worry that the reduced reliance on traditional clinical endpoints could lead to gaps in long-term safety data. In a JAMA study that looked into the approval of drugs based on limited data, one of the researchers stated that they had found: “numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion.” Further disruption came last month with the resignation of Dr Peter Marks, the FDA’s top vaccine official, over disagreements with US Health Secretary Robert F. Kennedy Jr., a vocal critic of vaccines and Covid. “The U.S. has long been recognized as the world leader in medical and scientific innovation and regulation, grounded in transparency and scientific rigor,” said John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), in a written statement. “It is imperative that we retain and recruit scientific expertise and strong leadership at our health agencies and that the high standards that are the hallmark of these health institutions are upheld and advanced.” Voicing similar concerns about the recent downsizing at the FDA, John Murphy III, President and CEO of The Association for Accessible Medicines (AAM) said: “While we support improving FDA efficiency to deliver more affordable generic and biosimilar medicines to patients faster, many of the reported cuts appear to do the opposite.” The cuts have appeared to gather momentum in recent weeks with senior FDA officials Peter Stein, Hilary Marston, and Jeanne Marrazzo, reported to have resigned, been laid off, and placed on administrative leave, respectively. Future considerations With one eye on the future, the trajectory of U.S. pharmaceutical policy under the Trump administration remains in a state of transition with reforms emphasising speed and flexibility. However, signs that the regulatory pendulum may swing back toward stricter oversight, point towards the FDA’s post-market surveillance policies. With questions raised over the accelerated approval process, regulators may move to introduce more robust real-world evidence demands to ensure that expedited drugs deliver on their early promise. Pricing reform is also a controversial issue too. While the administration leans towards transparency over price caps, growing pressure may force a shift toward more assertive cost-containment actions. The future and subsequent success of U.S. pharma regulation hinges on the policies’ balance between innovation, affordability, and public safety. The key question remains: Can the industry sustain its newfound agility without compromising public trust?” REGULATION WILL CHU Editor 24/7 BIOPHARMA
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