FDA admits drug, medical device approval process is a bribery system based on who pays the most

FDA approvals
(NaturalNews) The US Food and Drug Administration (FDA) is once again having to both defend the legitimacy of its bloated existence, and petition Congress to pass legislation that will allow it to continue collecting "user fees" from Big Pharma in exchange for drug approval. And during a recent testimony, FDA Commissioner Dr. Margaret Hamburg admitted that this lucrative process caters specifically to those industry players who are willing to pay the agency the most money.

Every five years, Congress must decide whether or not to re-approve the Prescription Drug User Fee Act (PDUFA), which allows the FDA to charge drug companies millions of dollars for agreeing to review new drug applications (NDI). It is essentially a "pay for play" system where the FDA gives preference to those who play, even if the drugs or devices they have to offer are neither safe nor effective.

In 2005, the FDA's annual budget was just over $1.8 billion, with about $350 million of that constituting user fees. For 2012, the FDA is proposing a budget of over $4.3 billion, with more than $1.6 billion of that to constitute user fees. So while the FDA's overall budget has more than doubled within the past seven years, its user fees have skyrocketed nearly fivefold.

When trying to defend its budget proposal before Congress -- many have accused the FDA of mishandling the drug approval process and using it to reward the highest bidders. Dr. Hamburg tried to quell the firestorm with anecdotes about how the agency has approved a number of new "life-saving" drugs within the past year, and how it needs more money to make sure it can keep approving them before other countries do (as if approving potentially dangerous, life-threatening drugs is some kind of competition).

FDA approval process more concerned with money than safety and efficacy

Dr. Hamburg also admitted that the agency has essentially "lowered some approval standards." These are the words used by The New York Times (NYT) to make this all happen for the drug industry. But when asked why medical devices were not being given the same rapid approval treatment, Dr. Hamburg stated that "[a] higher percentage of our overall drug program (is supported by fees from drug makers)."

Put another way, Dr. Hamburg basically insinuated that if medical device manufacturers were contributing as much in user fees as drug companies are, then they, too, would receive rapid and more frequent approvals. Until then, the agency will continue to focus its energies into approving drugs -- because, after all, Big Pharma will be providing the FDA with nearly one-third of its overall budget in 2012.

This sad testament shows where the FDA's true priorities lie -- money. It does not matter whether or not a product is actually safe and effective -- those companies willing to pay the most will be given special treatment and have their products approved more rapidly and efficiently than others. And if Congress once again re-approves the PDUFA, the FDA will continue to cater to the drug industry rather than objectively look out for the best interests of the people.

Sources for this article include:

http://www.nytimes.com

Views: 117

Comment

You need to be a member of 12160 Social Network to add comments!

Join 12160 Social Network

"Destroying the New World Order"

TOP CONTENT THIS WEEK

THANK YOU FOR SUPPORTING THE SITE!

mobile page

12160.info/m

12160 Administrators

 

Latest Activity

Doc Vega posted a blog post

In Memory of Those Who Served

 Bullets flew and ricochetedI was on that hill todayMy Company commander got blown awayI was on…See More
18 hours ago
Doc Vega posted blog posts
Tuesday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"cheeki kea I was wrong Emperor Penguins are big and powerful but still alive but this,  A size…"
Tuesday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"Cheeki kea here's another that they say there have been modern sightings of!  The name of…"
Tuesday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"cheeki kea, did you ever hear of the giant Imperial Penguins? They were about 6 feet tall and could…"
Tuesday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"cheeki kea I do not think these giant two legged birds would need to have a bad attitude as long as…"
Tuesday
Olivia Brooks updated their profile
Tuesday
John Miller was featured
Tuesday
tjdavis's 2 blog posts were featured
Tuesday
Zfort Group's blog post was featured
Tuesday
Doc Vega's 6 blog posts were featured
Tuesday
Burbia commented on tjdavis's video
Thumbnail

“What’s His Motive?” - Inside The Mind of George Soros

"Trump calls for George Soros and son to face federal…"
Tuesday
Burbia commented on tjdavis's photo
Tuesday
Profile IconSeeta Sathe and Olivia Brooks joined 12160 Social Network
Tuesday
tjdavis posted a video

Mossad, Terrifying CIA Technology, Blackwater & The Most Secret CIA Unit | John Kiriakou

John Kiriakou served 15 years in the CIA as a Case Officer (Spy) and as CIA's Head of Counterterrorism Operations in Pakistan where he lead the raid that cap...
Monday
tjdavis posted a photo
Monday
tjdavis posted a video

A Critique of the Tavistock Institute - The Mother Of All Conspiracy Theories

An examination of the Tavistock Institute, a theory which seeks to explain how Western societies have been brainwashed by a cabal of social scientists and th...
Sunday
tjdavis posted a video

“What’s His Motive?” - Inside The Mind of George Soros

In this short clip, Patrick Bet-David, Sebastian Gorka Adam Sosnick, and Tom Ellsworth George Soros and what motivates him to do the things he does. FaceTime...
Aug 27
Doc Vega posted blog posts
Aug 27
cheeki kea favorited Bob of the Family Renner's photo
Aug 26

© 2025   Created by truth.   Powered by

Badges  |  Report an Issue  |  Terms of Service

content and site copyright 12160.info 2007-2019 - all rights reserved. unless otherwise noted