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CareToLive Citizen Petition Pending at FDA for 556 Days!

February 15th, 2009 | Posted by Kerry Donahue
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The 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

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This entry was posted on Sunday, February 15th, 2009 at 5:59 am and is filed under The Cause, The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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Death by Wall Street - Rampage of the Bulls
Provenge is approved!

    Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
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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.
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.