The Ethical and Legal Challenges in Unapproved Drug Access: A Talk with Patti Zettler

Send us Fan MailImagine being given a shot at a cure before it's even approved. That's the fascinating world of expanded access programs for unapproved investigational interventions that we're exploring today with our esteemed guest, Patti Zettler, law professor and chair of the International Society for Cell and Gene Therapies Expanded Access Working Group. We delve into the history of these programs, the FDA's role in their regulation, and the surge of interest they've seen in the last decade. Ever wondered why a patient would be willing to be a first mover on a yet-to-be-approved drug? Patti provides enlightening insights into this unique field.We then delve deeper into the intriguing complexities of expanded access programs within the realm of cell and gene therapy. We navigate through the potential for these programs' misuse by pharmaceutical companies, and the tension between the need for scientific evidence and a patient's desire for early access. The conversation also explores the ethical and legal dilemmas these programs present, the doctor's role, and the challenge of effectively communicating associated risks to patients. We wrap up with a contemplation on the changes we hope to see in the industry. Patti's insights, coupled with our thought-provoking discussion, will leave you with a deeper understanding of this crucial aspect of modern medicine.Guest: Patti ZettlerVisit Labtolives.com Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander Booth aka the MedTech GuyDimitri Borisevich aka the start-up GuyIvanna Rosendal aka the R&D pharma Gal