Ready for this one?
Hundreds of pharmaceuticals in use today entered the market prior to 1938, before the Food and Drug Administration implemented safety reviews.
The 2006 Unapproved Drug Initiative requires manufacturers to pull these drugs and prove to the FDA that they are safe. Typically, fewer manufacturers remain in the market after the FDA intervenes, which allows price manipulation.
It sounds like a good idea but, remember, no good deed goes unpunished.
Four widely used drugs funneled through the Unapproved Drug Initiative will increase spending by more than $20.25 billion over a five-year span as manufacturers hiked prices between 525% to 1,644%, a new Vizient analysisfound. Vizient identified another 19 unapproved drugs that could increase costs by $8.75 billion.
Not a bad markup, eh? Here is my favorite:
Belcher Pharmaceuticals is charging $1,000 per milliliter, which equates to $30,000 for one shot of ethanol, since it received an orphan drug designation through the UDI, granting Belcher’s drug exclusivity through 2025, she said. Belcher won the orphan drug classification, a status for drugs that treat rare diseases, for its treatment of hypertrophic obstructive cardiomyopathy.
Yes, you read that right. Ethanol!
BTW, I love the name Belcher for this company.
These types of laws are bankrupting the hospitals and the system.
And the FDA works its magic again.