Food and Drug Administration (FDA) regulations have become the new pathway to riches for the pharmaceutical industry.
First, there was generic colchicine, used for years and years to treat gout for pennies a pill. The only problem was, there wasn't an FDA trial proving colchicine's efficacy in the treatment of gout. Takeda Pharmaceutical, seeing the opening, performed a trial and rebranded the formerly generic colchicine to Colcrys®, "the only authorized generic indicated to prevent and treat gout attacks." And how much does Colcrys® cost? Just $203 for thirty tablets at Costco.
But that's not all.
Today I learned that generic vasopressin (which can be stored at room temperature in stable form on crash carts), must be switched to the FDA-approved brand called Vasostrict® that requires dilution and refrigeration. It seems the generic form of vasopressin will no longer be available to be kept on crash carts since it's not "FDA-approved" for the indication of "increasing blood pressure in adults with vasodilatory shock (post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines." Vasostrict®, on the other hand, is "now the first and only vasopressin injection, USP, product with an NDA approved by the FDA." The catch is, it must diluted before use and discarded after 18 hrs (or after 24 hrs if refrigerated). This little regulatory quirk is a big deal for America's hospitals looking to save costs.
But hey, why should we worry about costs in health care? After all, you can never be too safe.