BIG FAT ZERO = FDA FOIA = Pazdur Deleted & Shredded Documents
May 19th, 2009 | Posted by CTLDr. Pazdur says he has no documents and those he did have he previously destroyed….BOTH his hard copies and electronic copies of communications with Scher/Hussain reportedly destroyed
Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any
From FDA, affidavit from Dr. Pazdur also enclosed:
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.
5/18/2009 Freedom of Information Act (FOIA) documents received
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
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8/7/07 Motion for Order to Preserve Evidence
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June 3rd, 2009 at 5:01 pm
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