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 — 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 — still addictive and harmful to health — 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 — Juul, Reynolds American, and Altria — 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 — which tobacco companies had donated heavily to — 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 — through its Make America Healthy Again slogan — 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.

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“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 ‘generally 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 — 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 — 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 — shade, clothing, hats, sunglasses — with sunscreen as the last layer, not the first.”

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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 Ñî¹óåú´«Ã½Ò•îl Health News 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 Ñî¹óåú´«Ã½Ò•îl Health News 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 Ñî¹óåú´«Ã½Ò•îl Health News 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 Ñî¹óåú´«Ã½Ò•îl Health News 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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At least that’s the way many Democrats see it.

They have seized on the situation to charge that the U.S. is ill prepared to respond to outbreaks — let alone a pandemic — after President Donald Trump and funding for public health infrastructure and pandemic preparedness. Infectious disease specialists have called on the White House to reverse cuts and rejoin the World Health Organization.

The White House, meanwhile, is on the defensive, trying to reassure a pandemic-weary public that the federal government can still mount effective responses to infectious disease outbreaks.

The FDA and the Centers for Disease Control and Prevention as part of an effort led by billionaire businessman Elon Musk and the Department of Government Efficiency, or DOGE, that also resulted in the cancellation of billions of dollars in federal contracts and grants.

“These outbreaks are unfolding at a time when the U.S. public health infrastructure is under significant strain,” said , an emergency medicine physician and former Baltimore health commissioner. “The CDC currently lacks a director, the FDA lacks a director, there is no surgeon general, and many leaders with outbreak response management experience have left the federal government.”

The U.S. government has and is monitoring potential exposures to hantavirus after an outbreak on a cruise ship. It is also implementing new restrictions for foreign travelers amid an Ebola outbreak in Uganda and the Democratic Republic of Congo that has grown to more than . While neither situation is seen as likely to become a global pandemic, Democrats and infectious disease leaders have seized on the outbreaks to criticize the effects of the DOGE cuts and other administration public health policies.

The hantavirus cluster occurred on the , an expedition ship that left Argentina on April 1 for a monthlong sojourn with almost 150 people aboard. The earliest cases, including two deaths, were on May 2. infected passengers have died. Hantavirus is typically spread to people from rodents, but this version, known as the , can be passed person to person.

The Ebola outbreak has captured public attention, though no cases have been confirmed in the U.S. The virus — a rare strain called Bundibugyo, against which there are no proven vaccines or treatments — spread undetected for weeks, prompting WHO Director-General Tedros Adhanom Ghebreyesus to say he’s concerned about the “” of the outbreak. , including a doctor exposed to the virus, were evacuated to Germany by the U.S. State Department.

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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 — and Trump-imposed limitations — 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 Ñî¹óåú´«Ã½Ò•îl Health News: “In Search of a New FDA Commissioner.”

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“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 — patients and sponsors and investors.”

Under Makary — who resigned this week — 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 — a sort of shortcut that allows a product to enter the market while a larger confirmatory trial takes place — 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 — 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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No surprise. About are “worried about being able to afford prescription drug costs for themselves or their families,” a recent KFF nationwide poll showed. More than 80% consider the price of prescription drugs “unreasonable,” and most support increased regulation to lower costs. Americans pay about three times as much as people in other countries for the same prescription drugs.

Last July, Trump sent letters to 17 drugmakers, demanding they voluntarily lower drug prices. Then the president said he’d negotiated one by one at the White House. In December, that he had compelled them to agree to on Medicaid, the government coverage for low-income Americans.

Then came the , a site where cash-paying patients could find discounted medicines, and a promise to speed biosimilar products — generic versions of certain high-priced specialty drugs — by cutting through FDA red tape.

The scope of these grand gestures remains uncertain. But it’s certainly less than what the announcement promised, partly because many details of the negotiations, even which drugs are covered, are hazy.

White House spokesperson Kush Desai did not answer queries about TrumpRx.

Medicaid already buys drugs at deep discounts. And other patients may well have better options through commercial drug discount programs, which offer far more products, or through their insurance and associated drug company copayment cards.

So, for all Trump’s showmanship, the share of Americans likely to benefit from these options remains slim, even if some people do come out ahead.

“If it makes a difference to any patient, it’s a win,” said Mark Cuban, a billionaire investor on his own mission to bring down drug prices. He pointed to discounted pricing on TrumpRx for branded fertility drugs and GLP-1 weight loss drugs for people without insurance or whose plans don’t include coverage. Cuban launched the Mark Cuban Cost Plus Drug Co., known as Cost Plus Drugs, in 2022 to sell drugs cheaply by eliminating middlemen — buying from factories and selling directly to consumers. Most of the drugs he sells are generics.

Aaron Kesselheim, a professor of medicine at Harvard Medical School whose research focuses on drug prices, said the Trump announcements are “one-off agreements made for publicity purposes. They don’t change anything about the way drugs are priced.”

He added: “The agreements are opaque and unenforceable.”

It was unclear, for example, which drugs would be sold at “most favored nation” prices or how exactly that was defined. But, clearly, not all were.

Doing the Math

46brooklyn, a consulting firm and data project that tracks brand-name drug prices, found that close to 1,000 brand drugs went up in price in January 2026. What’s more, 2025 had the highest number of list price increases ever. “This is not a material change, it’s business as usual,” said Antonio Ciaccia, the company’s co-founder.

In the first week of 2026, Pfizer raised the list prices of 71 drugs by an average of 5% and lowered the price of only one, by 9.8%, the data project found.

The biggest win for patients has likely been the Trump administration’s quiet continuation of a Biden administration program: Medicare drug price negotiation for expensive drugs. The negotiated discounts on the — from blood thinners to insulins to medicines for inflammatory disorders — went into effect Jan. 1. With reductions in price of on some products, the estimated $6 billion in annual savings allowed the program to cap Medicare patients’ out-of-pocket spending on Part D prescription drugs at $2,000 for 2025 and beyond.

An additional 15 high-priced drugs — including popular weight loss and cancer drugs — were subject to negotiation in 2025, with discounted Medicare prices taking effect next year. And 15 more high-priced drugs are . All told, the 40 negotiated drug prices are expected to save Medicare well over $20 billion a year.

Even as these discounts take effect, drug industry lobbyists have been working to limit the impact, with some success. For example, the One Big Beautiful Bill Act from negotiations.

Still, “this is historic because it’s the first time the United States has negotiated prices, like every other developed country,” Kesselheim said. “And guess what? Innovation didn’t stop.”

Of course, these discounts benefit only Medicare enrollees. The newer Trump administration initiatives help some other patients, but they are limited and require knowledge of how to access the discounts.

Trump’s One-on-Ones

The president’s televised appearances with the heads of major drug companies resulted in deals, but few, if any, will mean much to patients. For example, after Trump met with Albert Bourla, CEO of Pfizer, the company announced discounts on 30-plus drugs. Bourla “a win for American patients, a win for American leadership, and a win for Pfizer.”

The discounts are offered via TrumpRx, which, in turn, offer coupons co-branded on GoodRx.com, which already offers discount coupons for many hundreds of medicines.

Pfizer made hay of the deal, announcing it was part of Pfizer’s broader, landmark with the U.S. government, enabling patients to pay lower prices for their prescription medicines “while strengthening America’s role as the global leader in biopharmaceutical innovation.”

Pfizer spokesperson Steven Danehy cited a press release from September noting that the TrumpRx site offers patients savings that “range as high as 85%.”

Most of the list features brand-name drugs, competing with far cheaper generic versions from other manufacturers, such as the cholesterol-lowering drug Colestid, which TrumpRx lists for “50% off” at $127.91. Generic versions cost about $17 on the Cost Plus site.

This means the branded companies aren’t making a sacrifice by offering them at lower costs as reflected on Trump’s portal, said Sean Tu, a patent law expert at the University of Alabama. “That’s a sale they would not have made if not for TrumpRx.”

Others are very old drugs, such as Cortef, or hydrocortisone, whose 5-milligram branded Pfizer version is listed at $45 on TrumpRx, half its list price of $91.80. It sells for far less on Cuban’s Cost Plus site. Still others, such as the $607.20 HIV treatment Viracept, are useful only in combination with other drugs that are not discounted.

Last week, TrumpRx added AbbVie’s Humira, for years the world’s best-selling drug, at $950 a dose, down from a list price of nearly $7,000. But Humira lost its patent protection in 2023, and biosimilars — essentially generic equivalents — have since come to market. More to the point, two of those biosimilars are listed on TrumpRx for as little as $207.60 a dose.

Since most of the TrumpRx products are available only to customers without insurance who pay cash, the arthritis drug Xeljanz’s drop from $2,277 to $1,518 a month would still leave it unaffordable.

A Few Notable Deals

The much-touted TrumpRx site, launched Feb. 6, consists largely of Pfizer’s 30 drugs (30 of roughly 85) with a smattering of discounts likely to generate headlines.

These include three fertility drugs from EMD Serono, a subsidiary of the pharmaceutical giant Merck KGaA, the most expensive of which, Gonal-F, has a list price of $966 but is only $168 per IVF cycle using a TrumpRx coupon.

They will save women thousands of dollars — although the overall cost of fertility treatment will continue to put them beyond the reach of many, since drugs represent only a portion of the payment.

The TrumpRx discounts could reduce the $15,000-to-$25,000 cost of a single fertility treatment cycle — women typically need two or three cycles to become pregnant — by about 10%, said Sean Tipton, spokesperson for the American Society for Reproductive Medicine. In some European countries, each cycle costs about $3,000.

In exchange for lowering those prices, EMD Serono got tariffs lifted on its mostly overseas-produced medications. It also won the right to a sped-up FDA approval process for a fertility drug it’s been marketing heavily in Europe.

Another newsworthy offering on the site resulted from a deal with Novo Nordisk for Wegovy, its GLP-1 drug for weight loss and diabetes, with the price reduced to as little as $199 a month for the pen. (Many insurers cover such drugs only for diabetes, leaving those who are interested in losing weight paying out-of-pocket. Zepbound, Wegovy’s Lilly & Co. competitor, is also on the list, at $299.)

Pressure has been building on Novo and Lilly to lower the U.S. price of their GLP-1 drugs. The compounds have lost patent protection in India, and pressure from customers buying overseas will likely increase when generic Wegovy goes on sale in Canada, for as low as $73 a month, possibly this year.

In the United States, meanwhile, dozens of patents should keep Wegovy generics off the market until 2039, said professor Robin Feldman, a patent expert at the University of California Law-San Francisco. A from the research group I-Mak delved into several ways patent manipulation keeps generics off the U.S. market long after they are available in European countries and Canada.

And while the Trump administration has vowed to approve biosimilars more rapidly to ensure more competition and lower prices, that may not have much impact. The big hurdle in getting generics and biosimilars to market is often not FDA approval, but the time it takes to override the thickets of patents that U.S. law allows manufacturers to deploy to protect their intellectual property.

For example, in 2021, the FDA approved a generic of Otezla, a popular drug for psoriatic arthritis, but it will not hit the market until 2028. Its entry would to Medicare if they charged the program more than other developed countries for “single source” drugs and biologics. That would essentially allow the Medicare program to piggyback on other countries that negotiate the prices of some of the most expensive medicines. Those programs are still going through the rulemaking process and, again, would benefit only those covered by the Medicare program and only indirectly.

The average patient-consumer, if willing to pay cash, may find some bargains. But getting the best deal could take a lot of mixing and matching, forcing patients to become choosy shoppers, eyeing deals for essential medicines as they would for a carton of milk or eggs.

Data reporter Maia Rosenfeld contributed to this article.

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Céline Gounder, Ñî¹óåú´«Ã½Ò•îl Health News’ editor-at-large for public health, discussed a new weight loss pill approved by the FDA on CBS News’ CBS Mornings on April 2.

Ñî¹óåú´«Ã½Ò•îl Health News Southern correspondent Sam Whitehead discussed high Affordable Care Act premiums on WUGA’s The Georgia Health Report on March 27.

• Read Renuka Rayasam’s “When Health Insurance Costs More Than the Mortgage.”

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Julie Rovner Ñî¹óåú´«Ã½Ò•îl Health News Read Julie's stories. Julie Rovner is chief Washington correspondent and host of Ñî¹óåú´«Ã½Ò•îl Health News’ weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.

The Trump administration this week missed a deadline to nominate a new director for the Centers for Disease Control and Prevention. Without a nominee, current acting Director Jay Bhattacharya — who is also the director of the National Institutes of Health — has to give up that title, leaving no one at the helm of the nation’s primary public health agency. 

Meanwhile, a week after one federal judge blocked changes to the childhood vaccine schedule made by the Department of Health and Human Services, another blocked a proposed ban on gender-affirming care for minors. 

This week’s panelists are Julie Rovner of Ñî¹óåú´«Ã½Ò•îl Health News, Rachel Cohrs Zhang of Bloomberg News, Lizzy Lawrence of Stat, and Shefali Luthra of The 19th.

Panelists

Rachel Cohrs Zhang Bloomberg News

Lizzy Lawrence Stat

Shefali Luthra The 19th

Among the takeaways from this week’s episode:

• A federal judge ruled against the Trump administration’s declaration intended to limit trans care for minors, though the ruling’s practical effects will depend on whether hospitals resume such care. And a key member of the remade federal vaccine advisory panel resigned as the panel’s activities — and even membership — remain in legal limbo.
• Two senior administration health posts remain unfilled, after President Donald Trump missed a deadline to fill the top job at the Centers for Disease Control and Prevention — and the Senate made little progress on confirming his nominee for surgeon general.
• The percentage of international graduates from foreign medical schools who match into U.S. residency positions has dropped to a five-year low. That’s notable given immigrants represent a quarter of physicians, many of them in critical but lower-paid specialties such as primary care — particularly in rural areas. Meanwhile, new surveys show that more than a quarter of labs funded by the National Institutes of Health have laid off workers and that federal research funding cuts have had a disproportionate effect on women and early-career scientists.
• And new data shows the number of abortions in the United States stayed relatively stable last year, for the second straight year — largely due to telehealth access to abortion care. And a vocal opponent of abortion in the Senate, with his eyes on a presidential run, introduced legislation to effectively rescind federal approval for the abortion pill mifepristone.

Also this week, Rovner interviews Georgetown Law Center’s Katie Keith about the state of the Affordable Care Act on its 16th anniversary.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: Stat’s “,” by John Wilkerson. 

Shefali Luthra: NPR’s “,” by Tara Haelle. 

Lizzy Lawrence: The Atlantic’s “,” by Nicholas Florko. 

Rachel Cohrs Zhang: The Boston Globe’s “,” by Tal Kopan. 

Also mentioned in this week’s podcast:

• Stat’s “,’” by Jonathan Wosen.
• Ñî¹óåú´«Ã½Ò•îl Health News’ “Rising Health Costs Push Some Middle-Aged Adults To Skip the Doc Until Medicare,” by Sam Whitehead.
• Guttmacher’s “,” by Isaac Maddow-Zimet and Kimya Forouzan.
• United for Medical Research’s “.”

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Click here to find all our podcasts.

And subscribe to “What the Health? From Ñî¹óåú´«Ã½Ò•îl Health News” on , , , , , or wherever you listen to podcasts.

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They worked for a bit. But by 2011, Warfield struggled to walk.

And “by that time, I was addicted,” said Warfield, now living in Shelbyville, Kentucky.

After she lost her health insurance, Warfield started buying pills on the street. She tried to quit several times, but the debilitating withdrawal — so bad she couldn’t get out of bed, she said — kept driving her back to drug use.

Until last year.

Through her church, Warfield learned about the NET device. It’s a cellphone-sized pack connected to gel electrodes placed near the ear that deliver low-level electrical pulses to the brain.

“Once I got set up on the device, within 30 minutes, I didn’t have any cravings” for opioids, Warfield said.

After three days on the device in August, she stopped using drugs altogether, she said.

Warfield’s treatment was paid for with her county’s opioid settlement dollars — money from pharmaceutical companies accused of fueling the overdose crisis.

State and local governments nationwide are receiving over nearly two decades and are meant to spend it treating and preventing addiction.

Warfield wants them to allot a good chunk to the NET device, which costs counties about $5,500 a person. The pitch is gaining traction. , which makes the device, said it has signed about $1.2 million in contracts with more than a dozen counties and cities in Kentucky. 

But some researchers and recovery advocates say the company’s rapid consumption of opioid dollars raises red flags. They see the NET device as the latest in a series of products that have been overhyped as the solution to the addiction crisis, preying on people’s desperation and capitalizing on the windfall of opioid settlements. Many of these products — from to body scanners for jails — have little evidence to back their lofty promises. That has not stopped sales representatives from repeatedly pitching elected officials or circulating ready-made templates to request settlement money for the companies’ products.

In fact, a device similar to NET called the Bridge gained popularity several years ago, receiving more than $215,000 in opioid settlement cash nationwide. But about the study backing its effectiveness, and the device is currently off the market.

NET Recovery’s activity “fits the national trends of these industry money grabs,” said , a national expert on opioid settlements based in Tennessee. The device “could be helpful for some,” she said. “But it’s being sold as a silver bullet.”

This year, 237 organizations working to end overdose — including Christensen’s consulting company — to guide officials in charge of opioid settlement money. In it, they called the NET device an example of problematic spending on unproven treatment.

Treating Withdrawal or Addiction

The FDA has for a specific use: reducing drug withdrawal symptoms. It has not approved the device to treat addiction.

That’s a crucial distinction, said , executive director of the Institute for Research, Education and Training in Addictions. He co-authored evaluating the evidence on neuromodulation devices like NET.

“The term ‘treatment’ becomes confusing,” Hulsey said. “These devices were cleared to treat opioid withdrawal symptoms, not to treat an opioid use disorder.”

NET Recovery CEO said the company adheres to FDA rules and advertises the device only for withdrawal management. But “we are finding that physicians are prescribing this to folks for long-term behavior based on the results of our study.”

He’s referring to that he co-authored and the company funded, in which researchers followed two groups of addiction patients in Kentucky for 12 weeks. The first group received the NET device for up to seven days, while the second group received a sham treatment.

The study found no significant difference between the groups’ outcomes. Participants who got the NET device were similarly likely to use illicit drugs after treatment as those who got the fake.

Hulsey, who was not affiliated with the study, said the takeaway is clear: “They didn’t find that was effective.”

A subgroup of participants who chose to use the device for more than 24 hours consecutively, however, went on to use illicit drugs less often than other participants.

As the researchers acknowledged in their paper, that subgroup might simply have been more motivated to engage with any form of treatment. The results don’t necessarily show that the device is making a difference, Hulsey said.

Rapid Growth

Winston had a different take. He said the success of the subgroup is “intriguing and outstanding.”

So outstanding, in fact, that the company this month is opening a brick-and-mortar location in Miami, where the device will be available to anyone who can pay $8,000 out-of-pocket. (The cost is higher for individuals than for county governments.) It has also applied for opioid settlement dollars from the state of Kentucky to conduct a larger research study and aims to bring the NET device into metro areas such as Louisville and Lexington.

Last year, NET Recovery hired a magistrate in Franklin County, Kentucky, to head up its operations in the state. (Magistrates function as county commissioners.) , who is also a mental health clinician, travels to different counties, extolling the benefits of the device and encouraging officials to contract with the company.

Her county to NET Recovery prior to her joining the company. Moving forward, Dycus said, she would recuse herself from any contract votes in her county.

Christensen, the national expert on opioid settlements, called Dycus’ new role “extremely strategic” for the company and “an obvious conflict of interest” for a public official.

Giving People Choice

More options for people to enter recovery is generally good, said Jennifer Twyman, who has a history of opioid addiction and now works with , a nonprofit that advocates to end homelessness and the war on drugs.

But settlement funds are finite, she said, and when counties invest in the NET device, that leaves less money to support options like mental health treatment, housing, and transportation programs — critical for many people who use drugs.

“People slip through these big, huge gaps we have and they die,” Twyman said, pointing to photos of dead friends that line her office wall.

She added that people should have the option of taking medications such as methadone and buprenorphine — for treating opioid addiction. only 1 in 4 people with opioid addiction get them.

Many people can’t afford them, find a doctor willing to prescribe them, or get transportation to appointments, Twyman said. against those who use medications, with detractors saying they’re not truly abstinent or clean.

Companies like NET Recovery sometimes lean into that stigma, Twyman said.

For instance, Scott County, Kentucky, jailer — whom the company considers a key champion for its device — to other county officials that medication treatment is just “swapping one drug for another.” It’s a common refrain from critics that .

Winston told Ñî¹óåú´«Ã½Ò•îl Health News his company is supportive of all types of recovery but that the NET device can help the “underserved population” of people who don’t want medication.

Longtime addiction researcher has led studies for NET Recovery and consults for , one of the leading producers of medications for opioid use disorder. He said he sees value in both approaches. It just depends on whom you’re trying to treat.

For people injecting drugs or accustomed to high doses of fentanyl, who are more likely to return to using drugs after residential treatment, “I would hesitate to recommend the device,” he said. Abstinence-based approaches can . But for people who are “highly motivated to stay abstinent,” the NET device may be a good fit.

“Giving people choices is the right thing to do,” he said.

Community as Part of Recovery

Warfield, who has not used opioids since August, credits not just the NET device with her recovery but her community too.

“It’s not a miracle cure,” she said of the device. “You still have to manage your triggers, but it’s easier.”

She regularly attends individual and group therapy to address childhood trauma. She’s found close friends within her church and has reconnected with her daughter. She installed a car seat in her vehicle so she can drive her grandson to preschool.

Warfield explained her hope for opioid settlement money to reach others in her community simply: “I want people to get as much help as they can.”

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