Cool, I wasn't familiar with the Orphan Drug program. From the Wiki page it looks like it's focused on development of new drugs for rare diseases, for which the market is inherently small and thus impossible to do large clinical trials, etc. That's similar to but not quite the same as the problem here, where a drug already exists and the market is potentially quite large, but the lack of patent protection prevents any one company from funding its approval. Do you know if the Orphan Drug Act specifically designates some government body with the mandate and funding to study and approve pre-existing foreign drugs? If not, maybe that could be a useful extension.