
FTC probes trans care claims and risks
Why it matters: The action could help make the case for using unfair competition laws to crack down on health providers, by asserting gender-affirming care involves deceptive claims, legal analysts say.
Driving the news: The FTC solicited public comment through Sept. 26 from consumers who "may have been exposed to false or unsupported claims about 'gender-affirming care,' especially as it relates to minors."
The move followed a public workshop the FTC held in early July to "gauge the harms consumers may be experiencing" surrounding gender-affirming care for minors that featured prominent critics of youth gender-affirming care.
The agency justified its involvement by saying its role is to assess whether medical professionals have violated parts of the FTC Act by failing to disclose risks connected with gender-affirming care or making false or unsubstantiated claims about its benefits or effectiveness.
Reality check: Gender-affirming care for minors is supported by major medical organizations including the American Medical Association.
Drugs like puberty blockers and hormone therapy are prescribed based on individuals' needs and surgeries for minors are rare. Most people who accessed transition-related care as adolescents are happy with that decision as adults, research shows.
Zoom out: The Trump administration has used threats of federal funding cutoffs and law enforcement against providers of gender-affirming care, especially to minors.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


CBS News
a few seconds ago
- CBS News
Controversial vaccine official Dr. Vinay Prasad departs FDA
Dr. Vinay Prasad, the controversial FDA vaccine official who had been critical of the agency's moves to greenlight COVID-19 boosters, has left the agency, the Department of Health and Human Services said Wednesday. "Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family," HHS said. "We thank him for his service and the many important reforms he was able to achieve in his time at FDA." Prasad had been serving as the FDA's director of the Center for Biologics Evaluation and Research since May, replacing Dr. Peter Marks, who had been forced out by HHS Secretary Robert F. Kennedy Jr. Prasad was subsequently named chief medical and scientific officer, absorbing the roles of other top-ranking FDA officials who were removed or left under the Trump administration. In recent weeks, right-wing influencer Laura Loomer had launched a social media campaign against Prasad, highlighting his past support for Democrats, including Sen. Bernie Sanders. Loomer called Prasad a "Lifelong Progressive with a Vicious Anti-Trump Record" and writing that "Prasad's views are a slap in the face to the conservative values of limited government, deregulation, and economic freedom that YOU voted for!" But FDA chief Marty Markay over the weekend had defended Prasad over Loomer's comments, saying in a Politico podcast that Prasad is a "impeccable scientist … one of the greatest scientific minds of our generation." Long a critic of the FDA for granting emergency use authorization for COVID-19 vaccine boosters, Prasad had called Marks "one of the most dangerous, pro-pharma regulators of the 21st century" and said he was "either incompetent or corrupt to authorize a booster without clinical, randomized data." In his three-month tenure at the FDA, the agency decided to limit COVID-19 vaccine recommendations to people 65 years of age and older and others who are at high risk of becoming seriously ill if they are infected, and will require manufacturers to conduct clinical trials to show whether the vaccines are of benefit to healthy younger adults and children. Earlier this month, the FDA released records that showed Prasad overrode career staff at the agency to limit the approvals of COVID-19 shots from Novavax and Moderna. Alexander Tin contributed to this report.

a few seconds ago
FDA vaccine chief leaving agency after less than 3 months
WASHINGTON -- The Food and Drug Administration's polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of biotech companies, patient groups and conservative allies of President Donald Trump. Dr. Vinay Prasad 'did not want to be a distraction' and was stepping down from his role as the FDA's top vaccine regulator 'to spend more time with his family,' a spokesperson for the Department of Health and Human Services said in a statement late Tuesday. Two people familiar with the situation told The Associated Press that Prasad was ousted following several recent controversies. The people spoke on condition of anonymity to discuss internal personnel matters. Prasad joined the FDA in May after years as an academic researcher at the University of California San Francisco, where he frequently criticized the FDA's approach to drug approvals and COVID-19 vaccines. His contrarian approach appeared to match FDA Commissioner Marty Makary, who repeatedly praised Prasad's work and intellect. But in recent weeks Prasad became a target of conservative activists, including Laura Loomer, who flagged Prasad's past statements criticizing Trump and praising liberal independent Senator Bernie Sanders. 'How did this Trump-hating Bernie Bro get into the Trump admin???' Loomer posted on X last week. Prasad also attracted scrutiny for his handling of a recent safety issue surrounding the only approved gene therapy for Duchenne's muscular dystrophy. Under his direction, shipments of the therapy were briefly halted after a series of patient deaths, then resumed late Monday following vocal pushback from families of boys with the fatal muscle-wasting disorder. Prasad has long been skeptical of the therapy and other muscular dystrophy drugs sold by the drugmaker, Sarepta Therapeutics. As an academic, Prasad gained prominence by attacking the FDA for being too lenient in its standards for approving cancer drugs and other new therapies. That approach is at odds with Trump's Republican supporters, who generally favor speedier approvals and unfettered access to experimental treatments. During Trump's first term he signed the ' Right to Try ' law, a largely symbolic piece of legislation that won popular support from conservatives seeking to give dying patients expanded access to unproven drugs. Prasad's decision to pause Sarepta's therapy was criticized last week by a columnist and the editorial board of The Wall Street Journal. Separately, Prasad's division issued rejection letters this month to three small biotech firms seeking approval for new gene therapies. Prasad's predecessor in the role, Dr. Peter Marks, oversaw a steep rise in approvals for new gene therapies, which aim to treat or prevent disease by replacing or modifying a portion of patients' genetic code. Prasad has been an outspoken critic of Marks' leadership at FDA. which included overseeing the approval of the first COVID vaccines and therapies.


Politico
27 minutes ago
- Politico
Top FDA vaccine regulator abruptly exits post
With help from Lauren Gardner Driving the Day A SURPRISE VACANCY — Dr. Vinay Prasad, the FDA's chief vaccine regulator, departed unexpectedly from his position on Tuesday, POLITICO's David Lim reports. His departure follows recent accusations from conservative activist Laura Loomer that he was a progressive and not aligned with President Donald Trump's agenda. It also comes amid a dispute between the FDA and biopharmaceutical company Sarepta Therapeutics centering around Elevidys, a Duchenne muscular dystrophy treatment that Prasad had publicly criticized before his government service. 'Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,' HHS spokesperson Andrew Nixon said in a statement. 'We thank him for his service and the many important reforms he was able to achieve in his time at FDA.' While at the agency, Prasad served as FDA Commissioner Marty Makary's right-hand, playing a prominent role in developing the Trump administration's approach to Covid-19 vaccine policy. He was the director of the Center for Biologics Evaluation and Research and also worked as the FDA's chief medical and scientific officer. Prasad could not be reached for comment Tuesday night. Endpoints News and STAT previously reported the news of Prasad's departure. Prasad, a frequent guest on Makary's FDA podcast, was scheduled to participate in another round of meetings with pharmaceutical and biotech chief executives in New York, Raleigh and Atlanta in the coming weeks with Makary and top drug regulator George Tidmarsh. WELCOME TO WEDNESDAY PULSE. At least 85 people got sick last year after a pizza restaurant mistakenly used THC-infused oil to prepare dough, according to a recent CDC report. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. At the Agencies DIRECTING A CHANGING CDC — The Senate voted to confirm Susan Monarez as the next CDC director Tuesday, marking an end to the agency's four-month stint without a director or acting head and setting her up to helm an agency that's undergoing a rapid transformation. Over the past several months, the Trump administration has rapidly changed the CDC, terminating thousands of its employees and upending some of its key functions, like the way the agency recommends vaccines. Here are the biggest challenges Monarez will have to navigate over the coming months. — The impact of the reduction in force: In April, around 2,400 CDC employees were told they would be terminated, including scientists, communications officials and entire offices — though a few hundred of those employees have since been rehired. The administration is refocusing the CDC on infectious disease as it sheds much of its personnel working on chronic disease, occupational safety and health equity. The agency also absorbed some other agencies' work, including the Administration for Strategic Preparedness and Response. Implementing those changes — many of which are still up in the air — will now fall to Monarez. — Vaccine choices: In June, HHS Secretary Robert F. Kennedy Jr. overhauled the CDC's vaccine advisory panel, which votes on the immunizations that should be included in the agency's childhood and adult vaccine schedules. Kennedy fired the panel's 17 members and replaced them with eight new picks, with one withdrawing soon after their appointment. Several of Kennedy's choices have histories in the anti-vaccine movement, and the new panel has indicated it plans to revisit the childhood vaccine schedule. Monarez will likely have to approve any changes made by the committee before they become official policy. It's customary for the CDC director to approve such changes, but Kennedy himself could continue to do so. At her confirmation hearing in June, Monarez said she hasn't seen a causal link between vaccines and autism, though she dodged questions about whether she disagrees with any of Kennedy's moves. — Communication challenges: Over her tenure, Monarez will need to find a way to effectively communicate with various sectors of the public who say they have lost trust in the CDC. That could prove especially challenging, as public health experts question Kennedy's influence over the agency and post-pandemic distrust lingers. And some of the agency's key tools for communicating information to the public have also been impacted over the past few months — including the Morbidity and Mortality Weekly Report, the agency's flagship journal. An analysis of the journal's recent publications by MedPage Today found that MMWR has published fewer articles over the past three months compared with the output over the same period in past years. Eye on Insurers A NEW ALZHEIMER'S APPROACH — Nonprofit health insurer EmblemHealth launched a first-of-its-kind lifestyle medicine program Tuesday for patients with early-stage Alzheimer's disease, Kelly reports. The New York-based insurer announced it would cover the program, designed by preventive medicine researcher Dr. Dean Ornish and aimed at enhancing brain health and slowing disease progression through lifestyle modifications. Eligible enrollees who have mild cognitive impairment or early-stage dementia associated with Alzheimer's disease can enroll in the program for free. Why it matters: The new initiative aligns with the Make America Healthy Again agenda that HHS Secretary Robert F. Kennedy Jr. has spearheaded, focusing on targeting the nation's chronic disease crisis through lifestyle habits like healthy eating and regular exercise. It also comes as promising new Alzheimer's drugs have come to the market over the past few years, but some insurers have been reluctant to cover the treatments, given their steep price tag. Background: The program offers biweekly online or in-person classes to provide patients with clinical, emotional and food support, according to a news release from EmblemHealth, which serves more than 2 million people in the New York tristate area and is one of the nation's largest not-for-profit insurers. The services offered include access to 'nutritious, whole food, plant-based meals and snacks' and guidance on preparing the foods at home, getting daily exercise and mitigating stress. On Tuesday, Ornish announced results of a study he conducted on the program, where 26 people participated for 40 weeks and showed 46 percent improvement in 3 in 4 standardized tests — including measures of memory, judgment, problem-solving and in-home functionality. About 38 percent of the participants showed no decline, and 83 percent overall improved or maintained cognition. 'Partnering with a leading insurer such as EmblemHealth provides access to invaluable resources,' said Ornish, founder and president of the nonprofit Preventive Medicine Research Institute in Sausalito, California, in a news release. 'Bringing this program to seniors through a leading physician group and a mature community support system makes it possible to achieve groundbreaking results.' In the courts ALIGNING BEHIND PLANNED PARENTHOOD — Nearly two dozen Democratic-led states filed a lawsuit Tuesday challenging the GOP megabill's provision blocking Medicaid payments to Planned Parenthood affiliates, arguing that lawmakers are trying to force states to violate constitutional protections for free speech, Lauren reports. The suit, filed in federal district court in Massachusetts and led by California Attorney General Rob Bonta, echoes the constitutional arguments Planned Parenthood made in its own challenge to the law, for which a federal judge granted an injunction Monday. The states say the statute — and Congress' and the Trump administration's records of disparaging the nonprofit's abortion-rights advocacy — violates the First Amendment and the Fourteenth Amendment's equal-protection guarantees against government retaliation. The states also argue the provision violates the Constitution's prohibition of bills of attainder, a constitutional concept that blocks legislators from singling out entities for punishment without a trial. 'The President and Congress are implementing a cruel, backdoor abortion ban through this provision, putting their political agendas over people's lives,' Bonta said in a statement. State-specific arguments: The Democratic states' lawyers contend that lawmakers 'conscripted' states into unconstitutionally targeting Planned Parenthood clinics. The law also saddles states with determining which entities with operations across state lines would have to be excluded from Medicaid payments, they said. Why now? Judge Indira Talwani, an Obama appointee to the U.S. District Court in Massachusetts, granted Planned Parenthood's motion for a preliminary injunction Monday, putting the defunding provision on hold as the case moves through the courts. The states acknowledged that development in their Tuesday statement but said they 'remain committed to ensuring full relief.' Some Planned Parenthood clinics lost their Medicaid funding last week after a temporary restraining order expired on July 21, the same day Talwani granted a partial injunction that applied only to the few affiliates that wouldn't be subjected to the defunding provision because they don't provide abortions. At the White House PATIENT DATA PLEDGES — The White House and CMS are expected to announce today that roughly 60 entities in the health care sector will pledge to make patient data more accessible and speed its delivery among patients, clinicians and payers, according to an HHS employee granted anonymity to discuss the sensitive plans, POLITICO's Ruth Reader reports. The agency hopes the commitments will stoke companies to make it easier for patients to import their data into an app of their choice, where they can manage their day-to-day health and easily share their history with doctors. Pledges, not rules: The Trump administration has sought such commitments to compel the industry to make changes without having to engage in a lengthy rulemaking or guidance process. But the federal government has tried similar tactics in the past. In 2016, the then-secretary of the Department of Health and Human Services, Sylvia Burwell, under President Barack Obama announced at a health IT conference that dozens of health industry organizations would commit to easing the flow of health information to patients. Nearly 10 years later, those voluntary commitments haven't materialized into better data access. Still, the Trump administration thinks it can appeal to the private sector more effectively. Names in the News Andi Lipstein Fristedt is now executive vice president, chief strategy and policy officer at the Parkinson's Foundation. She previously was deputy director and chief strategy officer at the CDC. WHAT WE'RE READING STAT's Chelsea Cirruzzo reports that HHS is vetting potential new members for the U.S. Preventive Services Task Force, the federal advisory panel that recommends which preventive services insurers must cover.