Category Archives: News Stories & Editorials

FDA webpages on clinical trial diversity removed after Trump orders

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 inclusionmentions 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. 

recent draft guidance from the FDA’s Center for Devices and Radiological Health providing recommendations for medical device sponsors to consider sex- and gender-specific data in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

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

Daniel Gilbert, The Washington PostNovember 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

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.

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 devicesracial 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

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.

High Levels of Toxic Flame Retardants Found in Toys, Kitchen Utensils Made From Black Plastic

Researchers found flame retardants, linked to carcinogenicity, endocrine disruption, neurotoxicity, and reproductive harm, in toys, take-out containers and kitchen utensils made from black-colored plastic.

Michael Nevradakis Ph.D., The Defender, October 2, 2024

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.


Some common household products made from black-colored plastic — including toys, take-out food containers and kitchen utensils — contain high levels of toxic flame retardants, according to a study published Tuesday in the journal Chemosphere.

The contamination stems from the improper recycling of electronic products like televisions, whose casings are made from black plastic. When plastic casings containing flame retardants are mixed with other plastics during recycling, the contaminants make their way into the end product.

Toxic-Free Future and the Amsterdam Institute for Life and Environment conducted the study.

Megan Liu, science and policy manager for Toxic-Free Future, told The Defender:

“These flame retardants are hazardous because they are associated with a range of negative health effects, including carcinogenicity, endocrine disruption, neurotoxicity, and reproductive harm.

“The findings of flame retardants in children’s toys are of particular concern, because flame retardants have been found to leach from toys into children’s saliva.”

The researchers examined 203 products manufactured from black-colored plastics. They screened the products for bromine, a man-made chemical used in flame retardants.

Products containing 50 parts per million of bromine were further analyzed for the presence of brominated flame retardants, organophosphate flame retardants and plastic polymers.

The results showed that toxic flame retardants were present in 85% of the products analyzed, with concentrations reaching 22,800 milligrams per kilogram The contaminants detected included decabromodiphenyl ether, or decaBDE, a compound commonly used in the casings of electronics before the U.S. Environmental Protection Agency (EPA) banned it in 2021.

 

One compound, decabromodiphenyl ether, or BDE-209, was commonly found in black-colored plastic kitchen utensils at an average level of 34,700 nanograms per day, “exceeding estimates for intake from dust and diet.”

A 2014 study published in the journal Frontiers in Genetics found that BDE-209 has highly carcinogenic effects on humans.

Other contaminants detected include compound 2,4,6-tribromophenol, which has been detected in human breast milk, according to a 2023 study published in the journal Environmental Pollution.

According to a study published by JAMA Network Open in April, people with high concentrations of polybrominated diphenyl ethers or PBDE, a common flame retardant, are approximately 300% more likely to die from cancer compared to people with the lowest levels. DecaBDE belongs to this category of flame retardants.

Dr. Leonardo Trasande, a professor of pediatrics and population health at NYU Langone Health, told CNN that brominated flame retardants are of particular concern due to high levels of toxic contaminants that can remain in the human body for years.

“I’m not aware of any safe level of brominated flame retardants,” Trasande said. Earlier this year, Trasande co-authored a study, published in the Journal of the Endocrine Society, finding that such contaminants cost the U.S. healthcare system up to $249 billion in 2018 alone.

‘Mistakes in the recycling of electronic waste’ are behind widespread contamination

According to the Toxic-Free Future study, the presence of toxic flame retardants in a wide range of household and commercial products “indicates that recycling, without the necessary transparency and restrictions to ensure safety, is resulting in unexpected exposure to toxic flame retardants in household items.”

“Flame retardants are a highly hazardous class of chemicals, but they are still allowed for use in products like electronics, and as a result of dirty electronic-waste recycling, we’re seeing flame retardants appear in unexpected products, like our kitchen utensils, food service ware, and hair accessories,” Liu said.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, told The Defender that the findings of this study are “worrying” and reflect the need for better regulation of plastic recycling and toxins in plastics.

Zuckerman said:

“It’s become increasingly obvious that the public has been misled about the effectiveness and safety of recycling plastics and it is no longer possible to trust the information that we’ve been given, most of which comes from industry.

“For that reason, the FDA [U.S. Food and Drug Administration] and EPA need to scrutinize the safety of all plastic products used with foods, instead of the vague reassurances the agencies have been offering.”

According to Liu, the study focused on black-colored plastic “because we hypothesized that the black plastic used for television casings and electronic enclosures, which flame retardants are intentionally added to, were being recycled into non-electronic, household products.”

 

The study noted that the styrene-based plastics typically used in the casings of electronics contained “significantly higher levels” of toxic flame retardants, compared to plastics like polypropylene and nylon, which are less frequently used for such casings.

“It appears the plastics used to make the consumer products were contaminated with flame retardants due to mistakes in the recycling of electronic waste,” Liu told CNN.

The study focused on items such as kitchen utensils and toys “because of high-risk exposure concerns” and frequent use by children, Liu said:

“Kitchen utensils are things we use on a regular, maybe even daily basis, and studies have shown that flame retardants can leach out of kitchen utensils into our food.

“Children also play with toys for extended periods of time, so it’s important to think about the compounded exposures we might be getting from these products, as well as other products that may contain flame retardants, when thinking about how this is affecting people, especially vulnerable populations like children.”

Liu separately told CNN that studies specifically testing food contact materials, such as black plastic kitchen utensils or take-out containers, hadn’t previously been conducted.

According to the study, lax regulation in the U.S. has helped contribute to the widespread contamination:

“A lack of transparency related to chemicals in products and limited restrictions on use of FRs [flame retardants] in electronics have led to widespread use and dissemination of harmful FRs.

“Despite the lack of transparency and restrictions, plastics from electronics are often recycled and can be incorporated in household items that do not require flame retardancy, resulting in potentially high and unnecessary exposure.”

For instance, Liu told CNN that decaBDE was found in 70% of the samples tested in the study, at levels up to 1,200 times higher than the European Union’s limit of 10 parts per million. The contamination persists despite the EPA’s ban on decaBDE in 2021.

According to CNN, decaBDE is linked to “cancer, endocrine and thyroid issues, fetal and child development and neurobehavioral function and reproductive and immune system toxicity.”

High levels of toxic flame retardants found in toys, sushi trays

Aside from their use in casings for electronics, flame retardants are also commonly used in furniture, car upholstery, infant car seats, carpet padding, foam-padded yoga mats and padded baby items, according to the National Institute of Environmental Health Sciences.

These flame retardants can “leach from products into the air and then attach to dust, food, and water, which can be ingested,” the institute noted.

But according to the study, toxic flame retardants can be found in many more items commonly found in homes — including children’s toys.

Liu told CNN, “A product with one of the highest levels of flame retardants were black plastic pirate coin beads that kids wear.” This product had up to 22,800 parts per million of total flame retardants, which Liu said was “almost 3% by weight.”

Another product identified as highly contaminated were black plastic sushi trays. Liu told CNN such items contain 11,900 parts per million of decaBDE.

 

Calls for stronger regulations against toxic contaminants in plastics

Liu told The Defender the latest findings demonstrate the need for stronger regulations on hazardous chemicals and materials entering the recycling stream. She said she is unaware of any such regulations in the U.S.

“What we need is our state and federal government, along with retailers, to ban these harmful chemicals and materials,” Liu said. “We need policy and market change to increase the transparency of what’s being used in the supply chain, including for recycled materials, as well as require the use of safer solutions.”

“Taking these steps and turning off the tap on toxic chemicals and plastics will help protect the health of women and children,” Liu said.

She noted that the study’s results were published “at a critical time when leaders around the world are negotiating a Global Plastics Treaty.”

The proposed treaty has a stated goal of ending “plastic pollution by 2040 through a circular economy where all plastics are responsibly managed during production, use, and end-of-life, enabling a climate-neutral plastics industry.”

The ongoing negotiations for this treaty come two years after the United Nations Environment Assembly passed a resolution, endorsed by 175 nation states, to end plastic pollution. The resolution calls for the completion of a legally binding international treaty by the end of 2024.

Such a treaty “will chart a course for how quickly and effectively the plastics crisis is addressed,” Liu said.

In the meantime, Liu suggested people “reduce any uses of plastics,” including replacing plastic kitchen utensils “with safer options, like wood or stainless steel.” Plastic containers should be replaced with glass containers.

“When possible, choosing plastic-free when purchasing any item can help reduce your overall exposure to harmful additives in plastic,” Liu said.

Regular cleaning and ventilating will also help “clear out any flame retardants accumulating in dust or air,” as will “frequent handwashing, regular wet-dusting and mopping, and vacuuming,” Liu added.

Zuckerman advised the public not to “microwave food in any kind of plastic,” adding that “we’ve been advising that for well more than a decade.”

“But the onus shouldn’t fall onto consumers,” Liu said. “We can’t shop our way out of this problem. We need policies that restrict the use of the most hazardous chemicals and plastics at the corporate and government level.”

Zuckerman said it’s “unrealistic to offer advice to individual consumers because the information we need is not currently available.”

“What we all need is independent research, scrutiny and oversight to take unsafe products off the market.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. 

FDA to launch ‘active’ monitoring system to improve medical device safety

Mary Chris Jaklevic, Association of Healthcare Journalists, September 18, 2024


A congressional watchdog agency has reported that the FDA is launching a surveillance system to actively look for safety problems with medical devices — 12 years after it was mandated to do so.

The new system aims to detect potential safety issues nearly in real time by monitoring data like electronic health records and billing claims. That data is sometimes called real-world evidence (RWE).

Until now, the FDA has relied largely on spotty reports from manufacturers, hospitals, nursing homes and patients, which has resulted in underreporting and delays in identifying harmful products.

Often, physicians and patients aren’t warned in time. Surgical meshCPAP machines, and metal joint implants are just a few of the problematic devices that have been highlighted in news reports about their widespread harms.

Yet some experts are skeptical that the advent of active monitoring will do much to improve medical device safety. Journalists should continue to be watchdogs for medical device safety. Here are some factors.

Active surveillance will have a slow start.

In a report issued in July, the U.S. General Accounting Office said the FDA plans to begin actively monitoring two types of devices for safety issues this year: the duodenoscope, a lighted tube used for viewing the small intestine; and robotically assisted surgical devices used in gallbladder removal. The GAO said the FDA plans to expand to 18 or more devices by 2028.

That’s a tiny fraction of the more than 6,000 types of medical devices that the FDA regulates. Madris Kinard, MBA, chief executive officer of Device Events, a software service for tracking medical device adverse events, noted in an email that the FDA is “far behind” in implementing what the agency has heralded as a “collaborative national evaluation system for health technology.”

Tracking RWE for two products by the end of this year “doesn’t begin to scratch the surface” of objectives established by the National Evaluation System for health Technology, an organization that has been working with the FDA to establish the active surveillance system, she added.

Key narrative details could be missed.

The new system uses resources that could be directed to enforce requirements that hospitals and device makers promptly submit reports to the FDA’s MAUDE database, Kinard said.

“MAUDE is more proactive than is understood because often a malfunction appears that, if it were to happen again, could cause serious injury or death,” she said, adding that MAUDE “also contains a narrative that is publicly available and provides context for the event,” which active surveillance may not provide.

Implementation challenges remain.

According to the GAO report, the FDA has encountered “key challenges” of inadequate funding and limited use of unique device identifiers in electronic health records and billing claims, impeding the identification of patients who have a particular device. The GAO outlined steps that the FDA is taking to address those challenges.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, a public health watchdog group, said in an interview that Congress and the FDA could do more to resolve those issues. For example, she said, the FDA could require a percentage of device makers’ user fees to support safety monitoring despite industry objections.

More surveillance doesn’t address lax standards for new devices.

Surveillance does not address a basic issue: few, if any medical devices enter the marketplace with rigorous testing to show that they are safe or effective.

That’s in part because the FDA “clears” most devices via the Premarket Notification pathway known as 510(k),  which requires manufacturers only to show that a device is “substantially equivalent” to another product that is already on the market. The FDA often defines that broadly to include substantial differences in materials, shape, size or mechanism of action.

In 2016, Congress reduced standards of evidence for device approval via the 21st Century Cures Act.  Zuckerman said she expects some lawmakers to push for legislation that will further lower the bar this fall. For journalists, she said, “This would be the time to bring some attention to what Congress is doing and what they’ve done in the past.”

What questions should journalists be asking?

Investigative journalist Jeanne Lenzer, who wrote the book, “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It,“ said via email that journalists should ask questions about the new active surveillance system.

Lenzer offered the following:

  • The FDA has partnered with 18 hospitals and a pharmacy chain to share data for postmarket surveillance. What proportion of all hospitals and pharmacies does this represent, and might there be problems identifying safety risks due to inadequate numbers of patients?
  • How will reporting be complicated by the fact that patients frequently change providers and insurers or fail to seek care if they become uninsured?
  • Will this new system help patients who have been implanted with devices that do not have a unique identifier?
  • Why, after more than two decades of recognizing the problem, isn’t there a plan to have mandatory tracking of unique device identifiers for all higher and high-risk devices?
  • Does Congress need to grant the FDA the power to require manufacturers to maintain mandatory registries for all higher-risk devices and more funding to carry out postmarket surveillance?

 

Read the full Association of Healthcare Journalists Article here.

The untold trauma of thousands of women suffering from ‘Breast Implant Illness’, leaving them in agony for years… yet some doctors refuse to accept it is real

Isabelle Stanley, The Daily Mail, September 9, 2024


When mother-of-three Holly took the drastic step of having both her breasts removed, she did so believing it might save her life.

Breast cancer had claimed her mother when Holly was just 14 and her own chances of developing the disease now stood close to 90 percent.

Yet within months of the surgery and the breast reconstruction that followed, Holly felt like she was closer to death than ever before – struggling with a range of debilitating conditions including chronic pain, blurred vision and difficulty breathing.

‘I kept getting sicker and sicker,’ she told DailyMail.com. ‘I felt like I was going to die.’

It wasn’t until Holly, 57, stumbled across a Facebook support group with 50,000 women whose symptoms matched her own that she believed she had finally discovered the cause of her illness: Breast Implant Illness, or BII.

There is little support for sufferers, with some medical professionals preferring to dismiss BII entirely, but an increasing number of women – from working moms to celebrities – are speaking out about their experiences.

Crystal Hefner, wife of late Playboy founder, Hugh Hefner, had her breast implants removed in 2016 at the age of 38 telling Facebook followers that ‘my breast implants slowly poisoned me’.

Another former Playboy model and alleged former mistress of Donald Trump, Karen McDougal, had hers taken out the same year.

‘I would get sick every couple of months and be sick for six to eight weeks at a time,’ McDougal told People magazine at the time. ‘It just never went away.’

Still, despite these stories and BII cases being reported around the world for more than 30 years, the condition is neither widely researched nor well understood.

It is thought by medical professionals to be caused by either auto-immune or inflammatory responses to implants which, in turn, trigger a series of mental and physical conditions such as anxiety, rashes and chronic pain.

And the skyrocketing number of cases of women having their breast implants removed is difficult to ignore.

‘Removals have been going up for the last five years,’ confirms Dr Scot Glasberg, president of research group The Plastic Surgery Foundation.

Some 250,000 American women receive implants each year, and as many as 74,000 had their implants removed in 2023, a 40 percent increase from 2019, according to the latest data from The Aesthetic Society, a global organization of plastic surgeons.

Dr Glasberg says there is a ‘host of reasons’ behind the rise. ‘[Yet] the biggest is that women are worried about breast implant-related tumors and concerned over breast implant illness.’

BII has been reported by women regardless of whether their breast implants remain intact or rupture and leak. And the physical toll can be crippling.

It certainly was for Holly, who found herself so sick she couldn’t work while racking up $100,000 in medical bills.

She saw dozens of specialists in the ten years that followed the onset of her BII, yet none of them could figure out what was wrong.

[….]

Many plastic surgeons question whether the condition is truly real – ‘Unfortunately, it hasn’t reached the status of a defined illness [widely recognized by the medical community],’ Dr Glasberg said.

[….]

This lack of concrete medical advice has left thousands of American women with nowhere to go, resorting to online forums and support groups for guidance.

One such group, Breast Implant Illness and Healing by Nicole, has more than 190,000 members, receiving over 70 posts a day from women sharing symptoms and asking for advice.

Abbey Williamson, 28, from Columbus, Ohio, first discovered the group after multiple specialists told her she was ‘crazy’ for linking her debilitating symptoms to BII.

The police officer and mother-of-one had silicone implants put in in 2020 after feeding her daughter changed the shape of her breasts and left her self-conscious.

Abbey soon became sick, collapsing at work and on patrol and even having to be hospitalized.

[….]

‘I had doctors roll their eyes at me when I mentioned BII,’ Abbey told DailyMail.com. As her symptoms got worse, her friend who is a nurse recommended she join the Facebook group.

‘I scrolled for hours and just read women’s posts about the same thing. Honestly, that page quite literally saved my life, and changed my life, because I don’t know if I would ever have made the decision to explant had I not had that community.’

Abbey had her implants removed in 2023 and claims that her symptoms disappeared almost immediately.

‘I remember coming out of surgery and it was like I could see again,’ she said, ‘the rashes went away, I had no more joint pain, I could work out again.

‘I have not passed out or had a single episode like that since they were removed.’

The disbelieving attitude of health care professionals is a common theme among the women who spoke to DailyMail.com.

Women tell me they go to their doctors and say I don’t know what’s wrong with me,’ says Diana Zuckerman PhD, founder of the National Center for Health Research, ‘and doctors say, well you’re getting older, you’re 30.

‘Or they say ‘you’ve got children, you’re not getting enough sleep’.

‘It’s a combination of women not being listened to and doctors not knowing what to do, especially plastic surgeons being defensive and not helpful.’

Breast implants are a billion-dollar industry, bringing in an estimated $1.54 billion in revenue in 2021 alone, according to The Aesthetic Society.

There’s enormous money and pressure against doing better research,’ says Zuckerman, ‘there is so much money on the other side of this issue.’

Now, as more independent tests are done, the results are rather different, she says. And the picture they paint is increasingly damning.

One 2020 study, published in the Annals of Plastic Surgery by plastic surgeon Dr Lu-Jean Fang of 750 women with BII, found removing the implants caused a statistical improvement in every one of their symptoms.

Fang said the results showed the condition is real and that women’s symptoms are very likely caused by their implants.

This is real,’ agrees Zuckerman, ‘and it can be very serious, but we still don’t know how often it happens.

The Food and Drug Administration now lists the condition as a potential side effect of breast implants – a major step forward, according to BII believers.

‘Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants,’ states the FDA’s official website.

And around five years ago, the FDA required doctors provide patients with a checklist of potential complications, although Zuckerman says this doesn’t always happen and might be counteracted by the surgeons assuring their clients they are still safe.

‘As is true with all informed consent forms, patients often don’t read them carefully and what they remember is what the doctor told them,’ she says.

Holly and Abbey claim that they were never explicitly warned about the risks by their doctors.

‘Maybe it was in the terms and conditions small print, but they never told me,’ insists Holly, who says she’d been assured that her silicone implants were ‘lifetime devices’ that would leave her feeling healthy and looking the same.

[….]

In 2022 – 12 years after the operation – and with her condition finally confirmed by a plastic surgeon, 57-year-old Holly joined the soaring number of American women having silicone implants removed from their bodies.

[….]

‘With the implants I had 30 symptoms,’ Holly tells the Mail through her tears. ‘Afterwards, I could breathe again. I could finally take a deep breath.’

Read the whole article here.

He Regulated Medical Devices. His Wife Represented Their Makers.

Christina Jewett, The New York Times, August 20, 2024


When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.

Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.

In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.

Her partner at the helm of the firm’s life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California. While Dr. Shuren said he was recused from the matter, court records suggested he remained involved.

In another case, Ms. Shuren’s firm was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.

The couple’s work overlapped again in 2022 when Dr. Shuren announced a proposal to strengthen warnings given to patients preparing for LASIK vision correction surgery. Two of Ms. Shuren’s clients opposed the plan; the recommendations have yet to be put in place.

In response to inquiries over several weeks about these cases, the F.D.A. initially said it had no indication that Dr. Shuren had violated ethics rules and needed time to “substantively evaluate” follow-up questions from The Times. In a statement Friday, Shannon P. Hatch, an F.D.A. spokeswoman, said the agency had found that “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.”

Ms. Hatch confirmed that the lapses occurred in the Theranos case as well as another one identified by The Times involving Alcon, an eye care drug and device company that was a client of Ms. Shuren’s.

In 2014, Alcon went before an agency committee convened to advise on whether to approve a lens implanted in the eye. According to a meeting transcript, Dr. Shuren signed off on the appointment of eight new voting members and a new chairman for the hearing, which recommended approval.

Ms. Hatch said the agency “has no indication that any F.D.A. regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the F.D.A.”

While the agency conducts a nationwide search for Dr. Shuren’s replacement, he will work in the commissioner’s office to help ensure a smooth transition, according to the July statement by Dr. Califf announcing his retirement.

The F.D.A. said Friday, “Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance.”

Neither Dr. Shuren nor Ms. Shuren responded to requests for interviews.

When The Times initially requested Dr. Shuren’s ethics records from the division he led, an official in the information disclosure unit wrote that the request was “complex” and would take up to two years to fill. Four months later, the F.D.A. provided an agreement that turned out to be two pages long after a lawyer for The Times had requested that a branch of the F.D.A. other than Dr. Shuren’s address the matter.

During the decade and a half of overlapping career trajectories, “Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” Mr. Felberbaum said.

[….]

Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year.

Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.

Dr. Peter Lurie, a former F.D.A. associate commissioner, said he hoped the next division chief would shape a legacy that is more impartial toward device companies.

Early in his tenure, Dr. Shuren dismissed criticism from the business community over what it viewed as the slow pace of device approvals compared with Europe. Citing Europe’s lower standards and safety problems, he told The Times in 2011 that the F.D.A. would stand firm.

“We don’t use our people as guinea pigs in the U.S.,” he said at the time.

But congressional leaders on both sides of the aisle pressured the agency for faster medical device approvals. By 2014, Dr. Shuren pledged to make the United States the first place for device makers to sell their products.

[….]

In a recent presentation, he boasted that the number of first-in-the-world approvals had soared to 125 in 2023, from 25 in 2009.

“Do things now come here first?” he asked at a conference in May, referring to the new devices. “The answer is yes.”

Over time, Dr. Shuren drew closer to the medical device industry. In 2012, he co-founded a nonprofit called the Medical Device Innovation Consortium with a former executive from Medtronic, a leading device company.

To do so, Dr. Shuren secured a waiver from agency ethics rules, which prohibit federal officials from serving on boards of nonprofits to avoid divided loyalties or interests.

Most of the consortium’s board members were device industry executives, and many of its staff members had previously worked for the industry’s lobbying organizations.

As a board member, Dr. Shuren expanded the nonprofit while facing disturbing episodes at the agency over harm done by medical devices. Thousands of women reported injuries and side effects from Essure devices — small metal birth-control implants that dislodged from the fallopian tubes, tore delicate anatomy or caused allergic reactions. Other women were outraged to discover that an F.D.A.-cleared device called a power morcellator used to pulverize uterine growths might have actually spread their cancer.

Dr. Shuren promised in 2019 that a consortium project called NEST, or the National Evaluation System for Health Technology, would “empower the F.D.A. to more quickly identify, communicate and act on new or increased medical device safety concerns.”

The group has “obviously failed to do that,” said Diana Zuckerman, the president of the National Center for Health Research, a consumer watchdog group.

Agency critics have compared the NEST effort to a fox guarding a henhouse, citing the industry’s leadership at the consortium and a lack of specific safety accomplishments.

Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans.

The F.D.A. defended its approval process, saying it had increasingly sought more evidence before clearing products for sale. Regarding NEST, the agency noted a report by the U.S. Government Accountability Office, a watchdog agency, that said the program would begin monitoring the safety of two types of medical devices in December.

Medical specialists have also raised concerns about the safety and effectiveness of some devices approved during Dr. Shuren’s tenure. They include the CoolSculpting device, which was meant to zap fat but disfigured some people, and the Q-Collar sports safety device, which some experts say may offer little protection from injuries to the brain.

[….]
But safety issues multiplied on his watch. The most urgent F.D.A. recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern.

Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.

Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, said he believes the problems are a result of low standards and deference to industry. He emerged as a critic of Dr. Shuren’s after his wife died of a cancer that he said was spread by a power morcellator.

“Essentially,” he said, “he’s pumping medical products into the U.S. marketplace, outside of an evidence-based paradigm.”

When Dr. Shuren was named acting director of the medical device division in 2009, agency lawyers drafted an ethics agreement to prevent conflicts of interest involving his wife and her law firm. Top officials were to screen potential issues of concern, and other agency officials were to take the lead in such cases, according to the document.

[….]

A major test occurred in 2015. Daniel A. Kracov, Ms. Shuren’s partner in running the firm’s drug and device team, began representing Theranos.

At the time, he was challenging the F.D.A.’s authority to conduct an inspection at two Theranos offices in California. F.D.A. officials were concerned that the company was shipping its “nanotainer” blood-storage device without agency clearance. Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.

Dr. Shuren said around that time that he was recused from dealing with Theranos, recalled Alberto Gutierrez, then the F.D.A.’s senior scientist on diagnostic tests. But Dr. Gutierrez said he had not been informed that the agency expected another official to step in for Dr. Shuren, and Dr. Gutierrez continued to send him periodic emails about Theranos. Walter Brown, a lawyer for Mr. Balwani, gave the judge 91 documents that he said proved Dr. Shuren was dealing with Theranos matters.

Alison Daw, a lawyer representing the F.D.A., argued that Dr. Shuren had not had substantial involvement.

[….]

In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.

At the same time, Arnold & Porter was engaged in legal issues involving Allergan. In April, a member of Ms. Shuren’s team began to defend Allergan in a California lawsuit over Botox pricing. The firm was also ushering AbbVie through a $63 billion acquisition of Allergan — a success Ms. Shuren’s team highlights on the firm’s website.

Mr. Felberbaum said Dr. Shuren was not aware of either the Botox case or the acquisition.

[….]

In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In June, AbbVie announced its decision to purchase Allergan for $63 billion.

In July, Dr. Shuren and the other official reversed course and said that they would urge a recall, citing additional reports of injuries and deaths related to the lymphoma. Ms. Baumann of Arnold & Porter said that the firm represented AbbVie over antitrust questions and that Ms. Shuren had not worked on the matter.

[…]

To read the entire article, click here.