FDA Submits Brief in Opposition to CTL’s Motion to Conduct Discovery
June 14th, 2009 | Posted by CTLThe Department of Justice (DOJ) submitted a brief on behalf of the FDA, in opposition to CTL’s Motion to conduct discovery (see second link)
You can read their entire brief here >> fdafoiamotion-memocontra-0613.pdf
Plaintiff is not entitled to discovery, as it does not provide any factual support for its allegations that FDA acted in bad faith in responding to its request under the Freedom of Information Act (“FOIA”).* * * * *
CareToLive does not agree, and our attorney, Kerry Donahue, will be filing a response.
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CareToLive MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT
Link to Motion >> ctlfoiaresponse6-06-09c.pdf
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Here are the FOIA Documents we received from CDER, requested by us almost 2 years ago in August of 2007, requesting FDA correspondence with Richard Pazdur concerning the Provenge delay of approval.
Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any
Received 5/18/2009 Freedom of Information Act (FOIA) documents
Declaration of Richard Pazdur >> ctlpoaz29exbd-5.pdf
Defendant FDA’s Motion for Summary Judgment >> ctlsj29-1a.pdf
Declaration of Fredrick J. Sadler >> exba.pdf
Declaration of Nancy B. Sager >> ctlexhibitc3.pdf
Declaration of Beth Brockner-Ryan >> ctlryanexhibitb.pdf
From FDA, affidavit from Dr. Pazdur (above):
See id. at ¶ 6. Dr. Pazdur recalls receiving both hard
copies and electronic copies of the letters from Drs. Hussain and Scher in April 2007. See id. at ¶ 7. However, as these letters related to a specific regulatory application conducted by a different FDA Center (CBER), did not fall under his direct regulatory supervision, and did not require a response from him, Dr. Pazdur shredded the hard copies of these letters and deleted any electronic copies. See id. The documents were shredded and deleted within a month of receipt. See id. In fact, Dr. Pazdur does not keep personal copies of any regulatory communications. See id. at ¶ 8. Official copies of regulatory correspondence are kept in the official regulatory document room of the specific center assigned to an application. Id. Contrary to plaintiff’s suspicions, Dr. Pazdur never disclosed Dr. Scher’s or Dr. Hussain’s letters to “any individuals outside of the FDA, or any media outlet, including a publication called ‘The Cancer Letter.’” See id. at ¶ 9. In addition, he did not write any portion of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA. See id. at ¶ 10. He also never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge. See id. at ¶ 11.
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It took the FDA 2 years to deny the CareToLive Citizen’s Petition.
FDA’s Response to CareToLIve Citizens’ Petition >> fda-response-to-citizens-petition.pdf
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Tags: Care To Live, CareToLive, Dendreon, FDA, Howard Scher, Kerry Donahue, maha hussain, Michael Milken Prostate Cancer Foundation Remains Silen, Prostate Cancer, provenge, Richard Pazdur, survival, Tags: Andrew Von Eschenbach, Thomas Fleming