The rationale for the FDA's rigid standards is to avoid the sale of a drug like thalidomide. But the unintended consequence is almost certainly to allow many more people to die prematurely than would have died from side-effects under a less restrictive regime. We count and recount the costs of such side-effects. We do not count the costs of not allowing new drugs to be made available.
The FDA's strict drug approval standards are designed to prevent tragedies like the thalidomide scandal, which caused severe birth defects. However, this cautious approach may inadvertently result in more premature deaths, as many potential life-saving drugs never reach the market due to stringent regulations. The focus tends to be on the dangers of side effects, while the negative impact of restricting access to new treatments is often overlooked.
Niall Ferguson emphasizes the importance of weighing both the costs of side effects and the potential lost opportunities for patients who could benefit from innovative medications. The book argues for a reevaluation of how we balance safety with the urgent need for new therapies, as the current system may leave countless individuals without critical options for care.
