This Week at FDA: WH reviewing candidates for FDA boss, a pause on posting CRLs, 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, there were reports that the Trump Administration is reviewing candidates to head FDA, FDA was pressured to pause publishing complete response letters (CRL), and more.

STAT News reported this week that the White House is reviewing at least three candidates for FDA commissioner, including Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and CEO of New York Cancer & Blood Specialists; and Stephen Ferrara, the principal deputy assistant secretary of war for health affairs. Last month, Bloomberg and other outlets reported that those three had emerged as frontrunners in the commissioner search.

Fierce Biotech reported that FDA has paused its controversial policy of proactively publishing CRLs shortly after they’ve been issued. The letters, which detail why regulators denied an application, have long been published after a drug goes on to get approve; however, last year the agency began publishing them for drugs that have not yet been approved as part of a transparency push. Fierce reported that the agency temporarily paused the practice after it was challenged by an unnamed pharmaceutical company in April, citing the potential to disclose proprietary information.

FDA announced it has come to an agreement with medtech industry representatives on goals and metrics for the Medical Device User Fee Amendments (MDUFA VI) program for the next five fiscal years. The agency published a draft commitment letter that includes a new “focused follow-up” pre-submission pathway for faster responses, enhanced timeframes for de novo submissions, and to convert the total product lifecycle advisory program (TAP) pilot into a full-fledged program.

The Cellular, Tissue, and Gene Therapies Advisory Committee is scheduled to meet virtually on 30 July to discuss whether to recommend approval of Replimune's cancer drug vusolimogene oderparepvec. The drug is being considered in combination with nivolumab to treat adults with advanced melanoma who have previously received an anti-PD-1 containing regimen.

FDA proposed a rule that it said would streamline the registration pathway for distributed manufacturing establishments that operate as a single establishment using a 'hub-and-spoke' model. The rule would clarify registration requirements for certain foreign drug manufacturing facilities that indirectly enter the US market.

Acting FDA Commissioner Kyle Diamantas published a blog post celebrating the US's 250th anniversary and the agency's 120th anniversary. While highlighting the agency's accomplishments, he emphasized its commitment to scientific integrity.

FDA issued an alert to healthcare providers that it is investigating the safety of sevoflurane and other general anesthetics due to reports of unexpected catastrophic outcomes, including severe neurologic adverse outcomes and death, in patients who have been administered the drugs and who have maternal Venezuelan ancestry. The agency said it is investigating a potential link to a rare mitochondrial genetic variant, but for now, patients with maternal Venezuelan ancestry should consider alternatives.

Drugs & Biologics

The Center for Biologics Evaluation and Research (CBER) is accepting applicants for its Rare Disease Endpoint Advancement (RDEA) pilot program through 30 September. The program is intended to advance the development of novel endpoints for rare disease drugs.

CBER updated its staff Standard Operating Policy and Procedure (SOPP) manual on administrative processing and review management procedures for investigational new drug (IND) applications to allow cross-referencing to inactive INDs. The update includes other administrative changes, such as a staff reminder to load all documents in the regulatory systems before setting the IND to terminal status.

FDA approved Vera Therapeutics' kidney disease injection Trutakna (atacicept-vymj) as a treatment to help reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. The agency noted that the drug received priority review and breakthrough therapy designation.

FDA also approved Sanofi-Aventis' injection Sarclisa (isatuximab-irfc) to treat several multiple myeloma indications. It was approved in combination with pomalidomide and dexamethasone to treat adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor; in combination with carfilzomib and dexamethasone, to treat adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy; and in combination with bortezomib, lenalidomide and dexamethasone, to treat adults with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant.

Merck's Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) have each been approved by FDA in combination with Astellas Pharma's Padcev (enfortumab vedotin-ejfv) as a neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer (MIBC). The agency noted that the approval extends its prior approval of the drug combinations for cisplatin-ineligible patients to all patients with MIBC who are cystectomy candidates.

The Reagan-Udall Foundation for the FDA and FDA are hosting a hybrid meeting on 5 August to discuss selection criteria and prioritization when considering repurposing drugs for new indications or new populations. The meeting will include an overview of comments submitted to the agency in response to a recent request for information on the topic.

FDA has published updated over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists. The arrears list includes the names of facilities that have not yet paid their annual OMUFA user fees by 1 June, while the paid facilities list includes facilities that have at least partially paid their fees.

FDA announced free access to its Microphysiological Systems (MPS) Training Course co-developed with IQ MPS Affiliate. The agency said the curriculum educates users on design, characterization, qualification, and application of complex in vitro models, which are a class of new approach methodologies that can be used for drug development.

Medtech

Windstone Medical Packaging has issued a Class I recall for certain custom convenience kits produced by the company that include Cardinal Health Webcol alcohol prep pads used for skin preparation before injections or blood draws. The company is concerned that the pads may be contaminated with the bacteria paenibacillus phoenicis and could lead to infections.

Fresenius Kabi has issued two Class I recalls, including one for Ivenix Large Volume Infusion Pumps that may have been dropped or jarred. While the devices may not appear damaged, the company said they may have a loose touchscreen input cable, which could cause unintended touchscreen behavior, such as random screen touches and reduced responsiveness to user input.

Fresenius Kabi also issued a Class I recall for certain Ivenix Large Volume Infusion Pumps installed with Large Volume Pump Software version 5.10.2. The company said a software error could cause the devices to show a false battery-health value, which triggers a battery-depletion alarm that shuts them down unless other actions are taken.

FDA issued an early alert for certain convenience kits made by Medical Action Industries that include Medline’s Namic Angiographic Star Off Handle Manifolds. The company has issued a letter to customers advising them not to use the products due to concerns that particulates may be present in the fluid path of the manifolds that may become lodged in blood vessels.

FDA also issued an early alert for certain convenience kits made by Medline due to ChloraPrep applicators in the kits made by Becton, Dickinson and Company (BD). Medline notified customers that BD has initiated a recall of specific lots of the BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL applicators due to concerns about their sterility, which may expose users to microbial contamination.