This Week at FDA: FDA appropriations markup delayed, new guidances, 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. Amid ongoing over the US debt limit, House Appropriations Chair Kay Granger (R-TX) has postponed the markups of several appropriations bills that were set to take place this week, including one that would fund FDA in FY 2024.

Failure to reach an agreement on the debt ceiling would have major implications for FDA, Bloomberg Law reports. According to FDA Commissioner Robert Califf at the World Orphan Drug Congress in National Harbor, MD this week, reviews of drugs and devices would be stopped in their tracks as the agency would be unable to pay its reviewers.

This week, FDA issued its final program report on its Drug Supply Chain Security Act (DSCSA) Pilot Project program. The 53-page report reviews the program, its milestones, and the lessons learned from the various pilots.

On Tuesday, FDA announced the approval of Braeburn Inc.’s Brixadi (buprenorphine) extended-release injection for subcutaneous use to treat moderate to severe opioid use disorder. The drug is approved in two formulations, one weekly and one monthly, for patients who have started on or are already being treated with buprenorphine. “Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” Califf said.

Earlier this week, FDA approved Entasis Therapeutics Xacduro (sulbactam for injection; durlobactam for injection) to treat difficult to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by certain strains of Acinetobacter baumannii-calcoaceticus complex for adults ages 18 and older. “Today’s approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation’s hospitals,” said Peter Kim, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research.

We also read up on some recent research in Endpoints, including a JAMA Network Open paper that found that roughly one-fifth of Phase III oncology studies changed their primary endpoint at some point during the trial and a study by FDA officials that found that viewers might not understand all the nuances presented to them in television ads for cancer drugs.

STAT reports that FDA has delayed its decision on whether to approve Sarepta’s Duchenne muscular dystrophy gene therapy until June 22, following an advisory committee meeting earlier this month that voted 8-6 to recommend that FDA grant the drug accelerated approval.

Drugs & biologics

FDA issued several draft and final guidances, including a final guidance on adjusting for covariates in randomized clinical trials for drugs and biologics, a draft guidance on efficacy endpoints for investigational diabetes mellitius drugs and a final technical conformance guide for study data.

FDA warned consumers and pharmacies not to use or sell one lot of Novis PR LLC’s G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor after an apparent mixup led to the wrong product – Finafta Anesthetic/Analgesic Liquid – being put in the carton packaging. The Finafta product contains ethyl alcohol and benzocaine, which could cause serious health issues or even death in infants and young children if consumed. The company has issued a voluntary recall of the affected lot, Lot D20911, which was distributed solely in Puerto Rico.

The agency posted two recent warning letters, one sent to homeopathic drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) Private Limited in Gujarat, India and Deleware-based Pharmadel, LLC, and another to New Jersey-based Sure-Biochem Laboratories, LLC. The letter to CMHP and Pharmadel references a previous a warning letter sent last month to CMHP concerning the company’s inadequate testing of incoming high-risk glycerin components. The new warning letter cites both firms for manufacturing and distributing unapproved drug products Bebelyn Diarrhea and Bebelyn Colic, which the firms market as homeopathic products.

Center for Biologics Evaluation and Research (CBER) sent an untitled letter to New York-based company doing business as Regenerelle, LLC for marketing human stem cell products to treat various ailments without a valid biologics license or active investigational new drug application (IND).

FDA also released a Form 483 it handed to UCB Pharma detailing three observations at the firm’s Braine-L’Alleud, Belgium facility.

Medtech

Users can now track their pre-submission files on the Center for Devices and Radiological Health (CDRH) Portal. FDA said the move is part of its commitment to use technology to improve efficiency and transparency surrounding its pre-submission process as part of its agreement with industry under the Medical Device User Fee Amendments (MDUFA V) program.

FDA’s Suzanne Schwartz and Tammy Beckham are asking for additional congressional authorities to require manufacturers to notify the agency about potential medical device shortages outside of a public health emergency. In an article in Health Affairs, the two high-ranking officials echoed calls by other FDA officials in recent years that agency needs such information to head off product shortages.

Elon Musk's brain-implant company Neuralink said it has been given the go-ahead from FDA to start first-in-human clinical trials for its brain implants. Though the company did not elaborate what it aims to do with the devices, Musk has previously stated they could potentially treat a range of conditions such as obesity, autism, depression and schizophrenia.

Swing Therapeutics said its app-based fibromyalgia therapeutic Stanza has received de novo authorization. The app, which requires a prescription, takes patients through a 12-week self-guided acceptance and commitment therapy (ACT) that is intended to improve their symptoms.

There were a number of recalls announced this week, including a recall of replacement batteries for ICU Medical’s Plum 360, Plum A+, and Plum A+3 Infusion Systems. The company said a defect in the batteries can substantially diminish their effectiveness which may lead to early powering down of their devices.

Integra LifeSciences said it is recalling all medical devices manufactured at its Boston facility over the past five years, after an internal endotoxin investigation found levels exceeded what is permitted. The high level of endotoxins could cause immune responses that result in postoperative fever, Medtech Dive reports.

Draeger Medical is recalling its Seattle-Positive Airway Pressure (PAP) Plus system, VentStar and other breathing circuit/anesthesia kits after it found that glued connections may loosen before or during ventilation due to a manufacturing error. The error could cause partial or complete detachment of components including the water trap, y-piece, or hose connector that may lead to severe injury or death.

SD BioSensor, Inc. is recalling certain Pilot COVID-19 At-Home Test kits, distributed by Roche Diagnostics. The liquid solution in some test kits may be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia that may cause infections, impact performance of the tests and may lead to adverse health effects and even death, FDA said.

FDA and the US Department of Veterans Affairs (VA) have signed a memorandum of understanding to proactively work to increase medical product supply chain resilience and flexible manufacturing capacity for use in public health emergencies, disasters, and other emergent events. The partnership is meant to ensure they collaborate on digital stockpiles and distributed manufacturing frameworks, share information, resources, and subject matter expertise.

FDA also published a final guidance on non-clinical performance assessment of tissue containment systems used during power morcellation procedures including gynecologic and general laparoscopic use. It provides recommendations for recommendations on test methods, test parameters and test acceptance criteria for the containment systems.

This Week at FDA: FDA appropriations markup delayed, new guidances, and more

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