The Coronavirus pandemic has put a spotlight on drug supply and the approval process of new medications. In this episode, we will discuss what frontline pharmacists need to know to about the drug approval process. 

Guest speaker:

Amanda Melton, PharmD, BCPS

Senior Clinical Manager

Center for Pharmacy Practice Excellence

Vizient

Moderator:

Gretchen Brummel, PharmD, BCPS

Pharmacy Executive Director

Vizient Center for Pharmacy Practice Excellence

Show Notes:

[01:20] Patients accessing drugs through clinical trials

[02:29] Pharmacists should familiarize themselves with the inclusion and exclusion criteria of clinical trials in order to help clinicians identify good patients candidates

[03:00] ClinicalTrials.gov

[3:17] Patients that don’t qualify for a clinical trial can apply for access through an Expanded Access Program (EAP)  

[3:35] What Pharmacists need to know about Expanded Access Programs (EAPs)

[4:26] Goal of the EAP is to get the drug to the patient

[5:03] Step by step process for accessing a drug under the Expanded Access Program (EAP)

[5:42] Investigational New Drug (IND) application

[6:30] Four stakeholders: manufacturer, FDA, patient and Institutional Revenue Board (IRB)

[6:50] Getting access to the FDA by using Form 3926

[7:54] Timing for submitting an EAP

[9:00] How Emergency Use Authorizations (EUAs) differ from Expanded Access Programs (EAPs) 

[10:00] How long an EUA lasts

[10:41] When an Emergency Use Authorization (EUA) is issued, it does not mean the drug is approved

[11:15] Why apply for an EUA, instead of a biologics license

[12:07] Issuance of an EUA for a product doesn’t preclude the manufacturer from seeing approval for the product

Links | Resources:

FDA: Emergency Use Authorization Click here

FDA: Expanded Access Click here

NIH U.S. Library of Medicine: ClinicalTrials.gov Click here

Reagan-Udall Foundation for the FDA: COVID-19 Hub Click here

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