This Week at FDA: HHS supply chain white paper, upcoming FDA meetings, 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 HHS released a white paper calling for policy changes to mitigate drug shortages, and FDA announced several important meetings, approved a new antibiotic for several uses, and sought new members for some of its advisory committees.

The Department of Health and Human Services (HHS) published a white paper detailing policy changes that could help prevent drug shortages which have become an increasingly bigger concern especially since the COVID-19 pandemic highlighted vulnerabilities in the US drug supply chain. While the paper focuses on generic sterile injectables (GSI), the department says the proposed solutions could be applied to other markets.

As stakeholders continue to wait for to overdue guidance on clinical trial diversity, the Office of Minority Health and Health Equity (OMHHE) announced it will host a virtual panel discussion on 17 April to discuss strategies to increase minority clinical trial participation. FDA Principal Deputy Commissioner Namandjé Bumpus will present the keynote address during the meeting.

FDA announced its Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will meet virtually on 22 May to discuss provisions in the 2017 FDA Reauthorization Act that require sponsors of adult cancer drug premarket applications to also submit data that could be used to inform the use of the drug in children. The subcommittee is expected to meet to discuss implementing the law and how it could affect pediatric cancer drug development.

Two FDA advisory committees are seeking qualified candidates to join their ranks. The agency announced its Device Good Manufacturing Practice Advisory Committee is looking for a nonvoting industry representative to join the committee and those who are interested should apply for the position by 6 May. Similarly, the Patient Engagement Advisory Committee is also looking for voting members to join its ranks and should apply for the positions by 4 June.

Drugs & Biologics

Amid concerns of increasing antimicrobial resistance and lack of new antibiotics coming to market, FDA had some good news this week as it approved Basilea Pharmaceutica's Zevtera (ceftobiprole medocaril sodium for injection). The drug has been approved to treat Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and acute bacterial skin and skin structure infections (ABSSSI) in adults, and community-acquired bacterial pneumonia (CABP) in children three months old to 18 years.

Bristol Myers Squibb and 2seventy bio announced that FDA has expanded the indication for their cancer drug Abecma (idecabtagene vicleucel; ide-cel) to treat patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy. The drug was already approved to treat patients with multiple myeloma who have received four or more prior lines of therapy.

Amylyx announced it is voluntarily pulling its amyotrophic lateral sclerosis (ALS) drug Relyvrio/Albrioza (sodiumphenylbutyrate/ taurursodiol) from the US and Canadian markets after topline results from a phase 3 clinical trial failed to show efficacy. The company said patients who are already on the drug and wish to continue receiving treatment can transition to a free drug program.

The Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) published its 2023 OPQ Annual Report detailing how it has ensured quality of drugs entering the US market. The office said it performed quality assessment on more than 1,100 approved drug applications, conducted more than 60 pre-license inspections across 18 countries and 10 states, helped develop 10 guidance documents and authored more than 90 articles in peer-reviewed journals in 2023.

FDA published a question-and-answer interview with Gerald Dal Pan, director of the Office of Surveillance and Epidemiology (OSE) at CDER, about FDA's drug postmarket surveillance and risk assessment programs. During the interview he talked about how CDER monitors safety concerns and addresses them as well as the FDA Adverse Event Reporting System (FAERS).

FDA's Office of Generic Drugs (OGD) announced it will host a webinar on 9 May about its redesigned pre-submission meetings under the most recent Generic Drug User Fee Amendments (GDUFA III). The agency said it will discuss how the redesign may help sponsors better prepare their abbreviated new drug application (ANDA) submissions, present hypothetical cases, and answer questions from participants.

Medtech

The University of California San Francisco (UCSF) Lethal Arrhythmia Database (LAD) was qualified by the Center for Devices and Radiological Health (CDRH) as a Medical Device Development Tool (MDDT) to evaluate lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems. More specifically sponsors of arrhythmia devices for hospitals can use the MDDT to collect data used to evaluate algorithms used in hospital monitoring systems, test performance of their devices, and assess algorithms used detect three types of lethal cardiac arrhythmias.

FDA cleared Otsuka's Rejoyn, a prescription digital therapeutic smartphone app to treat Major Depressive Disorder (MDD) as an adjunct to clinician-managed outpatient care for patients 22 years and older who are on antidepressant medication. The software provides interactive cognitive-emotional and behavioral therapy, which includes exercises, cognitive behavioral therapy-based lessons, and text messaging to reinforce lessons and encourage its further use.

Teleflex, and its subsidiary Arrow International are recalling their ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits, according to FDA, due to concerns about electrical issues on the devices. The agency said the flaws could cause adverse events such as injuries to the blood vessel walls, artery blockages and potentially death.

Medos International Sàrl has initiated a class I recall of its neurovascular catheter, the CEREBASE DA Guide Sheath, which is used to deliver interventional devices into the blood vessels in the brain due to concerns about fractures of the distal catheter shaft. FDA reports that so far it has received reports of three injuries related to the devices, but no reports of deaths.

Smiths Medical issued a class I recall for the Smiths Medical ASD PneuPac paraPAC Plus 300 and 310 Ventilator Kits after concerns the ventilators may have mechanical problems that may lead to serious injury or death, according to FDA, which has already recorded 8 serious injuries. The ventilators are gas-powered and portable and are typically used in airplanes and helicopters.

This Week at FDA: HHS supply chain white paper, upcoming FDA meetings, and more

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