This Week: CDC director fired, FDA advances new MASH tool, CMC pilot extended

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, the CDC’s recently appointed director was fired, FDA accepted a proposal to develop a new biomarker for MASH, and the agency extended a chemistry, manufacturing, and controls (CMC) pilot for another year.

In a dramatic series of events, Susan Monarez, director of the Centers for Disease Control and Prevention (CDC), was fired by President Donald Trump after she refused to resign under pressure from Health and Human Services Secretary Robert Kennedy Jr. Less than a month after being confirmed for the position. Monarez and Kennedy clashed over her refusal to change CDC’s vaccine policies and fire agency leaders that Kennedy disagreed with.

According to Politico, CDC Chief Medical Officer Debra Houry, National Center for Immunization and Respiratory Diseases Director Demetre Daskalakis, and National Center for Emerging and Zoonotic Infectious Diseases Director Daniel Jernigan all resigned in response to Monarez's firing.

Following the news, Sens. Bill Cassidy (R-LA) and Bernie Sanders (I-VT), chair and ranking member of the Senate Health, Education, Labor, and Pensions (HELP) committee, respectively, called for an investigation into Monarez’s firing. Sen. Patty Murray (D-WA), a top Democrat on the HELP committee, went even further and demanded that Kennedy be fired.

Cassidy also said that CDC's Advisory Committee on Immunization Practices' (ACIP) September meeting should be postponed indefinitely until there's been an investigation. Kennedy recently purged the committee of all 17 of its previous members and replaced them with new members who are largely more skeptical of vaccines.

"Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting," said Cassidy. "If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership."

The Senate Finance Committee has announced it will hold a hearing on 4 September, during which Kennedy will discuss the Trump administration’s healthcare agenda.

Even though FDA has changed its COVID-19 vaccine requirements so that they are only intended for people over the age of 65 or those older than 5 with an underlying condition that puts them at higher risk, Reuters reported that health insurance coverage for the vaccines will not likely change at least until January, when health plans offer new annual benefits, according to two insurance trade organizations.

FDA said it has accepted a letter of intent (LOI) to qualify Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a potential clinical trial surrogate endpoint to evaluate adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis to develop drugs to treat the disease. The agency noted that the biomarker could be a non-invasive method to assess liver stiffness and may predict clinical outcomes in patients with MASH who otherwise had to be evaluated with liver biopsies.

The Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program has been extended by FDA by another year. The program is meant to expedite CMC development of investigational new drug (IND) products by allowing sponsors more opportunities to communicate with regulators.

FDA published the results of a study that evaluated the potential risks of using cannabidiol (CBD) products. It found that common CBD use may lead to liver enzyme elevations in healthy adults not taking any other medications, which consumers may not be aware of.

The Center for Biologics Evaluation and Research (CBER) withdrew a final guidance on COVID-19 convalescent plasma. The guidance was issued during the pandemic to allow sponsors to develop convalescent plasma to treat COVID-19.

Drugs & Biologics

FDA announced it will host a hybrid meeting on 24 September to discuss its hiring and retention performance requirements set in the Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Amendments (BsUFA III). In preparation for the meeting, the agency issued an independent final report on its hiring and retention between October 2023 and January 2025 that do not take into account the staff who were fired in the reduction-in-force (RIF) initiatives implemented by the Trump administration.

FDA announced that it has withdrawn its approval for Amylyx Pharmaceuticals' Relyvrio (sodium phenylbutyrate and taurursodiol) to treat Amyotrophic Lateral Sclerosis (ALS) at the company’s request. Fierce Biotech also reported that Amylyx has ended a program to evaluate the drug to treat progressive supranuclear palsy (PSP).

Reuters reported that FDA is recommending that patients with Alzheimer's disease being treated with Eisai and Biogen's drug Leqembi (lecanemab-irmb) get scanned for amyloid-related imaging abnormalities with edema (ARIA-E) brain swellings before their third infusion. The agency said it has received reports of sic patients early in the treatment who have died.

Outlook Therapeutics said FDA has again declined to approve the biologics license application (BLA) for its wet age-related macular degeneration (wet AMD) drug ONS-5010/Lytenava (bevacizumab-vikg) and issued it a complete response letter (CRL). The agency said the drug failed to meet its primary efficacy endpoint in the NORSE EIGHT clinical trial.

FDA announced it is hosting its second workshop on patient-focused drug development to discuss methodological and other challenges with patient experience data. The hybrid workshop will be held over two days starting on 18 September.

CBER suspended the BLA for Valneva Austria GmbH’s chikungunya vaccine Ixchiq (chikungunya live-attenuated) due to serious safety concerns that it said "appears to be causing chikungunya-like illness in vaccine recipients." The agency reported at least one death from encephalitis directly attributable to the vaccine and more than 20 cases of serious adverse events.

Medtech

After receiving reports of serious injuries and deaths related to the use of hyperbaric oxygen therapy (HBOT) devices, FDA sent healthcare providers a letter to remind them of the risks associated with HBOTs. The agency recommended healthcare providers follow manufacturer instructions, take fire prevention measures, ensure proper staff training, monitor patients, and more.

ICU Medical initiated a Class I recall for its Plum Duo Infusion System with certain software due to concerns that the pump software may cause it to become unresponsive and prevent patient care. The company said all the potentially affected devices should be quarantined until it issues a software patch, unless it would cause a pump shortage.

Integra LifeSciences announced it is removing its Extended Tip Applicators from the market as part of a Class I recall due to concerns that they may not have been thoroughly sterilized and may have harmful endotoxins. The company said users should immediately remove and quarantine the devices in question.

Hamilton Medical also issued a class I recall for its Hamilton-C6 ventilators due to defective circuits that may cause ventilation interruptions to patients. The company said users with the specific devices in question should contact them to have the circuits replaced by a trained service technician.

This Week: CDC director fired, FDA advances new MASH tool, CMC pilot extended

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