Makena (aka 17P), a compound used to control preterm labor got similar treatment. KV Pharmaceutical announced plans to multiply the price by x100 and set off a storm.[1]
The FDA has simply decided not to enforce the monopoly that KV legally acquired.
Beth Martino, a spokeswoman for the FDA, called the Makena controversy a "unique situation." Martino stressed that the drug agency's enforcement actions are discretionary, and that it has chosen at this time not to take action against other suppliers in order to "support access to this important drug." [2]
[1] It appears they spent something between $250,000 and $1m acquiring rights and commissioning studies for the FDA approval or existing practices. They appear to be set to reap 18 times that in monopoly rent.
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.
Makena (aka 17P), a compound used to control preterm labor got similar treatment. KV Pharmaceutical announced plans to multiply the price by x100 and set off a storm.[1]
The FDA has simply decided not to enforce the monopoly that KV legally acquired.
Beth Martino, a spokeswoman for the FDA, called the Makena controversy a "unique situation." Martino stressed that the drug agency's enforcement actions are discretionary, and that it has chosen at this time not to take action against other suppliers in order to "support access to this important drug." [2]
[1] It appears they spent something between $250,000 and $1m acquiring rights and commissioning studies for the FDA approval or existing practices. They appear to be set to reap 18 times that in monopoly rent.
[2] http://www.stltoday.com/business/local/article_26f67c9a-5ae9...