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# Unapproved Drugs Initiative Hiking Healthcare Costs: Analysis
- URL: https://www.fdaweb.com/unapproved-drugs-initiative-hiking-healthcare-costs-analysis/
- Published: 2020-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:04:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146188

Healthcare performance improvement consultants Vizient says the FDA Unapproved Drugs Initiative (UDI) will increase healthcare spending by $20.25 billion. In its [analysis](https://newsroom.vizientinc.com/sites/vha.newshq.businesswire.com/files/doc%5Flibrary/file/UDI%5FAnalysis%5FUS%5FMarket%5FSpend%5FFINAL%5F022420.pdf?ref=fdaweb.com), Vizient says UDI is an FDA mandate that unapproved drugs that have been in use prior to agency review of safety and efficacy must be approved or removed from the market. The goal of UDI, Vizient says, is to **(1)** remove potentially unsafe medications to protect the public from direct and indirect health threats, and **(2)** remove ineffective drugs to protect the public from using the products in lieu of effective treatments.

So far, four of the drugs have been formally approved in recent years — neostigmine methylsulfate, selenium 40 mcg/mL to selenious acid 60 mcg/mL, Vasopressin to Vasostrict, and dehydrated alcohol 98% to dehydrated alcohol 99%.

Vizient says that the products have experienced price increases following approval ranging from 525% to 1,644%. The company says it has identified 19 other unapproved products on the market that could experience similar increases potentially leading to $8.75 billion in added healthcare system costs over five years if manufacturers take similar price increases during their periods of market exclusivity.