This is a situation where inconsistent enforcement of law actually works to the consumer's advantage in reducing the number of edge cases where companies make speculative bets on exploiting weaknesses in the formal certification process. Especially with the FDA carefully trying to avoid setting any precendent.
It would be difficult to draft a definition of "abuse" that didn't encompass raising cost of a drug a hundredfold above the market rate in order to recoup costs invested not in research, but in acquiring the company that achieved FDA certification (mostly using existing NIH funded research) for an already widely-available treatment.
It would be difficult to draft a definition of "abuse" that didn't encompass raising cost of a drug a hundredfold above the market rate in order to recoup costs invested not in research, but in acquiring the company that achieved FDA certification (mostly using existing NIH funded research) for an already widely-available treatment.