This Week at FDA: Government shutdown looms again, COVID-19 enforcement policies end

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 Congress failed to make progress to prevent a government shutdown, FDA ended a slew of COVID-19 enforcement policies and the NIH has a new director.

It’s deja vu all over again. With only a week to go before a potential government shutdown that could have a significant impact on the US Food and Drug Administration’s (FDA) operations, newly elected House Speaker Rep. Mike Johnson (R-LA) is facing the same interparty challenges as his predecessor. The Louisiana Republican had to withdraw his proposed budget bills from the House floor twice this week, according to NPR, after he realized he didn't have the votes even within his own party.

The Alliance for a Stronger FDA notes that so far, there has been no indication of how Johnson plans to extend the Continuing Resolution (CR) to give lawmakers more time to come to a compromise while continuing to fund agencies such as FDA. While the House leader has said he intends to present a plan on how to avoid a shutdown on 10 November, as of the writing of this article, he had not unveiled a plan.

Almost two years after Francis Collins left the position, Monica Bertagnolli was appointed as the director of the National Institutes of Health (NIH). The former director of the National Cancer Institute (NCI) faced stiff opposition from Sen. Bernie Sanders (I-VT), who as chairperson of the Senate Health, Education, Labor and Pensions (HELP) Committee, has been critical of her willingness to challenge pharmaceutical companies and lower drug prices.

FDA announced a couple of important meetings this week, including a meeting of its Molecular and Clinical Genetics Panel, which is set to meet virtually on 29 November to discuss the design of multi-cancer detection (MCD) in vitro diagnostic tests as well as the clinical study designs and outcomes that can be used in their premarket applications. Stakeholders can comment on the topic on regulations.gov under Docket No. FDA–2023–N–4720. Those who submit comments by 15 November will have their comments shared with the committee, but the docket will remain open for additional comments until 29 December.

FDA plans to host a two-day webinar starting on 12 December on drug interactions from therapeutic protein products, interactions caused by changes to the gastric pH level and interactions that affect combined oral contraceptives. The webinar will also discuss how to evaluate such interactions when developing new drugs, what to consider when designing clinical drug trials and how to use the agency's drug interaction websites.

STAT News reported this week that two dozen attorneys general have written to FDA to act on pulse oximeters to measure blood oxygen levels that have been found to be less effective in patients with darker skin tones. They expressed frustration that while the agency held a public meeting last year on the issue, it has not made any significant progress since.

Nurse Assist has initiated a recall of saline and sterile water medical products that may be contaminated with bacteria. FDA issued a safety communication about the products to healthcare providers and other stakeholders and advised them to check their inventory and refrain from using them.

Drugs & Biologics

Valneva Austria's vaccine Ixchiq has been approved by FDA as the first prophylactic against the disease caused by the chikungunya virus. The approval comes after the vaccine received Fast Track and Breakthrough Therapy designations, and Valneva's biologics license application (BLA) received Priority Review from the agency.

It’s been a good week for Takeda as FDA approved its BLA for Adzynma to treat congenital thrombotic thrombocytopenic purpura (cTTP), a rare blood clotting disorder. The agency noted it is the first recombinant protein product approved as a prophylactic or on-demand enzyme replacement therapy (ERT) to treat the life-threatening disease.

The Japanese drug maker’s cancer drug Fruzaqla (fruquintinib) was also approved by FDA to treat metastatic colorectal cancer (mCRC) in adults who had already received certain other chemotherapy treatments. Takeda’s new drug application for Fruzaqla had priority review and was reviewed under the FDA Oncology Center of Excellence’s Project Orbis, which allows cancer drugs to be reviewed concurrently across regulatory regimes.

Eli Lilly's chronic weight management injection Zepbound (tirzepatide) was approved by FDA to treat obese and overweight patients with at least one weight-related condition. The agency notes that the active ingredient in the drug is already approved under the brand name Mounjaro to improve blood sugar in adults with type 2 diabetes.

FDA announced this week that it had revised its indication for Merck’s highly successful cancer drug Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy as first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The updated indication is limited to patients with tumors expressing PD-L1 (Combined Positive Score of at least 1) as determined by an FDA-approved test.

Medtech

Teleflex, and its subsidiary Arrow International, are recalling six types of their Pressure Injectable Catheter Kits used to access patients’ central cardiovascular system. The product lids incorrectly state that the kits are non-coated but even though the banner card lists them as coated with chlorohexidine. Patients allergic to chlorohexidine could inadvertently use the products and suffer serious allergic reactions, including death.

A slew of medical device enforcement policies that allowed certain products to stay on the market due to the COVID-19 pandemic expired this week, meaning that manufacturers of such products need to transition to a traditional marketing pathway. The agency notes, however, that devices and diagnostics that are currently on the market under an emergency use authorization (EUA) are allowed to stay on, but it encourages manufacturers of such products to start transitioning to traditional marketing pathways.

ACON Laboratories’ Flowflex has been cleared by FDA as the first over-the-counter (OTC) COVID-19 antigen at-home test. It was first allowed on the market under an EUA in 2021, and as EUA products transition to traditional marketing, it is now the second at-home COVID-19 test obtain 510(k) clearance.

After granting de novo authorization to the Hemanext ONE red blood cell (RBC) processing and storage system back in September, FDA announced this week it is down-classifying all container systems used to process and store RBC components under reduced oxygen conditions from class III devices to class II with special controls. The agency said that special controls and general controls around the authorization are sufficient to ensure the product’s safety and effectiveness, while also ensuring patients have access to them.

FDA announced this week it has recognized three new standards related to software security for medical devices. The standards address taking a total product lifecycle (TPLC) approach to medical device cybersecurity, data logging software use and reasonable software testing.

This Week at FDA: Government shutdown looms again, COVID-19 enforcement policies end

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