms people,” he said.

Califf defended the two-trial standard, particularly for new drugs when there are already effective therapies available, while emphasizing that the FDA frequently accepts less evidence for potentially life-changing therapies. As for Ramaswamy’s financial stake in biotech, Califf said, “at FDA, you’re not allowed to make decisions about industries in which you have a vested interest.” He added, “I would just say, the amount of money he has invested and what’s at stake speaks for itself.”

[….]

Of all novel drugs approved in 2020, more than half relied on a single such trial, one study found.

On Saturday, Ramaswamy praised Trump’s choices to lead the FDA and other health agencies, saying he had met with them and “it’s clear they’re serious about reducing cost & they understand innovation is a key part of the solution.” Marty Makary, whom Trump tapped to lead the FDA late Friday, has emerged as a forceful critic of the agency’s culture, faulting it in a 2021 op-ed for a “counterproductive rigidity and a refusal to adapt.”

Ramaswamy made his name as a wunderkind biotech analyst on Wall Street while earning a law degree at Yale, before striking out on his own as an entrepreneur. He told Forbes for a 2015 cover story that Roivant would be the “Berkshire Hathaway of drug development.”

[….]

Ramaswamy pulled off what was at the time, in 2015, the largest public offering in biotech, raising $360 million with the listing of Axovant, a Roivant subsidiary developing an Alzheimer’s drug. Controversy followed as a clinical trial failed to show a benefit and the stock value collapsed.

Roivant has gone on to develop several drugs that won FDA approval, but it has made a bigger splash for its savvy dealmaking.

[….]

Roivant executives have told investors its pipeline of experimental drugs could someday be worth $10 billion a year in sales. Ramaswamy holds a roughly 7 percent stake in the company, in addition to stock options to purchase millions more shares.

Trial results for two drug candidates — one to treat an autoimmune condition that causes a skin rash and muscle weakness, another for an eye inflammation disease — are expected in the second half of 2025, executives have said. The trial for the autoimmune condition is designed to support FDA approval without a second one, the company has said.

Roivant declined to comment.

Ramaswamy criticized the FDA during his failed bid for the GOP presidential nomination, a campaign where he sought to distinguish himself with a provocative style on an array of subjects. He called the agency “corrupt” and its actions “hypocritical, harmful & unconstitutional” in July 2023.

After he endorsed Trump, he continued to slam the agency. “It’s not at all obvious that we’re better off for having an FDA at all,” he said in May, dedicating an episode of his podcast to the issue. He suggested that the private market could be a better judge of what patients should trust, similar to how customers rely on J.D. Power ratings to buy cars. “The FDA has actually crowded out the rise of those alternative intermediary institutions,” he said.

[….]

Several academic scholars interviewed for this story said they disagree with Ramaswamy’s contention that conducting two major clinical trials to replicate results is unnecessary.

Sanket Dhruva, a professor at the University of California at San Francisco School of Medicine, acknowledged that clinical trials are expensive and add to the cost of developing new medicines. Still, he said, “What about costs that are passed on to the health-care system using tests and treatments that are relatively unproven?” He argued that approving less-studied drugs can give patients false hope or cause them harm and add to higher insurance premiums.

[….]

Read the full article in The Washington Post here.

What Trump’s election win could mean for AI, climate and health

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Jeff Tollefson, Max Kozlov, Mariana Lenharo, and Traci Watson, Nature, Nov 8, 2024

From repealing climate policies to overturning guidance on the safe development of artificial intelligence (AI), Republican Donald Trump made plenty of promises during his presidential campaign that could affect scientists and science policy. But fulfilling all of his pledges won’t be easy.
Trump, now the US president-elect for a second time, will have some advantages as he re-enters the White House in January. The first time he took office, in 2017, his victory was a surprise, and many government watchers who spoke to Nature say he didn’t have a solid plan. By contrast, the Trump administration that enters office next year will be better prepared, and Trump himself is likely to face fewer checks on his power now that he has consolidated control over the Republican establishment, says Matt Dallek, a political historian at George Washington University in Washington DC who studies the evolution of the modern conservative movement.
But that doesn’t mean he will be able to do as he pleases, Dallek adds. “There’s a kind of revolutionary sweep to a lot of Trump’s promises that may collide with the messy reality of implementation.”
Here Nature talks to policy and other specialists about what might be in store on a range of science issues during a second Trump administration.
[….]
Health
In the weeks leading up to the US election, Trump teamed up with political figure Robert F. Kennedy Jr on a platform promising to “make America healthy again” by tackling the root causes of chronic diseases, removing toxic substances from the environment and combating corporate corruption. Trump has said that he will let Kennedy, who has questioned the effectiveness of vaccines, “go wild on” health, unnerving public-health and health-policy researchers.
It remains to be seen whether Trump will appoint Kennedy to a position such as director of US Health and Human Services (HHS) — or whether the US Senate would approve such a move — but it’s clear that Kennedy will have Trump’s ear on health issues.
Georges Benjamin, the executive director of the American Public Health Association in Washington DC, worries about Kennedy’s role in the new administration because he has long cast doubt on the vaccine-approval process, threatening to undermine confidence in the jabs and cause a resurgence in illnesses such as measles. “People will get sick and die because of the confusion around vaccines, if [Kennedy and Trump] implement some of the things they verbalize,” he says.
Some of Kennedy’s goals, such as cracking down on ties to industry at regulatory agencies such as the US Food and Drug Administration, are good, says Diana Zuckerman, president of the National Center for Health Research, a non-profit think tank in Washington DC. But those goals don’t jibe with what occurred during the first Trump administration, when Trump installed people in important health posts who had close industry ties, such as former HHS director Alex Azar, so it’s hard to know what will happen, she says.
Considering Trump’s isolationalist approach and his past comments criticizing the World Health Organization, support for global health is also likely to be “greatly scaled back” during Trump’s second term, says Ezekiel Emanuel, a bioethicist and long-time observer of the US biomedical funding landscape at the University of Pennsylvania in Philadelphia. The United States is “the key player” in the funding of global-health initiatives, says Emanuel. This includes, for instance, a programme that aims to end the global AIDS epidemic. So it’s “hard to be optimistic” about the future, he adds.
Foreign science partnerships
During Trump’s first term, his administration barred people from half a dozen countries that it said were “compromised by terrorism” from entering the United States and implemented an anti-espionage programme called the China Initiative that led to the arrests of a number of scientists of Chinese heritage. Although the Biden administration overturned the travel ban and ended the China Initiative, federal officials have continued efforts to guard against foreign interference in US research.

Specialists says it’s unclear whether the second Trump administration will revive the China Initiative, although the Republican-led US House of Representatives advanced legislation in September that would do so. But a reinstatement of the travel ban is likely, says Adam Cohen, a lawyer at Siskind Susser in Memphis, Tennessee, who focuses on academic immigration and who says the president has broad authority to institute such policies.
Like the first Trump administration, the new one will probably clamp down on granting visas to foreign researchers and students from some countries, says Jennifer Steele, an education-policy researcher at American University in Washington DC. Policies that make it harder for international and US researchers to meet would also make it harder for new scientific collaborations to arise, says Caroline Wagner, a specialist in science, technology and international affairs at the Ohio State University in Columbus. That’s because such partnerships are fuelled by face-to-face contact. “Collaborations don’t begin with people just e-mailing each other across the miles,” she says.
But there might be one bright spot on the collaboration front, at least for US–China partnerships. Denis Simon, a non-resident fellow at the Quincy Institute for Responsible Statecraft, a foreign-policy think tank in Washington DC, thinks that a crucial pact governing US–China scientific cooperation that has been expired for the past year is likely to be signed by the Biden administration before Trump’s second inauguration in January. Although a renewed agreement would probably be more limited in scope owing to increased US–China tensions, its existence would show that “both governments give their blessing” to collaborations, Simon says.
Read the full article in Nature here.

Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.

In the News, News Stories & Editorials, We're In the News

Elise Reuter, MedTech Dive, Oct 31, 2024

Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges ahead.

Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices, racial bias in pulse oximeters, concerns about the recall process after Philips pulled millions of respiratory machines, and scrutiny of its former leader’s potential conflicts of interest.

Patient advocates, who have called for stronger device standards and faster, more transparent recalls, see an opportunity for change with a new director. Meanwhile, medtech companies hope to build on predecessor Jeff Shuren’s legacy of making the U.S. the go-to market for new medical devices.

“She is in a position to show a commitment to public health and safety, and possibly build that trust and confidence in the public for medical devices,” said Maria Gmitro, founder and president of the Breast Implant Safety Alliance, a nonprofit advocacy group.

Tarver’s leadership

Tarver was named permanent director last week after spending more than 15 years with CDRH. Some of her accomplishments include helping build the first patient engagement advisory committee at the FDA, developing patient-reported outcome measures, and conducting trials and surveys to capture patient preferences.

Both patient groups and device companies commended Tarver’s experience and focus on patients, describing her as thoughtful and approachable.

“She let it be known that she cared very much about patients understanding the risks and benefits of medical products, and including patients and consumer advocates in the process,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.

Madris Kinard, CEO of Device Events, a company that makes software to track adverse event reports and recalls, said Tarver has been receptive to suggestions in public meetings. For example, Tarver recently helped make certain demographic data available in the FDA’s adverse events database, which can be helpful in learning about off-label use in pediatrics.

Andrew Fish, CEO of the Medical Device Innovation Consortium, a public-private group founded in 2012, said Tarver is a respected leader in the agency and has been involved in efforts around patient input, patient engagement and clinical trial diversity.

[….]

House Democrats have called for an investigation into Shuren’s tenure after a New York Times report found Shuren’s wife, Allison Shuren, worked as legal counsel for medtech companies while he led CDRH. The FDA told MedTech Dive in August it found no evidence that Shuren violated the criminal conflict of interest statute or that regulatory decisions were affected by Allison Shuren’s employment.

One of the concerns raised in the report was that Allison Shuren’s firm worked on an acquisition of Allergan as the FDA asked the pharmaceutical company to recall certain models of breast implants for the risk of developing a type of lymphoma.

“It’s concerning reading about the timeline of the Allergan breast implant recall and Dr. Shuren’s wife being a part of the law group that was involved in the sale of Allergan to Abbvie,” Gmitro said. “It doesn’t build a lot of trust.”

The Department of Health and Human Services’ Office of Inspector General said it does not have an update to share publicly on whether an inquiry will be opened into Shuren’s tenure.

Michael Abrams, senior health researcher at Public Citizen, said an investigation is warranted to “advise and alert” Tarver to existing and future conflicts.

Future priorities

Tarver outlined some of CDRH’s priorities during a keynote at Advamed’s The Medtech Conference in mid-October. She spoke about the importance of listening to patients, based on her experience as an ophthalmologist.

“It ties directly into the vision of our center,” said Tarver, who still works with patients. “We put people in the U.S. first, and we want them to have access to high quality, safe and effective medical devices of public health importance first in the world.”

She called out three strategic priorities for the center: promoting a modern and diverse workforce, making the organization more agile and resilient to be prepared for future challenges, and advancing health equity.

Tarver will also lead CDRH through the next round of user fee discussions in 2027. The fees made up more than a third of the agency’s budget in 2022, according to HHS.

[….]

Patient groups, on the other hand, see the user fee process as giving industry too much of a voice in the FDA’s activities. Abrams would like the FDA to get more funding from Congress and less from industry.

Advocates have also called for more input into the negotiations between the FDA and industry leading up to the agreement. Those discussions are not open to the public and have been criticized for a lack of transparency. The FDA is required to hold meetings with patient groups and outside experts during user fee negotiations, but the discussions are separate from talks with industry.

“None of the rest of us are allowed in. … No patient groups, no consumer groups, no academic researchers, nobody else,” Zuckerman said. “It’s all behind closed doors, and we’re all shut out of the process.”

[….]

Focus on device safety

Patient advocates also called for stronger premarket review of devices. The majority currently go through the FDA’s 510(k) pathway, a less rigorous process where devices need to demonstrate they’re substantially equivalent to predicate devices, or products already on the market. The FDA has proposed changes in draft guidance, such as recommending devices not be based on a predicate that was recalled for design reasons.

Those changes are not enough, Zuckerman said. Higher-risk devices that go through more scrutiny under the FDA’s premarket review process often still submit data from single-arm trials without a control group, Zuckerman said.

Zuckerman added that it doesn’t make sense for the highest-risk medical devices to have lower evidence standards than low-risk prescription drugs. 

“Something for tummy aches shouldn’t be going through a more rigorous process than a cardiac implant,” Zuckerman said. 

Patient groups also called for stronger oversight after devices are on the market, as well as faster, more transparent recalls. They also called for broader adoption of unique device identifiers to ensure recalls are efficient and for less reliance on voluntary recalls.

“It’s great if we’re getting innovative devices to market faster. I understand people wanting to try new devices, especially if there are no other alternatives,” said Device Events’ Kinard. “But the FDA needs to be just as quick to act and recall a device when they find a problem.”

Read the full article on MedTech Dive here.

F.D.A. names a new chief of medical devices

In the News, News Stories & Editorials, Uncategorized, We're In the News

Christina Jewett, The New York Times, Oct. 22, 2024

The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.

Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.

She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.

In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.

The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.

A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.

“Dr. Tarver demonstrates a true passion about data, science, medicine and the evidence, all of which are critical to supporting and driving the F.D.A.’s decisions,” Dr. Robert Califf said in an announcement to agency staff Tuesday. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

Dr. Tarver said in a statement that she was honored to lead the division and planned to “remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices.”

Dr. Shuren headed the division for 15 years and has been credited with speeding the pace of approvals and solidifying the United States as a destination for medical device study and innovation. He has also been divisive, facing pressure from the start of his tenure to strengthen lax device-approval standards. Those calls have continued unabated over the years. The American Medical Association, a major doctors group, voted in 2023 on a resolution urging the agency to raise the bar on product authorizations and to more carefully monitor the safety of approved products.

 

Dr. Shuren announced his retirement in July, and the agency has said he will leave by the end of the year.

An investigation by The New York Times found that his official work had overlapped for years with that of his wife, Allison Shuren, a lawyer for major medical device companies. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have sought authorization or stepped aside in some matters, but asserted that the lapses had not affected regulatory decisions.

In recent weeks, two lawmakers called on the inspector general of the Health and Human Services Department to investigate whether those matters were “simply an appearance of impropriety or actual inappropriate and unethical conduct.”

Before joining the agency in 2009, Dr. Tarver had been an assistant professor at the Johns Hopkins School of Medicine.

At the F.D.A., she became a medical officer in the ophthalmology unit, and then took on other roles, including working with the division’s patient engagement advisory committee.

Dr. Tarver later moved on to an F.D.A. office focused on emergency preparedness and response as well as digital health.

Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.

Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.

“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”

Diana Zuckerman, president of the National Center for Health Research, a nonprofit that tracks F.D.A. device policy, said she had found Dr. Tarver to be concerned about patient safety and “in making sure that patients understand the risks and benefits” of devices.

Scott Whitaker, president of AdvaMed, the largest device industry trade association, said the group was pleased with Dr. Tarver’s appointment.

[….]

Dr. Tarver will face skepticism from advocates for people who have had unwanted symptoms after LASIK surgery, such as distorted vision and eye pain.

Dr. Tarver was a leader in the agency’s ophthalmology division for years and played a role in F.D.A.-backed research on the procedure. Yet after more than 15 years of advocacy and an agency proposal in 2022 to strengthen warnings to prospective patients, no change has come about, said Paula Cofer, who suffered harm from LASIK and served as a patient representative on a 2008 panel on the matter.

The F.D.A. has said it is still reviewing comments submitted on the 2022 proposal. Among its opponents are clients of Dr. Shuren’s wife, which include a group of prolific laser surgeons and a company that makes LASIK lasers.

“She’s been involved in LASIK device policy at the agency for what, 15 years, and during this time, the agency has failed to act on evidence of high rates of harm to the public due to LASIK devices,” Ms. Cofer said. “This is just not passing the smell test.”

To read the entire New York Times article, click here.