Conditional approvals that lapse automatically if the confirmatory trial is late
Drugs approved early on promising results should lose that approval automatically if the company fails to finish the follow-up trial by the agreed date.
Accelerated and conditional approvals have often stayed on the market for years after confirmatory trials stalled or failed (the 'dangling' approvals reviewed in 2021). The FDORA 2022 reforms gave FDA power to require confirmatory trials to be underway and to expedite withdrawal; the EU renews conditional authorisations annually. The proposal is a self-executing sunset: at approval, the sponsor agrees enrolment milestones and a readout date, and the authorisation lapses without further procedure if the milestones are missed, unless an independent panel grants a documented extension.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Incentives reward me-too drugs and marginal gains · The system pays the same for a drug that adds two months as for a cure, so companies race to copy rather than to cure.
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Shares Accelerated approval, Regulatory divergence between regions.