READ: Full Report From Make America Healthy Again Commission
A man holds a hat reading "Make America Healthy Again" at a press conference with Secretary of Health and Human Services Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Martin Makary at the Department of Health and Human Services in Washington on April 22, 2025.
Oliver Contreras/AFP via Getty Images
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CNBC
6 hours ago
- CNBC
FDA approves Moderna's new lower-dose Covid-19 vaccine
The U.S. approved a new Covid-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current Covid-19 vaccine, Spikevax — by refining its immune target. The approval "adds an important new tool to help protect people at high risk of severe disease from Covid-19," Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another Covid-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled Covid-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
Yahoo
10 hours ago
- Yahoo
Opinion - With his new prescription drug order, Trump fixes what Biden broke
Americans have been clamoring for sensible prescription drug reform for years. With the stroke of his pen, President Donald Trump answered that call. His executive order aims to bring down drug prices while 'once again putting Americans first.' Luckily, it specifically addresses one of the serious flaws in the Biden administration's Medicare Drug Price Negotiation Program — an oversight that has discouraged investment in affordable, widely used medications. This reform could deliver major savings to patients — without undermining the innovation that drives medical breakthroughs. Now it's up to Congress to finish the job. The reform in question addresses a flaw in the Medicare price-setting scheme put in place by the 2022 Inflation Reduction Act. That law gave the secretary of Health and Human Services sweeping new authority to impose price controls on certain drugs covered by Medicare. But it also drew an arbitrary line between different types of medicines by giving biologics, which are made from living organisms,13 years before price-setting kicks in, while small-molecule drugs, like pills and capsules, get just nine. That four-year gap makes no clinical or economic sense. Many of the most important drugs in history, from aspirin to statins to HIV treatments, are small-molecule medicines. Yet innovators are now steering investment away from them. According to a recent study, investment in small-molecule drugs has already dropped by 68 percent. And compared to pre-IRA levels, new small-molecule cancer drug development programs fell over 40 percent last year. President Trump's order calls for correcting this imbalance. The Republican-backed EPIC Act offers the clearest solution, aligning the treatment of small-molecule drugs with biologics by extending the price-setting window to 13 years. My hope is that this legislation will pass quickly with bipartisan support. Passing EPIC would protect innovation, preserve patient access and deliver on the president's promise to fix what the last administration got wrong. The order also directs the secretary of Labor to write new transparency rules to address some of the other significant issues affecting drug access and prices. That's a big win for patients and a critical step toward restoring fairness to the system and decreasing out-of-pocket costs for Americans. In addition to these transparency reforms, the order acknowledges the critical role of intellectual property rights in bringing new drugs to patients — and promises to optimize those protections in ways that improve access and lower drug costs. Patents and other intellectual property protections play a central role in pushing medical science forward. The previous administration's efforts to undermine these essential tools posed a direct threat to the foundations of America's innovation-driven economy. President Trump's unequivocal stance on this issue should come as welcome news to the nation's inventors and entrepreneurs — including those in the biotech sector. Equally encouraging is the executive order's treatment of the 340B Prescription Drug Program. The program was originally designed to help safety-net providers offer affordable medications to low-income patients. Yet today, less than 40 percent of hospitals that use the program are in underserved areas. During my time in Congress, I took up this issue — championing reforms to promote transparency, increase accountability and require participating hospitals to report patient's benefits. Now, emboldened by the White House, lawmakers should do the same. Altogether, this order is a blueprint for drug pricing reform that's patient-focused, pro-innovation and rooted in real-world solutions. Now, Congress can do its part, beginning with passing the EPIC Act. If they do, American patients could finally get the kind of affordable, innovative and equitable prescription drug sector they've long demanded. Larry Bucshon, MD, a cardiothoracic surgeon, served as the U.S. representative for Indiana's 8th District from 2011 to 2025. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
12 hours ago
- Yahoo
FDA chief wary of federal recommendations for Covid-19 vaccines
Dr. Marty Makary, commissioner of the FDA, on Sunday made it clear he was dubious of previous federal recommendations on Covid-19 vaccinations and the agencies who made them. In an interview with host Margaret Brennan of CBS' "Face the Nation," Makary responded to repeated requests from Brennan to clarify federal guidance (or the lack thereof) with variations on the same answer. "We believe the recommendation should be with a patient and their doctor," he said at one point, declining to give specific advice — or specifying how doctors might be able to offer guidance in the absence from direction from the federal government. Brennan was seeking clarity from Makary in the aftermath of Health and Human Services Secretary Robert F. Kennedy Jr.'s announcement that Covid-19 vaccines would no longer be recommended for healthy children and pregnant women. The CDC subsequently offered updated advice that somewhat countered what Kennedy said but also left room for interpretation. Makary there needed to be more controlled studies, so that decisions to approve vaccines would be more authoritative. The CBS host tried to get Makary to say what was lacking in the current data for such vaccines, and when that information might be available to the agency, as well as the general public. In his answers Sunday, Makary was not supportive of past guidance, criticizing the methodology of the CDC. "We know the CDC data is contaminated with a lot of false positives from incidental positive Covid tests with routine testing of every kid that walks in the hospital," he told Brennan. Makary also cast doubt on the CDC's Advisory Committee on Immunization Practices. "That panel has been a kangaroo court where they just rubber-stamp every single vaccine put in front of them," he said. At the time he was nominated in November, Makary was a Johns Hopkins surgeon who was best known for his criticism of the Biden administration's response to Covid, something for which Kennedy was also known. Trump said Makary was needed because "the FDA has lost the trust of Americans." Makary, he said, would "course-correct" the agency. On Sunday, when it came to discussing the shots and pregnant women, Makary was a model of consistency in his contention that the decision was a personal matter between a patient and her doctor. Brennan and Makary had this exchange: Brennan: "It is still unclear what pregnant women now should do until they get the data that you say." Makary: "I'd say talk to their doctor." Brennan: "When do they get the data you're promising? All these controlled studies." Makary: "In the absence of data, they should talk to their doctor ..." Brennan: "So no date?" Makary: "... and their doctor will use their best wisdom and judgment."
