Booting Earth Optimization System
Thank you for your patience. Your civilization is very important to us.
Thank you for your patience. Your civilization is very important to us.
Agency Report Card
Protect public health by ensuring safety and efficacy of drugs and food
Protect public health by ensuring safety and efficacy of drugs and food
2003 Medicare Part D signed — pharma lobbies a BAN on government negotiating drug prices ↗
2004 Vioxx withdrawn — FDA knew about cardiac risks for years, approved anyway ↗
2024 Same drug: Insulin US $300, Canada $30. Humira US $80K, UK $15K. ↗
Not graded: only two sourced estimates of drug development cost exist. FDA's total program level rose 466% (FY2000 $1.21B → FY2024 $6.88B, nominal). Tufts CSDD's estimated cost per approved drug rose 145% after inflation — $1.04B to $2.56B in 2013 dollars — between drugs first tested in 1983–94 and 1995–2007.
| Year | FDA total program level: budget authority + user fees (nominal USD, fiscal year; excludes COVID supplementals) | Tufts CSDD estimated R&D cost per approved new drug (USD millions, 2013 dollars; plotted at study publication year) |
|---|---|---|
| 2000 | $1.21B | – |
| 2003 | – | 1,044 |
| 2004 | $1.68B | – |
| 2008 | $2.42B | – |
| 2010 | $3.28B | – |
| 2012 | $3.83B | – |
| 2014 | $4.39B | 2,558 |
| 2016 | $4.75B | – |
| 2018 | $5.27B | – |
| 2020 | $5.92B | – |
| 2022 | $6.25B | – |
| 2024 | $6.88B | – |
“97% clinical trials, 3% overhead — the exact mirror of your NIH”
Total annual funding for the National Institutes of Health
Share of NIH budget that actually funds clinical trials — ~$1.55B of $47B
Average cost per patient in a traditional randomized controlled trial
Share of researchers' time spent writing grant proposals instead of doing science
“The FDA's budget grew more than fivefold and the cost of developing a drug more than doubled after inflation. That is not regulation. That is a protection racket with a government seal.”
These drugs PASSED the 8.2-year efficacy review. The process kills more through delay than it saves through rejection.
| Drug | Years On Market | Deaths ↓ | Fine | Jail Time |
|---|---|---|---|---|
| OxyContin (oxycodone) ↗ | 12 | 500K | $8.3B | Zero |
| Vioxx (rofecoxib) ↗ | 5 | 55K | $4.8B | Zero |
| Avandia (rosiglitazone) ↗ | 11 | 5K | $3.0B | Zero |
| Thalidomide (historical comparison) ↗ | 0 | 2K | $0 | Zero |
| Fen-Phen (fenfluramine/phentermine) ↗ | 24 | 300 | $21.0B | Zero |
| Bextra (valdecoxib) ↗ | 4 | 100 | $2.3B | Zero |
| Zantac (ranitidine) ↗ | 37 | 0 | $0 | Zero |
Total Deaths
562K
Total Fines
$39.5B
Cost Per Death
$70K
Why drugs stay expensive forever
78%
78% of drug patents filed in the US are for existing drugs — not new ones. Companies make minor modifications (different salt form, new coating, combination) to extend patent protection.
7+ years
Evergreening extends effective patent monopoly by an average of 7+ years beyond the original 20-year patent term.
132 patents
AbbVie filed 132 patents on Humira (originally patented in 2002). This patent wall delayed biosimilar competition until 2023 — generating $200B+ in revenue during the extended monopoly.
101 years
Insulin was discovered in 1923. The discoverers sold the patent for $1 each, wanting it to be affordable. Through reformulations, patents have been continuously extended. A vial costs $2-4 to manufacture and sells for $300 in the US.
$3.5B/yr cost to consumers
Brand-name drug companies pay generic manufacturers to delay entering the market ('reverse payment settlements'). These agreements cost consumers an estimated $3.5B per year in higher drug prices.
Faster drug approval through industry-funded review
Pharmaceutical companies now fund 65% of the FDA's drug review budget. The agency that decides if your drug is safe is paid by the company selling the drug. Drug development costs quadrupled.
65% of FDA drug review funded by pharma
$374M/yr
$7.6B total (1998–2024)
Block drug price negotiation, extend patent exclusivity, maintain FDA user fee dependency
Medicare banned from negotiating prices (2003-2022). PDUFA makes FDA dependent on pharma fees. Insulin stayed at $300 for 20 years.
3 of the last 5 FDA commissioners went to work for pharmaceutical companies or their boards after leaving office.
Science Magazine / BMJ Investigation ↗What drugs cost to make vs what Americans pay
$300
Manufacturing cost: $3.69. Markup: 81x.
Diabetes
Source: BMJ Global Health 2018
$10,000
Manufacturing cost: $159. Markup: 63x.
Leukemia
Source: Hill et al. JAMA Oncology 2017
$28,000
Manufacturing cost: $68. Markup: 412x.
Hepatitis C
Source: Hill et al. Clinical Infectious Diseases 2016
$345
Manufacturing cost: $8. Markup: 43x.
Allergic reactions
Source: Pharmaceutical Journal 2016
On a well-run planet, this agency would have been deprecated centuries ago. Here is what replaces it.
Decentralized Institutes of Health — National Institutes of Health + FDA