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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


Food and Drug Administration Division of Freedom of Information 12420 Park/awn Drive, Room 1050 Rockville, MD 20857

November 28, 2012

In Response Refer to File: 2011-5576 Anne Weismann Citizens for Responsibility and Ethics in Washington (CREW) 1400 Eye Street, NW Suite 450 Washington, DC 20005 Dear Ms. Weismann, This is in response to your request dated July 28, 2011, in which you requested communications from January 1, 2010 to the present regarding the Food and Drug Administration and Martin Shkreli or any person acting on behalf of Mr. Shkreli or his hedge fund, MSMB Capital Management. Your request was received in the Center for Drug Evaluation and Research on August 1, 2011. Per the conversation with Darshini Satchi of this office and myself on September 14, 2012, you agreed to narrow the search parameters in order to process the request on the simple track. In addition, we performed a search for the three new names you provided (Adam Gefvert, Marek Biestek, and Kevin Tang) on September 14, 2012. The records that were located pursuant to our search have been enclosed. A fee waiver was granted on August 2, 2011. If there are any problems with this response, please notify us in writing of your specific probiem(s) at the above

address. Please reference the above file number.


This concludes the response for the Center for Drug Evaluation and Research. If I can be of further assistance to you, please do not hesitate to contact me.

Elizabeth Lee
Lead Regulatory Counsel Office of Regulatory Policy Division of Information Disclosure Policy Center for Drug Evaluation and Research

Enclosure: Communications between FDA and Martin Shkreli/MSMB Capital Management (1 CD)