The 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

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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 documents responsive to plaintiff’s request.

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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