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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.