Wall Street Week New FDA with Old Problems, Stakeholder Capitalism
May 23, 2025
John Iwata, an executive fellow at Yale and former IBM strategist, alongside Francesco Storacci, former CEO of Enel, dive into pressing topics. They discuss the FDA's regulatory failures with opioid approvals and the resulting crisis. The duo contrasts corporate heritage with innovation, examining how companies like Enel and Mars maintain their core values amid rapid change. They advocate for stakeholder capitalism and emphasize the need for businesses to align strategies with foundational principles while navigating technological shifts.
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FDA's Regulatory Failure with Opioids
- The FDA violated its own rules approving opioid marketing, fueling the opioid epidemic and massive public health loss.
- Enforcement failures, not the law itself, caused this historic regulatory breakdown.
Purdue's Arrogant FDA Bypass
- Purdue Pharma aggressively marketed opioids without submitting clinical data, exploiting FDA's late application leniency.
- This set a precedent allowing ineffective opioid products to flood the market unchecked.
FDA's Fast-Track Opioid Approval Risks
- FDA's Pilot Drug division fast-tracked opioid approvals with loosened scrutiny, often disregarding scientific rigour.
- This shift toward partnership with industry sacrificed safety for speed, leading to reckless decisions.