FDA meeting on approving immune therapies: background and comment

The FDA brought together experts to discuss what advice the FDA should give to pharmaceutical companies on how they should go about testing immune-based therapies, in order to collect data which could lead to approval to market these drugs; without such clarification, industry has little incentive to research immune-based HIV treatments. Although the meeting went well, we are pessimistic, and explain why we believe that no satisfactory solution is possible within the current terms of discourse. We list several steps that are needed; some of them are already being done, but others are not on the table at this time. We argue that research in this critically important area will be seriously held back unless we can think "out of the box" and take full advantage of unexpected findings and successes.