SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

Hip fracture surgery reduces health care costs First study to look at societal impact

New technology can spot tiny strains in body tissues before injuries happen Imaging technology needs to get up to speed first

ACR calls for virtual colonoscopy coverage Coverage of fecal DNA testing set new precedent

First organ grown in animal using lab-created cells May be the foundation for thymus transplant treatment

Report suggests slow progress integrating electronic records with useful analytics Hospitals and vendors alike struggle to aggregate meaningful data

August's New Product Showcase This month's roundup of the latest industry products.

Video game console improves MS patients' balance MR shows changes in their brains

Simplified EHR alerts reduce hospital-acquired UTI infections Underscores need for simpler alerts

Medical imaging technology industry brings benefits to Washington Propels their economy and job market

Global laparoscopy device market will hit $12.3 billion Advances in ease of use and ergonomics

Budget sequestration could impact FDA device reviews

by Loren Bonner , DOTmed News Online Editor
Medical device approval processes could be severely impacted due to automatic, across-the-board spending cuts set for March 1.

According to analysts at the health care consulting firm Avalere Health, so-called sequestration would deprive the agency of critical resources needed for the timely review of important medical products. Sequestration would cut 8.2 percent from the federal budget unless Congress and the White House can agree on a way to cut spending through other means like tax reform.

Story Continues Below Advertisement

Click to see a vision of improved quality of care in the OR

A mobile C-arm with low power can cause a unit to overheat, leaving your team waiting as valuable minutes tick by. Click to learn about the new Cios Alpha - delivering the most powerful generator available in a mobile C-arm



"If you go whack the FDA budget there will be layoffs," Dan Mendelson, CEO of Avalere, told DOTmed News. "It's just the only way they can survive relative to a highly labor intensive environment."

For example, clinical trials for devices, which require FDA approval, could be impacted if the FDA lacks the resources to let the manufacturers know that the trial is unsafe and should not proceed.

"By statute, the FDA has to let them [manufacturers] know in 30 days to stop and fix something before going forward," said Lakshman Ramamurthy, director FDA regulatory policy at Avalere. "If no one is there because of confusion, then the trial will proceed because they haven't been told to stop." Post-review processes could be equally impacted, according to Ramamurthy.

In addition, sequestration sets up a rare situation for the agency where increased user fees for 2013 are collected but not available to the agency.

In 2013, new user fee rates went into effect and as a result, the FDA agreed to hire more people.

"It's ironic because all the user fee payments will continue unabated but the agency will not be able to access that money so it sets up this world where the life sciences companies have to pay but the agency does not benefit," said Mendelson.

The problem is further exacerbated by the fact that FDA appropriations for fiscal year 2013 are set at 2012 funding levels.

While the FDA will have to make its own plans in the event they face budget cuts, Avalere officials hope the FDA is prepared for what may come on March 1.

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

You Must Be Logged In To Post A Comment

Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2014 DOTmed.com, Inc.
ALL RIGHTS RESERVED