In a related area, American companies produce on-patent drugs in owned European factories by process-copy-identical methods. They purposely do NOT go through the paperwork of obtaining FDA approval for these processes and factories, though identical. (Of course rigorous European approvals are obtained.) NOW, it becomes illegal to import the European versions into the U.S. and Customs cooperates by random seizure of small shipments, thereby harassing American, mostly older citizens on limited budgets, directly.