Vizient Links FDA’s Unapproved Drugs Initiative to Higher Drug Costs

March 6, 2020

Drugs approved through the FDA’s Unapproved Drug Initiative could potentially cost $29 billion in extra healthcare costs, Vizient said in a new analysis.

The agency began the initiative in 2006, aimed at approving drugs that had been marketed prior to 1938. However, the program has been controversial because certain regulatory actions, such as approvals, tend to fluctuate drug prices.

The agency said that it is “keenly aware of price fluctuations that can occur on the heels of its regulatory actions.” The FDA said that although drug prices may rise in the short term following the approval process, “the risks to the individual patient are substantially reduced and the benefits are assured for the long term.”

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