Doing the FDA Petition Limbo
January 20th, 2008 | Posted by Kerry DonahueOn Thursday, 1/17/08, CareToLive received a response to the CTL Citizens Petition filed on July 27, 2007.
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.
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Tags: Care To Live, CareToLive, Dendreon, FDA, Jesse Goodman, Kerry Donahue, Petition, Prostate Cancer, provenge
January 23rd, 2008 at 5:57 am
Please–Please approve Provenge NOW! every day you delay another 80 men die a painfull death–without hope, Not only do the men die but their entire families suffer along with them
There is ample convincing evidence that Provenge works! Your own Advisory Committee says so. Your own team said that the data was convincing enough to submit a BLA. Your own Statistician said that the data was convincing.
It is long past time to grant approval, Dont let another man die unnecessarily
January 23rd, 2008 at 10:16 am
To disregard the overwhelming vote of confidence in the safety and substantial demonstration of efficacy of Provenge by your Advisory Committee strains credulity. You claim to be focused on science. Do you not understand that science will be vastly advanced with the issuance of at least a conditional approval for the licensure of Provenge?
Instead of being a protector and benefactor to the health and well being of the American people you serve, you have become, in my opinion, a bureaucratic impediment to the advancement of life saving treatments to terminal patients with no options left to forestall their death. If this indictment were not serious enough, it truly saddens me to say that there are also very disturbing signs pointing to corruption within certain elements of your agency. This is not meant to be a sweeping indictment or criticism. That would be grossly unfair to your thousands of dedicated, hard-working employees. But something has gone horribly awry. Get your act together!