If the referee’s paycheck comes from the teams on the field, the match tilts. The Food and Drug Administration was built to protect the public from unsafe or ineffective drugs, yet the core of its modern drug review machine runs on money from the firms it regulates. In fiscal year 2024, the agency collected 1.381B in prescription drug user fees, spent 1.377B of those fees on the human drug review process, and reported that user fees accounted for 77 percent of total human drug review obligations that year. Congressional appropriations covered the remainder. These figures are taken from the FDA’s own report to Congress.
The arrangement began in 1992 with the Prescription Drug User Fee Act, framed as a response to urgent pressure for faster HIV and cancer drug reviews. Every five years since, Congress has reauthorized the program after the FDA and industry produce a goals letter that sets performance targets, hiring plans, meeting timetables, and transparency commitments for the next cycle. In practice, the ground rules that shape how quickly companies receive decisions are negotiated first, then ratified by Congress.
The immediate benefits were clear. Reviews that once took three years dropped to less than one. Patients gained faster access, and capital flowed into biotech because companies could count on predictable timelines. But the costs sat in the structure itself. When most of the review program’s budget depends on fees set through talks with regulated firms, those firms gain leverage over timelines and process design. The agency now sustains entire divisions on this stream of money. If it were cut off, the reviewers and scientists who process applications would be unfunded, and the system would collapse. That dependency ensures the cycle continues.
What remains hidden from public view is how those negotiations and dependencies tilt decisions. The goals letters are highly technical, yet they dictate staffing levels, the number of meetings FDA must grant companies, and the timelines the agency must meet. Advisory committees that are supposed to be independent often seat members with industry ties, admitted under waivers because of their expertise. Patients rarely know that the panel advising on their treatment may include individuals financially linked to the drugmaker. Staff inside the agency understand that lucrative private sector jobs await them, and this revolving door quietly influences the culture. The impact stretches globally because smaller regulators often follow FDA decisions. A tilt in Washington can ripple into the standards that shape access to medicine around the world.
History shows how these pathways have delivered both speed and harm. Rofecoxib, marketed as Vioxx, was approved in 1999 as a painkiller positioned as gentler on the stomach. It remained on the market until 2004, despite mounting evidence of cardiovascular risks. Senate testimony from an FDA safety scientist estimated that at least 28,000 excess heart attacks or sudden cardiac deaths were linked to the drug. It was one of the most deadly drug withdrawals in U.S. history, and it revealed how much internal hesitation there was to act against industry data until the evidence became overwhelming.
The opioid crisis underscores the same point. Extended release formulations were approved with labeling that downplayed their addictive potential. These products were heavily marketed, and prescribing soared. The epidemic that followed left hundreds of thousands dead and millions addicted. While the FDA eventually tightened opioid labeling, the permissive assumptions built into earlier approvals had already reshaped medical practice for years.
The accelerated approval pathway, created in the AIDS era, has become another fault line. Bevacizumab, known as Avastin, was granted accelerated approval in 2008 for breast cancer on the basis of tumor shrinkage, a surrogate endpoint. Later studies showed no survival benefit and significant toxicities including bleeding and hypertension. In 2011, the FDA revoked that indication, but only after thousands of women had endured risks without proven gain. Makena, a drug intended to reduce preterm birth, was approved in 2011 under the same pathway. Confirmatory trials repeatedly failed, yet the drug remained on the market for more than a decade. Only in 2023 did the agency finally withdraw it.
Aduhelm, approved in 2021 for Alzheimer’s disease, showed how far the tilt had gone. The FDA’s advisory committee had overwhelmingly voted against approval, but the agency nonetheless cleared the drug under the accelerated pathway, relying on amyloid plaque reduction in the brain as a surrogate marker. The clinical trials had not demonstrated meaningful cognitive benefit. The decision triggered outrage in the medical community, sparked resignations from the advisory committee, and raised alarms about billions in potential Medicare spending on a therapy with unproven effect.
The economic consequences of these decisions are staggering. Once a drug is approved, Medicare, Medicaid, and insurers are under enormous pressure to cover it. Denying coverage is politically toxic, especially for conditions like cancer or Alzheimer’s. The default is to pay, which turns scientific uncertainty into guaranteed public spending. Aduhelm’s initial price of $56,000 per patient per year threatened to add tens of billions in annual costs to Medicare, raising premiums for every senior whether they used the drug or not. Makena, at more than $30,000 per pregnancy, absorbed public and private dollars for twelve years despite failing to show benefit. Cancer drugs cleared on weak surrogates often cost more than $100,000 annually, and when they later fail to show survival benefit, the money has already changed hands. Each ineffective drug that lingers drains budgets that could fund proven treatments, neonatal care, or preventive services.
For the public, the impact is felt in higher premiums, higher taxes, and strained hospital budgets. Seniors see Medicare costs rise. Families pay more for employer-sponsored coverage. State Medicaid programs must cut elsewhere to balance budgets. The result is a quiet transfer of wealth from the public to private firms, facilitated by a system that prioritizes speed over certainty. The revolving door amplifies this because executives moving into FDA leadership roles carry the assumption that high prices are a natural feature of innovation. Inside the agency, cost is not part of the approval standard, yet approval itself almost guarantees coverage and reimbursement. Industry knows this and sets prices accordingly.
The revolving door is not a side effect of the system. It is the system. Careers at the FDA have become stepping stones into higher-paying roles in the very companies once under review. This cycle is so normalized that young scientists entering the agency already understand it as a career path. Regulators gain prestige and credibility by serving on high-profile approvals, then translate that résumé into consulting contracts, board seats, or executive posts. The lure of those positions shapes behavior long before a person ever leaves government. A reputation for being collaborative with industry is remembered and rewarded later.
The BMJ’s analysis of hematology oncology reviewers from 2001 to 2010 revealed how many transitioned to industry roles after leaving the FDA. These were not outliers. They reflected a pipeline in which regulatory expertise was monetized as soon as officials crossed into the private sector. The 2024 BMJ investigation made the problem even clearer. Internal communications showed that staff preparing to leave the FDA were advised that while formal lobbying was restricted, behind-the-scenes contact remained permissible. This meant they could still shape the climate of decision-making after walking out the door. Official ethics rules gave the appearance of integrity, but the culture bent to quiet understandings that preserved influence.
The ethical dilemma runs through every layer of this structure. User fees and cross-pollination of staff give the agency resources and expertise that Congress never provided, but they also compromise independence. Accelerated approvals feel compassionate when patients are desperate, but they leave unproven drugs on the market long after confirmatory trials fail. The revolving door brings knowledge, but also divides loyalty between public service and private opportunity. Congress avoids hard funding choices by leaning on industry dollars, while claiming fiscal restraint. No one actor breaks the law, yet together they create a system that weakens trust.
The deepest dilemma is credibility itself. A regulator that moves too slowly is accused of denying hope. A regulator that moves too quickly is accused of serving industry. When its budget comes from the firms it oversees, every decision is suspect. Trust cannot be legislated. It must be earned. Each time a drug is withdrawn after years of use without benefit, or billions are spent on therapies that fail, public confidence erodes further. The ethical problem is not abstract. It is written in the lives of patients who relied on treatments that did not deliver, in the taxes of citizens who paid for wasted care, and in the skepticism that grows with every scandal.
The picture that emerges is one of an agency structurally pulled toward industry priorities. It negotiates its framework with regulated firms, depends primarily on their money, and tolerates conflicts in both personnel and committees. It leans on pathways that prioritize speed, while corrections arrive years later. The economic burden is as heavy as the human one. The likely trajectory if nothing changes is quiet normalization. User fees will continue to cover most of the program, negotiated goals will continue to emphasize speed, surrogate endpoints will gain ground, confirmatory trials will lag, costs will mount, and public trust will continue to erode.
Another path is available. Congress could fund a larger share of the drug review program, reducing reliance on industry to a minority. Remaining fees could be routed through a firewall or escrow system managed with statutory transparency and equal standing for patient and consumer groups. Advisory conflicts could be tightly limited, with waivers rare and publicly justified. Accelerated approvals could require confirmatory trials to begin at or before approval, with automatic withdrawal if deadlines are missed. Opioid labeling reforms show the agency can course correct. The same discipline could be applied across all classes where surrogate measures or industry influence tilt the balance. These reforms would not slow science. They would make its speed more reliable, its cost more justifiable, and its credibility more resilient.
Food for thought:
Should Congress reduce reliance on user fees to a minority share of human drug review funding?
Would routing remaining industry fees through a neutral escrow with statutory firewalls, published meeting minutes, and equal access for patient and consumer groups restore legitimacy?
Should all accelerated approvals require confirmatory trials to be underway at the time of approval, with automatic withdrawal if deadlines are missed?
What level of financial conflict, if any, should be acceptable for voting members on advisory committees, and how rarely should waivers be granted?
