1

people have died from curable diseases

since this page started loading...

💀

Source Quotes and References

Keywords

drug-development-cost, fda-regulation, kefauver-harris-amendment, clinical-trials, pharmaceutical-economics, regulatory-burden, health-economics, baily-1972, tufts-csdd, orphan-drugs

1.

Labor Statistics, U. S. B. of. CPI inflation calculator. (2024)

CPI-U (1980): 82.4 CPI-U (2024): 313.5 Inflation multiplier (1980-2024): 3.80× Cumulative inflation: 280.48% Average annual inflation rate: 3.08% Note: Official U.S. government inflation data using Consumer Price Index for All Urban Consumers (CPI-U). Additional sources: https://www.bls.gov/data/inflation_calculator.htm

.

2.

DiMasi, J. A., Grabowski, H. G. & Hansen, R. W. Innovation in the pharmaceutical industry: New estimates of r&d costs. Journal of Health Economics https://doi.org/10.1016/j.jhealeco.2016.01.012 (2016) doi:10.1016/j.jhealeco.2016.01.012.

3.

CSDD, T. Cost of drug development.

Various estimates suggest $1.0 - $2.5 billion to bring a new drug from discovery through FDA approval, spread across  10 years. Tufts Center for the Study of Drug Development often cited for $1.0 - $2.6 billion/drug. Industry reports (IQVIA, Deloitte) also highlight $2+ billion figures.

4.

FDA. Generic drug substitution savings. FDA https://www.fda.gov/drugs/generic-drugs/generic-drug-facts.

5.

C&EN. Annual number of new drugs approved globally:  50. C&EN https://cen.acs.org/pharmaceuticals/50-new-drugs-received-FDA/103/i2 (2025)

50 new drugs approved annually Additional sources: https://cen.acs.org/pharmaceuticals/50-new-drugs-received-FDA/103/i2 | https://www.fda.gov/drugs/development-approval-process-drugs/novel-drug-approvals-fda

.

6.

Ramsberg J, P. R. Pragmatic trial cost per patient (median $97). Learning Health Systems https://pmc.ncbi.nlm.nih.gov/articles/PMC6508852/ (2018)

Meta-analysis of 108 embedded pragmatic clinical trials (2006-2016). The median cost per patient was $97 (IQR $19–$478), based on 2015 dollars. 25% of trials cost <$19/patient; 10 trials exceeded $1,000/patient. U.S. studies median $187 vs non-U.S. median $27. Additional sources: https://pmc.ncbi.nlm.nih.gov/articles/PMC6508852/

.

7.

Baily, M. N. Pre-1962 drug development costs (baily 1972). Baily (1972) https://samizdathealth.org/wp-content/uploads/2020/12/hlthaff.1.2.6.pdf (1972)

Pre-1962: Average cost per new chemical entity (NCE) was $6.5 million (1980 dollars) Inflation-adjusted to 2024 dollars: $6.5M (1980) ≈ $22.5M (2024), using CPI multiplier of 3.46× Real cost increase (inflation-adjusted): $22.5M (pre-1962) → $2,600M (2024) = 116× increase Note: This represents the most comprehensive academic estimate of pre-1962 drug development costs based on empirical industry data Additional sources: https://samizdathealth.org/wp-content/uploads/2020/12/hlthaff.1.2.6.pdf

.

8.

Pre-1962 Drug Development Costs (Congressional Testimony, Alternative Estimate). https://www.congress.gov/95/crecb/1977/04/21/GPO-CRECB-1977-pt10-2-3.pdf (1977)

1962: Average cost $1.2 million (in 1962 dollars) 1972: $11.5 million 1977: Projected $40 million Inflation-adjusted to 2024 dollars: $1.2M (1962) ≈ $12M (2024), using CPI multiplier of  10× Real cost increase (inflation-adjusted): $12M (1962) → $2,600M (2024) = 217× increase Note: Lower estimate than Baily (1972); may reflect incomplete cost accounting or different drug types. Baily’s $6.5M (1980 dollars) = $22.5M (2024 dollars) is the more rigorous academic estimate Additional sources: https://www.congress.gov/95/crecb/1977/04/21/GPO-CRECB-1977-pt10-2-3.pdf

.

9.

Oren Cass, M. I. RECOVERY trial cost per patient. Oren Cass https://manhattan.institute/article/slow-costly-clinical-trials-drag-down-biomedical-breakthroughs (2023)

The RECOVERY trial, for example, cost only about $500 per patient... By contrast, the median per-patient cost of a pivotal trial for a new therapeutic is around $41,000. Additional sources: https://manhattan.institute/article/slow-costly-clinical-trials-drag-down-biomedical-breakthroughs

.

10.

Institute, M. RECOVERY trial 82× cost reduction. Manhattan Institute: Slow Costly Trials https://manhattan.institute/article/slow-costly-clinical-trials-drag-down-biomedical-breakthroughs

RECOVERY trial:  $500 per patient ($20M for 48,000 patients = $417/patient) Typical clinical trial:  $41,000 median per-patient cost Cost reduction:  80-82× cheaper ($41,000 ÷ $500 ≈ 82×) Efficiency: $50 per patient per answer (10 therapeutics tested, 4 effective) Dexamethasone estimated to save >630,000 lives Additional sources: https://manhattan.institute/article/slow-costly-clinical-trials-drag-down-biomedical-breakthroughs | https://pmc.ncbi.nlm.nih.gov/articles/PMC9293394/

.

11.

FDA Study via NCBI. Trial costs, FDA study. FDA Study via NCBI https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6248200/

Overall, the 138 clinical trials had an estimated median (IQR) cost of $19.0 million ($12.2 million-$33.1 million)... The clinical trials cost a median (IQR) of $41,117 ($31,802-$82,362) per patient. Additional sources: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6248200/

.

12.

Tufts Center for the Study of Drug Development. Cost to develop and win marketing approval for a new drug is $2.6 billion. (2014).

13.

Study of Drug Development, T. C. for the. Tufts center drug development cost estimate 2021. (2021)

Total cost to develop a new drug estimated at $2.6 billion as of 2021, nearly a 3-fold increase from $802 million in 2003 (inflation-adjusted).