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.
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Despite massive turnover and internal dysfunction at the FDA, biotech investors have largely shrugged off the regulatory uncertainty. This disconnect suggests the market believes the negative impacts, like drug review delays, are a lagging indicator that won't materialize immediately, creating a potential future risk for the sector.
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.
A regulator who approves a new technology that fails faces immense public backlash and career ruin. Conversely, they receive little glory for a success. This asymmetric risk profile creates a powerful incentive to deny or delay new innovations, preserving the status quo regardless of potential benefits.
Regulating technology based on anticipating *potential* future harms, rather than known ones, is a dangerous path. This 'precautionary principle,' common in Europe, stifles breakthrough innovation. If applied historically, it would have blocked transformative technologies like the automobile or even nuclear power, which has a better safety record than oil.
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.
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.
Top biotech VC Bob Nelsen contends the U.S.'s competitive edge is eroding because of slow, burdensome FDA processes. He points to Australia's model, where human trials can be approved in days, as the standard the US must adopt to compete with agile global players like China.
M&A is often framed as a win, but it can be detrimental to patients. The acquisition of an aggressive, fast-moving biotech by a large pharma company can lead to slowed development timelines and more conservative regulatory strategies, ultimately delaying access to life-saving treatments.
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 GIK solution (glucose, insulin, potassium) was known for decades and worked in animal studies where it was given immediately. It failed in human trials because it was administered six or more hours after a heart attack began. The key innovation was realizing the therapy's success hinges on immediate administration at the first sign of symptoms.
