Abstract: This study quantifies the cumulative mortality and morbidity costs associated with the Unitary Pre-Market Approval (UPMA) model mandated by the 1962 Kefauver-Harris Amendments. By enforcing efficacy testing prior to market entry, the current regulatory framework imposes an average "Efficacy Lag" of 8. 2 years (95% CI: 4. 85 years-11. 5 years) post-safety verification. Using data from the Tufts Center for the Study of Drug Development (CSDD) and the WHO Global Burden of Disease (GBD) database, we estimate two distinct mortality costs: (1) Historical mortality (1962-2024): approximately 102M deaths (95% CI: 36. 9M deaths-214M deaths) died waiting for approved drugs during their approval delays, representing a lower bound excluding drugs never developed due to cost barriers; (2) Future timeline shift: an additional 416M deaths (95% CI: 225M deaths-630M deaths) will eventually die because the disease eradication timeline has been pushed back by 8. 2 years (95% CI: 4. 85 years-11. 5 years). Combined, these represent 7. 94B DALYs (95% CI: 4. 43B DALYs-12. 1B DALYs) Disability-Adjusted Life Years when adjusted for morbidity, with a cumulative economic deadweight loss of approximately \1. 19 quadrillion (95% CI: \443T-\2. 41 quadrillion) (2024 USD). The societal cost of Type II Regulatory Errors (delayed access to effective therapies) exceeds the averted cost of Type I Regulatory Errors (market access for ineffective therapies) by a factor of 3. 07k: 1 (95% CI: 2. 88k: 1-3. 12k: 1). Summary: After proving a drug is safe, the FDA requires 8. 2 years to prove it works before patients can access it. We estimate this delay cost 102M deaths among people waiting for approved drugs (1962-2024). The cost of blocking good drugs is 3. 07k: 1 higher than the cost of approving bad ones.
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