Jan 6, 2020 · 44m · a16z
Food, Drugs, and Tech: 100 years of Public Health
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gold bands on the timeline = statements, start to end. Hover to read, click to jump. CC turns on captions
At the a16z Summit, FDA Principal Deputy Commissioner and CIO Dr. Amy Abernethy joins Andreessen Horowitz General Partner Vijay Pande to discuss how the FDA is modernizing its regulatory frameworks, embracing digital data, and balancing safety with technological innovation across pharmaceuticals, personalized medicine, and food supply chains.
How this conversation actually went
Every chapter scored 0–10 on four independent dynamics. Hover any point for the reasoning behind the score. How this is scored →
The host as informed peer 4.0 Guest teaching 3.9 Guest disagreement 1.1 The host pushing back 0.9
speaking balance: gold is the host, purple is the guest (3 minute bins)
Sharpest disagreement ▶ 21:39 Delineating Regulatory Limits on DIY Kits
The guest firmly rejects the premise that the FDA can regulate individual direct-to-consumer DIY kit purchases off the internet, stressing strict legal statutory limits.
Hardest push from the host ▶ 28:58 Proposing Elimination of Phase 2 and 3 TrialsThe host directly challenges the traditional drug approval architecture by arguing that Phase 2 and 3 efficacy trials should be replaced by real-world evidence and payer reimbursement decisions.
Biggest teaching moment ▶ 33:16 Legislative and Crisis Driven Tech EvolutionThe guest walks through a comprehensive history connecting the 2007 Institute of Medicine report, the 2008 financial crisis, the High Tech Act, and the 21st Century Cures Act to demonstrate how political events drive health IT infrastructure.
The host holds their own ▶ 42:45 Host Articulates Longevity Biomarker FrameworkWhen the guest prompts the host for his perspective on longevity, the host demonstrates deep domain expertise by explaining how biomarker measurements correlate with longitudinal health risks.
the scores for every segment, with the reasoning behind each
| Chapter | Topic | The host as informed peer | Guest teaching | Guest disagreement | The host pushing back | Why |
|---|---|---|---|---|---|---|
| Title Graphic and Legal Disclosures | 3 | 3 | 1 | 0 | The host sets up the podcast with historical context on the FDA's founding 113 years ago during the industrial revolution. The guest expands on this history, detailing the Chicago stockyards context and establishing the agency's modern public health mandate. | |
| Overview of the Drug Development Process | 2 | 4 | 1 | 0 | The guest lightheartedly corrects the host's historical timeline regarding data delivery methods. The guest then walks through the five core stages of drug development and outlines the shift from paper applications to structured digital data. | |
| Managing Risk in a Risk-Averse Culture | 5 | 3 | 1 | 1 | The host presents a well-structured premise regarding the structural asymmetry of regulatory risk, noting that unapproved cures cause no public outcry while approved harms trigger immense backlash. The guest agrees and explains the agency's risk-based decision framework. | |
| The FDA's Mandate and Response to the Opioid Crisis | 3 | 4 | 1 | 0 | The host asks how the FDA handles slow-moving public health threats like the opioid epidemic. The guest educates the host on the concept of agency statutory authorities and staying within regulatory swim lanes. | |
| Modernizing Border Inspections with Machine Learning | 2 | 4 | 1 | 0 | The host inquires how border inspectors determine which cargo trucks to search for unsafe food. The guest explains the decade-old PREDICT rules engine and how machine learning experiments are being deployed to modernize border checks. | |
| Preventing Drug Shortages and Foodborne Outbreaks | 3 | 4 | 1 | 0 | The host brings up consumer DIY CRISPR kits bought online as a transition into novel therapies. The guest lays out a comprehensive regulatory risk framework covering safety, biological plausibility, clinical endpoints, and ethics. | |
| N-of-1 Therapies and Lessons from Bone Marrow Transplants | 6 | 3 | 1 | 1 | The host demonstrates deep domain knowledge by drawing parallels between N-of-1 personalized medicine, surgical procedures, and CAR-T cell re-engineering. The guest validates the host's framing, adding bone marrow transplantation as an established historical parallel. | |
| Addressing At-Home Gene Editing and Unregulated Products | 5 | 4 | 2 | 3 | The host asks how the FDA handles unregulated biohacking, then directly challenges the guest on whether software regulation can ever keep up with rapid update cycles. The guest explains jurisdictional limitations regarding personal use and describes pre-condition frameworks for software updates. | |
| Health Data Ownership and Emerging Privacy Challenges | 5 | 3 | 1 | 1 | The host brings up Google's acquisition of Ascension healthcare data to explore privacy issues. The guest admits pushing internally for an FDA Chief Privacy Officer, acknowledging that HIPAA regulations are outdated and longitudinal healthcare data is re-identifiable. | |
| Blurring Trial Phases and Utilizing Real-World Evidence | 7 | 4 | 1 | 4 | The host puts forward a bold policy proposal that the FDA should eliminate Phase 2 and 3 clinical trials for life-threatening conditions and rely instead on real-world evidence. The guest agrees enthusiastically, detailing how trial phases are already blurring under 21st Century Cures legislation. | |
| Bipartisan Policy and Regulatory Evolution | 2 | 6 | 1 | 0 | The host asks about the interplay between politics and regulatory evolution. The guest offers a detailed historical account connecting the 2007 IOM report, the 2008 financial crisis, the High Tech Act, and the passage of 21st Century Cures. | |
| Cultured Meat, USDA Coordination, and Consumer Labeling | 3 | 4 | 1 | 0 | The host raises the topic of synthetic biology and lab-grown meat. The guest clarifies the division of regulatory responsibility between the FDA and USDA regarding cell culturing versus marketing. | |
| Whole Genome Sequencing and Traceability in Food Safety | 3 | 5 | 1 | 0 | The host asks how the FDA tracks foodborne outbreaks across complex supply chains. The guest explains how whole genome sequencing traces listeria back to specific equipment nozzles and outlines supply chain traceability via phone scanning. | |
| Longevity Science and Longitudinal Performance | 7 | 3 | 1 | 2 | The host brings up longevity science as a challenge to traditional disease-treatment paradigms. When the guest turns the question back to the host, the host articulates a clear framework centered on biomarker measurement and risk correlation. |
Statements from this episode (25)
Abernethy: FDA considers mobile app for consumers to trace produce supply chains
“One of the things we've been contemplating at FDA is, like, ultimately, could you imagine the application on your phone that allows you to scan peaches and understand did the peaches have a full supply chain that we can monitor?”
Abernethy: Emerging biology increases FDA responsibility to objectively assess safety
“And I would argue that in a time of rapidly emerging biology, when we've got more and more scientific innovations and potential products coming to bear, The need to make sure that we have an objective way of assessing safety and effectiveness and providing con…”
Abernethy: Traditional boundaries between clinical trial phases are increasingly blurring
“And a drug or biologic will go through a series of clinical studies, typically phase one through three, although these days those lines are blurring for exactly what drugs, followed then by a new drug application or biologics application of BLA to the FDA.”
Abernethy: Most FDA applications still arrive as static PDF files
“In fact, the way the majority of our applications still come in is through PDFs or sort of essentially large digital representations of what used to come in on trucks.”
Pande: FDA faces severe risk asymmetry from unapproved versus harmful drugs
“If there's a great drug that ah, that nobody ever gets, you know, nobody ever knows about it. Let's say there was a cure to cancer, but the FDA didn't approve it. There's no outcry because, ah, no one ever knew about it. But on the other hand, if the FDA let s…”
Abernethy: FDA can curb addiction by limiting post-surgical opioid prescriptions
“So practically speaking, we can help reduce the number of opioid tablets, for example, a patient has access to after back surgery or knee surgery in order to reduce the chance that this particular person has access and becomes addicted in the first place.”
Abernethy: The FDA regulates approximately 20% of international GDP
“Not only are we responsible for regulating about you know, 20% of international GDP as I mentioned, that sort of was across a broad number of products,”
Abernethy: FDA updates its border inspection engine rules manually every year
“And it's true that we update the rules every year, but we do so by hand.”
Abernethy: FDA is testing machine learning to predict border truck inspections
“And so right now we've got an experiment going on where we're looking at machine learning based prediction of which trucks we should inspect on the border.”
Abernethy: The FDA proactively averted over 160 drug shortages in 2018
“In 2018, we had something north of 50 drug shortages, but the little known secret is that we helped to avert over a 160 drug shortages.”
Pande: DIY CRISPR gene-editing kits are commercially available on Amazon
“You could get kits off of Amazon to do DIY CRISPR and that she could make our dog glow in the dark.”
Abernethy: Manufacturing consistency will be a major hurdle for gene therapies
“Manufacturing, I think, starts to become more and more of an issue across this space.”
Pande: CAR-T cell therapy can melt tumors away within days
“You take T cells out of your body, out of your blood, you re-engineer them to make them sort of supercharged, and you put them back into the patient, and the results of that are just mind-boggling, that tumors can melt away within days, and people are just lit…”
Abernethy: FDA jurisdiction over DIY gene-editing requires commercial intent and labeling
“Practically speaking, if the kit was going to be approved for commercial purposes with claims and labeling, et cetera, that's when it starts to get into the FDA perspective. It gets really murky when we live in this landscape of the internet without claims.”
Abernethy: FDA pilots preconditions to allow medical software updates without full review
“Can we come up with, essentially, preconditions for software updates? So that if there are strong quality controls in the way software is developed, well understood product performance as an expect, in terms of the expectation updates, can you now have algorit…”
Abernethy: FDA does not directly regulate non-diagnostic healthcare workflow software
“So it may not necessarily be a software product that's acting As a diagnostic or treatment activity, but it's a software product that's intended to support life sciences more globally, whether that's to make clinical trials more efficient, to match patients to…”
Abernethy: The FDA currently lacks and needs a Chief Privacy Officer
“In my CIO role, I just recently started pushing on the fact that I really think we need a chief privacy role at FDA, which we don't currently have.”
Abernethy: HIPAA is outdated and struggles to protect individual privacy today
“Our laws of the past, HIPAA, really contemplated a different world than we live in right now, whereby essentially in 2019 and going forward, it's very hard to maintain privacy of any individual.”
Abernethy: HIPAA-de-identified health data remains likely re-identifiable through modern analytics
“Even information that is de-identified from a HIPAA perspective actually still is probably re-identifiable even in our context.”
Abernethy: The FDA has approved pharmaceuticals based on Phase 1 data
“We've seen drugs approved based on phase one data.”
Abernethy: Phase 1 clinical trials are expanding to include a thousand patients
“We've seen expansion cohorts all happen within the phase one setting, which is Basically, you now end up with phase one trials with a thousand patients on a phase one trial.”
Abernethy: HITECH Act succeeded because a 2007 digital infrastructure blueprint existed
“So it was because that treatise was already ready, and also came along with the point of view of, we need a digital infrastructure to pull this off, that embedded within the context of the stimulus bill, we got the High Tech Act, which led to the full-scale di…”
Abernethy: FDA and USDA established a joint regulatory framework for cell-cultured food
“Last year we ultimately developed agreements with USDA so that the parts of the cell cultured food, food activity that's got to do with cell culture, for example, and that, that part of the equation ultimately became The FDA's responsibility, and then as we mo…”
Abernethy: FDA maintains an international bacterial genomic database to trace outbreaks
“And one of the things the FDA does in concert with CDC and now really through international database is have, is maintain a database of all the different genomes so that we can also track back and do this more quickly.”
Abernethy: Treatment evaluation will shift toward longitudinal performance tracking over time
“Historically, the way we've often thought about effectiveness is sort of as a fixed book of work, and I think that what you're going to see Over time is we're going to talk more and more about longitudinal performance, and this is a perfect example of that.”