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

Transformation in Trials

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Imagine 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 Zettler

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Chapter

1. The Ethical and Legal Challenges in Unapproved Drug Access: A Talk with Patti Zettler (00:00:00)

2. Clinical Trial Access Programs (00:00:13)

3. Expanded Access in Cell and Gene Therapy (00:13:34)

4. Expanded Access Challenges in Medicine (00:23:46)