FDA Drug Approval: A Trolley Problem? [Video]

Is the FDA drug approval process a modern-day Trolley problem? This video explores the ethical dilemma faced by the FDA in approving safe medications that could save thousands of lives while potentially harming a few. We examine the rigorous FDA approval process, from initial research to clinical trials and post-market surveillance, and discuss the challenges of balancing societal benefits against individual risks.

The video delves into the concept of FDA box warnings, their implementation, and their impact on prescribing practices. We look at specific examples of drugs with box warnings, including SSRIs and NSAIDs, and consider the rare but serious adverse events that led to these warnings.

Join Professor John R. Hoffman as he stimulates critical thinking at the intersection of science, ethics, and society. This video is ideal for high school science teachers, university students studying scientific ethics, and anyone interested in the complex decision-making processes behind the medications we use daily.

In this video we will examine:
How does the FDA approve a drug as safe and effective?
What is an FDA box warning?
What medications have FDA box warnings?

As we consider this week’s Ethical Dilemma in Science:

Is the FDA drug approval process a Trolley problem?

How much risk is acceptable in life-saving medications?

Is it ethical to withhold potentially life-saving drugs due to side effects?

Is it ethical to approve a drug that could save thousands but harm a few?

How do we balance societal benefit against individual risk in drug approval?

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Recommended Readings:

Delong C, Preuss CV. Box Warning. [Updated 2023 Jun 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538521/

Rovenstine (2022) What is a black box warning? The Checkup. https://www.singlecare.com/blog/black-box-warning/

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0:00 Introduction
1:19 Trolley Problem
1:55 How does the FDA approve a drug as safe and effective?
5:29 What is an FDA box warning?
6:32 What medications have FDA box warnings?
9:45 Ethical Dilemma in Science
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