A public option for off-patent drug trials

When drugs lose patent protection, the incentive for large-scale clinical trials of new indications dries up. A recent working paper estimates that hundreds of new uses for existing drugs have gone undeveloped as a result. Writing for the Good Science Project, Nicholas Reville proposes an NIH High-Leverage Trials program to fill this gap. The idea is to create infrastructure for running publicly funded Phase III trials of off-patent drugs and supplements. He points to some interesting precedent, including the 2002 Best Pharmaceuticals for Children Act, which empowered NIH to identify and study high-potential off-patent drugs; and he identifies a few dozen candidate trials and some strategies the program could use to run them more efficiently.