This Week at FDA: OST reorg correction, Califf’s supplement priorities, 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, we learned that FDA jumped the gun with its announcement of a reorganization within its device center, Commissioner Robert Califf talked supplements, and a judge upheld a ruling to restrict the sale of the abortion drug mifepristone.

After announcing that it had reorganized its Office of Strategic Partnerships and Technology Innovation (OST) in the Center for Devices and Radiological Health (CDRH) into five suboffices, the agency has backtracked and published a correction noting that while the reorganization has been approved, the agency still needs to complete certain requirements before it goes into effect.

Earlier this week, FDA sent out invoices to eligible drugmakers under its FY2024 PDUFA VII and BsUFA III programs based on the fee rates it released in the Federal Register last month. Program fee rates are $416,734 for PDUFA and $177,397 for BsUFA in FY2024, while BsUFA biosimilar biological product development fees are $10,000 for initial and annual fee BPD fees and $20,000 for BPD reactivation.

On Monday, Califf wrote a blog post stressing that dietary supplements remain a “critical priority” for the agency as it revamps its human foods program. He stated that the agency is proposing to move its Office of Dietary Supplements Programs (ODSP) under the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI).

“The vision for the new OFCSDSI is to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements,” Califf wrote, adding that ODSP “will remain a distinct office tasked with executing the agency’s dietary supplement oversight.

FDA is seeking a deputy director for its Office of Therapeutics Products (OTP) super office at the Center for Biologics Evaluation and Research (CBER). The deputy director will report to the OTP director and help plan and manage strategies at OTP.

This week FDA also published its annual report to Congress on premarket approvals for devices indicated for pediatric use. The 2019-2020 report notes that the agency approved eight premarket approval (PMA) and two humanitarian device exemption (HDE) products for children.

Stakeholders who want to comment on CDRH proposed guidances have a new web page with tips they can reference. The agency published tips on its website that include requests for commentators to be concise and clear, avoid repetition, and provide explanations to help regulators better understand their position.

In the ongoing battle over abortion rights, a New Orleans circuit court judge agreed FDA had overstepped its bounds and ordered a ban on telemedicine prescriptions and mail orders for mifepristone. According to Reuters, the Department of Justice plans to appeal the ruling to the US Supreme Court.

Drugs & Biologics

The Office of Management and Budget is reviewing an FDA draft guidance that proposes to update how biosimilars and interchangeable products are labeled in the US.

Janssen Biotech's combination drug regimen (Akeega) niraparib and abiraterone acetate with prednisone was approved by FDA to treat patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC). The treatment is only labeled for use after the cancer has been detected with an FDA-approved diagnostic test.

Ipsen Biopharmaceuticals' Sohonos (palovarotene) has been approved by FDA as the first treatment for fibrodysplasia ossificans progressiva, a rare genetic connective tissue disorder. The agency approved the drug intended to reduce extra-skeletal bone formation in girls with the disease as young as eight and boys as young as 10.

Pfizer's multiple myeloma drug Elrexfio (elranatamab-bcmm) got accelerated approval from FDA. Reuters reported that the pill is intended for patients with a hard-to-treat form of the blood cancer or who have been treated for the disease at least four times before.

FDA also approved Regeneron’s Veopoz (pozelimab-bbfg) as the first treatment for a rare genetic disorder known as CD55-deficient protein-losing enteropathy (PLE), or CHAPLE.

Delcath finally got approval from FDA for its Hepzato Kit to treat patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases. Fierce Pharma noted the approval comes a decade after the company was initially rejected for its drug-device combination product, which injects the chemotherapy drug melphalan hydrochloride into the patient's liver.

Medtech

FDA will hold a two-day meeting starting on 7 September of its Microbiology Devices Panel to get feedback on whether to reclassify certain hepatitis B virus (HBV), human parvovirus B19, and tuberculosis diagnostic tests from class III to class II devices.

FDA recently warned consumers not to use more than a dozen tests made by Universal Meditech, Inc., which the agency said were sold online by at least four distributors, as the agency “is not able to confirm the performance” of the tests. The agency said the company had ceased operations and will not provide support for its already distributed tests, and while Universal Meditech did recall its undistributed tests, it has not opted to recall tests already in the hands of consumers.

The American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI) released a new consensus standard covering water quality for medical device processing.

Philips is recalling its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators, according to FDA, after the company found contaminants around some of the devices used by patients for continuous positive airway pressure (CPAP) and intermittent positive airway pressure. The company is concerned that contaminants may block the airway of the devices, which could lead to a lack of oxygen and a build-up of carbon dioxide that could lead to serious injury or death.

According to FDA, Datascope/Maquet/Getinge is recalling its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) due to a circuit board problem that may prevent the devices from charging. The agency notes that the failure could lead to potential injury or death.

This Week at FDA: OST reorg correction, Califf’s supplement priorities, and more

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