The FDA commissioner argues that nutrition science is one of science's most corrupted fields. This led to a flawed food pyramid that demonized natural fats and promoted refined carbs, directly contributing to the epidemic of prediabetes in 38% of American children.
The FDA commissioner found that scientific reviewers only share groundbreaking ideas for process improvement when guaranteed anonymity, fearing repercussions from their supervisors. This highlights a stifling bureaucratic culture where true innovation happens in one-on-one meetings, not formal briefings.
The FDA's traditional focus on risk avoidance overlooks the inherent risk of delay. Unnecessary bureaucratic steps, like months of animal trials, prevent dying patients from accessing potentially life-saving treatments. The cost of inaction is measured in lives lost.
The FDA previously operated as seven distinct centers, each with its own legal and communications teams. This extreme siloing created nightmares for developers of combination products and led to absurd inefficiencies, like employees being unable to email files between centers.
The widespread medical recommendation for young children to avoid peanut butter until age 3 was tragically wrong. This advice ignited the modern peanut allergy epidemic by preventing the early exposure necessary to build immune tolerance, a complete reversal of correct science.
The requirement for prescriptions for many safe drugs stems from a paternalistic medical culture that distrusts patients, not from genuine safety concerns. This drives up costs and creates unnecessary barriers, similar to how the establishment initially resisted home pregnancy and COVID tests.
The FDA is eliminating mandatory animal testing because it's often misleading—90% of drugs passing animal studies fail in humans. The agency is embracing modern alternatives like computational modeling and organ-on-a-chip technology to get faster, more accurate safety data.
The FDA now allows a single, well-designed pivotal trial instead of the traditional two. This reform significantly cuts costs by $100M-$300M and shortens development timelines, enabling companies to test twice as many potential drugs with the same capital.
The FDA is abandoning rigid, fixed-length clinical trials for a "continuous" model. Using AI and Bayesian statistics, regulators can monitor data in real-time and approve a drug the moment efficacy is proven, rather than waiting for an arbitrary end date, accelerating access for patients.
The administration is leveraging the U.S.'s market power to demand "most favored nation" pricing from pharmaceutical companies. This forces them to offer drugs at the lowest price available in any other developed nation, slashing costs for American consumers.
The U.S. recommends 72 vaccine doses for children from birth to 18, a number significantly higher than 20 other developed nations. To combat falling vaccination rates and rebuild trust, the FDA is now highlighting a "core essential" list of approximately 38 vaccines.
The US is losing the biotech race not just at the FDA, but due to slow hospital Institutional Review Boards (IRBs) and contracting. A Phase 1 trial takes four weeks in China, while a simple university survey in the US can take over a year for approval, creating a major competitive disadvantage.
By using big data for continuous, real-time post-market surveillance, the FDA can identify safety signals almost instantly. This robust safety net after a drug is launched paradoxically allows the agency to lower the evidence threshold required for initial approval, accelerating access to new cures.