CMS Layoffs Broader Than Reports Indicate, Former Administrator Brooks-LaSure Says

The "interwoven" nature of the offices within the agency likely means Medicare and Medicaid benefits may be disrupted by staff cuts despite assurances from the administration, Brooks-LaSure warned.

CMS employees were laid off without official explanation or tally from the Trump Administration. (Shutterstock)

The extent of the Trump Administration’s layoffs at the US Centers for Medicare and Medicaid Services is unclear, but do go beyond reported cuts at the CMS innovation center and center overseeing insurance plans governed by the Affordable Care Act, former CMS administrator Chiquita Brooks-LaSure said.

More from Cell & Gene Therapies

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By 

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

EU HTA Regulation: Companies Can Talk To National Authorities As ‘Substitute’ For EU-Level Advice

 

Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.

More from Geography

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.