Thursday Mar 16, 2023

The promise and limitations of expedited approval, Part 2

On this episode of our award-winning podcast, Tom continues his discussion with two leading pharmacy experts on what medications and classes of medications are in expedited approval and what this means for patients in overall efficacy and safety, the benefits and the drawbacks.


Tomas Villanueva, DO, MBA, FACPE, SFHM
Senior Principal, Clinical Operations and Quality


Jeni Hayes, PharmD, MSPharm, BCPS
Senior Clinical Manager, Pharmacy Outcomes
Center for Pharmacy Practice Excellence


Steven Lucio, PharmD, BCPS
Senior Principal, Pharmacy Solutions
Center for Pharmacy Practice Excellence


Show Notes:

[00:44] Recap of approval pathways

[01:33] Examples of accelerated approval drugs and effect of delays

[03:59] Only 50 percent of accelerated approvals converted to full approval

[05:32] Challenge in keeping track of drugs in the process

[06:13] Huge cost of ineffective drugs that win approval

[07:02] Huge cost of developing drugs that end up not working

[09:55] Need for providers to look at evidence on approved drugs


Links | Resources:

To contact Modern Practice:

Steven’s email:

Jeni’s email:

FDA’s accelerated approval update page: Click here

Vizient Pharmacy Market Highlights – Dec. 2022: PMO322_PharmacyMarketOutlook_Highlights.pdf


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