The Food and Drug Administration, by law, takes no position on pricing. The advantages of their neutrality are occasionally offset, though, by stories like this:
Here’s yet another facet of the U.S. drug pricing conundrum: older treatments which have been around for years can win label expansions that significantly increase their value, and consequently, their list prices. That appears to be the case with Marathon Pharmaceuticals’ deflazacort, a steroid that has now achieved FDA approval for treating the devastating muscle-wasting disorder Duchenne muscular dystrophy (DMD). There’s a dearth of available DMD treatments (and the most recently approved one in the U.S. was cleared under a cloud of controversy), so it’s not hard to see why the FDA wants to speed treatments to the finish line. But Marathon also decided to price the drug, which is available for less than $1 per pill in Canada as a steroid, at $89,000 per year. And since the treatment isn’t already approved in the U.S. for other, cheaper indications, there’s no risk of doctors prescribing it for off-label purposes to Duchenne patients.
Then again, this sort of news is by now old news:
In recent years, companies that have gotten old or existing drugs approved to treat rare diseases have reaped big financial rewards. For example, tetrabenazine, a drug that was available from abroad and used for years to treat the uncontrollable tremors of Huntington’s disease, was approved as an orphan drug in 2008. In 1998, it cost $42.28 for a bottle of tetrabenazine pills from a European pharmacy, according to Joseph Jankovic, a neurologist at Baylor College of Medicine. After receiving approval as an orphan drug, that bottle of pills — now known by the brand name Xenazine — carried a list price of more than $6,000 in the U.S. in 2008. The price was repeatedly ratcheted up to more than $21,243 a bottle, according to Truven Health Analytics data. Xenazine accounted for $325 million in U.S. sales in 2015, the year it went generic, according to data from Evaluate, a market intelligence firm.
I suppose I should be grateful that none of the stuff I take costs as much as $10,000 a year. (Yet.)