Reading Room Production — page 459

-----Original Message----- From: Emanuel, Ezekiel (NIH/CC/BEP) [E] Sent: Saturday, January 30, 2010 9:49 PM To: Borio, Luciana L. (FDA): Korch, George (HHS/ASPRTO) no 0 20: I(@who.eop.gov; Ezekiel Emanuel; Lurie, Nicole 'ASPR/IO); Fauci, Anthony (NIH/NIAID) [E]: Robinson, Robin (HHS/ASPR/BARDA); Merchant, Raina (HHS/ASPR); Goodman, Jesse L. (FDA) Ce: Korch, George (HHS/ASPR/IO) Subject: RE: Synopsis of Conversation with Pharma/Bio Reps 29 Jan 2010 Very interesting but probably would not work for say Anthrax drug or drug for botulism toxin. Ezekiel J. Emanuel, M.D., Ph.D. Department of Bioethics The Clinical Center National Institutes of Health Bethesda, Maryland 20892-1156 and Special Advisor for Health Policy Office of Management and Budget Tel. Fax NE a OMB Cell--NIH Cell-Personal -----Original MessageFrom: Borio, Luciana L (FDA) Sent: Saturday, January 30, 2010 6:06 PM To: Korch, George (OS): Lcpemmram aE gov: (@who.eop.gov; Emanuel, Ezekiel (NIH/CC/BEP) [E]: Ezekiel Emanuel: Lurie, Nicole (OS); Fauci, Anthony (NIH/NIAID) [E]: Robinson, Robin (OS); Merchant, Raina (HHS/ASPR); Goodman, Jesse L (FDA) Ce: Korch, George (OS) Subject: RE: Synopsis of Conversation with Pharma/Bio Reps 29 Jan 2010 I would like to clarify one point in George's excellent summary with respect to "markets." Section 524 of the FD&C Act authorizes the Secretary to issue a priority review voucher (PRV) to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review (6 months) of another single human drug application. According to the Act, the recipient of a PRV may transfer (including by sale) the entitlement to such voucher to another sponsor. The Act lists the eligible tropical infectious diseases, and also allows the Secretary to designate "any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations." FDA issued its 1st PRV to Novartis for the development of Coartem Tablets to treat malaria in April 2009.