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Emanuel EEE @ 0 b.cop.gov>, "Lurie, Nicole (OS)" @hhs.gov>, "Fauci, Anthony (NIH/NIAID) [E]" <AFAUCI@niaid.nih.gov>, "Robinson, Robin (0S)" En © HHS.GOV>, "Merchant, Raina (HHS/ASPR)" ii @hhs.gov>, "Borio, Luciana L (FDA)" HE @ fd2.bhs.gov> Subject: RE: Synopsis of Conversation with Pharma/Bio Reps 29 Jan 2010 Date: Sat, 30 Jan 2010 14:48:01 -0500 Importance: Normal Thanks for this summary. From my perspective there were three main concrete suggestions/ issues: 1) Regulatory reform--"We need FDA to tell us up front what it will take to pass the hurdles and get to licensure." This is an issue--clarity bout the types of studies and levels of outcomes necessary for approval. There was also a call to use Bayesian statistics in this area and the need to have prompt FDA response to queries--being able to have a person with authority assigned to the development process. 2) Fostering Biotech-Pharma collaboration--the idea was to shift some money from SBIR or grants to a tax credit that big Pharma would get for investing in promising biotech for countermeasures. This would 1) give big Pharma a stake in developing a biotech product, 2) use big Pharma's ability to assess the promise of technologies, and 3) have the added advantage of attracting more investors in biotech since there would be big Pharma partners earlier in the process. So every dollar could be leveraged. 3) Liability reform--What I heard is that they wanted something like the National Childhood Vaccine Injury Act for countermeasures. Recent court case about FDA approval not serving as liability protection made this more important to big Pharma. I thought the market issue was important but that in this area the Pharma companies were willing to have a lower ROI--it is a matter of positive PR for them so the actual return could be lower as long as they were not losing money by doing it. 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 TE a OMB Cell--NIH Cell-Personal