Can We Trust the FDA? Marty Makary on Science, Power & Patients
In this episode of All-In, Marty Makary discusses his first 10 months as FDA Commissioner and the 42 major reforms he has introduced to modernize the agency. The changes include reducing animal testing, streamlining drug approval processes, and implementing advanced computational modeling. Makary also addresses the FDA's efforts to increase transparency by making rejection letters public and taking action on artificial food dyes.
The discussion covers the FDA's approach to improving U.S. competitiveness in biotech and biopharma, noting China's growing influence in licensing deals. Makary explains his work to rebuild trust in health institutions through more flexible decision-making, including changes to childhood vaccine schedules and dietary guidelines. He details the FDA's new initiatives in food policy and nutrition, challenging traditional perspectives on protein requirements and saturated fats.
This is a preview of the Shortform summary of the Jan 15, 2026 episode of the All-In with Chamath, Jason, Sacks & Friedberg
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1-Page Summary
Modernizing and Streamlining the FDA's Processes
In his first 10 months as FDA Commissioner, Marty Makary has introduced 42 major reforms to modernize the agency. These reforms include reducing animal testing in favor of advanced alternatives like computational modeling, implementing Bayesian statistics in clinical trials, and making certain drugs available over-the-counter. Under Makary's leadership, the FDA has also increased transparency by making rejection letters public and taken swift action to ban nine artificial, petroleum-based food dyes.
Makary aims to dramatically reduce the typical 10-12 year drug development timeline. His reforms include requiring only one pivotal trial instead of two for new drug approvals and launching a pilot program that has already demonstrated success by approving a medication in just 55 days. He's also implementing continuous post-approval monitoring using big data and lessening regulations around cell and gene therapy.
To support these changes, Makary has restructured the FDA's operations by centralizing previously fragmented services and bringing in fresh talent, including 1,000 new scientists to revitalize the agency.
Addressing US Competitiveness in Biotech and Biopharma
Makary points to concerning trends in US competitiveness, noting that Chinese companies have increased their share of licensing deals from 5% to 42% in just three years. A prime example is the recent $6 billion collaboration between 3S Bio and Pfizer. Makary suggests that his FDA reforms are crucial for improving US competitiveness in these sectors.
Reforming Healthcare Policies Around Vaccines, Drugs, and Food
Makary is working to rebuild trust in health institutions post-COVID-19 by moving away from what he calls "medical absolutism" toward more flexible, transparent decision-making. He has reduced the childhood vaccine schedule from 72 to 38 recommended doses and is implementing a common-sense standard for drug approvals.
On the nutrition front, Makary is reforming FDA food policy by promoting real food consumption through initiatives like realfood.gov. He's challenging historical dietary guidelines, particularly around protein requirements and saturated fats, while advocating for a more nuanced understanding of nutrition that considers factors like protein bioavailability and individual metabolic processes.
1-Page Summary
Additional Materials
Counterarguments
- Concerns about the safety and efficacy of drugs approved with only one pivotal trial instead of the standard two, which could potentially lead to less robust data.
- Potential risks associated with making certain drugs available over-the-counter, as it may lead to self-medication and misuse without proper medical guidance.
- The rapid approval of medications, such as the one approved in just 55 days, might raise questions about the thoroughness of the review process and long-term safety.
- The reduction of the childhood vaccine schedule could be seen as a step back in preventive healthcare, potentially leading to a resurgence of preventable diseases.
- The restructuring of the FDA and the introduction of 1,000 new scientists, while potentially beneficial, could also lead to challenges in integrating new personnel and maintaining consistency in regulatory standards.
- The focus on US competitiveness in biotech and biopharma might overlook the importance of global collaboration and the sharing of knowledge for the advancement of medicine and public health.
- The ban on nine artificial, petroleum-based food dyes may have economic implications for the food industry and could be met with resistance from stakeholders who question the evidence or the necessity of such bans.
- Continuous post-approval monitoring using big data analytics is a promising approach, but it also raises concerns about patient privacy and the security of health data.
- Lessening regulations around cell and gene therapy could accelerate innovation but might also increase the risk of unforeseen adverse effects or ethical issues.
- The challenge to historical dietary guidelines and the promotion of a nuanced understanding of nutrition, while potentially beneficial, may conflict with established research and consensus in the nutrition science community.
- The emphasis on real food consumption and the critique of dietary guidelines could be seen as oversimplifying complex nutritional science and public health messaging.
Actionables
- You can evaluate your medication and supplement choices by checking if any are now available over-the-counter, potentially saving money and trips to the doctor. For instance, if you've been prescribed a medication that is now OTC, discuss with your healthcare provider whether it's appropriate for you to switch to the OTC version.
- Enhance your diet by researching and incorporating foods that align with the latest nutritional guidelines, focusing on real food consumption and understanding protein bioavailability. Start by replacing processed snacks with whole food options and comparing the protein quality in plant-based versus animal-based sources to tailor your diet to your metabolic needs.
- Stay informed about the safety of food additives by checking the ingredients list on food packaging for artificial dyes, especially those recently banned, and opting for products that use natural alternatives. This can be as simple as choosing snacks colored with fruit and vegetable extracts instead of those with artificial colors.
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Modernizing and Streamlining the FDA's Processes
Marty Makary has spearheaded a series of reforms aimed at revolutionizing the Food and Drug Administration (FDA) by boosting efficiency and reducing regulatory burdens.
Marty Makary Introduces Reforms to Boost FDA Efficiency and Cut Regulatory Burdens
Marty Makary, within his first 10 months as FDA Commissioner, has introduced a total of 42 major reforms, signaling a clear break from the status quo. These reforms include measures to reduce animal testing, employing advanced alternatives like computational modeling, and organ-on-chip technology. Makary also leverages Bayesian statistics to enhance clinical trial evaluation and has shifted certain drugs to over-the-counter status.
Reforms: Reduce Animal Testing, Permit Bayesian Statistics in Trials, Switch Drugs to Over-the-Counter Status
Makary has focused on modernizing the FDA's approach, including reducing old animal testing requirements that could delay drugs helpful to humans. He emphasizes replacing outdated methods with modern techniques and speeding up processes overall. Transparency is another key aspect of Makary’s reforms; the FDA now makes rejection letters public, a move previously unadopted. Furthermore, amid discussions about food dyes, Makary took rapid action to ban nine artificial, petroleum-based dyes soon after taking office.
Makary Aims to Speed Up Drug Approvals, Cutting the 10-12 Year Development Timeline
Makary criticizes the decade-long timeline typically required to introduce a new drug to the market. He has put forth priority reviews and pilot projects to fast-track approval processes and introduced higher user fees for phase one trials conducted outside the United States, aiming to encourage domestic research. This series of strategic reforms is designed to reduce the drug approval process significantly, potentially cutting it down to just weeks.
FDA to Cut Drug Approval to Weeks
Under Makary's leadership, the FDA has shifted to require only one pivotal trial, instead of two, for new drug approval. This change alone proposes to reduce both cost and time considerably for pharmaceutical companies. A pilot program has also been launched with the goal of reducing drug approval timelines from years to mere weeks. An example of this newfound efficiency is the approval of a medication under the pilot program in just 55 days. Further, Makary speaks of continuous monitoring of drugs post-approval, using big data for surveillance, effectively changing the threshold of approval by ensuring immediate oversight of the drugs’ real-world performance. Regulations around cell and gene therapy have also been lessened, which could streamline the approval process even further.
Makary Aims to Improve FDA Culture and Operations
Makary has initiated changes within the FDA's culture and operations aimed at expediting drug approvals. This includes altering incentives, tweak ...
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Modernizing and Streamlining the FDA's Processes
Additional Materials
Counterarguments
- Concerns about the sufficiency of one pivotal trial for new drug approvals, as it may not provide enough data to ensure safety and efficacy compared to the traditional requirement of two trials.
- Potential risks associated with fast-tracking drug approvals, such as insufficient time to identify long-term side effects or rare adverse events.
- The possibility that increased user fees for phase one trials conducted outside the U.S. could discourage international collaboration and innovation.
- The shift to over-the-counter status for certain drugs might lead to misuse or overuse without proper guidance from healthcare professionals.
- The rapid banning of artificial, petroleum-based food dyes could have economic implications for the food industry and may not have allowed sufficient time for companies to adapt.
- Streamlining processes and fostering a private-sector-like efficiency within the FDA could lead to a culture that prioritizes speed over thoroughness, potentially compromising drug safety.
- The consolidation of HR and IT services might lead to initial inefficiencies or teething problems as the new system is implemented and staff adjust to the changes.
- The recruitment of a large number of new scientists in a short period could strain the FDA's training and integration resources, potentially leading to a temporary dip in review quality.
- Continuous post-approval monitoring using big dat ...
Actionables
- You can advocate for efficiency in your workplace by suggesting the adoption of streamlined processes similar to the FDA's reforms, such as consolidating IT services or simplifying approval procedures. For example, if you work in an office, propose a review of current workflows and identify areas where steps can be merged or removed to save time.
- Encourage the use of data-driven decision-making in your community organizations by introducing the concept of continuous monitoring for ongoing projects. This could involve setting up simple feedback mechanisms, like online surveys or suggestion boxes, to gather data on the effectiveness of community initiatives and adjust strategies accordingly.
- Promote accessibility and transpare ...
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Addressing US Competitiveness in Biotech and Biopharma
Marty Makary comments on the competitive landscape in biotech and biopharma, pointing out the advancements China is making and suggesting the US needs to step up its game.
US Lags China In Biotech and Biopharma Innovation
Recent statistics indicate that Chinese companies are gaining a solid foothold in the biotech and biopharma sectors.
Chinese Companies: 42% of Licensing Deals, Up From 5% a Decade Ago
Chinese companies have expanded their share of licensing deals from just 5% in 2022 to an impressive 42% by 2025. This leap indicates a significant growth in influence and activity by China in the biotech and biopharmaceutical industries, signifying that the US is lagging behind in these crucial areas.
One landmark licensing deal exemplifying this growth is the $1.25 billion upfront payment in a collaboration between 3S Bio and Pfizer, with a total deal value reaching a staggering $6 billion. This single deal reflects broader trends of aggressive investment and expansion by Chinese firms.
Makary Views FDA Reforms as Key to US Competitiveness
Streamlining Drug Approval and Reducing Regulatory Burdens Will Speed US Market Innovation
Marty Makary underscores that reforming the FDA is crucial to improving the US position in the biotech and biopharma industries. He suggests that streamlining th ...
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Addressing US Competitiveness in Biotech and Biopharma
Additional Materials
Clarifications
- Licensing deals in biotech and biopharma involve one company granting another the rights to develop, manufacture, or sell a drug or technology. These agreements often include upfront payments, milestone payments, and royalties based on sales. They enable companies to share risks, access new technologies, and expand market reach without developing products entirely in-house. Such deals are crucial for innovation and growth in the industry.
- The increase from 5% to 42% in licensing deals shows a major shift in global biotech influence toward China. Licensing deals are agreements where companies share or buy rights to develop and sell new drugs or technologies. A higher share means Chinese firms are gaining access to more innovative products and expanding their market power. This shift challenges the US dominance and signals changing competitive dynamics in the industry.
- 3S Bio is a Chinese biotech company specializing in innovative drug development and biologics. Pfizer is a major global pharmaceutical company known for developing and marketing a wide range of medicines and vaccines. Collaborations between companies like 3S Bio and Pfizer combine cutting-edge research with extensive market reach and resources. Such partnerships accelerate drug development and expand access to new therapies worldwide.
- An "upfront payment" is the initial sum paid by one company to another when signing a licensing deal, before any products are sold or milestones reached. It compensates the licensor for granting rights to use their technology or products. A $1.25 billion upfront payment is notable because it reflects high confidence in the licensed technology’s potential and represents a significant financial commitment. Such a large amount is rare and signals a major strategic investment in the biotech industry.
- The FDA (Food and Drug Administration) is a US government agency responsible for ensuring the safety and effectiveness of drugs before they reach the market. It reviews clinical trial data to approve new drugs, balancing patient safety with timely access to innovations. The FDA’s regulatory process can be lengthy and complex, impacting how quickly biotech companies bring products to market. Reforming FDA procedures aims to speed approvals while maintaining rigorous safety standards, fostering innovation in biotech.
- Streamlining the drug approval process means simplifying and speeding up the steps the FDA takes to review and approve new medicines. This can involve reducing unnecessary paperwork, shortening review times, and using more flex ...
Counterarguments
- The increase in licensing deals by Chinese companies does not necessarily equate to a lack of innovation in the US; it could also reflect a strategic shift in the global market or increased collaboration.
- High upfront payments in licensing deals, such as the one between 3S Bio and Pfizer, do not always guarantee successful outcomes or market dominance.
- The US may still lead in other key aspects of biotech and biopharma, such as research output, number of patents, or venture capital investment, which are not addressed in the text.
- FDA regulations are designed to ensure drug safety and efficacy; streamlining processes must balance speed with the need to protect public health.
- Reducing regulatory burdens could potentially compromise drug safety and lead to public health risks if not managed carefully.
- Bayesian statistics for continuous trial evaluation, while innovative, may not be suitable for all types of drug trial ...
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Reforming Healthcare Policies Around Vaccines, Drugs, and Food
Healthcare policy is undergoing significant reform under the guidance of Marty Makary, who seeks to rebuild trust in health institutions post-COVID-19 and address issues around drug costs, vaccine schedules, food, and nutrition policies.
Makary Rebuilds Trust In Health Institutions Post-Covid-19 Controversies
He Seeks a Shift From "Absolutism" in Medicine To Objective, Flexible, and Transparent Decisions
Marty Makary talks about confronting medical dogmas during the COVID pandemic, such as mask mandates for toddlers and vaccine requirements for college students. He advocates for a shift away from medical absolutism toward more objective, flexible, and transparent decisions. Makary is critical of past misconceptions, like the belief that opioids are not addictive, and holds that American medicine needs to exhibit more humility and acknowledge when the answer is not known.
Makary Cuts Fda Vaccine Schedule, Eases Otc Drug Status
Makary has reduced the childhood vaccine schedule from about 72 to 38 recommended doses to help improve vaccination rates. He emphasizes that childhood vaccines have declined as people lost trust in the absolutes promoted during the COVID pandemic. Additionally, Makary's approach to FDA regulation includes a shift to a common-sense standard rather than rigid ones, with a pilot program that may offer fast-tracked approval processes with the goal of evaluating more drugs and potentially lowering drug prices.
Makary Tackling High Drug Costs In Us
Marty Makary discusses the administration's priority to lower drug prices, significantly reducing the cost of high-priced drugs like GLP-1s. President Trump's directive for the United States to have the best drug prices in the developed world led to the Most Favored Nation Status Pricing. This policy aimed to lower drug prices and reduce the uneven share of R&D costs borne by the United States.
Makary Reforming Fda's Food and Nutrition Policy
Makary discusses the FDA's food and nutrition policy, implying a shift from the historically flawed guidelines influenced by the food industry. He emphasizes the importance of real food and proper nutrition, addressing [restricted term] resistance, and advocating for protein and whole grains. A new website, realfood.gov, has been ...
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Reforming Healthcare Policies Around Vaccines, Drugs, and Food
Additional Materials
Counterarguments
- Reducing the childhood vaccine schedule could potentially overlook the benefits of certain vaccines and their role in preventing diseases.
- Fast-tracking drug approvals might compromise the thoroughness of safety evaluations, potentially leading to unforeseen adverse effects.
- The Most Favored Nation Status Pricing policy could discourage pharmaceutical innovation if companies anticipate reduced profits from the U.S. market.
- Banning artificial food dyes may not significantly impact overall health if other dietary issues are not concurrently addressed.
- Reevaluating iron and protein requirements in the food pyramid could conflict with established nutritional science and may not be suitable for all populations.
- Emphasizing protein intake might not consider the potential benefits of a balanced diet that includes a variety of nutrients.
- The focus on real food and proper nutrition, while important, may not fully account for so ...
Actionables
- You can start a personal health journal to track your dietary habits and health outcomes, noting how different foods affect your energy levels, mood, and physical well-being. By doing this, you'll create a personalized record that can help you identify patterns and make informed decisions about your nutrition, such as increasing your intake of whole grains and proteins based on your observations.
- Create a "real food" challenge with friends or family where you commit to cooking and eating meals made from whole, unprocessed ingredients for a set period, like one month. Share recipes, experiences, and the impacts on your health and budget, fostering a supportive community that encourages healthier eating habits and a deeper understanding of nutrition.
- Develop a simple checklist for evaluati ...
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