This week at FDA: More layoffs at HHS, Prasad’s CBER hires, and Peter Marks joins Eli Lilly

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, there is no sign of the ongoing government shutdown ending as Congress remains deadlocked, and several news outlets reported that the White House has begun laying off furloughed federal health staff on Friday.

According to NBC News, Congress remains deadlocked on a funding plan. The Senate was unable to move forward with competing proposals from Democrats and Republicans aimed at funding the government this week.

On Friday, reports emerged that federal health employees are being terminated as the White House follows through on a pledge to lay off federal workers as the government shutdown ends its second week, according to STAT. A spokesperson for the Department of Health and Human Services (HHS) confirmed to STAT on Friday that these terminations have impacted the department. However, it is unclear which agencies were affected or how many employees would be let go.

“HHS employees across multiple divisions have received reduction-in-force notices as a direct consequence of the Democrat-led government shutdown. HHS under the Biden administration became a bloated bureaucracy, growing its budget by 38% and its workforce by 17%,” HHS spokesman Andrew Nixon told STAT.

Over 32,000 employees at the Department of Health and Human Services (HHS) have already been furloughed due to the government shutdown. Additionally, the department has faced significant reductions earlier this year as a result of previous efforts by the Trump Administration to decrease the size of the federal government.

Former CBER Director Peter Marks has joined Eli Lilly as senior vice president of molecule discovery and head of infectious disease, according to Fierce Biotech. Marks, who led CBER for nearly a decade, was removed from his position earlier this year by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. due to disagreements over vaccine policies.

According to MedPage Today, Vinay Prasad, the director of CBER, has started to shape his new staff, as announced in an email to his colleagues. Katherine Szarama, PhD, has been appointed acting deputy director of CBER. She previously worked at the Advanced Research Projects Agency for Health and the Centers for Medicare and Medicaid Services before joining the FDA. Prasad noted that Szarama “will focus on policy and governmental relations while also participating more broadly within the center.”

Sonday Kelly has also been named acting deputy director of CBER, although MedPage Today noted that it’s unclear why there are two individuals serving this role. The center’s former deputy director, Brittany Goldbergm will transition to the center’s chief medical officer.

In addition, Prasad promoted Scott Steele to head up pandemic preparedness in the Office of the Chief Medical Officer. Sundeep Agrawal will become branch chief of oncology, and John Scott and Stephen Chang will serve as acting deputy directors of the Office of Biostatistics and Pharmacovigilance (OBPV), while Prasad will continue to serve as the acting director of OBPV.

The US Centers for Disease Control and Prevention (CDC) will reschedule a vaccine panel meeting that was originally set for later this month, according to information from Reuters. The Advisory Committee on Immunization Practices (ACIP) meeting was planned for October 22, yet CDC has not provided a new date for when the meeting will occur. Earlier this year, HHS Secretary Robert Kennedy Jr. dismissed all 17 members of the committee, who are outside vaccine experts, and appointed new nominees in their place.

On Thursday, the FDA’s vaccine advisory committee held a routine vote to recommend strains for the composition of a trivalent influenza vaccine for the 2025-2026 flu season, according to Inside Health Policy.

According to STAT, the White House is preparing to negotiate a deal with AstraZeneca to reduce drug prices, according to sources familiar with the matter. This announcement follows the company's commitment to invest $4.5 billion in a new manufacturing facility in Virginia.

FDA has announced new import certification requirements for shrimp and spices from Indonesia following the detection of radioactive contamination. According to Reuters, firms placed on the red list due to evidence of Caesium-137 contamination must have an accredited third party verify their control measures for this radioactive element.

Drugs & biologics

FDA has approved Boehringer Ingelheim’s Jascayd (nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and serious disease that is progressive and currently has no cure along with limited treatment options. This marks the first new therapy approved for IPF in more than ten years.

The agency also approved Regeneron’s Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adults with high-risk cutaneous squamous cell carcinoma (SCCC) following surgery and radiation.

Additionally, FDA has approved Celltrion's biosimilar competitor to Eylea (aflibercept), Eydenzelt (aflibercept-boav), for the treatment of various eye conditions, according to Pharmaceutical Technology.

According to Bloomberg Law, Louisiana filed a lawsuit on Monday to prohibit the mailing of the abortion pill mifepristone within the state. The lawsuit argues that this practice bypasses state law. The state is seeking to have the agency restore in-person prescribing requirements and prevent mail-order pharmacies from dispensing mifepristone.

FDA issued a 483 to Aurobindo in Hyderabad, India, listing several good manufacturing practice (GMP) observations. These include inadequate procedures to prevent microbiological contamination of drug products that claim to be sterile, deficiencies in the aseptic processing area due to an insufficient system for monitoring environmental conditions, lax validation procedures, and failure to clean equipment at appropriate intervals.

FDA's draft guidance on scientific considerations for demonstrating biosimilarity to reference products reached OMB review this week and could be released soon.

An opinion piece STAT discusses the limits of FDA flexibility as a controversial decision regarding Biohaven Pharmaceuticals’ troriluzole, a treatment for spinocerebellar ataxia (SCA), nears. The drug treats a rare and debilitating neurodegenerative disease. The upcoming decision is scheduled for mid-November. This situation may provide valuable insights into regulatory flexibility under the current FDA leadership.

Sandra Retzky, director of FDA’s Office of Orphan Products Development has been removed from her role and reassigned to a new position. Her new position is unclear, according to Endpoints.

The International Council on Harmonisation (ICH) announced the release of a training module for interpreting and applying the ICH E6(R3) guideline on good clinical practices. Additional modules will be available soon.

Medical devices

FDA issued a warning letter on Tuesday to Technological Medical Advancements, located in West Palm Beach, FL, regarding its Diowave 250 WLS and Diowave 100 WLS laser systems. Investigators found that the company was making unapproved claims about its devices, asserting that they heal living tissue. Additionally, the company was cited for several violations of quality system regulations, including failures to establish adequate procedures to ensure that all purchased products and services meet specified requirements, and failure to perform supplier evaluations.

FDA awarded breakthrough designation to Abbott’s TactiFlex Duo sensor-enabled ablation catheter, according to MassDevice. The catheter includes a dual-energy modality for treating ventricular tachycardia (VT) using pulsed field ablation (PFA). An Abbott official posted the announcement on social media.

This week at FDA: More layoffs at HHS, Prasad’s CBER hires, and Peter Marks joins Eli Lilly

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