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Ask a cardiologist what success looks like, and you’ll most likely hear about the patients in front of them. Ask a public health official, and the answer will cover a population that includes people who never make it to a clinic.
Dr. Robert Califf has spent his career in both roles, and he thinks GLP-1 therapies are one of the clearest examples of how those two definitions of success can diverge.
We’re genuinely honored to share this conversation. Dr. Califf has served as Commissioner of the FDA twice, has led some of the most important clinical trials in cardiovascular medicine, and founded the Duke Clinical Research Institute. Having him on The Life Science Rundown is a highlight for us, and we’re grateful he gave us his time and such a thoughtful conversation.
The question we put to him was this: how can society turn the scientific promise of GLP-1 therapies into a true public health success, with affordability, equitable access, trustworthy information, and responsible regulation?
Dr. Califf is a cardiologist by training who grew up in South Carolina and has been associated with Duke University for more than half of its 100-year history. His interest in learning which treatments actually work drew him into clinical trials early, which led to the Duke Clinical Research Institute and, over time, to working closely with FDA. He was appointed Commissioner in 2016 and returned to the role in 2022. Between those terms he worked with Alphabet’s health businesses, Verily and Google Health.
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Dr. Califf's key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Individual care and public health answer to different people. In a doctor-patient relationship, Dr. Califf’s responsibility was to the individual patient. Public health aims to improve longevity and healthy longevity across the entire population, including all its segments. GLP-1s, in his view, are a good example of where those responsibilities can come into tension and need to be resolved.
Obesity was treated as a moral failing, and that never worked. He described a long period in which people gaining weight felt admonished for it, as if it were a personal shortcoming. The pharmacologic side didn’t go much better. Before GLP-1s, most drugs tried for obesity had serious toxicities, some where the harm clearly outweighed the benefit, which is why he spent part of his academic career pushing for outcome studies. Meanwhile, a great deal of money was made selling diet books and products whose net effect, as he put it, was almost nothing.
The biology may teach us far more than weight loss. When he refers to GLP-1s, he means a class of drugs acting on multiple pathways between the gut and the brain that researchers are only beginning to understand. What excites him most isn’t only that they work. It’s what the science is revealing about biology and behavior. Preliminary data and secondary analyses suggest effects on cravings for alcohol, tobacco, gambling, and ultra-processed food, and definitive trials are underway. He was careful to note that neuroscientists still debate whether all of this fits the classical definition of addiction.
The opportunity is to reverse a chronic disease trend. He acknowledged the irony plainly: a food environment contributed to widespread weight gain, and now an expensive class of drugs is helping reverse it. But given where things stand, he sees a real chance. If these drugs can be distributed equitably, and the class keeps improving, it’s possible to reverse much of the current chronic disease burden. He pointed to Global Burden of Disease research identifying nutrition and weight as the largest drivers of the flattening of improvements in life expectancy, particularly in the United States.
Early access followed resources rather than need. Dr. Califf borrowed a line from science writer Ed Yong about technological fixes drifting toward society’s penthouses while disease seeps into its cracks. In the early phase, GLP-1s went largely to people with money or the education to obtain them, while those who needed them most had little access. He considers that an ongoing problem.
The people most at risk are the ones with the least room to maneuver. Public awareness has grown that weight gain reflects the food environment rather than personal failure, and he expects that alone to slow the trend. GLP-1s could get there faster. The risk of falling short lands mostly on people without good insurance, without spare cash to buy direct to consumer, and without the influence to get a foot in the door, while high costs lead some insurers and employers to leave these drugs out of their plans.
Innovation needs rewarding, and broad impact needs a different path. Dr. Califf was explicit that he isn’t in the camp that thinks drugs cost nothing to make. Trials are expensive; nine out of ten drugs that enter Phase 1 never reach the market, and companies need incentives to take those risks. His concern is that the system now rewards charging a high price to a narrow slice of the population, partly because patent windows are short and clinical adoption takes time. For the occasional drug with outsized public health impact, he named Gleevec in cancer and GLP-1s as examples, he believes society would be better served if far more people used it at a lower price. He suggested an early way of identifying those drugs, and believes companies could still be profitable under such a model. He also noted that U.S. generic drug prices are actually lower than in the rest of the world.
Access is more than the prescription. Adhering to a GLP-1 can mean working through nausea and other side effects that often pass if you stay with it. The more support someone has, whether money, friends, or stable circumstances, the easier that is. Equitable access includes that support.
Compounding was legal during the shortage. It isn’t now. When demand outstripped what the two manufacturers could produce, the law allowed compounding, and it initially happened through relatively controlled channels. Now that manufacturing capacity has caught up, compounding look-alikes of approved GLP-1 drugs on the market is no longer permitted. People buying compounded versions today are getting products without the testing and quality control of approved medications, a risk he described as unquantified but definitely not zero. Much of the starting material also comes from different sources than those used by the approved manufacturers.
His larger worry is untested peptides. He sees a spillover from that period into something he considers genuinely dangerous: novel peptides sold online, including new GLP-1-type compounds that are essentially new drugs and haven’t been through even basic evaluation, such as whether they cause cancer in animals. People are buying them at high cost based on hearsay and online influencers. He also said he understands why people look elsewhere when their employer's plan won’t cover a drug they need.
Trust follows trustworthy behavior. Asked about misinformation, Dr. Califf reframed the question. Before the internet, health care largely served the people who showed up. Now we can see everyone, all 340 million people in the U.S. and the full global population, along with every disparity, which makes clear these problems are solvable. Surveys show people distrust large institutions while trusting their own doctors, nurses, and pharmacists. His view is that every sector is full of good people working inside a system that isn’t configured well, and that no messaging fixes a mismatch between need and access. He cited a line he likes: if you want to be trusted, act trustworthy.
Technology can help put care where the need is. He described an ARPA-H program he’s helping with called ADVOCATE, which is developing AI agents to support cardiovascular care. In parts of rural America, reaching a heart failure specialist can mean a three-hour drive, and the gap between rural and urban health outcomes is widening. Alongside technology, he’d like to see a system that distributes care to where the need is.
What success over the next decade would require. His first priority is reform of the U.S. insurance system, and he noted that even high-income countries with universal coverage aren’t distributing GLP-1s widely because of cost. Beyond that, he’d like to see the pharmaceutical model evolve, with better definition of who actually benefits from a drug or device, wider use among those people, and less use among those who don’t. Electronic health records and modern computational tools make that more achievable than ever. In his words, we don’t need to worship AI, but it can help with large problems like distribution, supply chains, and deciding who would benefit.
And underneath all of it, a sense of wonder. Dr. Califf asked that his concerns not be read as negativity. He called the GLP-1 story something like a miracle: a line of research tracing back to a lizard and years of basic science at NIH, first pursued for diabetes, then revealing far broader effects. We’re only scratching the surface of what it will teach us about behavior and biology. He sees the gaps as an opportunity for more people to live healthy lives.
One thing to bring back to your team
Two threads from this conversation sit squarely in the world our readers work in.
The first is quality. Dr. Califf’s distinction between approved products and compounded or novel peptides comes down to testing, quality control, and the provenance of starting materials, which is exactly the work quality and regulatory professionals do every day. His warning about untested peptides is a reminder of why that work matters outside the walls of any one company.
The second is evidence. His vision for the next decade depends on knowing more precisely who benefits from a product and who doesn’t. That’s a clinical development and data question as much as a policy one, and teams that design programs to answer it clearly will be well positioned for wherever the access conversation goes.
Robert M. Califf, MD, MACC, served twice as Commissioner of Food and Drugs: as the agency’s 22nd Commissioner from February 2016 to January 2017, and as its 25th Commissioner from February 2022 to January 2025. Before his first term, he served as FDA’s Deputy Commissioner for Medical Products and Tobacco. Between his terms, he was head of medical strategy and senior advisor at Alphabet, contributing to strategy and policy for Verily Life Sciences and Google Health. A cardiologist, Dr. Califf spent decades at Duke University, where he was a professor of medicine, vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and founding director of the Duke Clinical Research Institute. While at Duke he led major initiatives to improve clinical research methods and infrastructure, including the Clinical Trials Transformation Initiative, a public-private partnership co-founded by FDA and Duke. He earned his medical degree from Duke University School of Medicine, completed his internal medicine residency at the University of California, San Francisco, and completed his cardiology fellowship at Duke.
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