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CareToLive Citizen Petition for FDA to Reconsider Provenge Approval Update

January 23rd, 2008 | Posted by CTL
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On Thursday, 1/17/08, CareToLive received a response to the CTL Citizens Petition filed on July 27, 2007.
Read the FDA response to the CareToLive petition for the FDA to reconsider the decision to delay the approval of the immunotherapy Provenge (click this link)

Today 1/23/08 CTL received a call back from the person at the FDA that had previously faxed us the response to the CTL Citizen Petition.

She indicated that she could not give any kind of timeline on the reconsideration of the failure to approve Provenge. She was asked who could and if anyone else at the FDA could elaborate on the short letter received by CTL from Jesse Goodman, or if anyone could pinpoint a time frame.

She was an extremely nice lady but we sensed that she had strict marching orders.

She stated that “there is a group of people actively reviewing the matter”.

She was asked if the group consisted entirely of people from CBER and she said she was not comfortable answering that.

She was asked if Jesse Goodman was one of the people involved in the group considering the Petition. Again she indicated she was not able to confirm or deny that.

After a few similar type of questions it was sensed that she was very uncomfortable and CTL stated to her that we understood she was in a tough spot and understood that she was not able to tell us more. With that she was thankful.

CTL is sure she was told exactly what to say and not to deviate from what she was specifically told to disclose.

READ OUR PETITION HERE
Petition for the FDA to Reconsider the Failure to Approve Provenge (click this link)

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This entry was posted on Wednesday, January 23rd, 2008 at 2:20 pm 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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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.