Latest news with #RobertF.KennedyJr.
New York Times
44 minutes ago
- Health
- New York Times
Trump Administration Freezes $108 Million in Funds to Duke University
The Trump administration has frozen $108 million in federal funds for Duke University's medical school and health care system, according to two administration officials, after the government accused the university of 'systemic racial discrimination.' Duke University is the latest high-profile school, from Columbia University to Harvard, that the Trump administration has targeted and stripped of a large amount of federal funding, based on vague accusations that the university abets antisemitism or supports diversity, equity and inclusion programs. The move comes amid a wider pressure campaign from the Trump administration to shift the ideological tilt of American higher education. Robert F. Kennedy Jr., the health secretary, and Linda McMahon, the education secretary, sent a letter to Duke administrators on Monday expressing concerns about 'racial preferences in hiring, student admissions, governance, patient care, and other operations' in the university's health care system. In the letter, the officials accused Duke of violating Title VI of the Civil Rights Act, which prohibits discrimination based on race and nationality in programs receiving federal funding. Mr. Kennedy and Ms. McMahon called on Duke Health, the university's health care system, to review all policies 'for the illegal use of race preferences' and to create a 'Merit and Civil Rights Committee' that would work with the federal government. The $108 million cut could be permanent, if the government concludes the university violated the Civil Rights Act, according to the two administration officials, who spoke on condition of anonymity because they were not authorized to speak publicly. Duke University did not immediately respond to an email request for comment. The university is weighing layoffs amid a budget crunch. It's considering about $350 million in cuts, amounting to roughly 10 percent of its budget. In a video message last month, Duke's president, Vincent E. Price, said the university was trying to sort out proposals from the federal government 'that have quite dire implications for the university.' He added there was 'sadly, no scenario in which Duke can or will avoid incurring substantial losses of funding due to these policy changes.' The university has imposed a hiring freeze and developed buyout plans, but Dr. Price said that Duke would 'likely' resort to layoffs.
Axios
10 hours ago
- Health
- Axios
Feds launch crackdown on kratom byproduct
Federal health officials are launching a new campaign to control the distribution of an opioid substance derived from the kratom plant known as 7-OH that's sometimes referred to as "legal morphine." Why it matters: The compound, 7-hydroxymitragynine, is commonly sold online and in smoke shops and has been found in dangerous concentrations in tablets, gummies and drink mixes. Driving the news: FDA and Drug Enforcement Administration officials said Tuesday they are taking steps to schedule the compound as a controlled substance and released a report on its risks to educate the medical community, schools and parents. The FDA has also issued warning letters to seven companies for illegal marketing products containing 7-OH. The products advertise the compound as an added ingredient, or being included at enhanced levels. Distributors claim products with the substance act as "unapproved new drugs with unproven claims such as relieving pain and managing anxiety," the agency said. HHS Secretary Robert F. Kennedy Jr. referenced his own history with heroin addiction at a Tuesday event promoting the crackdown, during which he described the importance of cracking down on the easily available synthetic opioid. "I became an addict because [heroin] was so available, but I had to go to the South Bronx or the Lower East Side. But now you can go to any gas station," Kennedy said. "They're putting them around schools, putting them in our poorest neighborhoods and now they are putting them in every gas station," he continued. "They're marketing them to children, they're gummy bears, they're bright colors, they're candy flavored. This is really a sinister, sinister industry." Officials said they are not targeting the herbal supplement kratom but the byproduct. Research has shown 7-OH can be 13 times more potent than morphine, FDA Commissioner Marty Makary said. "7-OH is not just 'like' an opioid ... it is an opioid," Makary said. "And yet it is sold in vape stores, in smoke shops, in convenience stores, in gas stations that are popping up around the United States. And no one knows what it is." He declined to weigh in on the safety of kratom products, which have intoxicating effects and have been the target of new and proposed restrictions in Colorado and Louisiana. "Lets not let another wave of the opioid epidemic catch us blind-sided again," Makary said. The move was cheered by some kratom proponents who say the agency's action differentiates what's illegal from legitimate products. "For too long, the conversation around kratom has been polluted by bad actors and misinformation," said Paula Brown, director of Natural Health & Food Products Research at the British Columbia Institute of Technology. "FDA's data now supports what pharmacognosists have known for years: kratom is not a narcotic, and 7-OH is not a natural constituent of the plant. Differentiating them is both scientifically necessary and ethically urgent." The other side: "Over half a billion doses of 7-OH have been used without a single confirmed death. That's not a threat to public safety—that's a success story," said Jeff Smith, National Policy Director of the Holistic Alternative Recovery Trust (HART). "This compound deserves to be regulated like any responsible product."
New York Times
10 hours ago
- Health
- New York Times
Kennedy Announces Plan to Restrict Some Kratom Products
Health Secretary Robert F. Kennedy Jr. on Tuesday announced a plan to restrict access to a derivative of the kratom plant readily available online and in vape stores and used by millions of Americans to alleviate pain. In recent years, manufacturers have isolated and amplified a compound in kratom to make a more potent product. Concerns about addiction to 7-OH, or 7-hydroxymitragynine, have mounted because it binds to opioid receptors in the brain. Dr. Marty Makary, commissioner of the Food and Drug Administration, said his agency would begin the process to officially 'schedule' 7-OH, classifying the drug according to its risk for abuse and accepted benefits. The final steps will be handled by the Drug Enforcement Administration. Though 7-OH is not a traditional opioid derived from the poppy plant, Mr. Kennedy pointed to the opioid epidemic and said the new effort was meant to avert a similar wave of addiction. The action comes as the F.D.A. has struggled with a growing number of dangerous and even deadly psychoactive products lining gas station and vape shop shelves, from psychedelic candy bars — linked to three deaths last summer — to THC snacks to 'gas-station heroin.' The F.D.A. has been escalating enforcement against companies that make 7-OH products in recent months. The agency sent seven warning letters to manufacturers, a precursor to stricter enforcement action, which can range from fines to product impoundment. Dr. Makary said at a news briefing on Tuesday that federal health officials were trying to reverse a record of being 'asleep at the wheel' in the face of a public health crisis, citing the example of cigarettes. 'Let's be honest,' he said. 'There's also a lot we don't know. This may be the calm before the storm. It may be the tip of the iceberg, but let's be aggressive and proactive.' People can buy 7-OH online and in smoke shops, where it's often labeled kratom and 7 or 7-OH. It comes in the form of gummies, chewables, small drinks or tablets that melt in the mouth. Dr. Makary said the agency was issuing a report on 7-OH, a letter to health care providers, and a warning to consumers about the risks associated with 7-OH products. According to the F.D.A., 7-OH is not lawful in dietary supplements or when added to foods. The agency said there are no approved drugs containing 7-OH nor any regulatory basis for companies to claim that the products relieve pain or anxiety, as some do. 'Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use,' according to the F.D.A. The announcement runs counter to a plan unveiled during the Biden administration to lower restrictions on marijuana, a process known as rescheduling. That effort has hit procedural hurdles, but it was meant to reclassify marijuana from a Schedule I drug, akin to cocaine or heroin, to Schedule III, given its potential medical benefits. For 7-OH, federal officials are moving in the opposite direction, taking an unscheduled substance and advising the D.E.A. to place it in Schedule I. Such a process begins with federal health agencies performing an eight-factor analysis of a product's risk profile and potential for abuse, among other concerns. Kirsten Elin Smith, a Johns Hopkins University assistant professor who studies kratom, said she was initially very concerned about 7-OH when it began to show up online about two years ago. She said she braced herself for a flood of reports of harm. Those reports did not come, she said, though perhaps because there are no tests to detect 7-OH in the blood. There are routine tests for another component of kratom, but those did not yield evidence of increasing harm, either, she said. 'If you had asked me a year ago, I would have said this is evil,' Dr. Smith said. 'At this point I'm a little more equivocal.' She said she's been working to survey several hundred users and conduct in-depth interviews. Some people report benefits, such as improved mood and quality of life. Others tell her that 7-OH is habit-forming. Though most of the people she has surveyed said the product should not be prohibited, nearly 15 percent said they favored greater restrictions. Dr. Smith said she encountered similar results while studying kratom, which provides a different medley of psychoactive components. Overall, she said, more research needs to be done. 'Kratom is not a panacea without risk either,' she said. 'Both kratom products and 7-OH products have a benefit-risk profile.' Mac Haddow, a senior fellow on public policy for the American Kratom Association, which represents makers of botanical kratom, said his group has been sounding the alarm about 7-OH since it arrived on the market. Mr. Haddow applauded Tuesday's announcement. 'You can get addicted to 7-OH in a couple of days, and it's a horrible situation to get off of it,' he said. The F.D.A. has encountered a spate of problems with unauthorized products that have popped up in smoke shops and gas stations across the country in recent years. Last summer, more than 160 people fell ill and three died after eating Diamond Shruumz candy bars, which contained an array of unauthorized ingredients, some of which had psychedelic properties. People who ate the bars reported seizures, loss of consciousness and hallucinations. The agency has also scrambled to restrict tianeptine products known as 'gas-station heroin' after a number of reports of injury, addiction and death.
Politico
10 hours ago
- Health
- Politico
RFK Jr. eyes overhaul of vaccine injury program
Driving the Day 1986 ACT IN FOCUS — The nearly 40-year-old law that created the Vaccine Injury Compensation Program has received a lot of attention this month, both in federal courts and in the Humphrey Building (including Robert F. Kennedy Jr.'s X screed). Lauren is back from vacation with a primer on the latest developments: Let's make a deal? HHS requested a two-week extension Friday to respond to a lawsuit brought by the Children's Health Defense — the antivaccine group founded by Kennedy — challenging the department's failure to establish a vaccine safety task force — and indicated in its filing that a settlement could be coming. The department has asked for an Aug. 15 deadline to respond to the complaint — a timeline with which CHD attorney Ray Flores agrees — 'to allow the parties an opportunity to explore the potential for early resolution of this matter before engaging in further litigation,' DOJ attorneys wrote. The 1986 law required HHS to convene a task force on safer childhood vaccines that includes the heads of the CDC, the FDA and the NIH. The group briefly existed and issued a 1998 'final report and recommendations.' They included addressing concerns about vaccines' risks and benefits; boosting research and development efforts; and strengthening surveillance of vaccine-preventable diseases, potential adverse events and vaccine efficacy. Some vaccine scientists have expressed disappointment in the government's failure to steer some compensation fund money toward safety research, arguing that was Congress' intent at the time. More than $4.6 billion remained in the fund at the end of fiscal 2024, according to the Treasury Department. Kennedy on VICP: In an interview with conservative activist Charlie Kirk on Monday, the secretary offered no new details on his plans to revamp the compensation program. Kennedy instead focused on the length of the vaccine court process, which he lamented as taking anywhere from five to 10 years to resolve in some cases. Advocates for updating the program say increasing the number of so-called special masters who adjudicate claims would help with the backlog that grew after the number of covered vaccines nearly tripled by the mid-2000s. But that would require Congress to act, and legislation to add resources and increase the cap on payouts has languished for years. Kennedy also blasted a Clinton-era HHS decision to narrow the definition of encephalopathy — a broad term for brain dysfunction — in a way he says makes it nearly impossible to prove as a vaccine injury. Public health advocates fear the secretary will amend the injury table that serves as a guide for VICP cases in a way that deters vaccine makers from the market. 'What we're going to try to do is to make sure that the parents who do get injured get compensation, that they get it very quickly, and they get it without the kind of adversarial impediments that have now been erected over the past 40 years,' he said Monday. ICYMI: A federal court's ruling against a CHD lawyer who tried to revive a lawsuit tying his son's autism to vaccines was publicly released earlier this month. The attorney, Rolf Hazlehurst, told the group he plans to appeal. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you know why many FDA document links must now be downloaded? Send tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). In Congress A BUSY FINAL WEEK IN WASHINGTON — Congress is about to leave town for August recess, but a sizable amount of FDA business could potentially see action before lawmakers depart the heat and humidity of the Chesapeake Bay region. Wednesday: Following an overwhelming bipartisan markup in the House, the Senate Health, Education, Labor and Pensions Committee is scheduled to take up the Over-the-Counter Monograph Drug User Fee Amendments on Wednesday morning. Don't expect fireworks. Thursday: The Senate Finance Committee considers a slate of Trump nominees — including HHS general counsel nominee Michael Stuart. The West Virginian could play a key role in setting the legal agenda for the FDA if confirmed — he would be the direct boss of Robert Foster, the FDA's chief counsel. Appropriations: Senate leaders are still working to get consent from all 100 senators to start debate on the minibus funding package, after voting last week to clear the first procedural hurdles. The latest iteration of the bundle would include the bill that would fund the FDA at $7.2 billion. Eye on the FDA LATEST ON FDA, SAREPTA — Sarepta is resuming shipments of Duchenne muscular dystrophy treatment Elevidys to ambulatory patients after the FDA said the firm could lift the distribution pause, the company said in a news release Monday. 'We look forward to working collaboratively with the FDA to complete the safety label update for ELEVIDYS and to discussing the approach to risk-mitigation for non-ambulatory patients, who remain on pause pending the outcome of those discussions,' Sarepta CEO Doug Ingram said in a statement. Industry Intel HOPE FOR U.K. PHARMAS? President Donald Trump has indicated that he could take a softer approach to the U.K. on pharmaceuticals than some other countries, POLITICO's Dan Bloom and Sophie Inge report. In response to a question from POLITICO on whether the U.K. would avoid looming tariffs on pharmaceuticals — which Trump has indicated could happen as soon as August — the president said he would be announcing tariffs 'some time in the very near future.' 'We have a very big plan on pharmaceuticals. We want to bring a lot of the pharmaceuticals back to America where they should be,' the president told reporters at a joint press conference with British Prime Minister Keir Starmer at his Turnberry golf resort in Scotland. Trump has threatened tariffs of up to 200 percent on pharmaceutical imports to the U.S. 'But you also have a good pharmaceuticals business,' Trump said. 'We'll be dealing with you on pharmaceuticals also. And we certainly feel a lot better with your country working on pharmaceuticals for America than some of the other countries.' Meanwhile, in the European Union, Brussels is anticipating the Trump administration's Section 232 investigation into the pharmaceutical sector to eventually result in a top rate of 15 percent tariffs, POLITICO's Mari Eccles reports. That mechanism, under which tariffs can be imposed for national security reasons, is still not complete. But European Commission President Ursula von der Leyen said the EU deal would contain some exemptions for 'certain generics,' a boon for pharmaceutical companies that make low-cost drugs with narrow margins. Industry association Medicines for Europe wants more clarity on which drugs would see zero tariffs applied and is pushing the EU and the U.S. to 'expand the tariff-free list of medicines as widely as possible.' AROUND THE AGENCIES HHS TARGETS HEP C — The federal health department is launching a $100 million Substance Abuse and Mental Health Services Administration pilot program aimed at preventing, testing, treating and curing people with hepatitis C who have substance use disorder or a serious mental illness. Pharma Moves Laura Stevens Kent joined the American Clinical Laboratory Association as senior vice president of government affairs and policy. She previously worked as vice president of federal affairs at DeBrunner & Associates. Document Drawer The FDA is collecting public comments until Sept. 24 on menopause hormone therapy risks and benefits. The FDA published draft guidance containing recommendations on how firms can calculate aluminum content in parenteral nutrition to ensure it does not exceed acceptable thresholds. FDA Commissioner Marty Makary, top vaccine regulator Vinay Prasad and top drug regulator George Tidmarsh are gearing up for another round of meetings with pharmaceutical and biotech chief executives in New York, Raleigh and Atlanta. WHAT WE'RE READING The American Medical Association is urging HHS Secretary Robert F. Kennedy Jr. to not dismiss members of the U.S. Preventive Services Task Force, STAT News' Chelsea Cirruzzo reports. GSK and China-based Hengrui announced a drugmaking alliance Monday, BioPharma Dive's Ben Fidler reports. The Trump administration is narrowing subsidies for Medicare Part D plans, and CMS expects premiums will rise, POLITICO's Robert King reports.
Epoch Times
12 hours ago
- Health
- Epoch Times
LIVE NOW: HHS, FDA, and Sen. Mullin to Announce Action on Opioid 7-OH
Health and Human Services Secretary Robert F. Kennedy Jr., Deputy Secretary Jim O'Neill, Food and Drug Administration Commissioner Dr. Marty Makary, and Sen. Markwayne Mullin (R-Okla) host a press conference at 10:30 a.m. ET on July 29 to announce new measures to protect the public from the opioid 7-OH.
