As the government shutdown stretches into its second week, the U.S. Food and Drug Administration (FDA) continues to operate under constrained conditions—managing leadership changes, new product approvals, and emerging regulatory updates. Here’s a look at the most significant developments shaping this week across the FDA and the broader life sciences landscape.
Ongoing Shutdown Brings Federal Layoffs
Congress remains at an impasse over a government funding package, leading to a deepening impact across the Department of Health and Human Services (HHS). According to STAT and NBC News, the White House has begun laying off furloughed federal health employees as the shutdown persists. While details remain unclear, HHS confirmed that layoffs have affected multiple divisions.
The department had already furloughed more than 32,000 employees, reducing its operational capacity and delaying routine oversight functions. These staffing challenges follow earlier cuts implemented under broader federal workforce reduction efforts.
Leadership Transitions at FDA and Beyond
In leadership news, Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research (CBER), has joined Eli Lilly as Senior Vice President of Molecule Discovery and Head of Infectious Disease. Marks, who led CBER for nearly a decade, was dismissed earlier this year amid policy disagreements within HHS.
Meanwhile, current CBER Director Dr. Vinay Prasad continues to shape his leadership team. According to MedPage Today, Dr. Katherine Szarama has been appointed Acting Deputy Director of CBER, focusing on policy and governmental relations. Sonday Kelly will also serve as Acting Deputy Director, while Dr. Brittany Goldberg transitions to the role of Chief Medical Officer.
Additional appointments include Scott Steele leading pandemic preparedness initiatives and Sundeep Agrawal heading oncology efforts within the Office of Biostatistics and Pharmacovigilance (OBPV).
Vaccine and Drug Policy Developments
The Centers for Disease Control and Prevention (CDC) has postponed its October vaccine advisory meeting following the dismissal and reappointment of all 17 members earlier this year. Meanwhile, the FDA’s vaccine advisory committee voted to recommend the 2025–2026 trivalent influenza vaccine composition, continuing its annual process for flu strain selection.
In parallel, Reuters reports that the White House is in discussions with AstraZeneca to negotiate drug price reductions—a move following the company’s recent $4.5 billion investment in a Virginia manufacturing facility.
Regulatory and Enforcement Actions
FDA continues to address quality and safety concerns in manufacturing. A Form 483 issued to Aurobindo Pharma cited multiple GMP violations, including inadequate aseptic practices, poor environmental monitoring, and insufficient equipment cleaning procedures.
Additionally, the agency issued new import certification requirements for shrimp and spices from Indonesia after detecting radioactive contamination involving Caesium-137. Affected firms must now undergo third-party verification to ensure compliance.
In the medical device sector, FDA sent a warning letter to Technological Medical Advancements for making unapproved claims about its laser systems and failing to maintain adequate quality system controls.
New Drug Approvals and Pipeline Updates
Despite limited staffing, the FDA announced several major drug approvals this week:
- Boehringer Ingelheim’s Jascayd (nerandomilast) for idiopathic pulmonary fibrosis (IPF) — the first new therapy for the disease in more than a decade.
- Regeneron’s Libtayo (cemiplimab-rwlc) as an adjuvant therapy for high-risk cutaneous squamous cell carcinoma (SCCC).
- Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar to Eylea, expanding treatment options for multiple retinal disorders.
Meanwhile, a draft guidance on biosimilarity standards has reached review at the Office of Management and Budget (OMB), signaling its upcoming release.
Broader Regulatory Landscape
Legal and regulatory discussions continue to intensify nationwide. Louisiana filed a lawsuit to block mail-order dispensing of the abortion pill mifepristone, seeking to reinstate in-person prescribing requirements. Meanwhile, the FDA reassigned Sandra Retzky, former director of the Office of Orphan Products Development, to a new yet-undisclosed position.
On a global scale, the International Council for Harmonisation (ICH) released its first training module for the updated E6(R3) Good Clinical Practice guideline, aiming to promote consistent interpretation across international regulatory frameworks.
Medical Device Innovation
The FDA granted Breakthrough Device Designation to Abbott’s TactiFlex Duo sensor-enabled ablation catheter, which uses dual-energy pulsed field ablation to treat ventricular tachycardia (VT). The device marks another step forward in precision cardiac therapies.
The EMMA International Perspective
This week’s developments highlight the resilience of the FDA and life science community in the face of operational uncertainty. From leadership transitions to new product approvals, regulatory science continues to advance even amid disruption.
At EMMA International, we help organizations anticipate and adapt to these evolving dynamics—aligning compliance strategies with FDA priorities, supporting efficient submissions, and ensuring readiness for emerging policy shifts.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Eglovitch, J. (2025, October 10). This week at FDA: More layoffs at HHS, Prasad’s CBER hires, and Peter Marks joins Eli Lilly. Regulatory Affairs Professionals Society.
