The FDA And Vasopressin

The FDA got involved in trying to regulate marketed previously unapproved drugs, with results perhaps not unexpected to those of us who have taken a MBA-level course in economics.  From the (publicly available) paper linked above:

In May 2017, the US Food and Drug Administration (FDA) announced a Drug Competition Action Plan, designed to address competition and pricing in the generic market and improve access to prescription drugs. One of FDA’s stated goals is to reexamine “places where its rules—including standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access,” instead of ensuring the vigorous competition Congress intended. In this Viewpoint, we examine FDA’s 2006 Unapproved Drugs Initiative (UDI), designed to strengthen the agency’s regulatory oversight related to unapproved marketed drugs. Using an illustrative example, we discuss this initiative’s unintended consequences, as it appears to have created obstacles to generic drug access, likely increasing prescription drug costs…On November 14, 2014, Par received FDA approval for Vasostrict, and on December 15, 2014, FDA instructed all other suppliers of unapproved intravenous vasopressin to stop manufacturing their products by January 30, 2015, leaving only Par with a marketed product. Subsequently, the average wholesale price of intravenous vasopressin increased from $4.27 to $138.40 per vial in November 2016, a 3141% increase. In 2013, when there were multiple competing suppliers, total sales from intravenous vasopressin approximated $4 million. As of November 2016, Vasostrict achieved annualized sales of nearly $400 million. As a result of the high cost, reports have surfaced of vasopressin being removed from code carts, making it unavailable in life-threatening situations.

I’ll leave it to the reader to ponder whether the vast increase per vial price for vasopressin was a justifiable change, and whether the unavailability of this drug for endangered patients is somehow compatible with the FDA’s ostensible mission.

The FDA and Big Pharm: a match made in heaven…or hell.  You decide.  Look at the facts reported in the paper and the other link and ponder well.