...I think we should trade the 12-year exclusivity period from biologics to small molecule drugs.
Why would this help? Because small molecule drugs are far easier to copy and far easier to produce than biologics. Extending the exclusivity period for small molecules at the expense of biologics might provide the incentive needed to get biopharma to ramp up their chemistry departments again. And in the long term, more small molecule drugs could not only address a lot of serious illnesses, but would also mean more drugs will eventually be made available at extremely cheap prices once they become generic, rather than the more modest 20-50% discount expected for biosimilars (the generic version of biologic) drugs....
...There are practical reasons to try to do this now. In the world of biopharma, small molecule approaches have been losing favor to biologics because biologics can command higher prices, are harder to copy, face less severe competition, and tend to have much longer product life cycles. Given the attractiveness of biologics from a business standpoint, the industry has curtailed its discovery efforts around small molecules. A generation of expertise in medicinal chemistry is growing older and the few scientist replacements aren’t being trained quickly enough in all that institutional knowledge. Persuading biopharma to go back to small molecules would help stem the loss of knowledge, which would increase the odds of creating great, eventually generic small molecule drugs.Is it really true that "the few scientist replacements aren't being trained quickly enough"? Is there a demographic gap between soon-to-retire medicinal chemists and their younger replacements? I could believe such a thing, but I'd like to see some data.
Dr. Serikawa suggests that this would be a good long-term idea for the country; I'm inclined to agree (seeing as how the point is "employ more medicinal chemists".) Somehow I doubt biopharma management and their shareholders would agree, though.
Would a President Trump agree to this? It scratches his "drugs are too expensive" itch, and that might be worth something. I can't imagine that pharma-oriented senators would be excited, though.