This Week at FDA: Bumpus moves up, Congress stalls, and CDRH withdraws from GHWP

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 has lined up a replacement for Janet Woodcock when she retires, that no progress has been made in Congress on an agency appropriations bill, and that the device center has pulled out of a global harmonization organization.

The biggest news this week coming out of the US Food and Drug Administration (FDA) is that its chief scientist, Namandjé Bumpus, will be promoted to principal deputy commissioner when Woodcock, a 40-year veteran, retires early next year. It’s been a meteoric rise for Bumpus, who joined the agency just last year.

Another big story this week is that the FDA Center for Devices and Radiological Health (CDRH) has withdrawn its membership from the Global Harmonization Working Party (GHWP) which largely represents Asian regulators. The agency said it decided to leave after being sidelined on key issues and will instead focus on global medtech harmonization through the International Medical Device Regulators Forum (IMDRF).

President Joe Biden has invoked the Defense Production Act to boost US manufacturing investment to produce drugs and medical supplies that are critical to national defense. The measure is part of the administration's plans to help alleviate supply chain issues and counter inflation.

After Congress passed a continuing resolution bill to avert a government shutdown in early November, there hasn't been much progress made in terms of getting an FDA appropriations bill passed before a mid-January deadline. Steve Grossman at the Alliance for a Stronger FDA noted that the full-year funding right now looks uncertain but cited Senate Majority leader Chuck Schumer, D-NY, who said there have been discussions over the past week to ensure Congress can pass a full-year funding bill early next year.

Drugs & Biologics

Endpoints News reported that US Solicitor General Elizabeth Prelogar has written on behalf of FDA to ask the Supreme Court to overturn an appeals court decision that hampers the agency's ability to allow the abortion drug mifepristone on the market. She argued that the lower court ruling would "upend" FDA's current regulatory authority and hurt innovation.

The Center for Drug Evaluation and Research (CDER) has updated its NextGen Portal to include Drug Supply Chain Security Act (DSCA) data that is intended to allow FDA and manufacturers to share information on investigations regarding illegitimate products and address recalls. The update is part of the agency's strategy to tackle potential drug shortages and counterfeit drugs.

Reuters reported that the Biden Administration officials met with vaccine manufacturers such as Sanofi and AstraZeneca this week to discuss the importance of immunizing children against the respiratory syncytial virus (RSV), especially considering the increased risk of infections during winter. The two sides reportedly agreed to a plan on how to meet next year's immunization demands.

STAT News reports that the non-profit group Research Institute for Gender Therapeutics (RIGT) submitted a development plan to FDA for a Phase 3 clinical trial to ultimately get approval of estradiol as a gender-affirming hormone therapy. The drug is currently used off-label for that purpose.

SpringWorks Therapeutics announced its oral gamma secretase inhibitor Ogsiveo (nirogacestat) has been approved as the first cancer drug to treat desmoid tumors. The drug was approved in a limited capacity as a breakthrough therapy and had fast-track and orphan drug designations.

Medtech

FDA has proposed a rule to reclassify certain types of wound dressings and liquid wound washes containing antimicrobials due to their potential for causing antimicrobial resistance (AMR). The agency wants to classify products with a high level of AMR potential as class III and those with medium or low levels of AMR potential into class II.

GE HealthCare announced its x-ray software Critical Care Suite 2.1 with the Pneumothorax (PTX) algorithm has been cleared as the first of its kind to detect, notify, triage, and diagnose collapsed lung. According to the company, the software uses artificial intelligence/machine learning (AI/ML) to overlay the area where pneumothorax has been spotted on the X-ray image to speed up the detection and treatment of patients with the condition.

Vivos Therapeutics announced its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances have been cleared to treat severe obstructive sleep apnea (OSA). The company said its product is the first alternative treatment for people with severe OSA who otherwise would need continuous positive airway pressure (CPAP) treatment or surgical neurostimulation implants.

FDA published a safety communication warning patients and providers about overheating issues detected with Philips Respironics' DreamStation 2 CPAP machine used to treat sleep apnea. The agency said it had received medical device reports (MDRs) where the machines have caught fire and started smoking, and in some cases, patients have been injured. It is talking to the Dutch manufacturer about mitigating strategies and plans to update the public.

FDA announced that Unomedical has initiated a class I recall of certain VariSoft Infusion Sets used with Tandem insulin pumps to treat diabetes. The agency said concerns about the connector detaching from the infusion pump led to the recall because it could disrupt insulin delivery and fail to alert users that they are not receiving insulin, which could lead to serious injury or death.

This Week at FDA: Bumpus moves up, Congress stalls, and CDRH withdraws from GHWP

Related topics

Recommended content

Welcome to the new RAPS Digital Experience