US Food and Drug Administration
The FDA regulates drugs, biologics, medical devices, food safety, and cosmetics—affecting roughly 25% of the US economy. Established 1906 following The Jungle's exposé of meatpacking conditions, strengthened after the 1937 sulfanilamide disaster killed 100+ people and the 1962 thalidomide near-miss.
The FDA exemplifies regulatory mutualism: industry pays 65% of drug review costs through user fees, creating dependency that critics call capture and defenders call sustainable funding. Like a sea anemone dependent on its clownfish symbiont, the FDA has evolved to need the relationship even as it retains stinging capacity.
The FDA is funded 65% by the pharmaceutical industry it regulates. Under PDUFA (Prescription Drug User Fee Act), user fees from industry account for $3.3 billion of the FDA's $6.9 billion budget. More striking: 80% of PDUFA revenue comes from annual fees on already-marketed products, not new application fees—creating structural dependency on keeping existing drugs on market. The revolving door spins faster than most realize: 57% of FDA hematology-oncology reviewers who left between 2001-2010 went directly to industry, and 9 out of 10 FDA commissioners moved to pharmaceutical companies between 2006-2019.
Key Facts
Power Dynamics
Statutory authority to approve or reject all drugs, biologics, and medical devices sold in the United States. Advisory committees provide expert recommendations, but FDA makes final binding decisions.
The advisory committee system is increasingly sidelined. In 2010, 55% of FDA-approved drugs went to advisory committee; by 2021, only 6% did. When FDA does convene advisory committees, it overrides negative votes more often than public realizes—FDA approved Aduhelm despite 10-0 advisory committee vote against. FDA can switch approval pathways at last minute to bypass committee objections.
- Congress controls PDUFA reauthorization (required every 5 years)
- Industry negotiates PDUFA terms directly with FDA
- Office of Management and Budget can impose hiring freezes
- PDUFA trigger mechanism requires FDA to refund fees if appropriations fall below baseline
- Pharmaceutical industry (negotiates user fee agreements, funds 65% of drug program)
- Patient advocacy groups (often industry-funded, pressure for faster approvals)
- Members of Congress (especially on funding committees)
- Academic medical centers (provide advisory committee members, often with consulting relationships)
Revenue Structure
US Food and Drug Administration Revenue Sources
- Pharmaceutical user fees (PDUFA) 48% →
- Federal appropriations 45% →
- Other user fees (devices, generics, biologics) 7% ↑
65% of Human Drugs Program specifically
Declining as percentage over time
PDUFA non-reauthorization would trigger immediate crisis. If PDUFA lapses, FDA must refund collected fees and cannot collect new ones. Review times would revert from 10 months to 2.5 years (pre-1992 levels).
FDA's 50% industry funding is lower than EMA (91.5%) but creates more political controversy due to US regulatory capture debates.
Decision Dynamics at US Food and Drug Administration
Pfizer-BioNTech COVID vaccine received EUA in 36 days from submission, with rolling review starting October 2020.
Rintatolimod (Ampligen) for Chronic Fatigue Syndrome: first synthesized in 1970s, NDA filed 2007, still not approved as of 2025. Five decades across five review divisions—the longest FDA review in modern history.
Not science reviews (which happen on schedule under PDUFA), but political override mechanism. When career reviewers recommend rejection but political appointees want approval (or vice versa), decisions stall. Aduhelm case: career scientists recommended against, leadership approved anyway via accelerated pathway, leading to three advisory committee resignations.
Failure Modes of US Food and Drug Administration
- Vioxx (1999-2004): Approved May 1999, withdrawn September 2004 after VIGOR trial showed 4-5x heart attack increase. Estimated 88,000 Americans had heart attacks, 38,000 died.
- Aduhelm (2021-2024): Approved via accelerated approval despite 10-0-1 advisory committee vote against. Three committee members resigned, drug withdrawn January 2024.
- Pre-PDUFA era: Average review took 2.5 years, creating substantial 'drug lag' versus Europe
- User fee dependency creates approval bias—as industry funding grew from 20% (1995) to 65% (2024), critics note faster approvals but more post-market withdrawals
- Advisory committee bypass concentrates power in FDA management with revolving door incentives
- Post-market surveillance weakness—limited ability to force post-approval studies
If Kennedy administration blocks PDUFA reauthorization, FDA would lose $3.3B/year, forcing massive layoffs. Review times would revert to 2.5 years. US would transition from global leader to laggard in drug approvals within 3-5 years. Breakthrough therapies would launch in Europe 1-2 years before US availability.
Biological Parallel
The FDA resembles a sea anemone that has evolved to depend on the organisms it's supposed to predate. The anemone (FDA) technically has stinging cells (regulatory power) to kill prey (reject drugs), but has become reliant on a specific symbiont (pharmaceutical industry) that has evolved immunity to its stings through user fees and revolving door. The clownfish (industry) feeds the anemone through mucus-coating exchanges (user fees fund 65% of drug review staff). When removed from this symbiotic relationship (PDUFA non-reauthorization scenario), the anemone would starve without its clownfish bringing food.
Key Agencies
Reviews new drug applications
Regulates vaccines, blood products, gene therapy
Medical device approval