Drug companies are just similar to software in that regard. They acquire a bunch of companies that do basic R&D and get drug pipelines. Those founders get rich because they have patent protection. Just look at biosimilars for a taste of what might happen without patent protections.

I am more familiar with the 510(k) that most people are. It bypasses some testing, but there is still a fair amount of work. It has nothing to do with R&D expenditures that may or may not be behind an submission.