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The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.

David Hilzenrath — Fri, 18 Sep 2026 09:00:00 +0000

When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of , agency experts argued that would be a mistake, according to .

One problem cited: The manufacturer had provided only

As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market.

Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a . As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an and .

Meanwhile, the FDA has dozens of cases of “possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.

Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through.

A ��ýҕ�l Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.

As a result of delays, patients, doctors, and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health, or their lives on the products.

Postmarket study requirements “have often proven toothless,” said cardiologist , an associate professor of medicine at the University of California-San Francisco who has published .

The FDA’s reliance on postmarket studies reflects a balancing act.

Making new treatments available faster can save or improve lives, especially when patients with grim prognoses and no good options have little to lose. The full risks and benefits may be revealed only over the long term, and when therapies are used by far more people than even large clinical trials enroll.

But relying on post-approval studies to resolve questions risks exposing patients to products that do more harm than good. Whoever is paying the bills — patients, insurance companies, employers, or government health programs such as Medicare and Medicaid — can end up wasting money and rewarding manufacturers for useless or risky products.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty,” Dhruva said.

Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.

For example, in February, that “the default requirement” for agency approvals will be one clinical trial instead of two.

Reducing pre-approval testing “will inevitably put a lot of pressure on the post-approval system,” said , a professor at Harvard Medical School who postmarket studies.

FDA officials said the new policy would “substantially reduce costs” for manufacturers and “speed drugs to market.” Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that “erroneous conclusions may be reached even with two, three, or four studies.”

In response to questions for this article, a spokesperson for the Department of Health and Human Services, which includes the FDA, said postmarket studies can experience delays for legitimate reasons. “Assessing the significance of any delay requires a case-specific review,” said the spokesperson, Emily Hilliard.

The fact that a study is delayed “should not be treated as evidence that a product has an unresolved safety or effectiveness issue,” Hilliard said.

Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, “We remain committed to completing this important study.”

Amgen’s headquarters in Thousand Oaks, California, in May 2023. (Mario Tama/Getty Images)

Behind Schedule

An FDA database downloaded by ��ýҕ�l Health News in August tracks the progress of postmarket studies that makers of — such as vaccines and gene therapies — were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

Of those, more than 250 originally had final reports due before July 31, 2026 — the date that, according to an FDA webpage, the database last had been updated.

About a third of ongoing studies were listed as delayed.

In some cases, the FDA has granted extensions. In others, it has denied them. And in rare instances, the products were discontinued before the studies ran their course.

Postmarket studies can involve clinical trials or other analyses of patient data. They can look at safety or efficacy. A product can be the subject of more than one postmarket study.

The nearly 600 delayed studies involved almost 350 products, ��ýҕ�l Health News found.

The FDA has defined delayed as . That can mean off track or overdue.

As of August, other FDA databases tracking listed dozens of postmarket studies as behind schedule.

Products included:

The CustomFlex Artificial Iris, a prosthesis implanted in the eye in place of damaged, defective, or congenitally missing irises. The protocol for a study in children was accepted in 2019, the database said. The study was meant to follow patients for five years. According to an FDA page downloaded in August, zero patients were enrolled.

Barbara Fant of Clinical Research Consultants, to whom the FDA’s 2018 letter approving the product was addressed, said the rarity of an eye disease called aniridia poses challenges for post-approval studies. The German manufacturer, the U.S. distributor, and Clinical Research Consultants are working with the FDA to identify alternative ways to fulfill the postmarket requirements, Fant said.

“Confirming the long-term safety of the device remains a top priority for both the study team and FDA,” Fant said.

Paxlovid, a treatment for covid. A study to assess its safety in pregnant women was originally to be completed by the end of 2024, the FDA database said. “The trial completion and final report milestones were missed,” the database said.

Pfizer, the manufacturer, is working with the FDA and remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts said.

The Scandinavian Total Ankle Replacement system. The device and the original protocol for the clinical trial were approved in 2009. The study was meant to include a minimum of 500 subjects, the database said, but the actual number enrolled was 142. Almost half those patients had one or more adverse events, with dozens of “reoperations,” “revisions,” or “removals,” the database said.

Rachel Colloff and Cristina Pasquino — spokespeople for Enovis, which markets STAR Ankle — did not respond to multiple inquiries. Jenny Braga, a spokesperson for Stryker, which previously sold the product, did not answer questions about the postmarket study.

Oxaydo (originally named Oxecta), a form of the potentially addictive opioid painkiller oxycodone . When the FDA approved it in 2011, it required the manufacturer, , to conduct a postmarket study to assess whether it reduces “misuse and abuse, and their consequences: overdose, death and addiction.” The final report was originally scheduled to be submitted in 2016.

The FDA database listing the study as delayed said the agency “issued a failure to respond letter” in 2022.

Today the issue may be all but moot.

Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a that patents on Oxaydo would begin expiring that year and it didn’t intend to continue marketing the drug.

According to another FDA database, Oxaydo .

The FDA has enforcement powers and uses them “where appropriate,” HHS’ Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.

Delay Can Pay

For manufacturers, delay can pay, Harvard’s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.

“Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory trials past their original planned completion dates,” the HHS Office of Inspector General .

The FDA can demand postmarket studies for a variety of reasons, including to address concerns that arise after a product has been approved. Some look at uses not covered by the original approval, and some are meant to shed light on that are already known.

In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct additional research to assess a variety of concerns, including “retained gastric contents,” “major adverse cardiovascular events,” and “drug-induced liver injury,” as well as effects of exposure during pregnancy, such as “major congenital malformations,” “spontaneous abortions,” and “stillbirths.”

The FDA said it approved the drug under the new Commissioner’s National Priority Voucher program, intended for products that “.” The program strives for an “” review, the FDA has said — one to two months, instead of six months or more with other expedited pathways.

“Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA’s approach to evaluating newly approved medicines,” Eli Lilly spokesperson Kristiane Silva Bello said, “including ongoing monitoring in areas identified during clinical development.”

‘False Hope’

The FDA waded into a world of uncertainty in 2016 when it granted accelerated approval to a drug for Duchenne muscular dystrophy, a degenerative disease that primarily affects boys, disabling them at a young age and ultimately killing them.

Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.

Ellis Unger, then a senior drug evaluation official at the FDA, that “thousands of patients and their families would be given false hope in exchange for hardship and risk.”

The manufacturer, Sarepta Therapeutics, . “A clinical benefit of EXONDYS 51 has not been established,” it said when the drug, also known by the generic name eteplirsen, was approved.

The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.

The FDA required Sarepta to conduct further studies and it could withdraw approval if postmarket trials failed to verify a clinical benefit or were “not conducted with due diligence.”

Unger issued a warning of his own: “FDA has not succeeded in withdrawing the marketing of a single drug for lack of verification of clinical benefit following accelerated approval. The reality is that if eteplirsen is given accelerated approval, it is highly likely to remain on the market indefinitely, irrespective of whether or not efficacy is verified.”

Sarepta was originally required to submit a final report on a postmarket study by a May 2021 deadline, according to an FDA database and a 2016 FDA letter to the company.

Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database as delayed.

“The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,” the database said.

Meanwhile, in 2022 the website ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.

Last year, the drug generated for Sarepta, according to a company presentation to investors.

Sarepta found it difficult to recruit patients for the postmarket clinical trial, company spokesperson Tracy Sorrentino said. The target population is small, patients were hesitant to enroll, and Sarepta was competing with other clinical trials for participants, Sorrentino said.

The study has been fully enrolled since 2023, Sorrentino said, and the company plans to provide an initial look at the data late this year.

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Amgen is the maker of the drug Tavneos. (Hannah Yoon/Bloomberg via Getty Images)

Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.

When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen’s Chartan said.

The clinical trial supposed to be done . As of July 24, just 49 patients had been enrolled, Chartan said.

The FDA has said the study was to include , and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.

Tavneos was approved to treat severe cases of a group of diseases — known by the shorthand ANCA-associated vasculitis — in which, as the explains, the immune system inflicts potentially fatal damage on blood vessels and organs.

“As of January 2026, estimated real-world exposure” to Tavneos “exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,” Amgen has said. (For context, one patient taking a drug for five years would amount to five “patient-years.”)

A clinical trial sponsored by ChemoCentryx to secure approval of Tavneos failed to prove it was effective, the FDA now alleges. Instead of disclosing that outcome to the FDA, company personnel “” the , the FDA alleged in an to Amgen.

Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data “.”

Nonetheless, the recently of Tavneos.

The FDA is trying to , and Amgen is fighting that effort.

The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the , and when Amgen in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.

In a June , Amgen said the benefits of Tavneos outweigh the risks.

The FDA disagrees.

The FDA “can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,” .

Citing 76 cases of DILI — — the agency said it was “increasingly concerned about the safety profile of TAVNEOS.” Without proof of effectiveness, at least for its approved use, “the drug’s benefits its known risks,” the FDA wrote.

Data reporter Maia Rosenfeld contributed to this report.

��ýҕ�l Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

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With Midterms Looming, Journalists Consider Measles, Food Recalls, and Obamacare

Sat, 29 Aug 2026 09:00:00 +0000

Céline Gounder, ��ýҕ�l Health News’ editor-at-large for public health, discussed fatal measles cases on CBS News 24/7’s Mornings on Aug. 26. Gounder fact-checked Centers for Medicare & Medicaid Services Administrator Mehmet Oz’s comments about vaccines and drug prices on CBS News 24/7’s The Daily Report on Aug. 24. She also discussed food recalls this summer on CBS News 24/7’s The Takeout With Major Garrett on Aug. 24.

��ýҕ�l Health News chief Washington correspondent Julie Rovner discussed kindergarten vaccination rates on WNYC’s The Brian Lehrer Show on Aug. 25.

��ýҕ�l Health News contributor Mark Kreidler discussed the use of artificial intelligence for Medicaid reenrollment on KVPR’s Central Valley Daily on Aug. 24.

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Read Kreidler’s “AI Is Being Used To Boost Medicaid Enrollment, but Not Without Concerns.”

��ýҕ�l Health News senior correspondent Julie Appleby discussed the state of the Affordable Care Act on Vox’s Today, Explained podcast on Aug. 24.

��ýҕ�l Health News Georgia correspondent Briah Lumpkins discussed the importance of healthcare policy in upcoming elections on WUGA’s The Georgia Health Report on Aug. 21.

This article first appeared on ��ýҕ�l Health News and is republished here under a .

Trump and Kennedy’s Health Industry Deals Haven’t Been Enforced and Are at Risk of Vanishing

Stephanie Armour — Fri, 28 Aug 2026 09:00:00 +0000

In the thick of his competitive reelection race in Michigan, Republican Rep. joined Health and Human Services Secretary Robert F. Kennedy Jr. at a sprawling 400-acre . They touted Trump administration efforts to improve the American diet, including the removal of some artificial dyes from processed foods.

“We had a great discussion about healthy options for all Americans and taking back control of our healthcare,” Barrett said in a June , after sampling the farm’s apple cider.

Like the focus on artificial dyes, however, many of the administration’s highest-profile health initiatives rely on voluntary agreements. The goals, such as lower drug prices and nutrition classes for doctors, have widespread appeal, cutting across party lines and economic divisions.

But the administration-industry deals lack the enforcement teeth of more traditional federal regulation. Their details are vague, and minimal oversight makes it hard to monitor progress. In some cases, the administration has claimed victories that have yet to materialize.

Republicans consider the dealmaking a winning strategy. It fits with the party’s anti-regulatory stance, they say, and enables the administration to quickly forge agreements President Donald Trump and his allies can tout as accomplishments. In the run-up to the midterm elections, some, like Barrett, hope to woo voters by trumpeting the Trump administration’s efforts to shape health policy.

The practice also raises questions. Though the deals are announced with great fanfare — often during televised events on stages, with live audiences — there’s little documentation or follow-through, creating doubts about whether the administration’s health agenda will lead to lasting change or unravel once the political attention fades.

The distinction could prove important to voters as Republicans defend their health records in November’s midterm elections.

“These deals are often not transparent, so there’s no way for the public to judge how meaningful they are,” said Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes ��ýҕ�l Health News.

Dealing With Dyes

The push to remove certain artificial dyes from food and drugs, for example, was a headline grabber. In April 2025, Kennedy to announce deals with food makers. He was flanked by young children and mothers holding placards reading “Make America Healthy Again.”

He and former FDA commissioner drew a standing ovation from an audience selected by Kennedy’s staff as they said companies had pledged to phase out all petroleum-based synthetic dyes from the nation’s food supply and medicines. They targeted nine synthetic dyes for removal.

Voters love the idea of stopping the use of such dyes. In a nationally representative March survey by Consumer Reports, said they were at least somewhat concerned about synthetic dyes, and two-thirds said companies should be required to phase them out.

A year after making the first announcement at HHS, during a discussion at the Conservative Political Action Conference, an annual political event.

“We’ve gotten rid of the nine synthetic-based food dyes,” he said.

Not quite. At the initial HHS event, federal officials said companies would voluntarily stop using six specific synthetic dyes . (The administration has also revoked or proposed revoking authorization for two other synthetic food dyes.)

Later, the FDA on its website quietly to the end of 2027. So, most are still in use.

In fact, the FDA posted a list of 27 companies it said had made voluntary pledges as of December 2025 to remove six synthetic dyes from products such as Doritos and Kellogg’s Froot Loops. More than a year and a half later, — fewer than 30% of those who bought in — had met their promised goals.

Many major food makers, such as the Coca-Cola Co. and Unilever, have made “” to remove the synthetic dyes, according to Consumer Reports. In addition, no pharmaceutical companies have publicly said they have plans to remove dyes from drugs.

“It’s just all talk,” said Leslie Dach, who chairs , a healthcare advocacy group that supports the Affordable Care Act. “They just govern for a day of publicity, and then it’s over. None of it happens. Yet the people don’t know because they have busy lives, so they think, ‘Just look at all these initiatives.’”

In fact, the administration , allowing companies to say their products contain no artificial colors — as long as they don’t use petroleum-based dyes. Previously, food makers could not make that claim unless their products contained no added colors. Some food dyes made from natural ingredients can contain contaminants and may pose their own health risks, .

“The federal government hasn’t taken any regulatory action on food dyes, for the most part, since the beginning of this administration,” said , vice president for government affairs at the Environmental Working Group, an advocacy group.

HHS said the voluntary approach has yielded significant action, including commitments to remove synthetic dyes from products sold in schools for the 2026–27 school year.

“HHS and the FDA are moving forward with clear timelines and concrete industry commitments, with major changes expected in foods served in schools during the coming school year and across full product portfolios by the end of 2027,” HHS spokesperson Emily Hilliard said in an email.

At the same CPAC convention event, Kennedy said “the MCAT testing companies are going to put nutrition on the MCAT for the first time, so the students will actually want to do it.” MCAT refers to the Medical College Admission Test, an exam required for admission to medical schools.

Again, not quite.

The Association of American Medical Colleges administers the MCAT. Spokesperson said Kennedy misspoke and may have meant to refer to a test taken by students to be licensed as doctors.

An Insurance Deal Falls Short of Promises

Kennedy again took to the HHS stage in June 2025, this time with Centers for Medicare & Medicaid Services Administrator Mehmet Oz, to make what was billed as a game-changing announcement. to reduce the volume of healthcare services subject to prior authorization, a practice widely used by the insurance industry that often requires patients or their medical teams to seek preapproval before undergoing treatment.

The administration said 80% of insurers pledged changes to preauthorization requirements for 80% of diseases and injuries . The administration also promised “” to track progress.

“It will happen very quickly,” Oz said at the event. “Necessary care will be delivered when it’s needed, in the right way.”

As of July, months past that January target date, health plans had reduced prior authorization for medical services by about 11%, according to AHIP, the insurer trade group. But no public dashboards have debuted to track the deal, and some insurers that signed the pledge last summer told ��ýҕ�l Health News this year that they will not implement all the promised reforms as outlined by AHIP.

Hilliard did not respond to questions about the pace of progress.

The American Medical Association, in a 2025 web-based survey, asked 1,000 practicing doctors whether they believed the voluntary pledges would make a meaningful difference. said they believed they would.

Insurers made a , during the previous Trump administration. The next year, more than 80% of doctors said the number of prior authorization requests for drugs and medical services had been increasing, based on .

Meanwhile, the administration is testing an artificial intelligence-powered for Medicare, the federal health program for people 65 and older or with disabilities. In six states, Medicare beneficiaries must get preapproval for a few treatments that CMS considers to have little clinical benefit and to be susceptible to fraud or waste, including skin substitutes and knee arthroscopy for arthritis. The program began in January, the same deadline insurers had set for curtailing preauthorization delays.

Deals and Deregulation

The healthcare industry’s voluntary agreements appeal to voters who feel government regulation drives up costs and places unnecessary burdens on businesses, some supporters say.

“Secretary Kennedy is the antithesis of a public health industry that uses coercion over communication — and has demonstrated this by taking the time and effort to push voluntary initiatives over the typical approach of governmental mandates,” said , a political consultant who was a political appointee at HHS in Trump’s first term.

But voluntary agreements with the health industry can prove ineffective. Former President Jimmy Carter in 1977 proposed a legislative plan to curb rising hospital costs. Hospitals fought back, and Congress rejected the proposal, instead favoring a desired by the industry. It ultimately failed once public attention faded.

One upside: Deals are fast. can take two to three years. And some health analysts say the tempo of the agreements advanced by Kennedy and Trump may help take voters’ attention off the Trump administration’s inability so far to produce a long-promised health plan.

Instead, Republicans can point to the array of accords reached with industry, including the with drugmakers so they’re in line with lower amounts charged in peer countries. The White House calls it the “most-favored-nation” prescription drug pricing policy.

Seventeen companies, including Pfizer and AstraZeneca, with the administration to lower prices for Medicaid enrollees and cash-paying consumers using , a narrow, government-run consumer platform.

Many details remain unknown, but the lower prices apply only to new drugs and existing drugs available through Medicaid. And prices at TrumpRx aren’t as low as out-of-pocket prices for most consumers with insurance. But the voluntary deals appeal to an industry that has railed against mandatory approaches drugmakers deride as harmful price controls.

“Each company makes its own decisions about how it prices medicines, and our industry is committed to working with the Trump administration to ensure Americans have access to affordable medicines,” said Chanse Jones, a spokesperson for PhRMA, a pharmaceutical industry trade group.

Policies that lead to reductions in drug prices typically worry investors because profits also can drop. But rather than seeing their stock prices fall after the agreements were announced, the drugmakers saw largely .

Analysts say that’s partly because the deals are narrow in scope, largely exist only in principle, and don’t apply to existing drugs used by the more than 200 million Americans with commercial or private health insurance.

The Trump administration, however, is .

“The most-favored-nation agreements on drug prices that we just did are delivering the largest drug price cuts in history,” Trump said in June at a in Pennsylvania. “That alone should win us the midterms.”

This article first appeared on ��ýҕ�l Health News and is republished here under a .

How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages

Arthur Allen — Thu, 20 Aug 2026 09:00:00 +0000

Northwestern University economist Chuck Manski studies decision-making amid uncertainty. That prepared him better than many other cancer patients to decide whether to stay on an immunotherapy treatment that was making him very ill.

For six months in 2022, Manski received monthly infusions of nivolumab to fight advanced melanoma. The drug ruined his thyroid gland, he said, requiring him to go on a special medication for the rest of his life, and caused severe dryness in his eyes, lips, and mouth. The FDA’s protocol for the drug called for an entire year of treatment, but Manski said his oncologist couldn’t explain why. It’s FDA-approved, “so that’s what we use,” she said.

By that point, Manski showed no cancer signs or symptoms, and after reading a lot of medical journal articles, he concluded that the intense side effects probably meant the treatment had done about all it could do.

“She couldn’t tell me a year was the optimal dose. Nobody could,” he said in a June interview from Spain, where he received an award for his economics work. “So I made my own diagnosis. I took myself off.”

Manski’s decision was in line with what doctors in , , were already doing: giving lower doses of nivolumab, sold under the brand name Opdivo, and of a similar drug, pembrolizumab (Keytruda), or giving them for shorter periods or over longer intervals than the FDA recommended. In India, oncologists found that of nivolumab had a powerful impact on several cancers.

“There is incredible uncertainty in drug dosing,” Manski said.

His experience impelled him to join an informal yet determined community of researchers, doctors, and patients pushing for extra studies to help patients and doctors find the right dosage for an array of cancer drugs. They point to evidence suggesting that taking smaller doses of some cancer drugs, or remaining on them for shorter periods, could save billions of dollars and prevent some of the worst side effects.

In a , 43% of U.S. adults said they had skipped their medication in the past year because of cost. A Vanderbilt University study of Medicare enrollees released in 2022 found that went unfilled at the pharmacy.

But dose-optimization studies rarely occur after the early stages of a drug’s development, or once it’s on the market. By then, few parties in the U.S. healthcare system — beyond patients — have a stake in learning that a lower dosage could work as well while causing less harm.

Pharmaceutical companies have shown little interest in dialing back recommended dosages. Once they set the price for a drug, the more sales, the more profit. One study that examined 29 expensive cancer drugs estimated that if minimum necessary dosages had been used in 2024, the U.S. healthcare system could have saved roughly $31 billion.

“Decisions aren’t always made with the best needs of the patients in mind. The bottom line is another reason,” said Matthew Goetz, a breast cancer researcher at the Mayo Clinic Comprehensive Cancer Center.

Doctors in other countries have been giving patients lower doses of nivolumab or giving them for shorter periods or over longer intervals than the FDA recommends. (George Frey/Bloomberg via Getty Images)

Merck last year sold nearly $32 billion worth of pembrolizumab, a drug that’s FDA-approved for more than 40 cancer conditions. It accounted for almost half of Merck’s drug sales. Bristol Myers Squibb, meanwhile, brought in $10 billion from nivolumab, which works similarly to pembrolizumab in tweaking the immune system. Three important but often toxic breast cancer drugs — Ibrance, Verzenio, and Kisqali — at Pfizer, Eli Lilly, and Novartis by $4.1 billion, $5.7 billion, and $4.8 billion, respectively.

Pembrolizumab is usually prescribed at a fixed dosage; nivolumab is sometimes prescribed at a fixed dosage, sometimes based on the patient’s weight. If the patient is dosed less than what’s on the label, drugmakers generally get less money. And they aren’t the only ones who lose out.

Through a federal program known as 340B, created in 1992 to subsidize the treatment of low-income patients, hospitals that treat a certain percentage of low-income patients can buy drugs at a steep discount, while charging insurers or patients more. For Medicare patients, doctors are paid an additional for each infusion.

From 2010 to 2024, cancer drug revenue to doctors and hospitals increased from about $9 billion to nearly $36 billion, according to research by . About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.

“Pembrolizumab is ,” said Mark Ratain, a professor of medicine and chief hospital pharmacologist at University of Chicago Medicine. “That’s why you don’t see hospitals in this country running to do trials that test lower doses.”

Mark Ratain, a University of Chicago oncologist and clinical pharmacologist, battles what he sees as unnecessarily high dosages of high-cost cancer drugs such as Keytruda and Opdivo. (Taylor Glascock for ��ýҕ�l Health News)

Merck spokesperson Julie Cunningham said the drug’s dosage recommendations were based on extensive testing. “In a life-threatening and challenging disease such as cancer, it is critical that the dosing for a cancer therapy is established through well-designed clinical trials,” she said. “Changes in dose or duration that have not been similarly studied may potentially compromise the therapeutic effect.”

Still, some oncologists start their patients off slowly on any of a variety of cancer drugs, although there may be concerns about lawsuits by a patient or their survivors over a prescription of lower-than-labeled dosages.

Kathy Miller, a professor of oncology at the Indiana University School of Medicine, routinely starts metastatic breast cancer patients with 400 milligrams of Kisqali daily for three weeks (with one week off), rather than the 600 milligrams recommended on the label. Sometimes patients ask for the standard dosage.

“I have to tell them, ‘I don’t want to kill you,’” she said.

Insurers routinely challenge her lower-dosage prescriptions, Miller said, presumably because price rebates from the drug company are set to the standard dosage. To avoid endless phone battles with insurers, she prescribes 600 milligrams but tells her patients to take only two of the 200-mg pills and save the third for the next cycle.

Follow the Cures — And the Money

On May 31, at the annual meeting of the American Society of Clinical Oncology, or ASCO, at Chicago’s McCormick Place convention center, most of the audience of 8,000 rose in a prolonged standing ovation for the experimental drug daraxonrasib. Patients with pancreatic cancer who took the drug, presented that day, lived nearly twice as long — a median of 13 months — as those receiving chemotherapy.

The next day, in a slightly smaller hall, Amol Patel, a medical oncologist from New Delhi, discussed studies in various cancers in which 20- or 40-mg doses of nivolumab biweekly — one-sixth or one-twelfth the recommended dosage — gave Indian patients several months to a year longer survival than patients who underwent chemotherapy, and with fewer side effects.

Fewer than 100 people attended Patel’s talk.

The ingenious development of daraxonrasib was big news, since pancreatic cancer has been a death sentence until now. But from a global perspective, the news out of India might be just as important.

At the ASCO meeting, “the focus is always on the shiny new drug,” said Daniel Goldstein, an oncologist and drug policy researcher at the Rabin Medical Center in Israel who has fought for a decade, with some success, to lower pembrolizumab dosages in hospitals there and in other countries. “It can be quite lonely to be us,” he said, adding that he’s seen increasing appreciation of his work.

The data from India offered a glimpse of what could be. However, the studies Patel referred to compared ultralow-dosage immunotherapy to older chemo drugs; none compared ultralow doses against standard nivolumab or pembrolizumab treatments. In India, this would be a sterile exercise, because full-dose treatments are beyond the reach of any but the very wealthy, said Vanita Noronha, an oncologist at Tata Memorial Hospital in Mumbai.

Bristol Myers Squibb, or BMS, to make its drugs available in lower-income countries. But the company hasn’t been involved in the lower-dose nivolumab trials and, in a statement to ��ýҕ�l Health News, said the evidence suggested that or shorter duration harmed patients.

While not all U.S. oncologists agree with BMS’ assertion, the Indian data is, to most, a mere curiosity. “Can we really give 20 milligrams as opposed to 240?” asked Jessica Bauman of the Fox Chase Cancer Center in Philadelphia. “The only way we know for sure is a randomized study between the low dose and the highest.”

And such trials are unlikely to occur. That means only poorer countries are going to host “this groundbreaking research,” said Ratain, who is also a cancer doctor at the University of Chicago Medical Center. “The Indians may have better immunotherapy than we do.”

Clinicians in Europe, where maximizing healthcare dollars has long been a priority, have taken a middle course, studying lower, but not ultralow, doses of immunotherapy.

Pulmonologist Michel van den Heuvel at Utrecht University is comparing the standard nivolumab dosage for lung cancer patients with one that is as much as 50% lower. He also considered giving the low doses half as frequently, but that would have raised ethical concerns and led to a more cumbersome research protocol, van den Heuvel said.

In the United States, researchers led by a group at the Dana-Farber Cancer Institute are taking another tack: who’ve done well on 27 weeks of pembrolizumab can stop taking it, rather than doing the additional six months per FDA protocol.

At the Veterans Health Administration, which has more leeway in testing money-saving medical procedures, doctors saved $1.5 million, about 10% of the previous pembrolizumab cost, over two years at three Veterans Affairs hospitals where they implemented a pilot program to dose patients less frequently, said Garth Strohbehn, a University of Michigan oncologist who also works at the VA.

It saves money and requires fewer visits for veterans who often live hours from the hospital, he said. “It also helps other patients because it opens more slots for infusion.”

Julie Gralow, ASCO’s executive vice president and chief medical officer, has made testing dosage a priority. She’s working with scientists in India on an ambitious clinical trial to compare standard nivolumab with four lower dosage levels.

She’s also leading an , supported by the federally funded Patient-Centered Outcomes Research Institute, to see whether breast cancer patients can be effectively started on lower doses of the drugs Kisqali and Ibrance, which, along with Verzenio, are in a class of key breast cancer drugs known as CDK4/6 inhibitors.

“We want to maintain efficacy. But we also want patients to have excellent quality of life,” she said. Especially for patients with advanced cancers, where absolute cure is unlikely, “it’s our job to make sure we’re not compromising quality of life with higher doses that are unnecessary.”

In 2021, at Ratain’s urging, Richard Pazdur, who led the FDA’s cancer drug division for many years, launched , intended to get companies to conduct dosing studies that are more precise before launching the large clinical trials they use to obtain FDA approval for new drugs.

The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug is approved, and by law the agency does not influence drug pricing, says Emily Hilliard, a Department of Health and Human Services spokesperson. (Valerie Plesch/Bloomberg via Getty Images)

The agency issued for dosing studies in 2024 and has incorporated Project Optimus principles into the approval process for new cancer drugs, said Health and Human Services spokesperson Emily Hilliard. For example, two dosing regimens were evaluated for each of four lung cancer drugs (fam-trastuzumab deruxtecan, tarlatamab, zongertinib, sunvozertinib), and the lower dose with fewer toxicities was approved in each case, she said.

The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug’s approval, Hilliard noted. And by law the agency does not influence drug pricing, she said.

Future drugs should have better dosage information, Bauman said, but “newer drugs will probably be just as expensive at lower doses.”

Financial Toxicity

Verzenio’s side effects made Allegra Warfield feel so sick, tired, and bewildered, she said, that she considered suicide. She switched to Kisqali, which was tolerable until last September, when coverage of the drug stopped despite her monthly premium payment of $6,000. The cash price for Kisqali was at least $16,000 a month.

After fighting her insurer for three months, Warfield, 42, sold her house and belongings in Palm Desert, California, and moved with her fiancé to Durham, North Carolina, where they’d found what they considered a reasonable insurance plan.

The cancer, the side effects, and the unpayable bills were bad enough. The lack of good answers for her treatment made everything worse, she said.

“I was left to research these medications on Facebook and Reddit. The only people talking about the daily reality of these drugs were other patients,” she said. “But I wanted the studies. I wanted practical guidance.”

Stories like these launched a new life mission for Kelly Shanahan, who was an OB-GYN in South Lake Tahoe, California, until side effects from a breast cancer drug caused her to lose sensation in her hands. Unable to practice medicine, Shanahan became a patient advocate who works with a group called the Patient-Centered Dosing Initiative. In 2021, Shanahan developed profound fatigue (“worse than caring for a newborn baby while being on call in my solo practice”) within a few weeks of going on Ibrance. Lowering the dosage caused her worst symptoms to lift, she said.

After gathering countless anecdotes, her group has approached drug companies seeking data — so far with little success — that might indicate what percentage of patients have needed dosage reductions, and how they fare on lower doses.

“If going down two dose levels cuts effectiveness by 50%, patients need to know that while making decisions. If it doesn’t, they need to know that,” Shanahan said — even if it means “the companies won’t make as much money.”

Shanahan suggested the data could be found in clinical trials and postmarket studies. But if drug companies won’t provide the necessary studies, Manski said, governments should.

“The knowledge to be gained is a common good,” he said.

Manski’s research, focused on how people deal with conditions of uncertainty, helped him decide whether to stay on a melanoma treatment after it caused severe side effects. (Taylor Glascock for ��ýҕ�l Health News)

Has an insurance company or pharmacy benefit manager refused to cover a drug an oncologist recommended or prescribed for you or a loved one because the cancer is unusual or rare and lacks clear guidelines? Click here to contact ��ýҕ�l Health News’ reporting team.

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Watch: Why Abortions Are on the Rise Since ‘Roe’ Was Overturned

Kate Wells and Hannah Norman — Fri, 07 Aug 2026 09:00:00 +0000

Say you live in deep-red Louisiana, a state that has effectively banned abortion. It may be easier for you to get abortion pills now than before the Supreme Court overturned Roe v. Wade. Here’s why — and what it means for future battles over abortion access.

And as a federal court mulls a case that could result in significant restrictions on a pill used in most abortions, healthcare providers say they have alternatives to preserve access even in states with bans in place. Read more here.

A Ban Won’t Stop Abortion Pill Access, Telehealth Providers Say

By Kate Wells June 24, 2026

This article first appeared on ��ýҕ�l Health News and is republished here under a .

Journalists Catch You Up on Fauci Hearing, Peptides, and Kids’ Caffeine Consumption

Sat, 01 Aug 2026 09:00:00 +0000

Céline Gounder, ��ýҕ�l Health News’ editor-at-large for public health, discussed how children’s caffeine consumption is affecting their health on CBS News’ CBS Mornings on July 30.

��ýҕ�l Health News senior correspondent Arthur Allen discussed the recent Anthony Fauci Senate hearing on CBS News 24/7 on July 29.

��ýҕ�l Health News chief Washington correspondent Julie Rovner discussed the Fauci hearing on WBUR’s Here & Now on July 29. Rovner also discussed exceptional Affordable Care Act enrollment in New Mexico on KJZZ’s The Show on July 29.

��ýҕ�l Health News national public health correspondent Amy Maxmen discussed the FDA potentially easing restrictions on peptide drugs on CBS News 24/7 on July 24.

��ýҕ�l Health News Georgia correspondent Briah Lumpkins discussed the local impact of the loss of Environmental Protection Agency grant money on WUGA’s The Georgia Health Report on July 24.

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Read Lumpkins’ “Public Health Improvements Stall Amid Trump’s DEI Crackdown.”

��ýҕ�l Health News Hawaiʻi correspondent Ashley Mizuo discussed the challenge of finding placement for prisoners after their compassionate release from detention on Hawaiʻi Public Radio’s The Conversation on July 22.

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Read Mizuo’s “Severely Ill Prisoners Granted Early Release Are Left Stuck Behind Bars.”

This article first appeared on ��ýҕ�l Health News and is republished here under a .

Cyclospora Boosts Fears That Worse Foodborne Outbreaks Are Ahead

Kate Wells and Stephanie Armour — Tue, 28 Jul 2026 09:00:00 +0000

The next foodborne illness outbreak could be much worse.

That’s the concern of food safety leaders across the U.S. who are raising alarms over federal cuts they say have made it harder to detect and stop the spread of foodborne illnesses, such as the recent outbreaks of cyclospora, which has in dozens of states. And they’re especially worried the next pathogen will be much more deadly.

Food safety in the U.S. is monitored by a piecemeal system of state and federal agencies. That network is in charge of detecting, investigating, and stopping outbreaks of foodborne illnesses. Key to the system is the Centers for Disease Control and Prevention’s FoodNet program, created after four children died from E. coli in hamburgers in the early 1990s. States participating in the program, officially called the Foodborne Diseases Active Surveillance Network, contact labs to get case data that can signal when a problem is emerging.

But in President Donald Trump’s second term, his administration has slashed billions of dollars in public health funding and fired thousands of workers at federal health agencies. It has also curtailed FoodNet, stopping the program’s mandatory tracking of cyclospora and five other pathogens that together kill hundreds of people in the U.S. each year.

“You’re basically allowing for outbreaks to continue without being figured out. Invariably more people will get sick,” said Bill Marler, a Seattle-area food safety lawyer and advocate who has filed lawsuits against Taco Bell on behalf of people who allege they were sickened by cyclospora after eating there.

Under the changes to the FoodNet surveillance system, the 10 participating states — meant to represent a cross section of the broader population — no longer have to report cases of listeria, for example. That bacteria of people who are diagnosed with it.

Complications from listeria infections can include convulsions, miscarriage, and sepsis that damages organs. It’s much more rare than the type of E. coli bacteria still required to be tracked by FoodNet, but of people infected with listeria wind up hospitalized. Listeria infections result in an estimated according to numbers from the CDC and the Food and Drug Administration.

“It’s very hard to identify listeria outbreaks,” said Neal Fortin, the director of the Institute of Food Laws and Regulations at Michigan State University. Seeing it cut from FoodNet’s mandatory surveillance “really does disturb me,” he said.

Thirty-three people died and a pregnant woman had a miscarriage in 2011 after with listeria. The FDA identified the cause in .

States participating in FoodNet also no longer have to report illnesses caused by campylobacter, a bacteria often contracted from raw and undercooked poultry that afflicts an estimated 1.5 million people each year. The bacteria sickened about 60 people in Idaho this year in an outbreak linked to raw milk — a product Health and Human Services Secretary Robert F. Kennedy Jr. has championed, even though pasteurization kills harmful bacteria.

HHS denies that the changes to FoodNet or Trump administration staffing cuts have elevated the risk that future outbreaks will be harder to identify and stop.

“FDA investigators were not affected by staffing changes or force reductions, and the FY 2027 President’s Budget proposes a $33 million increase for food safety activities,” HHS spokesperson Emily Hilliard said in an email. And the CDC never stopped monitoring illnesses caused by cyclospora, she said.

The CDC has other, passive surveillance systems, but they rely on states to report problems.

“There’s no requirement of how long it takes them to do that,” said Barbara Kowalcyk, the director of the Institute for Food Safety and Nutrition Security at George Washington University.

And the FDA meets only a fraction of the number of inspections mandated by Congress. The FDA for domestic and foreign inspections since 2018, according to a report early last year by the Government Accountability Office.

Food safety by the FDA plummeted from 10,641 facilities in 2011 to about 4,500 a decade later. The agency had for domestic and foreign inspections in 2024, according to a GAO report.

That was before the Trump administration in a push to reduce federal spending.

Now, food safety leaders say the situation could get worse, because the Trump administration wants to push more routine food inspections to the states and further reduce the number of federal staffers that handle investigations and inspections.

State health departments are already overburdened from federal funding cuts and staffing shortages, forcing some to reduce or halt prevention programs so they can focus on more emergent concerns.

The cuts are being felt in Michigan, which has reported more than 7,000 cases of cyclosporiasis, the most of any state. The cyclospora parasite can cause frequent diarrhea that can last for days or even weeks, as well as abdominal pain, nausea, and fatigue.

The health department in Washtenaw County, Michigan, already pulled some staff off other work, such as immunizations and sexual health, to handle a recent measles outbreak that sickened seven people, including five kids. Now those same nurses are spending hours on the phone with hundreds of people with cyclosporiasis, trying to trace the source of their illness through weeks-old takeout receipts, bank statements, and recollections.

“We are starting to see the consequences of an underfunded public health system in 2026,” said Natasha Bagdasarian, Michigan’s chief medical executive. “Currently it’s cyclospora. Eventually, we are going to lose the ability to detect something else.”

This article first appeared on ��ýҕ�l Health News and is republished here under a .

Lawmakers Look To Make Abortion Shield Laws Less Dependent on Who’s Governor

Jackie Fortiér — Tue, 14 Jul 2026 09:00:00 +0000

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When Gov. Gavin Newsom, using his , refused to extradite a physician accused of prescribing and mailing abortion pills to a Louisiana woman, he said California would “not ever” allow “extremist politicians” to punish its doctors.

Newsom, who is considering a run for president, has long championed reproductive rights, but state lawmakers in the Democratically controlled California legislature know future governors might not have the same political beliefs.

Republican gubernatorial candidate Steve Hilton, a former Fox News host endorsed by President Donald Trump, has vowed to honor these types of extradition requests from other states if he’s elected, Louisiana “is trying to uphold what its people voted for, and California is undermining it.” His opponent, Democrat Xavier Becerra, has said he would deny the requests.

Legislation advancing in Sacramento is the latest chapter in a tit for tat that’s been happening between conservative and liberal states since 2022, when the U.S. Supreme Court overturned Roe v. Wade, ending federal legal protections for abortion.

by state Assembly member Rebecca Bauer-Kahan, which is being heard in committee, would take some decisions out of the governor’s hands, requiring governors to deny extradition requests for healthcare providers who prescribe abortion medication or administer gender-affirming care. It would also shield anyone in California who helped patients travel to California or another state to receive legal care. While opponents cast “shield laws” as an incursion on other states’ authority, supporters of the bill view it as insurance — even with Becerra leading Hilton 52% to 31%, according to by the University of California-Berkeley Institute of Government Studies.

Newsom spokesperson Marissa Saldivar said the governor doesn’t comment on pending legislation. Hilton and Becerra didn’t return calls for comment.

“Protecting providers from prosecution should not rely on shifting political winds or a single person’s decision,” said Alyssa Sherer, a nurse practitioner who spoke in support of the bill at a Senate committee hearing in June. Sherer is also the medical director at Hey Jane, a telehealth medication abortion provider.

Thirteen states have banned abortion outright, and 28 other states ban abortion somewhere between six weeks and viability. At the same time, other states that allow abortion have enacted shield laws to protect doctors and nurses from liability when they prescribe across state lines.

People living in states with total abortion bans are increasingly getting abortion pills prescribed via telehealth, from 74,000 abortions in 2024 to 92,000 abortions in 2025, according to the Guttmacher Institute, citing numbers from its Monthly Abortion Provision Study.

Critics of shield laws say that states have a legitimate interest in enforcing their own statutes and that such laws represent an attempt by some states, like California, to nullify the legal decisions of others.

“If California says, ‘We’re not going to honor any other state’s laws. We’re going to ship abortion pills into your states. You can’t have a law that says abortion is illegal,’ I don’t know — that doesn’t seem like a workable situation,” said Greg Burt, who is vice president of the California Family Council and has spoken in opposition to shield laws at the State Capitol.

Twenty-one other states and Washington, D.C., have similar shield laws, but Arizona, California, Michigan, North Carolina, and Pennsylvania’s rely on an executive order, which could be reversed by a successor, according to the Guttmacher Institute.

Amanda Barrow, a senior staff attorney at the Center on Reproductive Health, Law, and Policy at UCLA Law, said passing extradition protections would put California on firmer footing, because an executive order “could be revoked by a governor who is anti-abortion or anti-gender-affirming-care.”

Hilton has said he would do just that if elected.

“Just as I wouldn’t want to see Louisiana coming in and undermining something that we voted for here in California,” the GOP candidate told KQED in January.

During a , Becerra said he was strident about protecting reproductive rights as the state’s attorney general. “Absolutely no,” Becerra said of allowing California physicians to be extradited.

This year, Hawai‘i to its existing shield laws. And Oregon , including banning law enforcement from cooperating with out-of-state or federal investigations into care that’s legal in the state.

But Republican legislators in conservative states have cast telehealth visits as an end run around their laws. And some have moved to restrict abortion pill access.

The governors of , , and have signed bills this year that criminalize the sale, purchase, or distribution of medication that induces an abortion. Those states make it a felony to provide medication abortion drugs to people who are seeking to end a pregnancy. The laws impose up to 10 years in prison with potentially tens of thousands of dollars in fines.

Mississippi amended the state’s controlled substances code to add abortion pills as a criminal category. Although the state already prohibits abortion broadly, the measure specifically addresses distribution, which could subject out-of-state providers to prosecution.

In January, Louisiana a California doctor, Remy Coeytaux, mailing abortion pills to a patient. Newsom denied the request. Likewise, New York Gov. Kathy Hochul denied Louisiana’s February 2025 extradition request for a .

Texas has taken a slightly different legal tact. Attorney General Ken Paxton, a Republican running for the U.S. Senate, obtained a default judgment of more than $100,000 against the New York doctor targeted by Louisiana, but a , citing New York’s shield law. Neither Paxton nor Louisiana Attorney General Liz Murrill responded to requests for comment.

Fear of being charged with a crime for providing quality medical care is contributing to physicians leaving medicine, said Sacramento emergency room doctor Kamara Graham, who is vice president of the California chapter of the American College of Emergency Physicians, which is supporting the bill.

“It’s really conflicting and hard for us to weigh that concern of: Will I get extradited and charged and potentially be taken away from my family? Or do I do the right thing for my patient?” Graham said.

The availability of medication used in most abortions could soon change nationwide. Under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., the Food and Drug Administration it is conducting a safety review of mifepristone, one of two medications in pill form that is used in most U.S. abortions. The FDA maintains the drug is safe and effective.

If the FDA were to decide that mifepristone is not safe, such a ruling would supersede state laws, even in states where abortion is legal. If mifepristone is restricted, many telehealth groups have said they would switch to using only the other medication, misoprostol.

“The elephant in the room is whether the Trump administration, particularly after the midterms, makes some kind of move to put national limits on access to abortions,” said Mary Ziegler, a law professor at UC-Davis who has written several books on reproductive health law.

“Not everything is something that the legislature can solve for,” Ziegler said, “because there’s some uncertainty about how the federal courts are going to react to all of this.”

This article first appeared on ��ýҕ�l Health News and is republished here under a .

A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.

David Hilzenrath and Holly K. Hacker — Thu, 02 Jul 2026 09:00:00 +0000

In September 2016, a distraught mother sent infant formula maker Mead Johnson a message:

“REMOVE ME FROM YOUR LIST!!!! DO NOT EMAIL OR MAIL ME ANY MORE!

“It is because of your animal based pre-term artificial baby food crap that you peddle to hospital NICU’s that my son is dead from NEC.”

The mother was referring to neonatal intensive care units and necrotizing enterocolitis, an often fatal condition in which intestinal tissue can die and allow infection to spread through the body of an infant born prematurely.

In an internal memo, Mead Johnson cited its “extensive quality and safety checks” and concluded there was “not a reasonable possibility” that the formula caused the baby’s death. “No further investigation is needed. This file can be closed,” the memo said.

And with that decision, the company narrowed the chance that the mother’s anguish could draw attention to any danger the formula might pose to other infants.

The mother’s email and the company’s memo assessing it were used as evidence in the court cases and .

When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry.

Mead Johnson’s handling of the mother’s email showed how that can play out.

Under , if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate.

But it doesn’t always have to inform the government agency that oversees the safety of infant formula.

A company must complete an investigation and notify the Food and Drug Administration within only if it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.”

If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.

‘Never Reported’

Under the Freedom of Information Act, ��ýҕ�l Health News asked the FDA for all notifications that manufacturers of infant formula sent the agency per the regulatory requirement since Jan. 1, 2020. The agency’s Human Foods Program “did not receive any,” Kimberly Jones, a government information specialist at the FDA, responded in March.

��ýҕ�l Health News then asked the FDA to go back decades further — to Jan. 1, 2000. “After a diligent search of our files, we did not locate any responsive records,” Jones wrote on May 5.

The FDA’s search results were consistent with court testimony.

John Wallingford, a paid expert witness for Abbott, testified in a Missouri court in October 2024 that Abbott had under any regulation for preterm infant formula.

that he was not referring to adverse events in clinical trials, which are studies used for research and development and are subject to different procedures. Abbott informed the FDA about adverse events that occurred during a clinical trial, .

John Wallingford, an expert witness for Abbott Laboratories, testified in 2024 that, outside of clinical trials, the company had never reported to the FDA that there was a reasonable possibility a death was caused by an Abbott preterm formula, according to a transcript posted by the Missouri Court of Appeals Eastern District in an appeal of the Whitfield v. St. Louis Children’s Hospital case. (CVN courtroom video from the Whitfield trial.)

Christina Valentine testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her seven years as Mead Johnson’s medical director for North America. In the deposition, used in the Whitfield case, she said she never concluded there was a reasonable possibility that an infant’s death from NEC might have been related to a Mead Johnson product.

As medical director for North America, she was responsible for signing off on those determinations, she testified in the Watson trial.

In the deposition, Valentine said she wasn’t sure whether anyone else at the company sent a death report to the FDA.

In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added to the picture.

“Where there is a physician report that includes an opinion that one of our products caused NEC in a preterm infant, we have treated that as a ‘reasonable possibility of a causal relationship,’ and we submitted an adverse event report to the FDA,” she wrote.

“These physician reports were generally made by plaintiffs’ paid experts, with which we disagree,” she wrote.

O’Neill left unclear whether events Mead Johnson reported to the FDA were raised in lawsuits and, if so, whether the company reported them to the FDA before they surfaced in litigation.

Asked repeatedly when Mead Johnson filed the reports, O’Neill didn’t say.

It’s unclear why the FDA found no record of them.

Nor would O’Neill say whether the company submitted one related to the distraught mother’s September 2016 complaint.

That mother’s name wasn’t publicly disclosed in the court record containing her complaint.

“[P]rior to the current litigation, we received very few reports relating to our products and NEC and even fewer for which our investigation uncovered any evidence supporting a reasonable possibility of a causal relationship,” O’Neill wrote.

Industry personnel have reacted to some complaints with circular reasoning, as shown by court records from the Watson, Whitfield, and cases. Company personnel didn’t think their products caused harm, and they didn’t view new cases as evidence of harm, records show.

‘Reprehensible’ Conduct

About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost , according to a ��ýҕ�l Health News analysis of a for those years. The database doesn’t attempt to explain what caused those babies to develop NEC, and it doesn’t count babies who survived NEC.

A wave of lawsuits has alleged that infant formula made by Abbott or Mead Johnson harmed or killed preterm babies by causing or contributing to cases of NEC. As of late January, 1,760 NEC lawsuits were pending against Abbott, company spokesperson Scott Stoffel said, clarifying a disclosure in a .

This article is based largely on transcripts, deposition videos, and exhibits from three court cases that went to trial in 2024. The lawsuits were filed by parents of babies who suffered or died from NEC.

Abbott and Mead Johnson have denied fault. They, along with various medical authorities including and the , have said that, when nutritional needs can’t be met with human milk, formula is vital.

One of the cases, , led to a against Mead Johnson. , Gill v. Abbott, led to a against Abbott. , Whitfield v. St. Louis Children’s Hospital, et al., led to a jury verdict in favor of Abbott and Mead Johnson, but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and .

The judge’s ruling in the Whitfield case is on appeal.

On May 5, a Missouri appeals court against Abbott, saying “we find Abbott’s conduct significantly reprehensible.”

“Throughout the trial, the jury heard evidence that Abbott knew its formula posed significant risks to preterm infants weighing under 1500g yet made little effort to mitigate that risk,” the court wrote.

On June 12, an Illinois appeals court against Mead Johnson and sent the case back for a new trial. The trial court risked prejudicing the jury by improperly admitting evidence about Mead Johnson’s finances, including its revenues, profits, and executive compensation, the appeals court said.

In addition, the trial judge gave the jury erroneous instructions, the appeals court ruled. Any negligence on Mead Johnson’s part hinged on a failure to warn, and the company’s duty was not to warn the mother in that case of any danger, as she had claimed, but rather to warn doctors, the appeals court ruled.

In April, after another trial, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is contesting that verdict and the Missouri appeals court’s decision.

In at least four cases, judges have in favor of Abbott — ruling for the company before the lawsuits reached trial.

‘Branding NICU Babies’

Abbott makes Similac products, and Mead Johnson makes the Enfamil line.

The two companies have vied to place their products in neonatal intensive care units, which serve as entry points to hospital contracts and the retail market, ��ýҕ�l Health News reported in a March article based largely on records from court cases.

For instance, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”

A Mead Johnson slide for a 2020 national sales meeting outlined a plan for “Branding NICU Babies.” The slide featured a product for babies born prematurely transitioning to home. The slide deck was used in the Whitfield v. St. Louis Children’s Hospital lawsuit.

The litigation opened a wider window into the business and regulation of infant formula, including adverse event reports.

“Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints,” Stoffel said in November. “FDA routinely conducts audits that include Abbott’s adverse event investigations and reporting as part of its active regulation of infant nutrition.”

Mead Johnson’s O’Neill echoed that.

“Our adverse event reporting complies with all applicable regulatory requirements,” O’Neill said in a November statement to ��ýҕ�l Health News. “The FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.”

The reports the company filed with the FDA were submitted through the agency’s regional office in Detroit, she said.

It’s unclear whether the FDA looked in Detroit.

FDA rules require manufacturers to send written confirmations in the Washington area that oversees infant formula and other foods.

Asked if the company sent them to that office, O’Neill did not answer.

��ýҕ�l Health News requested an interview with Mead Johnson to clarify its statements about how it handled adverse event reports. The company did not grant one.

Plaintiffs have used internal documents from the companies to allege that, in house, people have long recognized a correlation between NEC and the use of preterm formulas made from cow’s milk.

For example, in a 2010 research proposal shown in a deposition used in the Gill case, Abbott scientists wrote that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”

An Abbott document from 2010 said necrotizing enterocolitis “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.” The document was displayed in deposition video clips ��ýҕ�l Health News obtained from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

A Mead Johnson document used in the Whitfield lawsuit cited “80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.”

Abbott that correlation does not equal causation.

“Numerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; it’s the absence of human milk that increases NEC risk rather than anything harmful in formula,” Abbott spokesperson Stoffel said.

The FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health weighed in with a in October 2024, saying, “There is no conclusive evidence that preterm infant formula causes NEC” and “there is strong evidence that human milk is protective against NEC.”

Mead Johnson’s O’Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.

O’Neill cited a statement by the saying the causes of NEC “are multifaceted and not completely understood.”

In a legal brief filed with an Illinois appeals court in the Watson case, the company said “the NEC related risks” of a formula for preterm infants “are the subject of medical debate.”

Managing Potential Warnings

Court records from lawsuits shed light on how the manufacturers have managed potential warnings from the field.

Fabrizis Suarez, who was director of medical safety and surveillance at Abbott from 2006 to 2023, said in a January 2024 deposition used in the Gill and Whitfield cases that he knew of no instance in which Abbott notified the FDA that a baby had died of NEC that could have been caused by Abbott’s formula for preterm infants.

There were numerous cases in which healthcare providers told Abbott they believed the formula caused the NEC, but Abbott disagreed every time, Suarez testified.

Abbott tracks and reviews every NEC report it receives and looks for patterns, Suarez testified.

Fabrizis Suarez, identifying himself as director of medical safety and surveillance at Abbott from 2006 to 2023, testified in a January 2024 deposition about Abbott’s handling of adverse event reports. ��ýҕ�l Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

Courtney Colombo, who identified herself in a March 2024 deposition used in the Gill and Whitfield cases as director of postmarketing medical safety and surveillance at Abbott, likewise testified that she knew of no instance in which Abbott reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a death caused by NEC.

Abbott from the FDA, according to testimony from Wallingford, a paid expert witness on regulatory matters who spent 10 years at the FDA. The complaints were in company files FDA inspectors reviewed during annual inspections, he said in the Whitfield case.

Wallingford also testified that inspections are for reporting infant deaths.

Questioning Wallingford in court, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché about the .

Wallingford declined to comment for this article. Valentine and Colombo did not respond to messages sent via LinkedIn. Valentine and Suarez did not respond to letters mailed to addresses that appeared to be associated with them. A letter to Colombo with signature required, sent to an address apparently associated with her, was returned unopened.

Not Publicly Reported

Adverse event reports can prompt the FDA to take action to protect the public.

For example, in 2011, the parents, caregivers, and healthcare providers not to feed SimplyThick, a thickening gel, to premature infants fitting a particular profile. The product, used to manage swallowing difficulties, might cause NEC, the FDA said.

The FDA first learned about possible problems with SimplyThick from physicians, according to an FDA document that an attorney for Abbott, Sierra Elizabeth, read from during the Whitfield trial.

The stakes for companies and consumers are high.

A finding under the “reasonable possibility” standard could trigger a product recall, said Martin Hahn, a regulatory attorney for Mead Johnson.

The FDA’s handling of adverse event reports for infant formulas — and fortifiers, which are used to nutritionally supplement a mother’s milk when babies are born prematurely — contrasts with its handling of reports about drugs and medical devices.

The FDA posts manufacturers’ adverse event reports on and online in databases available to the public.

But the notifications manufacturers are required to submit about formulas and fortifiers are not publicly reported, said Emily Hilliard, a spokesperson for the Department of Health and Human Services, which includes the FDA.

In addition, the FDA’s reporting requirements for drugs and medical devices are, in key ways, more demanding than those for infant formula.

Device makers not just deaths but also “serious injuries” that the product “may have caused or contributed to.”

Drugmakers are required to report any “” adverse event, “.” That fatal or life-threatening events.

The FDA also maintains a about dietary supplements, foods, and infant formulas, among other products, that includes from consumers and healthcare practitioners.

��ýҕ�l Health News searched that database and found one death report that mentioned NEC and a formula made for premature or low-birth-weight babies.

The search turned up seven other reports of infant deaths that mentioned NEC and fortifiers designed for premature or low-birth-weight babies. One of those reports, obtained by ��ýҕ�l Health News through the Freedom of Information Act, said three preterm babies at the same hospital had NEC and died within a month of one another in 2024.

The FDA cautions that reports are not verified and do not prove causation.

A former attorney for Abbott now leads the FDA.

Before becoming the FDA’s last year and being named acting head of the agency in May, Kyle Diamantas in the and lawsuits, court records show.

Diamantas “complies with all applicable ethics laws and regulations,” said Hilliard, the HHS spokesperson. “That included a specific recusal related to Abbott Laboratories, which concluded in January 2026.”

“During that period, Mr. Diamantas voluntarily recused himself from all matters involving infant formula to avoid any appearance of partiality,” Hilliard said.

‘No Health Hazard’

��ýҕ�l Health News asked the FDA a series of questions for this article. The agency left many unanswered.

“Infant formula safety is a top priority of the FDA given the vulnerability of the intended population,” Hilliard said.

��ýҕ�l Health News asked Abbott and Mead Johnson for data on all infant death reports the companies received and those they forwarded to the FDA. Neither company provided that information.

Court records provide fragmentary data.

Abbott lawyer Elizabeth said in court that, before Wallingford took the stand as an expert witness, the company gave him from 2005 through 2022 that contained the search term “NEC.”

When Wallingford went through the files, he found that mentioned death and NEC, he testified.

If Similac Special Care products for preterm infants were a problem, and if only 1% of adverse events led to a report, “you would expect to see of complaints,” Wallingford testified.

In 2010, a registered dietitian at a Cincinnati hospital notified Abbott that three babies had died of NEC shortly after starting on an Abbott formula. The dietitian thought there might be a correlation, according to an internal Abbott summary of the complaint shown during Colombo’s deposition. The babies, who were about 17 days old, had no complications other than prematurity, the summary said.

After reviewing the complaint, Abbott’s Colombo wrote, as shown in a deposition video, that she found “NO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE.”

“PREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD,” she concluded.

Courtney Colombo, who identified herself in a March 2024 deposition as director of postmarketing medical safety and surveillance at Abbott, testified about Abbott’s response to a report that three babies had died of NEC shortly after starting on an Abbott formula. ��ýҕ�l Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

As for Mead Johnson, Valentine “testified that NEC was not one of the top adverse event complaints for Enfamil premature formulas of the 68 received between 2015-2019,” O’Neill, the company spokesperson, told ��ýҕ�l Health News.

Valentine — who was Mead Johnson Nutrition’s medical director for North America from 2014 to 2021 and parent company Reckitt’s chief medical officer from 2022 to 2023, according to a LinkedIn profile — signed off on the decision to close the 2016 file on the distraught mother’s complaint, according to an exhibit and her deposition testimony played in the Whitfield trial.

When she signed off, Mead Johnson didn’t know which of its products the complaint involved, Valentine said in the deposition.

Asked about it during the Watson trial in February 2024, Valentine testified that, in light of the mother’s request never to contact her again, it wouldn’t have been appropriate to call her back for more information.

Valentine “testified that she believes that the Mead Johnson complaint team appropriately investigated reports of death from NEC based on the information provided,” Mead Johnson’s O’Neill said.

Valentine also testified that the FDA encourages infant formula companies to send in all adverse event reports and that nothing prevented Mead Johnson from doing so.

As reflected in an email thread used in the Watson case, Valentine reacted skeptically in 2019 when a colleague told her a particular hospital wanted to exit its contract with Mead Johnson.

“They had 3 cases of NEC since they started using our formulas. They had 0 cases when they were with Abbott,” the colleague reported.

Valentine agreed to follow up but added: “Sad but please reassure them we are not seeing this with our formula … so no science basis for sure.”

Christina Valentine, who was Mead Johnson Nutrition’s director of medical affairs for North America, testified that she approved the decision to close the company’s file on a 2016 complaint about a baby’s death. (CVN courtroom video from the Whitfield v. St. Louis Children's Hospital, et al., trial.)

Share your story with us: Do you have experience with necrotizing enterocolitis (NEC) or infant formula that you’d like to share? We’d like to hear from you. Click here to contact the ��ýҕ�l Health News reporting team.

This article first appeared on ��ýҕ�l Health News and is republished here under a .

Reporters Talk Through FDA Sunscreen Move and Closure of Rural Dialysis Clinics

Sat, 27 Jun 2026 09:00:00 +0000

��ýҕ�l Health News freelance contributor Michael Scaturro discussed the FDA’s new approval of a sunscreen chemical on Science Friday on June 19.

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Read Scaturro’s “FDA’s Greenlight of Old Chemical Offers Chance To Restore Faith in Sunscreen.”

��ýҕ�l Health News South Dakota correspondent Arielle Zionts discussed the closure of dialysis clinics in rural Nebraska on The Daily Yonder’s Yonder Radio on June 18.

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Read Zionts’ “Rural Nebraska Dialysis Unit Closes Despite the State’s $219M in Rural Health Funding.”

This article first appeared on ��ýҕ�l Health News and is republished here under a .

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