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Deregulation, Safety, and the FDA: Why Prescription Standards Matter

Broadcast Date: August 26, 2026


ABOUT THIS PODCAST

Efforts to deregulate certain prescription drugs outside the Food and Drug Administration’s (FDA) established review framework are gaining momentum in several states, raising concerns about patient safety and regulatory consistency. This episode explores ASHP’s new policy opposing such legislative actions and highlights the risks of bypassing evidence based FDA pathways for Rx to over-the-counter (OTC) switches. We’ll also examine past attempts to move medications, such as statins and other drug classes, to OTC status and why these proposals did not meet FDA standards.

SHOW NOTES

SPEAKERS

  • Monica Mehta, PharmD, MPH
    Director, Policy Planning, ASHP
  • Kellie J. Goodlet, PharmD, FCCP, BCIDP, BCPS, BCTXP
    Associate Professor, Director of Pharmacy Practice, Midwestern University
  • Kristi Kelley, PharmD, FCCP, BCPS, BCACP, CDE, BC-ADM
    Clinical Professor, Pharmacy Practice, Auburn University Harrison School of Pharmacy
  • Ilisa Bernstein, PharmD, JD
    President, Bernstein Rx Solutions, LLC

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The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

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