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

Legionnaires' outbreak in New York's South Bronx continues Since July 10 there have been 46 cases, two deaths

Yes, heavy cell phone usage increases risk of brain tumors Researchers identify RFR-induced 'oxidative stress' as the culprit

CMS report on medical homes finds no evidence of cost savings Concluding they don't work, however, 'a mistake'

UK researchers determine five types of prostate cancer Some are 'tigers', others are 'pussycats' — knowing which is which could save lives

Music festival takes aim at regional heroin epidemic In New Jersey, drug addiction does not rock

Leidos, Cerner, Accenture, win highly sought Department of Defense EHR contract Military Health System contract worth at least $4.3 billion

Pantheon acquires IBSL, expands into biomedical service segment Will significantly increase footprint in Italian market

Strength in numbers: The microbiome versus 'superbugs' New insight into how bacteria fight invasion could inform probiotic development

GE invests $1 billion to improve global training over next five years Over 300 million patients globally could benefit

Genetic test predicts sensitivity of tumors to radiation therapy Customizing dose to a particular tumor instead of standard uniform dose

FDA's new budget heavily reliant on user fees

by Brendon Nafziger , DOTmed News Associate Editor
The Food and Drug Administration requested a $4.5 billion budget in the Obama administration's $3.8 trillion 2013 federal budget proposal, released Monday, more than 40 percent of which will come from industry user fees.

FDA's budget, a 17 percent or $654 million increase on last year's, includes $387 million in program level expenses for medical devices, $11 million more than last year, according to the budget released by the Department of Health and Human Services. The FDA said it has allocated nearly $1.7 billion for medical products.

Story Continues Below Advertisement

Joint Commission changes are here! Are YOU ready?

As the leading Joint Commission accreditation service provider in the U.S., WEST PHYSICS knows these new requirements in depth. Click here to find out how WEST PHYSICS can help guide you successfully through the process.



The budget places a heavy burden on user fees, which the agency collects from industries to help pay for inspections and speed up product approvals. Such fees account for nearly 40 percent of the proposed budget, FDA Commissioner Margaret Hamburg told reporters at a press conference Monday.

User fees also account for 98 percent of the growth in spending, the FDA said. The amount requested from Congress, at $2.5 billion, is basically the same as last year's.

The current budget assumes the reauthorization of two user fees expiring in October, one for medical devices and one for drugs, and also includes seven new proposed fees, including a $299 million generic drug fee and a $20 million biosimilar fee.

Patient advocates are often critical of the agency's growing financial reliance on user fees. A Science Insider blog on Monday cited a 2007 Public Citizen letter to Congress which warned that the agency was becoming "dependent for its funding upon the very industry over which it has regulatory authority." Science Insider said that, at the time, the agency drew 20 percent of its budget from user fees.

But user fees weren't the whole story of the proposed budget. The agency also plans to use $10 million in "new resources" to improve inspections of foods and drugs coming from China. The agency has about $1.4 billion devoted to food safety, it said.

About $62 million would also go to pay for the consolidation of offices at the agency's new campus in White Oaks, Md., the agency said.

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 Central
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