This Week at FDA: Bracing for a shutdown, new chief of staff, Califf at CES

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, all eyes are on Congress, as time is running out for lawmakers to agree on a budget deal before a potential government shutdown on 19 January.

Congressional leaders have reached a tentative $1.7 trillion budget deal for FY2024, of which $773 billion is set aside for non-defense spending. As the Alliance for a Stronger FDA's Steve Grossman points out, the Senate version of the budget would provide $3.55 billion for FDA, but the bill also includes a highly controversial provision to stop FDA from allowing easier access to the abortion drug mifepristone.

As it looks ever more likely that Congress will again fail to come to an agreement on the budget and trigger a government shutdown, Senate Majority Leader Chuck Schumer (D-NY), has proposed a short-term continuing resolution (CR) that would keep the federal government funded. As The Hill notes, Schumer hasn't said how long the CR would stay in effect.

Earlier this week, FDA updated its guidance on sterility information for medical devices, up-categorizing vaporized hydrogen peroxide (VHP) as a sterilization agent, as part of its work to encourage manufacturers to rely less on ethylene oxide (EtO).

FDA also issued a final guidance adopting the International Council for Harmonisation's (ICH) Q5A(R2) viral safety evaluation guideline for products derived from human or animal cell lines. It details principles and strategies sponsors should consider to ensure the viral safety of their products.

FDA is hosting a virtual meeting on 16 January on how it funds extramural research through its agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science. The webcast is meant to allow interested BAA applicants to learn more about the agency's application process.

FDA will host a webinar on its pilot program for generic drug sponsors who are interested in using a Model-Integrated Evidence (MIE) approach to establish bioequivalence (BE) of their product in abbreviated new drug applications (ANDAs). The agency says it will discuss what its expectations are for sponsors who participate in the pilot and the process to apply.

This week, FDA announced Elizabeth Jungman, CDER associate director for policy in the Office of Regulatory Policy, will take over as FDA chief of staff, starting on 28 January. Former Chief of Staff Julie Tierney announced on LinkedIn that she has been hired as CBER's new deputy center director for strategy, policy and legislation.

A report from the Government Accountability Office (GAO) released this week recommends that Congress consider giving FDA additional oversight of dietary supplements after a review found that 11 of 12 tested prenatal supplements contained more or less than the labeled amount of at least one ingredient.

Drugs & biologics

The Center for Drug Evaluation and Research (CDER) published a report stating it had approved 55 novel drugs in 2023 and expanded the use of patient populations for previously approved therapies and drugs approved in new dosage forms and formulations. The report notes that between 2014 and 2023, CDER has averaged approximately 46 novel drug approvals per year.

FDA gave an update on its review of reports of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RA) to treat type 2 diabetes and weight loss. The agency said it has not identified any causal link between the drugs and suicidal thoughts or auctions, though it said it will continue to look into the issue.

The Center for Biologics Evaluation and Research (CBER) published updated standard operating procedures and policies (SOPP) used by its staff to evaluate biologics license
applications (BLA) and new drug applications (NDA). The document also clarifies key terms used by the agency and its responsibilities for handling applications.

CBER also published a webpage listing common ingredients found in FDA-approved vaccines. The web page lists certain common adjuvants such as aluminum salts, antibiotics, formaldehyde, and preservatives found in vaccines and explains why they are used.

Medtech

Politico reports that FDA Commissioner Robert Califf discussed the challenge of regulating artificial intelligence (AI) in healthcare during a panel at CES 2024 this week. Califf stressed the “dramatic” changes AI could bring to the healthcare space and said the agency will need outside help to continuously assess algorithms.

Troy Tazbaz, director of CDRH's Digital Health Center of Excellence, published a blog post asking stakeholders for input on how digital health technologies (DHT) can help the early detection of type 2 diabetes, especially in underserved populations. Stakeholders can comment on the issue on www.regulations.gov under docket no. FDA-2023-N-4853 until 31 January.

FDA announced a class I recall of Insulet's Omnipod 5 App, which is compatible with Android smartphones and is used with the company's automated insulin delivery system, the Omnipod 5 System, to deliver insulin to type 1 diabetes patients 2 years old and older. The agency said a software error could lead to patients not getting the right amount of insulin. So far, there have been reports of two injuries due to the issue.

FDA also announced a class I recall of Megadyne Medical's family of Mega Soft Universal Patient Return Electrode electrosurgical instruments. The company said it has so far received 99 reports of patients that have gotten burn injuries from using the tools, and it is updating its instructions and labels to ensure they are not used in patients under the age of 12.

FDA sent a letter to healthcare providers alerting them that certain chemicals such as formaldehyde may be released when General Electric's EVair or EVair 03 (Jun-air) compressors are used with certain ventilators. In December, the company issued a statement that there is a potential for elevated levels of formaldehyde being released from the products when used with the Carescape R860 or Engström Carestation/Pro ventilators, though they have not reported any adverse events yet.

Additionally, FDA labeled ResMed's recall of its AirFit and AirTouch masks that are used with continuous positive airway pressure (CPAP) machines a class I recall due to potential magnetic interference. The company said it is recalling the devices to update the labeling so users know which devices may be prone to magnetic interference, and so far, there have been six reported injuries.

FDA also labeled Busse Hospital Disposables’ recall their Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set due to Nurse Assist's November recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, a class I recall due to sterility concerns.

This Week at FDA: Bracing for a shutdown, new chief of staff, Califf at CES

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