Tuesday, April 13, 2004

White House (West Wing) – 2 meetings. First regarding the issue of the HIV Vaccine Enterprise and whether we should make this an initiative for the POTUS to present at the upcoming G-8 Summit in Sea Island, GA. Present was Kristen Silverberg, Martina Strong (Gary Edson’s assistant), Joe O’Neill, Carol Thompson. I presented the idea to Kristen and explained what Gary and I had been working on for the past several weeks. I explained how we wanted the POTUS to challenge the G-8 to 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.