GAO Report Indicates FDA Rarely Pulls Defective Medical Devices Off Market
The Government Accountability Office's new report says the FDA's understaffing means it has difficulty ensuring companies are taking critical steps to protect patients.
ProPublica, Pittsburgh Post-Gazette:
FDA Rarely Forces Companies To Recall Defective Devices: GAO Report
The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it’s sometimes unable to make sure companies are taking critical steps to protect patients during health emergencies, according to a new report by the Government Accountability Office. The inquiry by the congressional watchdog was requested nearly two years ago by top members of the Senate in the wake of an investigation about the 2021 recall of breathing machines that threatened the health of millions of Americans. (Hamill, Dai and Medill Investigative Lab, 12/12)
More pharmaceutical updates —
MedPage Today:
Anticoagulant Reversal Drug Pulled From U.S. Market
Andexanet alfa (Andexxa) will officially be taken off the U.S. market this month as an emergency reversal medication for contemporary blood thinners. "The Biologics License Application for Andexxa has been withdrawn for commercial reasons, effective December 22, 2025," a spokesperson from drugmaker AstraZeneca said in an email to MedPage Today. (Lou, 12/12)
Bloomberg:
Sanofi MS Drug Takes Double Hit With FDA, Trial Setbacks
Sanofi’s experimental multiple sclerosis drug got hit with two setbacks on Monday: a regulatory delay in the US as well as a failure in a late-stage clinical trial. The US Food and Drug Administration decision on the medicine, called tolebrutinib, to treat an advanced form of multiple sclerosis will likely be delayed, with further guidance from the regulator at the end of the first quarter, the French drugmaker said. The shares plunged as much as 6.4% in early Paris trading, the biggest decline in more than three months. (Furlong, 12/15)
Bloomberg:
Novo’s High-Dose Wegovy Gets Green Light From EU Drug Panel
Novo Nordisk A/S said its high-dose version of blockbuster Wegovy has been cleared by the European Union’s drug advisory board, opening the way for use of a shot that delivers more weight loss than the standard dosage. The European Medicines Agency’s drug review committee recommended allowing the new high-dose shot based on the results from large clinical trials in people with obesity, with and without diabetes, Novo said in a statement. The committee’s backing means the shot could be available early in the new year, pending final approval from the European Commission, Novo said. (Kresge, 12/12)
The Washington Post:
Demand Climbs For Trump-Boosted Autism Treatment, But Doctors Are Divided
Pediatrician Kristin Sohl has lost count of how many times parents of children with autism have asked her for a prescription for leucovorin — the drug thrust into the spotlight after President Donald Trump touted it at a White House event this fall. Since September, despite the rising queries, Sohl has typically told her patients no. Early clinical trials of the drug showed hints of promise in boosting communication and cognition for some children with autism. But the studies have been small, often just a few dozen participants. (Eunjung Cha, 12/14)
KFF Health News:
FDA Panelists Questioned Antidepressants In Pregnancy. But Doctors Call Them A Lifeline
Before giving birth to her second child, Heidi DiLorenzo was anxious. She worried about her blood pressure, and the preeclampsia that prompted her to be hospitalized twice during the pregnancy. She worried that some terrible, unnamed harm would come to her 3-year-old daughter. She worried about her ability to love another baby as much as she loved her first. But DiLorenzo, an attorney in Birmingham, Alabama, did not worry about taking Zoloft. She had used the medication to treat anxiety before she had her first child, and she continued it throughout that pregnancy and this latest one. (Rab, 12/15)
In other health care industry news —
The New York Times:
Private Equity Finds a New Source of Profit: Volunteer Fire Departments
Rural departments have long relied on cheap software solutions to keep their operations running. But fire chiefs report sharp price increases as investors have entered the market. (Baker, 12/14)
Modern Healthcare:
Mass General Brigham Launches AI Spinoff Company AIwithCare
Mass General Brigham has launched a spinoff artificial intelligence company, the system said Friday. AIwithCare, developed by researchers at Mass General, aims to speed up the process of finding patients for clinical trials. It offers a tool, the RAG-Enabled Clinical Trial Infrastructure for Inclusion Exclusion Review, that the health system said streamlines finding eligible clinical trial participants and enrolling them faster than using standard manual entry procedures. (DeSilva, 12/12)
Modern Healthcare:
CMS’ ACCESS Model Has Headspace, Cadence Cautiously Optimistic
Health tech companies are eager to see if they will benefit from a new payment model designed to reward providers that improve outcomes for traditional Medicare beneficiaries with chronic conditions. Earlier this month, the Center for Medicare and Medicaid Innovation announced the creation of its ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model. The agency is looking for Medicare Part B-enrolled organizations that offer tech-enabled care that may include remote patient monitoring, wearables, coaching, behavioral support, patient education and medication management. (Perna, 12/12)
