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On our busy agenda for the rest of the week, three main items: 1) House and Senate Republicans need to come together to pass a continuing resolution to keep the federal government open. If they can't, stay tuned for furloughs. The CR keeps the FDA's funding levels at the same levels as during the Biden administration, and the rare pediatric PRV reauthorization is not included. 2) FDA commissioner nominee Marty Makary and NIH director nominee Jay Bhattacharya face Senate HELP committee votes
tomorrow. They're expected to sail through. 3) Trump's picks to lead CMS and the CDC will face Senate grillings on Thursday and Friday, respectively. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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Elon Musk (L) and President Donald Trump in the Oval Office (Alex Brandon/AP Images) |
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by Zachary Brennan
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Two days after announcing plans to shut down an FDA lab devoted to ensuring the US drug supply remains safe and potent, the Trump administration has changed plans and will leave the lab open, Endpoints News has learned. The St. Louis lab, known as the Office of Testing and Research, is one of the drug agency’s most important facilities for ensuring drugs are of
high quality. In addition to its day-to-day work, the lab has been called in to investigate high-profile drug safety issues. In 2008, for example, it led a probe into contaminated supplies of the blood thinner heparin, which likely killed dozens of Americans and was eventually traced back to a supplier in China. More recently, it led a probe into common heartburn medications that were found to have unsafe levels of nitrosamine, a carcinogen. That investigation helped lead to popular products like Zantac and related over-the-counter drugs being
pulled from shelves. |
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by Zachary Brennan
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The FDA told staff on Monday that reviewers of medical products and inspectors of manufacturing facilities cannot take the buyout offer circulated on Friday from HHS that would've provided as much as $25,000 in severance, three FDA officials confirmed to Endpoints News. The carveouts for staff funded by industry user fee
dollars show the extent to which the FDA and HHS are not targeting drug and device reviewers in the Trump administration's wider government staffing cuts. The move also will help ensure that all ongoing drug and device review timelines remain on schedule. The agency email on Monday, according to the three sources, noted that "ineligible positions" for the HHS buyouts include: "Inspectors and investigators in the Office of Inspection and Investigations including positions within the Office of Criminal Investigation;
Reviewers in CDER, CBER, CDRH, CVM, CTP and OC offices; physical security positions; cybersecurity positions; and all PHS Commissioned Corps Officers." |
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by Zachary Brennan
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Since President Donald Trump took office, Elon Musk's Department of Government Efficiency has laid off thousands of government workers through broad, sudden cuts — some later reversed — that have thrown the operations of the government into a period of uncertainty. That includes plans to halve the Internal Revenue Service, and the widespread purge of the US Agency for International Development, which will lose more than 80% of its staff. But for now, the FDA’s units responsible for reviewing new medical products have remained untouched — and may remain so. On Monday, days after more than
83,000 HHS employees were offered a $25,000 buyout package to quit their jobs, FDA staff were told that workers in the agency’s units that review medical products and inspect manufacturing facilities wouldn’t be eligible, Endpoints News reported. Subsequently, two people familiar with the agency's operations told Endpoints that reviewers and inspectors in the drug, biologics and devices centers would likely be shielded from
cuts. |
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Robert F. Kennedy Jr. (Allison Bailey/NurPhoto via AP Images) |
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by Zachary Brennan
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President Donald Trump's nominees for NIH director and FDA commissioner sailed through their respective confirmation hearings this week, facing few difficult questions and offering few controversial answers. But some of the views they expressed may conflict with the priorities of their new boss, Robert F. Kennedy Jr. While NIH nominee Jay
Bhattacharya and FDA pick Marty Makary made frequent mention of Kennedy's "Make America Healthy Again" slogan, both positioned themselves as more moderate on several crucial issues, such as vaccines. And on other major Kennedy priorities, like the influence of the pharma industry, it wasn't clear from the hearings what they think. Here are six takeaways from the hearings, and what they indicate — and what's still unknown — about drug and health policy in the Trump administration. |
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by Nicole DeFeudis
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A federal judge on Wednesday blocked the NIH from issuing a cap on indirect cost payments for grantees after finding that the challengers are likely to show the cuts conflict with the law. Judge Angel Kelley in Massachusetts granted a nationwide preliminary injunction after hearing arguments last month in three separate lawsuits brought by 22 states, several universities and organizations representing schools and hospitals. Kelley had previously issued a temporary restraining order, which prevented the cuts from taking effect while she considered the details of the case. The federal government can appeal the preliminary injunction while the cases proceed in district court. It’s unclear whether it plans to do so at this time. |
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