This Week at FDA: Inspection reorg, acting CBER chief eyes IND reforms, and more

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, FDA leaders spelled out the case for an upcoming overhaul of the agency’s inspectional operations, the agency’s top biologics regulator proposed steps to make the US more attractive for early stage research, and the agency approved a controversial cancer drug after twice rejecting it.

Elizabeth Miller, FDA associate commissioner for inspections and investigations, and Lowell Zeta, FDA acting chief of staff and deputy commissioner for strategic initiatives, published a blog post on the agency's efforts to modernize its inspections and investigations operations. The officials said they are transforming the agency's inspectional enterprise by taking steps such as establishing the Inspectional Affairs Council (IAC), a cross-agency governance body that addresses inspectional issues.

The two officials argued that the overhaul—part of a greater reorganization of the agency under the Trump Administration’s “Simple Reform” effort—is not simply a backstep to employing inspection generalists. “The next-generation [Office of Inspections and Investigations] OII workforce model is not a move to generalists — far from it; it has been carefully designed to deepen talent by expanding investigators’ capabilities, strengthening specialized expertise, and creating better career pathways that support mobility and retention across the FDA,” they wrote.

Karim Mikhail, the FDA's acting director at the Center for Biologics Evaluation and Research (CBER), published a blog post arguing that the US is falling behind in attracting researchers to conduct early-phase clinical trials, especially compared to China. He lays out why he thinks the current investigational new drug (IND) process is outdated and failing, and what the FDA can do to fix the issue, including conducting an Expedited IND Pilot program.

Replimune's genetically modified oncolytic viral therapy Tudriqev (vusolimogene oderparepvec-wtpg) was granted accelerated approval in combination with Bristol Myers Squibb’s Opdivo (nivolumab) by FDA to treat adults with unresectable advanced cutaneous melanoma whose cancer progressed despite a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. The treatment had previously been rejected twice by the agency under former FDA Commissioner Marty Makary but was overwhelmingly recommended by an advisory committee last month.

After Elon Musk's Department of Government Efficiency (DOGE) conducted mass firings and cut grants across the federal government last year, the Government Accountability Office (GAO) published a report this week, finding that DOGE inflated claims of saving $110 billion. CNBC reports that the GAO found a significant lack of transparency and reliability in DOGE's claims, including overstating savings, and noted that thousands of contracts had not been terminated despite its claims.

FDA will host a virtual workshop on 23 September on using next-generation sequencing tests to detect adventitious agents AA in biologics. The agency notes that the technology has emerged as a new approach methodology (NAM) that can significantly improve the safety of biological products while also reducing the need for animal testing.

The Medical Device Innovation Consortium (MDIC) and FDA are co-hosting an in-person public meeting on 25 September to discuss advancing regulatory science to support breakthrough devices and disruptive medical device technologies. The agency said the objective of the meeting is to get stakeholder feedback on regulatory science needs of emerging device technologies and evolving clinical scenarios, as well as identifying critical regulatory science gaps.

Drugs & Biologics

FDA will host a virtual webinar on how to communicate drug interaction and QTc information in the drug's prescribing information. The agency said it will discuss an October 2024 guidance on drug and biologics interactions, as well as a December 2025 guidance on including QTc information.

Seegene received Emergency Use Authorization (EUA) for its Allplex HSV-1&2/VZV/MPXV Assay by FDA to simultaneously test for viral nucleic acid from monkeypox virus (MPXV clade I/II and MPXV clade II), herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV). The announcement follows a 2022 public health emergency declaration by the Health and Human Services secretary over monkeypox.

Liebel-Flarsheim has recalled a lot of its OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intravenous use that was sold in the US and Mexico due to concerns that there may be particulate matter consisting of polyethylene and other plastic materials, stainless steel, and glass. The company said the particulates may block blood vessels and cause blood clots.

Fresenius Kabi recalled one lot of Morphine Sulfate Injection USP, Simplist 2 mg/1 mL, due to a label mix-up where the products may actually be prefilled syringes of Dilaudid 0.5 mg/0.5 mL. The company said the mix-up could lead to life-threatening respiratory depression and death.

FDA approved Takeda Pharmaceuticals' Orzeyful (oveporexton) as the first drug approved to treat narcolepsy type 1 as a complete disorder. The agency said it is intended to address the full range of symptoms that define narcolepsy type 1, and the first treatment aimed at directly targeting the loss of orexin signaling that causes the disease.

Victory Medical Center Pharmacy has recalled certain lots of compounded Glutathione 200 mg/mL multi-dose vials after testing found elevated levels of bacterial endotoxin. The company said it has received reports of patients suffering from fever, chills, severe headache, nausea, vomiting, tachycardia, changes in blood pressure, body aches, and injection site reactions.

Medtech

The Center for Devices and Radiological Health (CDRH) has published a webpage describing its Patient and Caregiver Connection project, which enables FDA staff to gather input from patients and caregivers about their experiences with medtech products. The agency said its partner organizations will collect information through the project for CDRH, which will then be used to inform its regulatory decisions.

The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on 23 September to discuss whether to recommend GRAIL's Galleri NGS test to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood. The test will be evaluated as an early in vitro diagnostic for detecting multiple cancers in patients aged 50 years and older. FDA said it will also be evaluated for predicting Cancer Signal Origin in patients with a Cancer Signal Detected test result, as that may indicate the presence of an invasive solid tumor or hematologic malignancy, which should be followed by a diagnostic workup.

Becton Dickinson has sent letters to customers asking them to stop using certain intraosseous needle sets because they were manufactured out of tolerance, and as a result, users may find it difficult to remove the obturator after placing the sets. In an early alert from FDA, the agency said the company has so far reported 45 serious injuries and four deaths associated with the issue.

Fludeoxyglucose F18-guided radiation therapy systems have been classified as class II devices with special controls. FDA said that some of the mitigation measures manufacturers must undertake include clinical and non-clinical performance testing; software verification, validation, and hazard analysis; and compliance with labeling requirements.

FDA also proposed reclassifying digital breast tomosynthesis (DBT) systems that are currently class III devices to class II devices with special controls. The agency said the mitigation measures would include steps such as performance testing; software verification, validation, and hazard analysis; clinical image evaluation; and appropriate labeling.

Medline has issued a class I recall for certain of its convenience kits containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose injections due to quality issues raised by FDA at its manufacturing facility that can lead to reduced anesthetic effectiveness. The company has asked users not to use the products until an over-label has been provided.