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

Elekta is building the hybrid linac-MR of tomorrow The Atlantic is a linear accelerator with a built-in 1.5T MR scanner

BC Technical acquires Virtual Medical Sales Will improve company's service capabilities

Gearing up for China Med 2015 The trade show promises to continue breaking records in attendance and exhibitors

Global MR market set to more than double by 2020: report Technological advancements and less expensive systems drive market

Health care cannot afford uninformed, cost-conscious public: study Cost fears may lead to unaccountable patients cramming the ER

Teen posing as doctor in Florida hospital is nothing to kid about How normalization of deviance in hospitals can open doors for trespassers

GE and Volpara sign agreement over breast density measurement software GE looks to personalize breast cancer screening

Hybrid OR for Swedish hospital is latest partnership between Siemens and IMRIS Sahlgrenska University Hospital to offer intraoperative MRI

Medical Tourism - Health care disrupter or fringe service? Where does medical tourism fit in today's health care environment?

Most health care managers expect return on population health investments: survey But there is still work to be done

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

OiHealthcare - ISO 9001 & 13485 Certified - Call 888-673-5151

Oxford Instruments Healthcare, is a leading ISO 9001 & 13485-certified organization, that specializes in providing quality after-market GE CT and MRI systems, service and parts - at prices you can afford.



"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

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Center
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
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 ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED