Archive for April 2021

Expedited drug reviews in the time of COVID-19 (Part 2)

The Coronavirus pandemic has put a spotlight on drug supply and the approval process for new medications. In this episode, we will define the different expedited drug approval processes, and take a closer look at how successful these programs are in identifying drug efficacy.

 

Guest speaker:

Steven Lucio, PharmD, BCPS

Senior Principal, Pharmacy Solutions

Vizient

 

Moderator:

Gretchen Brummel, PharmD, BCPS

Pharmacy Executive Director

Vizient Center for Pharmacy Practice Excellence

 

Show Notes:

[01:19] Four mechanisms used by FDA to expedite approval of medications: Fast Track, Breakthrough, Accelerated Approval and Priority Review

[01:48] Fast track and breakthrough help drug developers increase communications with the FDA to make approval process flow smoothly

[02:07] The “Fast Track” designation

[2:35] A “Breakthrough” designation – FDA will talk to you more, give advice  

[3:12] Example of an Accelerated Approval

[3:55] Accelerated Approval looks at a surrogate indicator of a disease state’s ultimate outcome

[4:26] “Priority Review” – FDA reviews drug within six months

[5:12] Three reasons why pharmacists need to be aware of the approval programs

[6:00] Expedited approvals are used for serious diseases

[6:08] Analysis: In 2018, 81% of new molecular entities took advantage of at least one expedited program

[6:32] Drugs that use expedited programs have fewer clinical studies and a smaller profile of how they work

[7:14] Survey: 3/4th physicians didn’t know what Breakthrough Therapy meant

[7:50] Analysis of “Accelerated Approval” between 1992 - 2017

[8:38] Why you should know about the expedited drug approval processes

 

Links | Resources:

JAMA Network: FDA Approval and Regulation of Pharmaceuticals, 1983 – 2018, Click Here

JAMA Network: Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation, Click Here

JAMA Network: Assessment of the Clinical Benefit of Cancer Drug Receiving Accelerated Approval, Click Here

 

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