On March 6, 2025, Martin Makary, a Johns Hopkins surgeon with a gladiator’s contempt for inertia, was named by President-elect Donald Trump to lead the Food and Drug Administration. He inherits a pharmaceutical industry frozen in time—a half-century where drugs still take a decade to emerge, cost $2.6 billion each, and fail 90% of the time in trials, unmoved since the moon-landing era. Eroom’s Law, that grim reaper of progress doubling costs for dwindling gains, reigns supreme.
Peter Thiel, the contrarian sage of Silicon Valley, would nod grimly: here lies his indictment of a civilization stalled—not in “bits,” where digital marvels abound, but in “atoms,” where physical innovation withers under risk aversion and bureaucracy. Makary’s charge could be salvation: an “AI Development Pathway,” to reward and expand the use of AI-driven platforms and non-animal models, slashing costs, and timelines by half or more. This isn’t just reform—it’s an antidote to stagnation.
For 50 years, drug development has been a mausoleum of wasted potential: animal tests that mislead, trials that lumber to collapse. Medicine still clings to rituals predating the microprocessor. Life sciences has become a culture cowed by safety, choked by red tape, bereft of the daring that once split the atom. Pharmaceuticals epitomize this—Eroom’s Law mocks Moore’s Law, the semiconductor triumph where progress halved costs and doubled power biennially. Makary, a man who thrives on exposing such folly, can shatter the shackles with a pathway that dares to innovate where it matters: in the health and wealth of Americans.
An AI Development Pathway would be no timid tweak—it’s a gauntlet thrown at stagnation. Grant companies 30% tax credits for ditching animal cages for AI simulations, fast track medicines willing to exit the dirt road of the current pathway to digital superhighways, provide precommitments to purchase the products once FDA approves.
Clinical trials, those profligate sinkholes of time and treasure, beg for the same audacity. Digital twins—AI avatars of patients—cut the fat: Unlearn.AI trims recruitment by 20%, Sanofi shaves testing by a fifth, saving $100 million per trial. These technologies could halve timelines from a decade to five years, costs from $2 billion to $1 billion or less.
Another startup called Vial is expanding into full-stack drug discovery with an AI-first platform to advance their own medicines. Instead of reinventing each stage, they're integrating the best technologies by partnering with leading providers to create preclinical data without animal studies.
Vial aims to revolutionize drug development from lab to patient by cutting clinical trial costs through innovative technology. They're leveraging cost-efficient trials and building an AI-driven platform, integrating top technologies and partners for preclinical data, all without animal studies.
As Elon Musk has shown: the factory or the process of production is the product. Halve development costs and time, boost success rates—as Pfizer did with COVID-19’s agile trials—and you flood the market with drugs. Manufacturers, freed from the roulette of failure, invest. Competition generates more shots on goal and more new medicines at a much lower cost. No federal program is required to bring about this revolution: Instead, replacing the centuries old animal model requirement with labs on a chip could turn the entire life science enterprise into operation Warp Speed.
The path isn’t smooth—validating AI, guarding data, shaking a risk-averse industry. Makary’s disdain for bureaucracy arms him with the right mindset to shatter 50 years of pharmaceutical torpor, halving costs and time while rebuilding U.S. manufacturing. Doing so will not only make medicines more affordable, but it will also make America healthier and wealthier.
Nobel Prize-winning economist Robert Fogel studied the impact of medical innovation on health, economic growth, and well-being. He found that healthcare spending is driven by demand, influenced by income and effective biotech advances. Like electricity and manufacturing in the early 20th century, healthcare is the leading growth industry of the 21st century, driving various other sectors including manufacturing, education, finance, communications, and construction.
America should be the leading edge of this leading sector. Unfortunately, biotechnology is slowly sinking into a regulatory moat designed to protect the largest corporations. American global leadership is going down with it. Makary has made a career of leapfrogging over the ‘scientific consensus’ in cancer surgery and primary care to implement smarter techniques and systems. He has a mandate to do the same at the FDA by forging an AI Development Pathway.
Dr. Robert Goldberg is Vice President of Research Programs at the Center for Medicine in the Public Interest.
