This Week at FDA: FDA’s final LDT rule nears, Cardinal Health warning letter, 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’s final rule on laboratory developed tests (LDTs) may soon see the light of day.

On Monday the Office of Management and Budget (OMB) announced it had completed its review of the final rule. The controversial proposed rule, which was published in September 2023, has faced opposition from test developers and medical centers, while the medical device industry has backed greater FDA oversight of such tests. (RELATED: FDA proposes long-awaited LDT enforcement rule, Regulatory Focus 29 September 2023)

The measure has also drawn much debate in Congress when in late March, members of the US House Energy and Commerce (E&C) health subcommittee sparred over whether the FDA was within its right to develop a rule to regulate LDTs. Republicans were largely opposed to these products being regulated by the agency, while Democrats argued the agency was left with no alternative after Congress failed to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. (RELATED: This Week at FDA: Lawmakers spar over LDT rule, new guidances, and more, Regulatory Focus 22 March 2024)

On Wednesday, FDA sent a warning letter to Cardinal Health following an inspection of the firm’s facility in Waukegan, Illinois for marketing syringes which are unapproved and adulterated; these products are intended to inject fluids into or withdraw fluids from the body and to deliver fluid to a patient’s feeding tube.

The warning letter comes after FDA has advised healthcare providers and consumers not to use plastic syringes made by two Chinese firms, Jiangsu Caina Medical Co Ltd and Jiangsu Shenli Medical Production Co Ltd, and warned other firms who marketed or distributed their syringes following reports of device failures, such as leaks and breakage. FDA’s warning letter notes that Cardinal Health switched manufacturing of the syringes to the two Chinese firms, which resulted in products not adhering to their initial specifications.

Drugs & Biologics

On Friday, Reuters reported that FDA has approved Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for hemophilia B; Beqvez is the second gene therapy approved to treat the disorder.

FDA announced the approval of UTILITY Therapeutics’s Pivya tablets (pivmecillinam), a new treatment to treat adult females with noncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

On Wednesday, FDA announced the retirement of Mary Beth Clarke, director of the Office of Executive Programs (OEP), effective 1 June. Clarke joined CDER in 2010 as a senior advisor to former CDER Director Janet Woodcock and has led OEP since 2012. FDA said Clarke “was instrumental in guiding the launch of the Generic Drug User Fee Amendments (GDUFA), which has reshaped our generics program.”

Endpoints reported that FDA has issued a complete response letter to Abeona for its cell therapy for epidermolysis bullosa.

FDA has announced the release of three guidance addressing cancer trial eligibility: the first addresses considerations for enrolling patients with lower performance status; another addresses laboratory values; while the third covers washout periods and concomitant medications.

FDA has established a public docket soliciting public comment on how its Office of Clinical Pharmacology can promote effective drug development.

Healthy Women submitted a citizen petition urging FDA to revise the labeling for all fenofibrate drugs to “remedy the widespread misimpression” among healthcare professionals that using fenofibrates, when used alone or in combination with statins, can reduce cardiovascular risk. The group argues that current labeling of these products has resulted in “pervasive, improper utilization of fenofibrates.”

On Tuesday, Endpoints reported that FDA granted accelerated approval to Day One’s targeted treatment for pediatric brain cancer, Ojemda (tovorafenib) five years after the company’s founding.

Medtech

This week, FDA announced several Class I medical device recalls, including for DeRoyal Industries, Inc’s Tracecarts containing 16FR Urine Meter Folies affected by another recall; Fresenius Medical Care’s Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters; InfuTronix, LLC’s Nimbus and Nimbus II Infusion Pump systems; Outset Medical, Inc.’s Tablo Hemodialysis Systems; Elekta Instrument AB’s Disposable Biopsy Needle Kit for Leksell Stereotactic System; and Draeger, Inc.’s Perseus A500 Anesthesia System.

Medtech Insight reports that several small ethylene oxide (EtO) sterilizers that spoke to them are not concerned about complying with the Environmental Protection Agency’s final rule that would restrict EtO emissions by sterilizers and limit exposure to the substance by employees at commercial sterilization facilities.

FDA updated its list of medical devices in shortage to add four product codes to the discontinuance list: ITX (transducer, ultrasonic, diagnostic), IYN (system, imaging, pulsed doppler, ultrasonic), IYO (system, imaging, pulsed echo, ultrasonic), and GCJ (laparoscope general and plastic surgery). The agency also updated the duration of intra-aortic balloon and control systems under product code DSP, which is expected to last until winter 2024.

This Week at FDA: FDA’s final LDT rule nears, Cardinal Health warning letter, and more

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