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 鈥� meant to represent a cross section of the broader population 鈥� 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 鈥� 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 吃瓜不打烊 and is republished here under a .

Can’t see the audio player? Visit kffhealthnews.org to listen.

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 鈥� 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, 鈥榃e’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 鈥� 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鈥榠 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 吃瓜不打烊 and is republished here under a .

“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 鈥� such as a report of an adverse event 鈥� 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.

鈥楴ever Reported’

Under the Freedom of Information Act, 吃瓜不打烊 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.

吃瓜不打烊 then asked the FDA to go back decades further 鈥� 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, .

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 鈥榬easonable 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.

鈥楻eprehensible’ Conduct

About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost , according to a 吃瓜不打烊 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 鈥� ruling for the company before the lawsuits reached trial.

鈥楤randing 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, 吃瓜不打烊 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 鈥� later used in the Whitfield trial 鈥� outlined a plan for “Branding NICU Babies.”

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 吃瓜不打烊. “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.

吃瓜不打烊 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.”

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.

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 鈥� and fortifiers, which are used to nutritionally supplement a mother’s milk when babies are born prematurely 鈥� 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.

吃瓜不打烊 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 吃瓜不打烊 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.

鈥楴o Health Hazard’

吃瓜不打烊 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.

吃瓜不打烊 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.

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 吃瓜不打烊.

Valentine 鈥� 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 鈥� 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 鈥� so no science basis for sure.”

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 吃瓜不打烊 reporting team.

This article first appeared on 吃瓜不打烊 and is republished here under a .

吃瓜不打烊 freelance contributor Michael Scaturro discussed the FDA’s new approval of a sunscreen chemical on Science Friday on June 19.

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

吃瓜不打烊 South Dakota correspondent Arielle Zionts discussed the closure of dialysis clinics in rural Nebraska on The Daily Yonder’s Yonder Radio on June 18.

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

This article first appeared on 吃瓜不打烊 and is republished here under a .

The drug is now marketed and sold across the state in roadside shops and small-town strip malls with little oversight from health authorities. Highway billboards advertise ivermectin as “Available Without a Prescription in Tennessee!” while dozens of pharmacies offer highly concentrated pills, sometimes at 10 or 20 times the potency of a standard tablet.

Ivermectin is a approved by the FDA for treating , which can generally be done with a single dose of three or four prescription-strength tablets. It is also used as a dewormer for horses and other livestock.

Its popularity surged during the pandemic as fringe doctors and anti-vaccine activists promoted it as a treatment for covid. have shown that ivermectin is against covid.

Nonetheless, it has since become a symbol of resistance against the medical establishment among conservatives and followers of the Make America Healthy Again movement, championed by Health and Human Services Secretary Robert F. Kennedy Jr.

Timothy Caulfield, a professor at the University of Alberta who studies health misinformation, said ivermectin became an “ideological flag” during the covid pandemic, opening the door for influencers to push the drug for other ailments to a “captured audience” even without proof it works for those conditions.

“This is really about profit. This is about political identity. This is about creating distrust in the existing biomedical community. This is about money,” Caulfield said in an interview with ABC News, which partnered with 吃瓜不打烊 to report on ivermectin.

After a hantavirus outbreak on a cruise ship earlier this year, unproven claims that ivermectin is effective against the virus have been spread by some popular social media accounts and right-wing figures, including former congresswoman . The World Health Organization says it has seen that shows ivermectin is an effective hantavirus treatment.

Tennessee’s ivermectin bill was shepherded by a Republican supermajority in 2022. Its passage blindsided state medical officials and handed a victory to medical groups that spread covid misinformation.

Some pharmacy websites now offer the drug as a treatment for covid, “long haul vax symptoms,” diabetes, or cancer — despite no evidence of its effectiveness for those purposes — while the largely gives pharmacists immunity from lawsuits or professional sanctions related to ivermectin.

The law was also a harbinger of legislation to come: More than two dozen states have since considered look-alike bills that would make the politicized medication available without a requiring a doctor visit. 

John Mafi, a UCLA internal medicine physician who has studied the rise of ivermectin among cancer patients, worries it will lure people away from proven treatments. He co-authored a new study in prescribing rates for ivermectin and another antiparasitic drug, particularly in the South. The rise followed a January 2025 episode of the Joe Rogan Experience podcast in which actor Mel Gibson claimed ivermectin and other drugs cured three friends with stage 4 cancer.

“It’s going back to 19th-century quack science,” Mafi said about off-label use of ivermectin. “It is alarming that I’m seeing this really unproven therapy being touted to so many potentially vulnerable Americans.”

The FDA says ivermectin can be . Tennessee has seen a small but concerning rise in signs of overuse. The Tennessee Poison Center, which fields calls from people exposed to drugs or toxic substances, received more than 60 calls for possible ivermectin poisoning in 2025, the most since 2021. They included reports of vomiting, blurred vision, neurological problems, and difficulty walking.

“People are taking this because they just feel unwell. It’s almost like a panacea now,” said Rebecca Bruccoleri, the poison center’s medical director. “I’ve heard rumblings on the internet of using ivermectin for an alternative cancer treatment, and we’re seeing it definitely in here.”

Pharmacist Paul Hughey has dispensed ivermectin under the new law at two Tennessee pharmacies: Mt. Juliet Pharmacy and Compound Rx. He estimated that “up to 20 people in a week” are buying ivermectin but that peak demand was double or triple that amount.

For years, Hughey said in an interview, customers have relayed emotional “testimonies” about the drug healing the sick, “especially with the cancer patients.”

“I’ll get a doctor call in and they say: ‘Guess what. So-and-so is cured.’ And it’s just amazing to hear that. So anybody who doubts that,” Hughey said, “I don’t really know that they’re practicing medicine. I think they’re just following the narrative.”

‘I’ve Taken Bucketloads of This Stuff’

The linchpin of Tennessee’s ivermectin market is , a conservative doctor to the creation of the 2022 ivermectin law. She has with pharmacies across the state empowering them to sell the drug.

Tennessee’s law to dispense ivermectin without a specific prescription for each patient, through a “collaborative pharmacy practice agreement” with a doctor who provides what is functionally a pre-written, nonspecific prescription for all potential customers.

In podcast interviews, Sibley has said she has made as many as 40 of these agreements with Tennessee pharmacies, which she said forward her the paperwork on each ivermectin customer. Before selling the drug, pharmacies are required to ask customers questions about medical conditions and medications that could cause complications if taken with ivermectin. Afterward, the collaborating physician also is expected to receive a record for each person who purchases ivermectin.

“We literally have folks coming from all over the world to get our ivermectin,” Sibley said on in February 2025. “As the collaborator for these pharmacies, I get every person’s sheet.”

“They’re from every state,” she said. “They’re from Canada. They’re from Europe.”

Sibley did not respond to requests for comment.

吃瓜不打烊 has independently confirmed that Sibley signed agreements with at least 10 pharmacies. The agreements say pharmacists shall dispense ivermectin only in Tennessee, where Sibley is licensed, although one of those pharmacies said friends and family in Tennessee can “.”

Hughey, the Tennessee pharmacist, said Sibley had prescribing agreements ready to go when the law was enacted. He credited her with advancing ivermectin sales throughout the state.

“Had Dr. Sibley not stepped in and really pushed forward, there’s no telling how hard it would have been,” Hughey said. “It would have been a lot less widespread.”

Sibley also works with Children’s Health Defense, the Kennedy-founded group that has become one of the nation’s most influential anti-vaccine organizations. In podcasts, Sibley has referred to the covid vaccine as a “” and “ that’s ever been produced.”

Separately, before Tennessee legislators in 2024 about an alleged plot to change the weather and block sunlight. The New York Times then included her .

Sibley has said in podcast interviews that she was told by God to treat covid patients. She said she has advocated for ivermectin ever since.

“God agrees with what I’m doing,” Sibley said in 2023 on the podcast , which is recorded in Nashville. “I wake up every day and I say: ‘Yes, sir. I’m reporting to duty.’”

In legislative and government hearings throughout 2022, Sibley testified that she had treated around 4,400 people with ivermectin, including some Tennessee lawmakers, all without taking payment. Sibley described ivermectin as “a wonder drug” and said making it more available “.”

“I’ve taken bucketloads of this stuff myself,” Sibley said . “I feel like I’ve been a good test subject.”

Sibley has said she dispenses ivermectin using treatment guidelines developed by Paul Marik, who in 2020 co-founded the Independent Medical Alliance, a medical group that has promoted ivermectin as an effective treatment for , , , and .

Some Tennessee pharmacies now follow those protocols, too. The protocols recommend patients take 1.5 to five times as much ivermectin as is normally prescribed to treat parasites, with the dose taken for days or weeks instead of just once.

Marik and other ivermectin proponents sued the FDA in 2022 after it discouraged the use of the drug for covid by tweeting: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The agency settled the lawsuit with no admission of wrongdoing and deleted the viral tweet in 2024.

The American Board of Internal Medicine has revoked Sibley’s and Marik’s board certifications but declined to explain why. Sibley still holds a Tennessee medical license; Marik is based in Virginia and is not licensed. Sibley and Marik the internal medicine board’s actions.

In response to questions from 吃瓜不打烊, Marik, through an Independent Medical Alliance spokesperson, said medical science benefits from “open discussion of ideas and treatments.”

“Many independent doctors have reported that treatments like Ivermectin, in conjunction with traditional treatments, are showing promise. These ideas should be explored,” alliance spokesperson Lynne Kristensen said in an emailed statement.

Marik testified in favor of Tennessee’s ivermectin legislation in 2022, telling lawmakers that it is necessary because people would otherwise buy animal-grade ivermectin in stronger dosages meant for livestock.

“They’re buying ivermectin from farm stores. We don’t know the quality,” Marik said at a March 2022 legislative hearing on the Tennessee bill. “So this would prevent that from happening.”

Tennessee Does Not Track Its Ivermectin Market

Arkansas, Idaho, Louisiana, and Texas enacted similar laws in 2025, and legislation that makes ivermectin available without the need for a doctor visit has been introduced or debated in at least 24 other states, according to a 吃瓜不打烊 analysis. That means half the country could be following Tennessee down an unlit path, because no one knows the full scope of its ivermectin market.

Tennessee does not effectively track which pharmacies offer ivermectin this way, and the state government has been unable to produce some foundational documents that pharmacies are legally required to file before they sell the drug, according to a 吃瓜不打烊 investigation.

Doctors and pharmacies are the Tennessee Department of Health when they sign agreements that allow ivermectin to be dispensed without patient-specific prescriptions, although it is not clear whether this consistently occurs.

In response to a 吃瓜不打烊 public records request for those ivermectin notifications filed by pharmacies, the agency over three months produced records from only 12 pharmacies, half of which have agreements with Sibley. The agency said it did not locate records related to at least 13 others that 吃瓜不打烊 has identified as selling ivermectin without requiring individual prescriptions.

Department of Health spokesperson Dean Flener said the agency would not answer questions about whether or how it regulates ivermectin or the pharmacies that distribute it.

Tennessee has said it does not track how much of the drug is sold in the state, and the amount is not well captured by federal or insurance data sources. That’s because the drug is often sold at compounding pharmacies, which make customized medications that are not FDA-approved and rarely covered by insurance. Drugmakers and wholesalers did not respond to questions about how much ivermectin they supply to pharmacies in the state.

Even the Independent Medical Alliance, one of ivermectin’s , says it doesn’t know how much is flowing through Tennessee.

States are getting pressure from clinicians ”who have had success with the use of ivermectin,” said IMA President Joseph Varon, a physician based in Houston. “That’s what happened in Texas, and that’s what happened in Tennessee.”

‘An Unproven, Potentially Unsafe Drug’

Once signed by Tennessee Gov. Bill Lee, the state’s ivermectin law took effect immediately — even before the state’s physician and pharmacy licensing boards created rules to guide the process, which Tennessee law also requires. 

Some board members were shocked.

“We’re talking about an unproven, potentially unsafe drug,” Shant Garabedian, a doctor on the state’s Board of Osteopathic Examination, said of off-label ivermectin use during a . “It’s already law. Somehow it passes without our sort of input.”

In meetings that followed, at least five members of Tennessee’s medical boards voiced concerns about the law beyond safety and efficacy. Some said pharmacists could overcharge for a drug that normally costs pennies per pill. Some worried that a loosely regulated, cash-based ivermectin market might attract shady characters, especially because the law also shields prescribers from ivermectin-related civil lawsuits.

“This involves no clinical engagement,” Melanie Blake, then-president of the Board of Medical Examiners, said during a . “If they’re exempt from liability as well, I hate to think of things that individuals could do just to make money, but this would be one.” 

The boards eventually enacted regulations affirming that ivermectin could be dispensed without any diagnosis. Board members said the law left them no choice.

“This is more of a situation where, legally, the legislature has decided for us,” John McGraw, another board member, said in a . “This has sort of tied our hands in a lot of ways.”

The first known sale under the new law occurred in Sibley’s home of Johnson City, a city of about 74,000 people in northeastern Tennessee. According to a , Sibley entered into a collaborative agreement with pharmacist Josh Harrison at The Compounding Lab, which dispenses drugs for people and animals. 

The first customer was Bernadette Pajer, an anti-vaccine activist who has worked with Children’s Health Defense. In a of the Nashville podcast Rebunked With Scott Armstrong, Pajer said Sibley was a medical adviser for the group and described the first ivermectin sale.

“On that day, she was the doctor, he was the pharmacist making the sale, and I was the first customer,” Pajer said. “So that was pretty cool.”

Ivermectin pharmacies have spread across the state. In the suburbs of Nashville, Roman Pharmacy advertises ivermectin on at least four billboards along Interstate 65, and is mostly focused on the drug. Outside Knoxville, allows customers to order ivermectin for multiple sclerosis and Parkinson’s disease, or “to use it to detoxify.”

Roman Pharmacy did not respond to interview requests. Fresh Pharmacy declined an interview.

In Chattanooga, the Medicine Counter pharmacy says on its website that ivermectin should be taken “only as prescribed by your healthcare provider.” And yet the pharmacy sells some of Tennessee’s available without a prescription from a doctor — up to 21 times as strong as a standard tablet, for nearly $19 per pill — according to the 吃瓜不打烊 analysis.

Himanshu Patel, Medicine Counter’s head pharmacist, declined to be interviewed. He said in an email that the pharmacy operates in a “very competitive market” and that its strongest pills were below the maximum dose for humans evaluated by the FDA for safety purposes.

And then there is Compound Rx, which, in addition to selling ivermectin in its store, has built a website in preparation to ship nationwide. The site, which is in “test mode,” cannot currently make any sales. It also asks customers how they heard about the pharmacy, with a dropdown menu of answers that features right-wing figures such as Donald Trump Jr., Steve Bannon, Laura Ingraham, and Kevin Sorbo.

Who is not listed as an option? Your doctor.

Hughey, the Compound Rx pharmacist, said he wasn’t involved with the website, which he said may never launch.

The highly concentrated pills are a concern for Tennessee state Sen. Richard Briggs, who worries lawmakers have created a “dangerous” ivermectin market rife with “misleading advertising” about what the drug can actually do.

Briggs, who is a surgeon and the only Republican who voted against the ivermectin bill in 2022, said he planned to introduce legislation to rein in the sale of ivermectin when lawmakers reconvene in 2027.

“But it may be a hard sell, because with the anti-vaxxers and some of these other folks,” Briggs said. “We don’t base a lot of things that we do on science, data, or facts. To a lot of folks in the legislature, the facts are just an inconvenience.”

‘Enough Trouble With Ivermectin’

Lawmakers in at least seven states have considered ivermectin legislation this year, including Alabama, Florida, Oklahoma, and South Carolina. If enacted, these bills would allow people to obtain ivermectin without an individual prescription, like in Tennessee, or make it available over the counter.

Kennedy praised such legislation at an event in Texas last August.

“I think it’s a really good bill,” he said of Texas’ ivermectin legislation, according to . “I think Americans should have the choice.”

But proponents have hit roadblocks. A Utah bill failed to advance out of the state House this year. In Oklahoma, some lawmakers have put up a fight.

“I’m a scientific person. I need to see some research and some data that shows what we’re treating,” Oklahoma state Rep. Cynthia Roe, a Republican and nurse practitioner who opposes the state’s ivermectin bill, said in an interview. “And God forbid somebody start giving it to their kid.”

Back in Tennessee, one of the medical boards that was alarmed when the law was enacted in 2022 started to distance itself from ivermectin altogether.

In January, the Board of Medical Examiners grappled with how to punish Ricky Lee Jackson, a doctor who was licensed in Tennessee and had been sanctioned and fined by Washington state’s medical commission. The Tennessee board normally mirrors punishments from other states without hesitation. But the Washington case centered on Jackson prescribing ivermectin for covid, which in Tennessee no longer required a patient to see a doctor.

After a debate, the board voted to reprimand Jackson — but told its staff to ensure the public record made .

“This board has been in enough trouble with ivermectin,” member Keith Anderson said, according to a . “Maybe we ought to just leave that out.”

journalist Blake Farmer and reporter Adam Friedman contributed to this report.

This article first appeared on 吃瓜不打烊 and is republished here under a .

He also had holdings in Altria and a third leading tobacco company, though an apparent discrepancy in his disclosures clouds the extent of his investments. In 2025, tobacco interests donated $6 million to MAGA Inc., a super PAC that supports the president, and Trump’s inauguration. And, on April 30, a week before FDA guidance that provided a critical boost to the industry, Reynolds American dropped an additional $5 million into the super PAC’s coffers.

The stock trades and political contributions occurred as the Trump administration pursued a broadly pro-tobacco agenda: Its FDA piloted a fast-track program to approve nicotine pouches. It unveiled a program to allow vapes on the market more rapidly, despite resistance from career civil servants and leadership, culminating this year in guidance waving through flavored electronic cigarettes. It cut public health employees focusing on anti-tobacco policy. And it broadened enforcement against illicit e-cigarettes, competitors to the big industry players with a financial relationship to Trump.

It amounts to the most pro-tobacco, pro-nicotine presidency in some time 鈥� a remarkable policy given the tens of millions of deaths cigarettes caused during the 20th century. Even in recent years, anti-smoking groups say a half-million Americans a year die from cigarettes. Industry advocates say the toll helps justify a shift to e-cigarettes and nicotine pouches, which they say are less harmful. However, public health advocates say these products carry their own risks, such as addiction.

Lawmakers and public health leaders have criticized the recent FDA guidance and approvals as a “” that ignored scientific evidence to deliver what investment analysts have described as “very positive” steps for influential tobacco companies.

The scale of the money is “unprecedented and problematic,” said Brian King, who was pushed out of the FDA’s tobacco office last April and now works as an executive at the Campaign for Tobacco-Free Kids. He fears that steering public policy toward tobacco 鈥� still addictive and harmful to health 鈥� puts Americans at risk.

“It’s a gift on a platter with a side of public health malpractice,” he said.

The White House did not comment on the president’s investments or industry donations to MAGA Inc. Spokesperson Kush Desai said, “The only guiding factor behind the Trump administration’s health policymaking is Gold Standard Science. FDA’s regulatory treatment of nicotine pouches and vapes is rooted in recent evidence that has found that these products can help adults quit smoking.”

Philip Morris disputed any connection. Company representatives “regularly attend events and forums where we share our commitment to improving public health in the United States,” spokesperson Samuel Dashiell said, “starting with providing better options to America’s 45 million legal-age nicotine consumers.”

“We do not comment on individual engagements or on the personal financial matters or disclosures of public officials,” he added.

Other tobacco companies whose stock Trump has bought and sold during his second term or that donated to groups aligned with Trump 鈥� Juul, Reynolds American, and Altria 鈥� did not respond to requests for comment.

The financial stakes are huge. Investment analysts at Goldman Sachs say the newer products, touted as safer, make more money per sale than traditional cigarettes. Philip Morris expects Zyn pouches, for example, to make eight times the gross profits of its cigarettes, Goldman Sachs analysts said in March 2025.

When he ran for his second term, Trump promoted himself as a pro-tobacco candidate, posting that he had and that President Joe Biden and Democratic nominee Kamala Harris “want everything banned.”

Since late 2023, MAGA Inc. has received over $20 million in funding from the industry, federal campaign records show. Trump’s inauguration garnered nearly $4 million more. His ballroom project donations of an unknown amount from Altria and Reynolds American.

Recent Trump administration actions show he’s followed through with his campaign rhetoric. In May, the FDA released that allows manufacturers to market their vapes and nicotine pouches while awaiting agency approval. It also approved several vaping products. The month before, the Vapor Technology Association, which donated $1.25 million to Trump’s inauguration, it had met with the White House to discuss its concerns.

By that point, Trump had gone on a stock-purchasing spree. In March he made eight separate purchases of Philip Morris or Altria stock, worth as much as $275,000, according to a disclosure form that bears Trump’s signature.

It is difficult to be precise about Trump’s tobacco investments, because the financial disclosures show only ranges of investment amounts. They also have an apparent discrepancy. In January, the president sold $500,000 to $1,000,000 in Altria stock. But that’s confusing because previous disclosures didn’t show Trump held that much equity in Altria. The White House declined to comment on the matter.

The FDA’s May guidance and approvals drew condemnation from public health leaders, who worry that the agency is allowing products with flavors especially appealing to young people. “After years of recognizing the dangers flavored e-cigarettes pose to youth, it is deeply troubling to see FDA ignore the scientific evidence and reverse course,” American Lung Association CEO Harold Wimmer said .

“I think it’s blatantly illegal, both on its merits and also procedurally, because it was issued as a final guidance without even giving the public an opportunity to comment on it,” said Mitch Zeller, a former head of the FDA’s tobacco center.

A group of Democratic senators called the decision a “a free pass to addictive and harmful vapes” in letters to Reynolds American and Altria. It would lead to “a lucrative payday after years of unsuccessful legislative and regulatory efforts to weaken federal tobacco oversight,” they concluded.

Members of Congress are barred from insider trading, and many legislators would like to see trading of individual company stocks banned for all members. In the wake of Trump’s most recent financial disclosures, with revelations that he often traded in companies manufacturing GLP-1 drugs before his administration steered policy in a favorable direction, some members are calling for the president, too, to be barred from stock trading.

Trump’s tobacco policies have garnered favorable grades from investors. At Goldman Sachs, bankers described the May FDA guidance as “very positive” for Philip Morris and “a significant step in the FDA’s positioning toward enforcement and acceptance of nic pouch (as well as e-vapor) innovation generally.”

And Barclays analysts said the FDA’s guidance was good news for Juul, a leading vape producer. (In November, the company contributed $1 million to MAGA Inc.)

FDA resistance to speeding up approvals for these products reportedly contributed to the ouster of agency commissioner Marty Makary, who did not respond to requests for comment. According to and , the White House repeatedly intervened in the approval process.

“I served during the entire first Trump administration as center director, and there was never any pressure from any political appointee at FDA, at HHS, or the White House when it came to application review,” Zeller said.

But recent changes in FDA policy can be traced to the access tobacco firms have had to the White House, he said.

By and large, the Trump administration has delivered on industry priorities. Soon after the inauguration 鈥� which tobacco companies had donated heavily to 鈥� the administration withdrew a Biden-era proposal to ban menthol cigarettes. The administration has eased the path for nicotine pouches like Zyn, which were first approved under Biden. Investment analysts viewed government crackdowns on illicit e-cigarettes positively: Barclays wrote in January that “company commentary on enforcement has also been upbeat, suggesting that the tide could begin to turn in favour of the legal players in the market.”

What’s more, the Trump administration’s government layoffs have decimated public health’s tobacco control offices. The work of the Centers for Disease Control and Prevention’s office of smoking has been sharply curtailed; its flagship “Tips From Former Smokers” campaign, which seeks to persuade viewers not to smoke, has been off the air for months, King said.

“It’s not difficult to see that less dollars invested in prevention and control is going to lead to more tobacco product use and tobacco-related disease,” King said, especially given the government’s decades-long success in reducing cigarette usage.

The shift is particularly ironic given the administration’s focus 鈥� through its Make America Healthy Again slogan 鈥� on chronic disease. “Attempting to combat chronic disease without tobacco control is like attempting a triathlon without a bicycle: You are destined for failure before leaving the starting line,” King concluded.

This article first appeared on 吃瓜不打烊 and is republished here under a .

“Bemotrizinol has been used safely in Europe for decades,” Health and Human Services Secretary Robert F. Kennedy Jr. about the approval. “FDA’s action will increase competition and consumer confidence in sunscreen products.”

Nonprofits that advocate for health, such as the Environmental Working Group, and the skin care industry alike had lobbied for approval of the ingredient, which makes sunscreens sheerer and lighter on the skin than many available American options while blocking a wider spectrum of ultraviolet rays that can cause premature aging and skin cancer.

The newly approved sunscreen filter will allow companies to reformulate sunscreens to address consumers’ concerns, said Carl D’Ruiz, a senior manager at , a Swiss maker of sunscreen chemicals that applied for the FDA approval. In addition to allowing companies to offer what the FDA calls safe and effective formulations, he said, the approval will allow sunscreens that are more like sought-after South Korean brands to be sold in the U.S. by autumn.

Confidence in U.S. sunscreen has faltered on two fronts: among those concerned about what’s in the sunscreens they use and those who believe sun exposure is healthy. But will the new ingredient win the trust of Make America Healthy Again skeptics and Gen Zers intentionally tanning? RFK Jr., strikingly bronzed, has helped stoke this confusion by pledging in 2024 to fight what he called the FDA’s “war on public health” and . Under his leadership, the FDA from a plan in March to ban people under 18 from using tanning beds.

All this matters because by age 70 in the United States. It is the in the nation, where about 3.3 million people are diagnosed each year with basal and squamous cell carcinomas.

D’Ruiz said he thinks bemotrizinol, also known as BEMT, will change the dynamic. “People will talk more positively about sunscreens,” he said.

In the U.S., new sunscreen chemicals are regulated as over-the-counter drugs like aspirin or cough syrup rather than as cosmetics, as in Japan and the European Union. That means they face more elaborate testing and safety protocols, such as animal testing that runs afoul of EU laws, which is why the for bemotrizinol took nearly two decades, D’Ruiz said.

What’s “generally recognized as safe and effective,” otherwise known as “GRASE” in FDA-speak, is at the center of the American sunscreen debate. Bemotrizinol joins zinc oxide and titanium dioxide on the FDA’s .

That could help rebuild trust, said , an environmental epidemiologist at the , a nonprofit that researches the ingredients in consumer products.

“It has strong safety data,” Friedman said. “The documents submitted to the FDA to achieve 鈥榞enerally recognized as safe and effective’ include tests of irritation, sensitization to allergies, two-year animal studies for carcinogenicity, and reproductive health.”

The approval will also give consumers access to sunscreens that don’t leave as much of a white cast, she said, which makes some people hesitant to use mineral sunscreens such as zinc oxide and titanium dioxide.

Bemotrizinol’s approval won’t change the possibility of several chemicals with unclear safety profiles being added to sunscreens.

In 2019, the there was insufficient data to support a positive “generally recognized as safe and effective” determination for 12 commonly used sunscreen chemicals.

The concerns emerged after the that said some sunscreen ingredients had been found in humans’ bloodstreams. Though the industry has since phased out several of those chemicals lacking GRASE status, four are still widely used: avobenzone, homosalate, octisalate, and octinoxate.

“The European Union had that homosalate was not safe at concentrations that they were using and recommended a very low percentage 鈥� which was effectively a ban,” Friedman said. “The U.K. also issued a safety evaluation.”

Octisalate and octinoxate have been associated with disruption of the endocrine system, and octinoxate was due to concerns that it harms marine life and bleaches coral reefs.

Avobenzone breaks down when exposed to light, making it less effective, Friedman said, and has been associated with allergic reactions.

Mark Mitchnick, a pediatrician who , which is known under the brand Z-Cote, said bemotrizinol will give chemists a new tool to make sunscreens that people will want to wear.

“It’s a good UVA block,” he said. “It gives us good flexibility. In my mind, it allows you to make really good products without using avobenzone, which I think has a lot of baggage.”

Most of the UV rays people are exposed to are UVA rays that can penetrate the middle layer of the skin and cause up to 90% of skin aging, along with a smaller amount of UVB rays, which are . falls on the electromagnetic spectrum between X-rays and visible light.

Mitchnick said major companies have used chemical filters because they work better on a per-pound basis compared with mineral sunscreens made with zinc oxide and titanium dioxide. “That’s why hybrids are great 鈥� you get the best of both worlds.” He said he expects companies, including , to release hybrid products containing bemotrizinol and zinc oxide later this year.

J. Frank Nash, a senior director and research fellow at Procter & Gamble, said skepticism about sunscreen is unfortunate because properly formulated sunscreens do an excellent job blocking solar UV, “which we know is responsible for skin cancers and aging.”

He worries the industry has contributed to the trust gap by , called boosters, to mineral sunscreens, to raise sun protection factor ratings, or SPF. This leads consumers to wonder what’s in the products they’re buying.

Still, in Australia, where bemotrizinol has been used in sunscreens for years, a shows that even when regulators allow lauded UV filters, bad actors can taint a whole industry.

“People are not shunning sunscreen because they have stopped believing UV is dangerous,” said Joseph Mizikovsky, a director of the . “They are shunning it because they have lost trust in what is in the bottle.”

He applauds the FDA’s transparency with American consumers about the lack of safety data for filters without GRASE status, and FDA’s insistence on mandatory microbial testing of products.

But he said the FDA could do more to rebuild trust in sunscreens.

“My view is the FDA should move faster to ban filters that are missing safety data, and the public should focus on physical protection 鈥� shade, clothing, hats, sunglasses 鈥� with sunscreen as the last layer, not the first.”

This article first appeared on 吃瓜不打烊 and is republished here under a .

The 31-year-old compliance consultant from Hendersonville, Tennessee, said she couldn’t stop vomiting.

“Sunday morning, it all hits,” McClain recalled, as she described what happened that weekend in January. “I can’t keep anything down.”

McClain said she thought the dosage the telehealth company had prescribed seemed too high. She tried to contact her doctor, but when she didn’t get an immediate response, she said she called the company and a “care team” representative confirmed the instructions — which said to inject 2.21 milligrams of the semaglutide medication once a week — were correct.

It turned out, however, that was nearly nine times the amount patients are typically told to take for their first dose.

Nearly a month after she was diagnosed with an overdose, McClain said she was “still dealing with the residual side effects,” including an elevated heart rate and vision problems she felt were tied to the medication.

Most patients who have taken a GLP-1 received their prescription through a primary care doctor or a specialist, shows. But as the uptake of telehealth has grown substantially since the start of the covid pandemic, McClain is one of millions of Americans who have used online companies to meet a variety of their medical needs.

Many of the companies have started offering GLP-1 medications for weight loss as demand for these drugs has exploded. But certain medication errors tied to GLP-1s have exploded too, according to a 吃瓜不打烊 review of Food and Drug Administration data, and physicians and telemedicine researchers worry that adverse experiences tied to telehealth companies are becoming more common.

Bad outcomes aren’t unique to telehealth providers or to the compounded weight loss drugs many of them offer. In fact, product liability lawsuits alleging patient injuries have been filed overwhelmingly against pharmaceutical giants Eli Lilly and Novo Nordisk, which manufacture name-brand weight loss drugs, court data shows. The drugmakers have defended their products.

However, some critics are also concerned that getting a weight loss prescription online is usually much easier than getting one through an in-person appointment. Not only do many telehealth companies write quick prescriptions for GLP-1s, but they often sell the medications, too, allowing patients to bypass in-person pharmacy visits. This one-stop shopping isn’t necessarily a good thing, according to critics who say some telehealth providers are writing prescriptions for people who should not be taking GLP-1s and then providing little or no follow-up care.

“It gives a black eye to telemedicine,” said Elizabeth Krupinski, an experimental psychologist at Emory University who has conducted research on the effectiveness of telehealth.

Telemedicine stands to benefit “so many people,” Krupinski said, particularly when the technology is integrated within a larger healthcare system. That way, patients benefit from the convenience of telehealth while maintaining a connection with their in-person providers.

But some telehealth companies are marketing GLP-1s as an easy way to lose weight — sometimes with the help of paid celebrity endorsements — without emphasizing the importance of healthy eating and exercise, she said.

They may be following the letter of the law, Krupinski said. But writing prescriptions while skimping on care “is not in the Hippocratic oath.”

The Perfect Storm

Starting around 2020, many states loosened restrictions on telehealth, which allowed online companies to proliferate. This helped accommodate patients who could not, or chose not to, be seen in person at the height of covid transmission.

Expanded telehealth access was also intended to lower barriers in rural communities, as well as mitigate doctor and nurse shortages. In many places, telehealth doctors and nurses are legally allowed to treat patients across state lines. But the way telemedicine is practiced , and state laws largely dictate rules that telehealth providers must follow.

Some companies, such as Mochi Health, require patients to meet virtually with a provider, such as a doctor, nurse practitioner, or physician assistant, before they can get a GLP-1 prescription.

But others, including Ro, sometimes require nothing more of patients than an “asynchronous” evaluation, which does not include a live conversation with a healthcare provider. During this type of evaluation, customers are typically asked to fill out an intake form and answer a medical history questionnaire before they are evaluated for a prescription. Ro requires a conversation in real time when required by state law, or when requested by a patient or clinician, said Nicholas Samonas, a spokesperson for the company.

“Every patient is counseled by their provider on the potential benefits and risks of treatment based on their individual medical history,” Samonas said. Ro’s clinicians can order lab work when necessary and, when appropriate, may recommend patients seek in-person care, he said.

But some medical experts are concerned that virtual care may be insufficient for prescribing weight loss drugs.

Patients with a history of pancreatitis, for example, should be counseled about potential complications, medical studies show. The same goes for people with a condition called gastroparesis, which affects stomach nerves and muscles, and those susceptible to medullary thyroid cancer.

Some patients may also benefit from blood work or muscle mass screening before starting a GLP-1.

But not all telehealth companies are adequately evaluating patients before writing prescriptions, said Marc-Andre Cornier, an endocrinologist at the Medical University of South Carolina and the immediate past president of The Obesity Society.

When it comes to parsing the good from the bad, “whose job is it to police that?” he asked. The problem, he said, is there aren’t criteria written by a government agency or a medical society to determine which providers are treating patients appropriately and which aren’t.

While the first GLP-1 was approved by the FDA more than 20 years ago, to treat Type 2 diabetes, the use of these drugs took off in 2021 when Novo Nordisk received approval for a semaglutide drug to treat obesity, with the brand name Wegovy. In a 2025 KFF poll, said they had taken a GLP-1.

In a in The New England Journal of Medicine, physician Amanda Banks noted that the proportion of GLP-1 prescriptions written for people who were not diabetic, obese, or overweight increased from 4.5% in 2018 to 17% in 2023.

In the paper, Banks called it “troubling” how easy it is to obtain a prescription for weight loss drugs and worried they might exacerbate existing eating disorders or cause new cases, including of anorexia.

Cornier, who has received compensation from Novo Nordisk for serving as a consultant, echoed some of Banks’ concerns. “It’s not just filling out a form online and then having some random healthcare provider sign off on it,” he said. “There are concerns with some of these online programs that there’s not a proper evaluation, there’s not a baseline, and there’s not proper supervision.”

The American Telemedicine Association, which advocates for the expansion of “digitally enabled care,” has not addressed how telehealth providers prescribe GLP-1s, spokesperson Gina Cella said.

“This is a bit out of our scope,” Cella said, when asked if the association had addressed the topic of telehealth providers and GLP-1 prescriptions.

The lack of clarity makes choosing a company potentially confusing for patients, and the medical profession is partly to blame, said Jamy Ard, an obesity doctor and researcher at Wake Forest University School of Medicine in Winston-Salem, North Carolina.

Doctors have historically done a bad job counseling patients about weight loss, and many people aren’t comfortable talking to their primary care doctor about it, Ard said. Patients think, “Why would I go to my doctor and have them say, ‘Eat less and move more,’ when I have heard that a million times and I don’t want to have that lecture again?” Ard said.

This problem, combined with past shortages of name-brand versions of GLP-1s, such as Ozempic, Mounjaro, and Trulicity, has created a “perfect storm” for telehealth companies to flourish, said Ard, who has received support from pharmaceutical and telehealth companies.

While some telehealth companies prescribe only name-brand weight loss drugs, many also offer cheaper, compounded versions. They act as intermediaries between customers and mail-order compounding pharmacies, which create GLP-1s by mixing active ingredients, such as semaglutide, with additives. The ingredients for compounded drugs are commonly sourced from overseas suppliers, and the formulations are not reviewed by the FDA for safety.

The environment is “very much uncontrolled and poorly, if at all, regulated,” Ard said. “There is just no standard of care.”

Emily Hilliard, a spokesperson for the Department of Health and Human Services, told 吃瓜不打烊 that compounded drugs “should only be used in patients whose medical needs cannot be met by an FDA-approved drug.”

Hilliard said the agency urges “consumers to be vigilant and know the source of their medicine.”

Understanding the Risks

While weight loss drugs have helped millions of people lose weight, they’re not without risk, the data shows.

A 吃瓜不打烊 data analysis of the FDA’s Adverse Event Monitoring System found that medication errors made by providers or patients with popular weight loss drugs exploded from just over 2,000 reports in 2020 to over 25,000 in 2025. Those self-reported events involved semaglutide, tirzepatide, dulaglutide, and liraglutide, the generic names for leading GLP-1s.

Among frequent issues cited in the adverse event reports were administration of an extra or incorrect dose, issues with communication about a product, and prescribing errors.

Since 2019, the National Poison Data System has fielded a related to overdoses or side effects from injectable weight loss drugs. The data does not distinguish between overdoses tied to a telehealth prescription and those stemming from an in-person medical appointment, but it is a reflection of how prevalent these drugs have become.

Yet data on potential medication errors and adverse reactions to GLP-1 medications is incomplete, because many issues are never reported to federal officials.

For example, in a , the FDA accused drugmaker Novo Nordisk, the maker of Wegovy and Ozempic, of failing to report some adverse events to the federal government, including suicidal ideation and death.

Nobody knows how often adverse events occur, said Kristen Nixon, a Johns Hopkins University researcher who has studied posts about weight loss drugs on Reddit, a popular online forum.

Her team analyzed hundreds of Reddit posts from 2020 through last August and identified frequent mentions of drug reactions and user errors, such as patients’ not knowing how to correctly dose and inject the medication.

But another finding also stood out to her.

“Wow, there are a lot of people talking about telehealth,” Nixon recalled thinking. Reddit commenters said they got GLP-1 prescriptions from scores of telehealth platforms, Nixon found. Commenters also mentioned several dozen compounding pharmacies — often in the same posts about telehealth.

Pharmacies are typically required to counsel patients on medications they receive. But Nixon’s research found that telehealth companies often mail the medications directly, meaning patients do not need to go to a pharmacy.

“Anecdotally, it seems like the telehealth companies are really facilitating access to compounded medications,” Nixon said.

Leslie Gammon, 54, an office manager from Wendell, North Carolina, said she turned to a telehealth company called Amble Health for a weight loss drug prescription. She was given a GLP-1 after filling out an online form, she said.

Like McClain, when she received her mail-order compounded medication in late October, she thought the dosage that accompanied it seemed too high. She’d received a box of semaglutide earlier in the month with a much lower dose. But the refill she received was a stronger formulation, and the instructions told Gammon to inject three times the volume she had been taking in previous weeks.

Even though she injected slightly less than that recommended amount before bed on a Sunday evening, she woke up in the middle of the night “throwing up every 20 to 25 minutes,” she said. And it didn’t stop until Tuesday. She was eventually admitted to a hospital in Raleigh and now owes the hospital over $9,000, a medical bill shows.

Amble Health did not respond to questions for this article.

The delivery system for injectable versions of weight loss drugs is more complicated than for a pill. In its National Poison Data System alert, America’s Poison Centers noted that some people reported “accidentally taking 10-times the recommended dose due to confusing measurement units while using a syringe.”

And people who are eager to lose extra weight — before a wedding or a vacation, for example — may choose to self-administer a higher-than-recommended dose, said Arthur Caplan, a bioethics professor at New York University’s Grossman School of Medicine.

Some telehealth companies aren’t doing enough, he said, to make sure patients understand the risks or the complex delivery system associated with the injectable drugs.

“The consent is not adequate,” Caplan said. “There’s no probing to see if you understood anything.”

Cella, with the American Telemedicine Association, said the group has not addressed the difficulty of educating patients about the risks of injecting weight loss drugs. But she pointed to the association’s “,” which states that telehealth business models “must put the patient first.”

Proceed With Caution

Pharmaceutical companies must list potentially harmful side effects when they advertise the name-brand versions of their FDA-approved medications. Potential include nausea, vomiting, changes in vision, low blood sugar, and, in rare cases, thyroid cancer. Meanwhile, telehealth companies have not historically followed the same rules that drugmakers have in disclosing medication risks in advertisements. But the FDA has started cracking down on misleading drug ads.

A national shortage of weight loss medications in 2022 opened the door for compounding pharmacies to manufacture these drugs. But since the FDA declared the shortage over last year, companies that offer compounded drugs are increasingly facing legal and regulatory challenges related to their marketing tactics.

Mounjaro manufacturer Eli Lilly and other drugmakers are suing multiple telehealth companies for promoting compounded versions of their drugs. In one legal complaint, Eli Lilly alleged Mochi Health had engaged in “deceptive” business tactics. In a motion to dismiss the lawsuit last year, lawyers for Mochi Health called the complaint part of a “nationwide campaign to bolster Lilly’s profits by dictating patient care through the elimination of compounded drugs as a treatment option for weight management.” The lawsuit is ongoing.

Eli Lilly spokesperson Michael Jamison said in a written comment that telehealth companies sued by the drug manufacturer threaten “patient safety by falsely promoting supposedly ‘personalized’ compounded tirzepatide” and mislead “consumers about the safety, clinical testing, and effectiveness of their compounded knockoffs.”

Meanwhile, Novo Nordisk has filed 130 lawsuits against “entities engaged in unlawful marketing and sale of knockoff semaglutide drugs,” said Liz Skrbkova, a spokesperson for the drugmaker.

She said the company is committed to “protecting patients from unapproved knockoff drugs made with foreign, inauthentic active pharmaceutical ingredients that pose significant safety and efficacy risks.”

The Trump administration sent a in September and February to online companies such as , , , and . The FDA said these and other companies had made false or misleading claims related to compounded versions of weight loss drugs.

“Your claims imply that your products are the same as an FDA-approved product when they are not,” the agency’s Center for Drug Evaluation and Research on Sept. 9. HHS later referred the company to the Department of Justice after it announced the launch of a $49 version of Novo Nordisk’s Wegovy pill.

When asked about the FDA warning, Abby Reisinger-Moley, a spokesperson for Hims & Hers, pointed to a announcing a shift away from compounded weight loss drugs. The company said in the press release that it had entered into an agreement with Novo Nordisk to sell name-brand versions.

Alex Smith, CEO of Join Josie, an online platform that helps women in menopause lose weight by prescribing GLP-1s, said his company also made changes in response to an FDA letter, to include removing Join Josie’s name from medication vials. “Which I agree with,” Smith said, “because you don’t want patients thinking you’re the compounding pharmacy.”

SkinnyRx and Genesis Health International did not respond to requests for comment.

But these warnings aren’t the first time the federal government has stepped in to ensure that telemedicine is being used appropriately, said Mei Wa Kwong, executive director of the Center for Connected Health Policy.

Prior cases involved attention-deficit/hyperactivity disorder medications and other controlled substances prescribed by telehealth providers, she said. While those drugs pose more risk to patients than GLP-1s, the companies were also accused of improperly screening potential customers.

The onus still falls on consumers to research companies before signing up for their services, Kwong said.

“Always approach anything on the internet with a hint of skepticism,” Kwong said.

‘Keeps Getting Worse’

McClain, the Tennessee woman hospitalized this year after a GLP-1 overdose, said she lost 50 pounds a few years ago by taking a name-brand GLP-1 prescribed by her doctor.

At the time, the medication was covered by her health insurance. This year, when she was ready to take a GLP-1 again following a pregnancy, the drug was no longer covered for weight loss.

To save money by obtaining a cheaper, compounded GLP-1, McClain signed up for Mochi Health after doing her own research. “That was just the most affordable option,” she said.

But within hours of her first dose, she said, she found herself on the phone with poison control.

After her overdose, McClain said, she spoke to a clinical director at Mochi Health, once by phone but mostly via email, about her lingering symptoms before communication paused.

David Pilip, a spokesperson for Mochi Health, said in a statement that the company would not discuss individual patients due to privacy obligations. But he said adverse events are “immediately flagged” and “investigated with extreme precision.”

“Mochi Health takes patient safety extremely seriously,” Pilip wrote in an email. “We promptly initiated a review and have been in direct and ongoing communication with the patient to reach a resolution. We remain committed to doing so.”

McClain anticipates her healthcare bills related to the hospital stay will total at least $900. She said that to get the $159 refund for her three-month membership and reimbursement for the hospital expenses, she has been asked to sign a document saying she won’t take legal action against the company. Her experience, she said, “just keeps getting worse.”

NBC News producer Jessica Herzberg and 吃瓜不打烊 senior correspondent Fred Schulte contributed to this report.

Do you have an experience using an online company for healthcare services or medicinal products that you think others should know about? Click here to contact our reporting team.

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Baldwin, who is a member of the Senate Appropriations Committee and the Senate Health, Education, Labor and Pensions Committee, said lawmakers have been forced to take unprecedented action to ensure the Trump administration properly spends taxpayer dollars.

“In this most recently passed bill that Donald Trump signed into law, we had to put guardrails that we’ve never had to put into our appropriations laws before to enforce our spending bills,” Baldwin said. “And those laws have made it clear that we expect that they must spend what we have appropriated, and not just all of it at the end of the fiscal year, but in a timely manner throughout the year.”

The conversation also addressed the success 鈥� and Trump-imposed limitations 鈥� of the 988 Suicide & Crisis Lifeline. The resource, which was created through a bipartisan effort, has led to a notable reduction in youth suicide, according to in the Journal of the American Medical Association.

“It’s heartwarming to know that this work matters,” Baldwin said.

This interview aired May 14 on Episode No. 446 of What the Health? From 吃瓜不打烊: “In 吃瓜不打烊 of a New FDA Commissioner.”

This article first appeared on 吃瓜不打烊 and is republished here under a .

“It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.

“This is life or death for maybe 2,000 patients,” added Eric Whitman, medical director of the Atlantic Health System’s oncology service. A assailed the ruling, noting that it “will have a chilling effect on drug development.”

Despite the benefit to some patients, oncologists and pharmaceutical industry analysts say there were legitimate concerns about the treatment, called RP1, that may have led the FDA to reject it in any event. The company, they noted, had ignored repeated FDA suggestions that it change the design of the trial used to seek approval for the medication.

The FDA’s decision would have raised few eyebrows before the current administration took power. But Marty Makary, who took charge as commissioner 13 months ago, altered the agency’s culture and damaged the trust it had built over decades while regulating 20% of U.S. consumer spending, said Steven Grossman, a regulatory consultant and former Health and Human Services official.

“People have to speculate about the standards and processes by which the agency makes decisions,” he said. “And that uncertainty is bad for everybody 鈥� patients and sponsors and investors.”

Under Makary 鈥� who resigned this week 鈥� senior officials have or some at the behest of President Donald Trump or HHS Secretary Robert F. Kennedy Jr., ignoring the advice of agency professionals. In defending his actions, Makary often eschewed the agency’s traditionally measured language about its decisions.

In response to criticism for rejecting the melanoma treatment, for example, Makary accused its manufacturer, Replimune, of “corruption,” saying it was “engaging in corporate spin” to make the FDA look bad.

“I don’t work for Replimune. I work for the American people,” Makary said in a May 5 interview on CNBC. Kennedy backed him up during a congressional budget hearing in which Kennedy mistakenly claimed that patients in Replimune’s clinical trial had also received chemotherapy.

Makary did not respond to requests for comment.

“All the norms have been thrown out the window, so we don’t know what underlines an agency decision,” said , a former FDA staffer and Senate aide to Sen. Edward Kennedy who’s now a pharmaceutical industry consultant in Boston. “Even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play.”

A Doomed Cancer Drug

Melanoma is the fifth most commonly diagnosed cancer in the United States, with about 112,000 new cases each year. The American Cancer Society projects that from melanoma this year in the U.S. If Replimune’s treatment, RP1, worked as well as it did in the clinical trial, Whitman said, as many as 2,500 of those patients could be saved.

RP1 is a genetically engineered virus designed to destroy tumor cells and alert the immune system to swing into action against them. Replimune sought accelerated approval 鈥� a sort of shortcut that allows a product to enter the market while a larger confirmatory trial takes place 鈥� by presenting data that showed a third of 140 people in the trial had their tumors shrink or disappear. But the agency had warned Replimune in July that it risked denial unless it changed its development plans. In particular, the FDA noted that the trial had no control arm to compare RP1 to an approved melanoma treatment. Instead, all patients were given RP1 along with Opdivo, a type of immunotherapy.

Replimune’s scientists don’t entirely understand how the drug works, but research indicates that, in addition to destroying cancer cells, it releases chemicals that revive Opdivo’s capacity to stimulate the immune system. The company argued it would be unethical to give Opdivo alone as a control arm, because all the patients entered in the trial had already stopped getting better while taking only Opdivo or other drugs in its class.

“Having a control arm would have been unethical,” Wise-Draper said. Some of her patients responded extremely well to RP1 and no longer have evidence of melanoma, she said.

Replimune currently has a larger trial that includes a control arm, but “the bigger question is whether the company will survive,” Whitman said. The FDA-accelerated approval would have persuaded investors to provide enough cash to finish the larger trial, he said.

Replimune did not respond to repeated requests for comment. But it is firing more than half its staff and closing some operations in the wake of the FDA ruling.

RP1 wouldn’t have been the first melanoma drug approved based on a single-arm trial. Keytruda, the best-selling Merck cancer drug, was approved to treat melanoma some 12 years ago based on such a trial design. But in its denial statement, the FDA said it wasn’t convinced that the positive effects of the combination regimen were all due to RP1 and not partly to Opdivo.

Replimune arguably could have found an ethical way to set up a control arm for its treatment, Kim said. On the other hand, the FDA could have “given them a provisional yes” with accelerated approval, he said. The whole point of the three-decade-old accelerated approval program is to “take a gamble,” Kim said. The agency’s statement, stressing the company’s methodology over the result, “is a recalibration of how confident sponsors can be with similar studies,” he said.

Vinay Prasad’s Final Days at FDA

Much of the criticism of the FDA under Trump has focused on Vinay Prasad, who was fired then rehired last summer and held various leadership roles at the agency. Prasad, an oncologist known for critiquing the statistical bases of studies, repeatedly intervened in approval processes for drugs and vaccines normally decided by lower-ranking FDA professionals.

Prasad, who did not respond to requests for comment, resigned for good May 1, three weeks after the Replimune decision. “There’s this lingering question of whether this was Vinay’s last stand, or an objective decision made by careful scientists,” Kim said.

Makary ran afoul of Trump administration officials over various decisions, the last being his reluctance to approve flavored vapes for smoking cessation. Trump’s anti-abortion supporters wanted him ousted for allowing a generic form of mifepristone on the market, and for failing to speed up studies they hoped would lead to the abortion drug’s withdrawal from the market.

But in the industries regulated by the FDA, ranging from gene therapy to vaccines and cancer, officials are frustrated by the agency’s uncertain direction. In past administrations, the agency generally swung on a narrow arc between loosening and tightening requirements for drug approvals. Under Makary, “it’s been swinging in every conceivable direction,” Grossman said.

“It’s very inconsistent; it’s all over the place,” Whitman said. “The inconsistency is part of the concern.”

During his tenure, Makary made a series of categorical statements that either claim credit for progress made during earlier administrations or exaggerate the agency’s ability to move forward on goals.

For example, he set a goal of , which is considered impractical at the moment, Kim said, and moved to artificial intelligence at the FDA 鈥� prematurely, critics say. Makary and Prasad also promised to reduce the from two to one. FDA statutes require two well-controlled clinical trials for drug approvals, but exceptions to that rule are already frequent.

“The FDA is sending signals that it wants to even further reduce the evidence needed to support drug approval,” said Aaron Kesselheim, a Harvard Medical School professor and an expert on the drug industry. “Of course, if we’re talking about vaccines, the total opposite is the case. FDA has been taking real steps to make it harder to get vaccines approved.”

The FDA fired about 4,000 staffers at the start of the Trump administration. Makary promised to hire thousands back, but considering the upheavals at HHS and the FDA, these positions may be hard to fill. “What magic trick will get that done?” Grossman asked.

“The unfortunate thing is that there has been so much chaos at FDA that this Replimune decision, which may have needed to happen, has gotten mired in the controversy,” said Evan Seigerman, leader of healthcare research at BMO Capital Markets.

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