880 - “The FDA As We’ve Known It Is Finished”
Public Health On Call
The Johns Hopkins Bloomberg School of Public Health
4.8 • 620 Ratings
🗓️ 8 April 2025
⏱️ 23 minutes
🧾️ Download transcript
Summary
About this episode:
Last week, the Department of Health and Human Services abruptly fired around 10,000 employees, 3,500 of which were within the FDA alone—an organization of around 18,000 total employees as of January 2025. In this episode: A look at the work of the FDA and how it may be hampered by such significant cuts, and how patients may be among those most impacted.
Guest:
Dr. Robert Califf served as the FDA Commissioner under Presidents Barack Obama and Joe Biden.
Host:
Dr. Josh Sharfstein is vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, a faculty member in health policy, a pediatrician, and former secretary of Maryland’s Health Department.
Show links and related content:
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Dr. Peter Marks’s Resignation Letter (PDF)—The New York Times
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Widespread firings start at federal health agencies including many in leadership—NPR Shots
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The U.S. Food Safety System—Public Health On Call (June 2022)
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FDA Commissioner Dr. Robert Califf on Bivalent COVID-19 Vaccines, Combating Misinformation, and Building Trust—Public Health On Call (August 2022)
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Transcript
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| 0:00.0 | Welcome to Public Health On Call, a podcast from the Johns Hopkins Bloomberg School of Public Health, |
| 0:05.9 | where we bring evidence, experience, and perspective to make sense of today's leading health challenges. |
| 0:16.3 | If you have questions or ideas for us, please send an email to public health question at jh.h.edu. |
| 0:23.8 | That's public health question at jh.u.edu for future podcast episodes. |
| 0:30.7 | Hi, listeners. It's Lindsay Smith Rogers. |
| 0:33.5 | Last week, thousands of employees were abruptly dismissed from the FDA, including Dr. Peter |
| 0:39.5 | Marks, the lead regulator of vaccines and other biologics. |
| 0:43.9 | Dr. Robert Caliph served as the FDA Commissioner under President's Barack Obama and |
| 0:48.9 | Joe Biden. |
| 0:50.1 | He joins Dr. Josh Sharfstein, who was a former principal deputy commissioner at the FDA under President Obama, to talk about the latest developments and what they mean for the agency, for drug development, and for patient care. |
| 1:04.7 | A reminder that these podcasts are a conversation between the participants and do not represent the position of Johns Hopkins University. |
| 1:13.0 | Let's listen. |
| 1:14.4 | Dr. Robert, Caleb, thank you so much for coming back to public health on call to talk to me about FDA. How are you? |
| 1:22.0 | Personally, doing well, but I'm very worried about where we are as a country and where our public health is headed. |
| 1:28.3 | Well, I want to start with a statement that you made following an enormous number of people being let go at the Food and Drug Administration. |
| 1:37.3 | You said FDA, as we've known it, is finished. And I wanted to start by asking to explain what you meant. Well, over the years, |
| 1:47.6 | I think a number of us have become comfortable with the idea that there are a set of laws |
| 1:53.6 | that dictate that from medical products, that there's an assessment of risk and benefit before a product |
| 1:59.8 | gets on the market and that will be judged |
| 2:01.9 | by a group of civil servants who don't have a financial conflict of interest, |
| 2:09.4 | but really uphold a professional standard for looking at evidence. |
| 2:13.5 | In other parts of FDA, there are similar things, but medical products is easiest to talk about |
... |
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