Diary Prequel Package — page 96

endorse and support the enterprise. The USG is already investing for FY-04 about $488 million while the entire world's contribution (including the USG) is about $600 to $640 million (these non-USG numbers are estimates. Hence, most of the action is us. She liked the idea and wanted to pursue it. She said that it would be a home run if we could spice it up with some new money. She mentioned about $100 million. I brought up that the usual scenario would be that NIH would have to absorb this "new" money since there really is no new money. Kristen feels that if anyone can squeeze new money out of Josh Bolten, it is me. She is going to bring the issue up to Josh. The second meeting was with Kristen, Joe O'Neill, Carole Thompson, Mark Dybul, Randy Tobias, Jenday Fraser (new US Ambassador to South Africa). Meeting took place in Margaret Spellings office since it is one of the larger offices. Margaret was not there. Discussion was regarding the options of how to address the FDC/generics situation in the context of the PEPFAR. We discussed a number of options. Our goal is to get the lowest possible price for drugs that are clearly safe and effective. Big issue with FDA since they clearly will not approve a drug based only on "pre-qualification" by WHO. There is much misunderstanding (see above) about the USG supposedly blocking generics since we are in the pocket of PHARMA. This is nonsense since we are concerned that we will be buying drugs that are not even generics; they are "knock-offs" from branded drugs. I like the option of pressuring our drug companies to put 3 drugs in a blister-pack (would take 1 month for the FDA to approve) to avoid the issue of potentially low quality Faces. Other good option is to work with the FDA to speed approval (probably take 1 year since you would have to do some pharmacokinetics and bioavailability studies first) of FDCs contained the branded drugs. Simultaneous option would be to ask the South African Medicine Control Council (their FDA) to regulate the knock-off FDCs and to only buy it if they approve them. This would be Africans making decisions for Africans. The only problem is that if they reject the drugs, it might look like a typical erratic South African move, i.e. Mbeki and Shabalala Misemang are notoriously weird. Alternatively, if they accept the drugs with scrutinizing them and they are no good, we would be buying bad drugs. April 14, 2004 - White House meeting (EEOB 476) with Gary Edson, Rick Klausner, Rachel Ingram (Gates) and David Lane (Gates), Martina Strong, Carol Thompson to discuss the role of the Gates Foundation in the HIV Vaccine Enterprise. Rick presented the same case as I did and said that Gates would be willing to invest $100 million this year and that the whole project would probably need $400 million per year for 10 years. He wanted the USG to try to put in more money. Gary was concerned about the fact that we have no new money, although he really likes the Enterprise concept. After Rick left, Gary and I discussed how much if any money would be feasible to invest as new money. As opposed to just challenging the G-8 to join and endorse the process. He wanted to think about it more. One of the issues that he brought up even when Rick was there was the problem of doing something and then getting criticized the way that we have been criticized about PEPFAR. April 15-16, 2004 - Series of phone calls and e-mails involving Gary, Kristen and me. Apparently, Kristen really likes the idea about putting some substance (new resources) into the POTUS proposal to the G-8 and Garry asked me to cost out a real center a virtual