FDA Policy/General
In striking testimony delivered to a House Committee on Oversight and Government Reform hearing 4/9, former FDA commissioner David Kessler issued a dire warning about the future of the U.S.’s public health and scientific leadership, pointing to recent sweeping FDA staff cuts as “devastating, haphazard, thoughtless, and
FDA Policy/General
Former FDA acting commissioner and CDER director Janet Woodcock says the situation at FDA in the Trump administration is “like the flat earthers taking over NASA.” Speaking on 4/7 at the Biopharma Congress on a panel on “The Future of FDA: Where Do We Go From Here?”, the agency
FDA Policy/General
FDA’s user fee programs — long recognized as the financial backbone of the agency’s medical product reviews and authorizations — could be in jeopardy, according to regulatory experts, as sweeping layoffs and political indifference from the Trump administration threaten their reauthorization. AgencyIQ regulatory intelligence director Alec Gaffney warned last week
FDA Policy/General
Rhythm Pharmaceuticals is reporting “positive topline results” from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor agonist, for treating acquired hypothalamic obesity. The company says the trial met its primary of a “statistically significant and highly clinically meaningful reduction in body mass index (BMI)” for setmelanotide
FDA Policy/General
FDA has approved an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease (IgG4-RD), which is described as a chronic and debilitating immune-mediated inflammatory condition that can affect and damage multiple organs. The approval is based on data from the MITIGATE
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. admitted 4/3 that many mistakes were made in cuts across HHS health agencies, including FDA, this week. He told the media that in the course of making cuts, “personnel that should have not been cut were cut,” and he said some have been
FDA Policy/General
The U.S. House Committee on Oversight and Government Reform is holding a 4/9 hearing on “Restoring Trust in FDA: Rooting Out Illicit Products.” While no FDA official is invited to attend, the committee says other expert witnesses will testify on the “necessary steps to reduce inefficiencies and bureaucracy
FDA Policy/General
Commentary by Contributing Editor John Hope Decades ago, when I made the difficult decision to leave my position as a statehouse reporter for a major daily newspaper to become a state agency public information officer, one of the things that helped convince me to make the change was the belief
FDA Policy/General
Former FDA commissioner Scott Gottlieb says FDA commissioner Marty Makary will likely face political interference from the Trump administration attempting to impact decision-making at the agency, especially due to HHS secretary Robert F. Kennedy Jr.’s vaccine skepticism. Speaking at Politico’s 2025 Health Care Summit in Washington, DC
FDA Policy/General
Apparently unprepared for the significant disruptions to daily FDA activities caused by this week’s firing of several thousand staff, the agency is now looking to bring some of those workers back for a short period to assist in the transition. FDA’s new chief operating officer, Barclay Butler, reportedly
FDA Policy/General
Former FDA commissioner Mark McClellan says he hopes FDA will be able to come through the current difficulties caused by a massive reorganization and use technology to “do more with less.” But, he continued, “it will be a challenge for the new team coming in to deliver on it.” McClellan,
FDA Policy/General
In the wake of dramatic layoffs at FDA this week, industry associations are busy sounding alarms as they weigh how the staff cuts will impact product development, FDA reviews and approvals. The Pharmaceutical Research and Manufacturers of America questioned the cuts and their impact on the agency’s ability to
FDA Policy/General
Sens. Bill Cassidy (R-LA) and Bernie Sanders (I-VT), chairman and ranking member of the Senate HELP Committee respectively, have invited HHS secretary Robert F. Kennedy, Jr., to a 4/10 committee hearing on his reorganization of the department. The 4/1 invitation letter said the senators were “following
FDA Policy/General
FDA is looking to reprioritize its planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff were cut 4/1 under HHS’s mass firings. Many routine surveillance inspections will likely fall to the wayside as the agency prioritizes “for cause”
FDA Policy/General
HHS secretary Robert F. Kennedy, Jr. promised at his confirmation hearings to enhance transparency at HHS and the health agencies it manages, but HHS-directed employee terminations that began 4/1 will most likely diminish transparency instead. “Public health agencies should be transparent,” he said before being confirmed by the
FDA Policy/General
In a move presumably to make it easier to terminate federal employees, president Trump late last week signed an executive order to remove organized union representation from the majority of government agencies, including FDA and other HHS health agencies. Government watchers are predicting that the order will vigorously be challenged
FDA Policy/General
FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced HHS restructuring in response to president Trump’s Department of Government Efficiency (DOGE) Workforce Optimization Initiative executive order. This is in addition to the 1,000 agency probationary employees who were cut
FDA Policy/General
The U.S. Senate 3/25 voted 56 to 44 to confirm the nomination of Marty Makary as the next FDA commissioner. The floor vote follows the Senate Health Education Labor and Pensions (HELP) Committee’s vote 3/13 to advance the nomination. Makary will likely be sworn in sometime
FDA Policy/General
AstraZeneca says new study data on Tagrisso (osimertinib) show an “improved overall survival trend” in patients with epidermal growth factor receptor-mutated non-small cell lung cancer. Results from the Phase 3 LAURA trial demonstrated that patients on Tagrisso lived a median 58.8 months compared with 54.1 months
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says its review of the “Efficacy Results” Web page for Taiho Oncology’s Lytgobi (futibatinib) tablets found it makes false and misleading representations about the drug’s benefits. A 3/21 Notice of Violation says the violations are particularly concerning because the
FDA Policy/General
FDA has approved an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Vutrisiran was previously approved for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. “By rapidly knocking down both mutant and wild‑type transthyretin (TTR), vutrisiran
FDA Policy/General
FDA has approved a Novartis NDA for Fabhalta (iptacopan) for treating adults with C3 glomerulopathy (C3G) to reduce proteinuria. The rare and progressive kidney disease has historically lacked targeted treatment options, and Fabhalta is the first oral inhibitor of the alternative complement pathway, which is believed to drive C3G progression,