Vizient analysis shows ending Unapproved Drugs Initiative could save up to $26.59B

November 23, 2020  –  An updated analysis by Vizient, Inc. showed that ending the Food and Drug Administration’s (FDA) Unapproved Drugs Initiative (UDI), as President Trump recently announced he intended to do, could save the U.S. healthcare system billions of dollars.

Vizient estimates that there are 18 drugs that still could be approved through the program, which, based on a modest analysis, would add $7.52 billion to U.S. health care costs if drug manufacturers continue to take increases over the next five years of potential market exclusivity as allowed by the UDI.

A further $19.07 billion could be saved by ending the market exclusivity for the five drugs approved through the program that have already added $3.15 billion in spending, Vizient says.

The initial analysis, which was shared with senior HHS officials earlier this year, illustrated how the increases in costs are an unintended consequence of the UDI, launched in 2006. This analysis, which incorporates an additional seven months of market data, confirms that the total the program, if left unchanged, would add $29.7 billion in healthcare costs, according to Vizient.

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