The Journal: The FDA Boss on the Agency’s MAHA Makeover
Hosted by The Wall Street Journal & Spotify Studios
Episode Overview
In this episode of The Journal, hosts Jessica Mendoza and Ryan Knutson engage in an in-depth conversation with Dr. Marty Makary, the newly appointed Commissioner of the Food and Drug Administration (FDA). Just four months into his tenure, Makary is spearheading significant reforms aimed at modernizing the agency, reducing drug approval times, and addressing public health challenges. This summary delves into the key discussions, insights, and conclusions from their comprehensive interview.
1. Introduction to Dr. Marty Makary and His Vision for the FDA
[00:10 - 00:32]
Dr. Marty Makary emphasizes the need for change within the FDA, acknowledging past instances where the agency was influenced by the very industries it regulates.
“We are rewriting the food pyramid. The food guidance has been misinformation.”
— Dr. Marty Makary [00:27]
Makary aims to transform the FDA under the MAHA (Make America Healthy Again) movement, targeting reforms in Big Food and Big Pharma to combat the nation's declining health.
2. Modernizing Drug Approval Processes
[01:37 - 06:21]
Makary discusses his proactive approach in engaging with pharmaceutical CEOs to identify overregulation and streamline processes. He highlights the lengthy drug approval times, questioning the necessity of prolonged waits for life-saving treatments.
“Why does it take 10 years for a drug to come to market? Do we really think if you have the cure for breast cancer, we should tell people just to wait until we get around to these applications that might be sitting on a shelf?”
— Dr. Marty Makary [01:45]
Key initiatives include:
- Reducing Animal Testing: Eliminating unnecessary animal trials to expedite drug reviews.
- AI Integration: Implementing AI tools like ELSA to assist scientific reviewers, significantly cutting down review times from days to minutes.
“The reviewers love it. They said it did in six minutes. What would normally take them a couple days to do.”
— Dr. Marty Makary [06:10]
Despite initial criticisms about AI reliability, Makary defends its efficacy, likening potential inaccuracies to those found in general internet searches.
3. Enhancing FDA Independence and Addressing Industry Influence
[03:24 - 04:36]
Makary acknowledges the historical challenges of industry capture within the FDA and outlines steps to maintain the agency's scientific independence.
“We have to keep the scientific process impeccably independent. That is our review has to be free of that contamination.”
— Dr. Marty Makary [04:23]
One of his first actions was removing pharmaceutical and industry members from all FDA scientific expert panels, ensuring unbiased decision-making.
4. Fast-Tracking Drug Approvals Through Price Commitments
[04:36 - 07:08]
Introducing a pilot program, Makary explains that companies willing to keep drug prices aligned with those in other high-income nations may receive expedited approval.
“If a company has shown that they will equalize the prices to make drugs more affordable, that's something that we will consider to try to support MFN or Most Favored Nation status pricing.”
— Dr. Marty Makary [05:02]
This initiative aims to balance affordability with expedited access, although Makary admits the process will require time to implement effectively.
5. Addressing Vaccine Regulations and Public Trust
[07:48 - 10:07]
Makary touches on the FDA's approach to vaccine regulation, particularly in response to COVID-19. He emphasizes the importance of predictability for companies and the need for nuanced communication to rebuild public trust.
“We have to show humility, say what we know and don't know, and avoid one of the most dangerous things you can do in public health, and that is to say something with such absolutism to say you must absolutely do something.”
— Dr. Marty Makary [09:00]
He highlights a significant decline in public trust, citing a JAMA study showing a drop from 71% to 40% trust in doctors and hospitals post-pandemic.
6. Regulating Ultra-Processed Foods
[10:07 - 13:11]
Transitioning to the FDA's role in food regulation, Makary distinguishes between processed and ultra-processed foods, advocating for public education and stricter regulations on the latter.
“We're talking about ultra processed. These are foods that are addictive. We don't think, and I don't think that our nation's childhood obesity epidemic is a willpower problem.”
— Dr. Marty Makary [10:45]
Initiatives include:
- Banning Harmful Additives: Removing nine petroleum-based food dyes and other chemicals like titanium dioxide.
- Public Education: Seeking to define and inform the public about what constitutes ultra-processed foods.
7. Combating Synthetic Additives: The Case of 7oh
[14:16 - 16:24]
Makary raises alarms about synthetic compounds like 7oh (derived from Kratom), highlighting their opioid-like properties and potential public health threats.
“7oh acts like an opioid and yet you can walk into some of these vape stores and just buy it.”
— Dr. Marty Makary [14:51]
Key points:
- Addictive Nature: 7oh is reportedly 13 times more potent than traditional opioids.
- Regulatory Actions: The FDA is pushing to schedule 7oh as a controlled substance and urging distributors to cease its sale.
- Public Safety: Emphasizing the lack of comprehensive data and the urgent need for proactive measures to prevent another opioid crisis.
8. Vision for a MAHA FDA: Overhaul or Tweaks?
[17:23 - 18:31]
In concluding remarks, Makary outlines his vision for a reformed FDA under the MAHA initiative, focusing on:
- Comprehensive Modernization: Updating outdated structures from the 1960s to facilitate faster and more efficient drug and device approvals.
- Holistic Health Approach: Integrating food, microbiome, and lifestyle factors into public health strategies.
- Active Listening: Continually engaging with stakeholders, including parents, doctors, and drug developers, to ensure responsive and informed decision-making.
“We want devices that empower people with good information about their health... We have to listen.”
— Dr. Marty Makary [17:36]
Conclusion
Dr. Marty Makary's tenure as FDA Commissioner marks a pivotal shift towards a more agile, transparent, and independent agency. By addressing overregulation, integrating advanced technologies, and prioritizing public health through strategic reforms, Makary aims to fulfill the MAHA movement's promise of making America healthier. His proactive stance on emerging threats like synthetic opioids and ultra-processed foods underscores a commitment to safeguarding public well-being while fostering innovation and affordability in the healthcare landscape.
Notable Quotes with Timestamps
- Dr. Marty Makary: “We are rewriting the food pyramid. The food guidance has been misinformation.” [00:27]
- Dr. Marty Makary: “Why does it take 10 years for a drug to come to market? Do we really think if you have the cure for breast cancer, we should tell people just to wait until we get around to these applications that might be sitting on a shelf?” [01:45]
- Dr. Marty Makary: “We have to keep the scientific process impeccably independent. That is our review has to be free of that contamination.” [04:23]
- Dr. Marty Makary: “The reviewers love it. They said it did in six minutes. What would normally take them a couple days to do.” [06:10]
- Dr. Marty Makary: “We have to show humility, say what we know and don't know, and avoid one of the most dangerous things you can do in public health, and that is to say something with such absolutism to say you must absolutely do something.” [09:00]
- Dr. Marty Makary: “We're talking about ultra processed. These are foods that are addictive. We don't think, and I don't think that our nation's childhood obesity epidemic is a willpower problem.” [10:45]
- Dr. Marty Makary: “7oh acts like an opioid and yet you can walk into some of these vape stores and just buy it.” [14:51]
- Dr. Marty Makary: “We want devices that empower people with good information about their health... We have to listen.” [17:36]
Final Thoughts
Dr. Marty Makary's leadership signals a transformative era for the FDA, characterized by bold reforms and a steadfast commitment to public health. From expediting drug approvals to tackling the complexities of modern nutrition and emerging synthetic substances, Makary's strategies aim to position the FDA as a forward-thinking agency capable of addressing contemporary health challenges effectively.