FDA Policy/General
Federal Register notice: FDA is rescheduling a previously planned joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss the findings of completed postmarketing epidemiologic studies that examined the serious risks and predictors of misuse,
FDA Policy/General
FDA is advertising for contractors to replace the travel operations staff who were terminated from employment as part of an agency-wide reduction in force (RIF). Federal News Network reports that about a week after its employees were terminated, the agency began drafting a statement of work seeking contractors for
FDA Policy/General
Recent FDA layoffs are raising red flags across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approvals and challenge companies’ ability to maintain GMP compliance. Pre-approval inspections are likely to suffer from staff shortages, according to a Morgan Lewis legal update.
FDA Policy/General
FDA has approved an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for treating generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Vyvgart Hytrulo is now approved as a 20-to-30-second subcutaneous injection administered
FDA Policy/General
In a further blow to FDA morale, a 4/11 address to the agency’s White Oak, MD staff by HHS secretary Robert F. Kennedy Jr. was filled with unusual statements about the “Deep State” and accusations about employees becoming industry “sock puppets.” The Kennedy address failed on all levels
FDA Policy/General
Hundreds of U.S. biomedical innovators and investors are urging the Senate to help restore critical FDA staff that were recently laid off so that institutional knowledge at the agency is not lost. In a 4/6 letter to senator Bill Cassidy (R-LA), the stakeholders say that having an
FDA Policy/General
Attorneys Sarah Wicks and Anne Walsh (Hyman, Phelps & McNamara) say the recent and drastic reduction in force at FDA “is quickly becoming an information bottleneck — one that threatens to erode the transparency that stakeholders rely on.” Writing in their firm’s FDA Law Blog, Wicks and Walsh say that
FDA Policy/General
FDA has decided to allow some product review staff and supervisors to resume working from home at least two days a week, the Associated Press reports in a story based on conversations with three anonymous agency staffers. The story says an email on the subject was sent on 4/8
FDA Policy/General
Rep. Jamie Raskin (D-MD) and other federal lawmakers from the state are asking for a meeting with FDA commissioner Martin Makary to discuss the impact of significant cuts to the agency’s workforce. The Baltimore Sun reports the lawmakers said in a letter that “entire offices were reportedly eliminated,
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