The poster “emrssf” did a very good job of conveying to everyone here the environment at the oral argument. While it is not entirely accurate or complete (he states at the beginning that he does not take shorthand and so it is not presented as entirely accurate) it is close to accurate and in fact it helps me to recall the chronology of events better than I could without it. While he was taking notes on what was being said I was focused on responding to the Judges questions and anticipating my next argument. So I cannot be entirely accurate or complete either.

Continue Reading Where it stands…CareToLive vs. FDA (long winded version) »

Popularity: 9%

First, please understand that the call for hearings is not over. There are still numerous Congressman that do not agree with the Dingell response. Hearings could still happen they just won’t happen soon and they won’t likely be championed by E & C. Please keep lobbying your representatives and keep the health staffers informed. The Petition has got lots of signatures but it can do so much better if those reading this, yes you, sent it to 25 people each and asked them to send it to 25 of their friends. If you do not have 25 friends then you might be named Scher or Pazdur. There should be 5,000 signatures by now.

Second, the legal action is pending on two fronts. There is an appeal pending in the 6th circuit court of appeals that should be fully briefed by all parties by the first of March. We also have the pending FOIA claim against CDER. In my opinion Richard Pazdur has the smoking gun but he is not giving it up. Richard Pazdur has still not responded to the August CTL FOIA request. It is my belief that the FDA intentionally withheld these documents (consequences be damned) because of the scrutiny. They are damaging and would have assured consequences in the face of hearings. I am 100% certain that if we saw Dr. Pazdur’s hard drive the conspiracy against Provenge would be fully uncovered. Continue Reading Where do we go from here »

Popularity: 36%

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)

The response was from Jesse L. Goodman at CBER who we believe and hope is a friend to our cause and who we hope would also like to see Provenge approved.

The letter in substance stated:

“In your citizen petition you request the Commissioner of Food and Drugs to reconsider FDA’s failure to grant a biologics license application for Provenge…We are still considering your request and supporting information stated in your citizen petition….we will respond to your petition as soon as we have reached a decision on your request”.

I have a call into CBER to try and find out more about the meaning of the response and will advise if and when I know more.

While the letter might be an attempt to qualify as a response that satisfies 21 CFR(e)(2), it does not satisfy it in my opinion. Below are the parameters that the response must contain are containd in (iii) below, which this response does not contain.

2) Except as provided in paragraph (e)(4) of this section, the Commissioner shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either:

(i) Approve the petition, in which case the Commissioner shall concurrently take appropriate action (e.g., publication of a Federal Register notice) implementing the approval;

(ii) Deny the petition; or

(iii) Provide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished.

While CTL is happy to report that the petition was not denied and is still being actively considered, they are unhappy that the FDA did not grant the petition.

I have been instructed by CTL to find out if the delayed response is a legitimate and short delay or just a stalling tactic. Once I ascertain this, a decision will be made by CTL what further legal action they wish me to properly pursue on their behalf.

(Attorney, Kerry Donahue, is suing the FDA on behalf of CareToLive, a prostate cancer advocacy group, to gain immediate access to Provenge, an immunotherapy voted 17 to 0 safe and 13 to 4 substantial evidence of efficacy and then delayed in an unprecedented act by the dysfunctional FDA for a treatment voted so overwhelmingly safe and effective, that showed survival benefits, where no other viable options exist. CareToLive believes foul play was afoot, as 2 of the naysayers had substantial undisclosed conflicts of interest and profited by seeing Provenge delayed.)

READ OUR PETITION HERE
Petition for the FDA to Reconsider the Failure to Approve Provenge
Tell the FDA what you really think about the delay of Provenge
Submit any comments to the CareToLive Citizen’t Petition plus attachments that might help our cause.

You may fax, email and/or snail mail them.

Please include:

Docket number 2007P-0297

Request to Reconsider the Failure to Approve Provenge

Fax 301-827-6870

email lyle.jaffe@fda.hhs.gov

Mail:
Lyle D. Jaffe
Division of Dockets Management
Food and Drug Administration, 5630 Fishers Lane
Room 1061 (HFA-305)
Rockville, MD, 20852

If you have any trouble you may call Lyle Jaffe at 301-827-6869.

PLEASE, if you had trouble getting your documents through, please use these contact points at the FDA and resend them.

Popularity: 26%

By: Kerry M. Donahue, Counsel for CareToLive, a not for profit corporation.

Now that we have enjoyed our Turkey Day it is time for me to get back to work for CareToLive.

When CareToLive requested I investigate and look into the Provenge debacle back in May 2007 and consider filing a law suit against the FDA we talked about what we wanted to accomplish.

Over the course of the following two months, as we investigated and researched the potential litigation, we decided that we needed to do three things.

Continue Reading 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. »

Popularity: 100%