Can We Trust the FDA? Marty Makary on Science, Power & Patients
Episode
89 min
Read time
2 min
Topics
Fundraising & VC, Leadership, Sales & Revenue
AI-Generated Summary
Key Takeaways
- ✓Drug Approval Acceleration: FDA reduced pivotal trial requirements from two to one, saving companies $100-300 million per drug. New pilot program delivers approval decisions in 55 days versus traditional 10-12 years. Eliminates 144 chimpanzee studies previously required for monoclonal antibodies, using computational modeling instead.
- ✓Biosimilar Revolution: FDA cut biosimilar approval timeline from 5-8 years to 2.5 years and reduced development costs by over $100 million. This targets biologics representing 51% of fastest-growing drug spending. Changes mirror small molecule approval principles, enabling competition with $60,000-150,000 medications like Humira.
- ✓Vaccine Schedule Reform: US reduced recommended childhood vaccine doses from 72 to 38 core essential vaccines, aligning with 20 developed countries studied. Hepatitis B vaccine no longer pushed for newborns with negative mothers. Aims to rebuild public trust after vaccination rates dropped during COVID-19 pandemic.
- ✓Food Pyramid Overhaul: New guidance prioritizes protein intake, reverses 50-year saturated fat dogma that led to 60-70% of children's calories coming from refined carbohydrates. Addresses 38% of kids having prediabetes or diabetes. Eliminates all nine petroleum-based artificial dyes banned in other countries but allowed in US.
- ✓Drug Pricing Strategy: Most favored nation pricing brings GLP-1 drugs from $1,300 to $149 for three months, matching lowest developed world prices. US previously financed 60% of global pharmaceutical R&D costs. FDA pushing more prescription drugs to over-the-counter status to enable price transparency and bypass pharmacy benefit manager markups.
What It Covers
FDA Commissioner Marty Makary details his first year transforming the agency through 42 major reforms, accelerating drug approvals from years to weeks, eliminating animal testing requirements, removing petroleum-based food dyes, and restructuring vaccine schedules based on international standards.
Key Questions Answered
- •Drug Approval Acceleration: FDA reduced pivotal trial requirements from two to one, saving companies $100-300 million per drug. New pilot program delivers approval decisions in 55 days versus traditional 10-12 years. Eliminates 144 chimpanzee studies previously required for monoclonal antibodies, using computational modeling instead.
- •Biosimilar Revolution: FDA cut biosimilar approval timeline from 5-8 years to 2.5 years and reduced development costs by over $100 million. This targets biologics representing 51% of fastest-growing drug spending. Changes mirror small molecule approval principles, enabling competition with $60,000-150,000 medications like Humira.
- •Vaccine Schedule Reform: US reduced recommended childhood vaccine doses from 72 to 38 core essential vaccines, aligning with 20 developed countries studied. Hepatitis B vaccine no longer pushed for newborns with negative mothers. Aims to rebuild public trust after vaccination rates dropped during COVID-19 pandemic.
- •Food Pyramid Overhaul: New guidance prioritizes protein intake, reverses 50-year saturated fat dogma that led to 60-70% of children's calories coming from refined carbohydrates. Addresses 38% of kids having prediabetes or diabetes. Eliminates all nine petroleum-based artificial dyes banned in other countries but allowed in US.
- •Drug Pricing Strategy: Most favored nation pricing brings GLP-1 drugs from $1,300 to $149 for three months, matching lowest developed world prices. US previously financed 60% of global pharmaceutical R&D costs. FDA pushing more prescription drugs to over-the-counter status to enable price transparency and bypass pharmacy benefit manager markups.
Notable Moment
Makary discovered FDA employees physically carrying drug application boxes between buildings because lawyers claimed they could not email files between different centers within the same agency. Each of seven FDA centers operated like separate governments with own press releases, legislative affairs, and communication staff before restructuring.
Episode Transcript
Marty McCary, commissioner of the FDA. Welcome to San Francisco. Great to be here, Dave. Good to be with you. Yeah. Thanks. It's JPMorgan Healthcare Conference this week in San Francisco considered, I think, probably the biggest, most important biotech conference globally, very important week. So you're visiting this week, for the conference? Yeah. Yeah. 120,000 people. Great conversations. You hear from everybody. Just not enough time to meet everybody you wanna meet with, but it's a great time. Well, thanks for sitting down with me. You and I have gotten to know each other a little bit over the last year or so. Yeah. And I'm really excited, to hear a little bit about how things are going. It's been almost a year since you've been in the role. I think maybe for our audience, you could share a little bit about how you got this role. How did you get involved with this administration? How did you get connected with them? And maybe we can go all the way back to your very outspoken views, during the COVID pandemic and maybe how that brought attention to you and your philosophies that that drove this role. Yeah. So my, interest in academia, I, went to graduate school for public health and served on the faculty of the Johns Hopkins School of Public Health as I also had a clinical practice in GI and cancer surgery at Johns Hopkins. And my interest was always in the root causes of our health care system problems from quality, transparency, and price. And then the work on price, I led sort of a national effort to try to get more price transparency of hospital prices. I wrote a book on it that did very well. It took me to the White House where they had read the book, invited me in. And in that first Trump administration, we had a lot of great conversations. And then they implemented the idea, and I was so impressed. This makes sense. You know, we want common sense ideas. And so we got the hospital price transparency executive order signed by the president. That's where I developed some of the relationships and got to know the folks. And then when, president Trump got reelected, he gave me a call days after the election, and I was very honored to be offered this role. So it's been awesome. COVID you mentioned COVID. It was a crazy time. I mean, the sort of sociology of medical dogma is a fascinating historical thing, and we still suffer from it. Paternalism, the sort of suppressing ideas that are not the legacy ideas, the sort of sacrificing the basic principles of science to question everything to have no sacred cows. And you saw the worst of that bad behavior during COVID. Cloth masks on toddlers for three years, vaccine mandates for young college students, recommending COVID boosters with such absolutism in young, healthy children. You the, ignoring natural immunity, one of the …
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