Recent layoffs at the U.S. Department of Health and Human Services, including the Food and Drug Administration, are expected to impact the medical device regulatory process. According to Ben Wolf, a former FDA attorney and current partner at Alston & Bird’s Health Care Group, these staffing cuts could lead to longer review times for medical device approvals. Wolf suggests that the FDA might experience a slowdown in processing applications, potentially extending approval times by up to 50%. He also mentioned that the industry might push back against these delays, possibly leading to a reversal of some layoffs or a reallocation of resources within the agency. Additionally, a recent court decision regarding laboratory-developed tests could free up FDA resources, potentially mitigating some of the impact of the layoffs. Wolf advises companies to streamline their regulatory submissions by being clear and concise, which could help expedite the review process despite the reduced staffing.
Matthew Herper
@matthewherper
·
Apr 1 The entire STAT staff is updating this story about layoffs at HHS. There will be a lot of info.
But the short version is this: a lot of the people who would keep drugs safe and effective, to protect patients in trials, and to fight bird flu and future pandemics are gone — even
Rod D. Martin
@RodDMartin
·
Mar 27 2/ The numbers are STAGGERING:
• FDA: -3,500 jobs (19% CUT)
• CDC: -2,400 jobs (18% GONE)
• NIH: -1,200 positions axed
• CMS: -300 out
This isn’t a trim – it’s a FULL REDESIGN of our health system
PBS News
@NewsHour
·
Mar 27 Most of the cuts will come from the public health agencies: The FDA, responsible for setting standards for Americans’ foods and medications, will shed 3,500 workers, while the CDC, which tracks infectious disease outbreaks, will cut 2,400 positions.
Everett Kelley
@AFGEPrezKelley
·
Apr 4 Trump and Musk’s FDA layoffs will raise drug costs for working people
https://nytimes.com/2025/04/03/health/fda-layoffs-food-and-drug-safety-rfk-jr.html…
“Sudden And Unexpected”
@toobaffled
·
Apr 5 The FDA is “finished.” One of its leading boosters for accelerated approval of mediocre drugs left in a huff. Drug stocks are dropping.
The shared interests of regulators and the industry they often join after or between federal service became unmistakable in the past week amid
carolyn johnson
@Carolynyjohnson
·
Apr 3 FDA laid off thousands of workers this week – and now they’re looking for people willing to come back for 2 months – great scoop by
@rachel_roubein
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