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Posts Tagged ‘Citizens Petition’
LATEST POSTS
- 07/29/2010 - Provenge Works & Costs the Same as Chemo & Comments by Bishop
- 07/25/2010 - Setting the Record Straight
- 07/15/2010 - The Bloodshed, Bogus Threats, Birth Defects, Bashers Cover Letter
- 07/15/2010 - Provenge Is Approved But The Lies Continue
- 07/08/2010 - PROVENGE WILL BE COVERED BY MEDICARE
- 07/06/2010 - CareToLive sends a Freedom of Information Request to the Centers for Medicare & Medicaid Services
- 07/04/2010 - The Centers for Medicare and Medicaid Services are requesting comments.
- 05/20/2010 - Dr. Snuffy Myers Advocates For Provenge Treatment
- 05/03/2010 - The Real Provenge Story
- 04/29/2010 - BREAKING NEWS! PROVENGE APPROVED!
MOST POPULAR
- PROVENGE MAKING THE ROUNDS
- Sleepless in Asentar
- BREAKING NEWS! PROVENGE APPROVED!
- Michael Milken and the Prostate Cancer Foundation's Foul Balls
- The Real Provenge Story
- Dr. Snuffy Myers Advocates For Provenge Treatment
- The FDA is uncaring, the world won’t change their thought process and meanwhile Congress remains asleep at the wheel, when it comes to Provenge for the terminally ill.
- THEY'RE BACK!
- The Centers for Medicare and Medicaid Services are requesting comments.
- CareToLive sends a Freedom of Information Request to the Centers for Medicare & Medicaid Services
WHATS GOING ON
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
CareToLive Citizen Petition Pending at FDA for 556 Days!
February 15th, 2009 | Posted by Kerry DonahueThe Citizen Petition filed with the FDA by CareToLive has now been pending for decision with the FDA for 556 days. The Petition which asked the FDA to reconsider its decision to deny a license to Provenge, was followed up by 200 positive comments in the months following that filing, by patients, families of patients, physicians, scientists, researchers and other fine citizens.
The petition process is the only formal way for patients and their advocates to ask the FDA to consider and address their wishes.
It has been 384 days since CBER head Jesse Goodman wrote to CareToLive and said that they needed some additional time to decide the petition.
It has been approximately 372 days since a CBER employee told CareToLive counsel that a committee had been formed and they were actively reviewing the petition.
It has been approximately 365 days since counsel for the CBER division of the FDA told counsel for CareToLive that they took the petition very seriously and that while she could not say who was on the committee considering the petition, she could make the assurance that they were in fact actively reviewing it.
God bless all the patients that watch and wait. Stay strong!
Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016
Popularity: 60%
Tags: CareToLive, Citizens Petition, Dendreon, FDA, Howard Scher, Jesse Goodman, maha hussain, provenge, Richard Pazdur, Thomas R Fleming
Posted in The Cause, The Dysfunctional FDA | Post a Comment »