Between 2006 and 2016, a single pharmacy in Kermit, West Virginia, a town of 392 people, received 9 million oxycodone pills.
Nine million pills. For 392 people. Over ten years.
The shipments were legal. They were approved by the drug manufacturer, processed by the distributor, accepted by the pharmacy, and dispensed by licensed pharmacists operating within the regulatory framework of the United States Drug Enforcement Administration. Every transaction in the chain had a paper trail. Every actor had a license. The system was working exactly as the system was designed to work.
What the system produced: West Virginia became the state with the highest opioid overdose rate in the country. Rural counties, the places where the pills concentrated, where the clinics were sparse, where the treatment options were distant and expensive, suffered mortality rates that belong in a different country’s statistics. The opioid epidemic killed approximately 500,000 Americans between 1999 and 2019. The deaths did not distribute evenly. They concentrated in rural communities, in post-industrial towns, in exactly the places most removed from the regulators who were supposed to be protecting them.
The puzzle is not why the pills killed people. The puzzle is why the system that was built to prevent this allowed it, for years, with full visibility into what was happening, before anything changed.
The Anti-Federalists explained the mechanism in 1787.
The Warning Before the Agency Existed
Brutus, writing in February 1788, was analyzing the federal government’s economic powers, the Commerce Clause, the taxing power, the ability to regulate industry at the national level. He was not opposed to economic regulation as such. His concern was structural: a government that exercised broad economic authority from a distance, subject to the influence of those with resources to navigate federal institutions, would drift from regulating in the public interest toward regulating in the interest of those closest to it.
He wrote:
“When the interest of the government and the governed are the same, there can be no danger; but when they are different, the strongest will prevail… In a government where the power of laying taxes and regulating commerce is vested in a few, those few will make use of that power for their private interest.”
The Federal Farmer pressed the geographical point further. Regulators stationed in Washington, removed from the daily economic and social conditions of ordinary people, would naturally develop relationships with the organized interests that could reach them, the industries, the trade associations, the lobbyists, while remaining genuinely distant from the people whose lives depended on the regulations they wrote. The regulated industry is motivated to maintain relationships with regulators. The ordinary citizen is not.
This dynamic, organized industry interest versus diffuse citizen interest, is the mechanism the Anti-Federalists were identifying. They did not call it regulatory capture. That term did not exist in 1787. But they described the mechanism with enough precision that when economists formalized the concept two centuries later, they were essentially confirming what the Federal Farmer had observed about the structural incentives in any system of distant, centralized regulatory authority.
How the FDA Approved What It Was Warned Against
In 1995, the Food and Drug Administration approved OxyContin, a controlled-release formulation of oxycodone, with a label claiming that the drug’s extended-release mechanism made addiction “less likely.” The FDA reviewer who approved that label, Curtis Wright, left the agency the following year and took a position at Purdue Pharma, the manufacturer of OxyContin, where he earned a compensation package worth millions of dollars.
The claim on the label, that extended-release delivery reduced addiction risk, was not supported by long-term clinical evidence. Purdue had argued the point; the FDA had accepted it. Subsequent studies would establish that the extended-release formulation, when crushed or dissolved, delivered a more concentrated opioid hit than the immediate-release pills it was supposed to replace, making it, in certain use patterns, more dangerous than what it had been positioned to improve upon.
The DEA, responsible for monitoring controlled substance distribution, had access to data about prescription volumes at the pharmacy level. The Automation of Reports and Consolidated Orders System, ARCOS, tracked every order of every Schedule II drug from manufacturer to pharmacy. The data showing that a 392-person town was receiving 9 million oxycodone pills over ten years was available. The DEA did not act on it for years.
Congressional investigations and subsequent legal proceedings have documented what happened: drug distributors flooded rural areas with opioids that no legitimate patient population could explain. Pharmacies accepted the shipments. Prescribers who asked few questions received payments, meals, and speaking fees from pharmaceutical manufacturers. The DEA’s enforcement actions declined during the peak years of shipments, as the agency, subject to intense lobbying from the distribution industry and facing legal challenges to its authority, pulled back from aggressive enforcement.
This is not a story about uniquely villainous individuals, though some individuals behaved criminally and were prosecuted. It is a story about a system whose incentive structure produced predictable outcomes. The FDA’s experts came from pharmaceutical science, which meant they came from the pharmaceutical industry and would return to it. The DEA’s attorneys faced a well-funded industry with sophisticated legal teams and the resources to challenge every enforcement action. The companies with the deepest interest in shaping the regulatory environment had the deepest access to the people who ran it.
The Structure, Not the Scandal
Regulatory capture is frequently presented as a story of corruption, specific bad actors who crossed legal or ethical lines for personal gain. The opioid crisis produced some of that: there were prosecutions, civil settlements in the tens of billions of dollars, congressional findings of specific misconduct.
But focusing on the corruption misses the structural point. The revolving door between the FDA and the pharmaceutical industry is not illegal. It is common. It is, in many respects, inevitable: the people with the deepest expertise in pharmaceutical development are pharmaceutical scientists, and pharmaceutical scientists come from industry because that is where the resources to develop drugs exist. When regulatory agencies need expertise, they hire it from the same pool. When former regulators enter the private sector, they return to the same pool. The system produces this outcome not because of specific bad decisions but because of its structural incentives.
The Federal Farmer’s warning was precise on this point: regulators stationed at a distance from the consequences of their decisions, with career trajectories that run through the industries they regulate, will develop perspectives and relationships that align with those industries’ interests, not through corruption but through proximity, expertise, and the ordinary human tendency to identify with the professional world you inhabit.
The FDA official who spent years reviewing pharmaceutical applications with scientists from pharmaceutical companies, attending the same conferences, using the same technical vocabulary, operating within the same professional norms, that official sees the pharmaceutical industry from the inside. The rural West Virginian whose son died of an overdose is not in the room. The professional community is.
This is what the Federal Farmer meant when he warned that federal economic authority exercised far from ordinary people would serve those closest to it rather than those most in need of its protection. The distance is not geographic alone. It is social, professional, and institutional.
Both Parties, Across Decades
The opioid crisis developed across multiple administrations and multiple congressional majorities.
OxyContin was approved during the Clinton administration. The peak years of distribution, when the DEA’s enforcement declined and the pill shipments reached their maximum volume, ran through the Bush and Obama administrations. Purdue Pharma continued operating and marketing opioids through both Republican and Democratic congressional majorities. The first meaningful federal legislative response came in 2016 with the Comprehensive Addiction and Recovery Act, a bipartisan bill that critics argued arrived a decade too late.
Regulatory capture is not a partisan phenomenon because the underlying dynamic does not change with elections. Career bureaucracies persist. Professional relationships persist. The revolving door runs in both directions regardless of which party controls the executive branch, because the structural incentive, regulatory agencies need expertise, expertise comes from industry, former regulators are valuable to industry, does not respond to electoral outcomes.
Both parties have proposed revolving door restrictions. Both have passed legislation with cooling-off periods and post-service restrictions. None have been sufficient to break the fundamental dynamic, because the fundamental dynamic is about expertise and proximity, not about rules that can be papered over with a one-year waiting period before former officials join the industries they regulated.
What Happened to the Rural Communities
The communities where the opioid crisis concentrated had several things in common. They were predominantly rural. They had limited access to treatment, the psychiatrists, addiction medicine specialists, and recovery programs that concentrated in urban and suburban areas were not present. They had economies that had contracted, leaving people with physical labor injuries, unemployment, and diminished futures. And they were far from Washington.
The distance the Federal Farmer identified was not merely regulatory. It was political. A community of 392 people has limited ability to influence a DEA enforcement posture or an FDA label decision. It has no lobbyists. Its congressional representative is one of 435, and the pharmaceutical industry has relationships with many of them through campaign contributions, advocacy, and the employment of former congressional staff.
The $35 billion in OxyContin revenue that Purdue Pharma earned before the crisis fully registered did not flow back to the communities where the pills were consumed. It flowed to the Sackler family, to distribution networks, to marketing operations. The communities absorbed the human and economic cost. The regulatory apparatus that was supposed to prevent this was shaped by the industry that produced it, at a distance from the people it was supposed to protect.
The Federal Farmer said that regulatory authority exercised far from ordinary people would serve those closest to it. Kermit, West Virginia is 504 miles from Washington. Purdue Pharma’s lobbyists were not.
What Structural Reform Would Actually Require
The opioid crisis eventually produced a regulatory response: tighter prescribing guidelines, DEA enforcement actions against specific distributors, civil litigation that bankrupted Purdue Pharma and produced settlements with several states. These responses addressed consequences. They did not address the structural mechanism.
Addressing the structure requires naming it honestly: regulatory capture is the expected outcome of a system where regulatory agencies are staffed by industry experts who return to industry after government service, exercise authority at a distance from the people most affected by their decisions, and lack the institutional incentives to prioritize diffuse citizen interests over concentrated industry interests.
The remedies that would meaningfully address this:
Genuine revolving door restrictions, not the current one-year cooling-off periods that serve as a brief pause before the revolving door completes its rotation, but multi-year bars on regulated-industry employment for officials in senior positions, combined with restrictions that run in the other direction (limiting direct industry-to-regulator transitions for officials in positions where industry perspective conflicts with regulatory independence).
Local accountability structures, for industries whose effects are primarily local, decentralizing regulatory authority to states and localities closer to the affected populations. Not eliminating federal standards, but building in genuine accountability to the communities bearing the costs rather than only to the industries bearing the compliance burden.
Transparency requirements that make regulatory decision-making visible, not just the final rule but the communications, the data, the meetings, the personnel decisions that shaped it, to people outside the professional community of the regulated industry.
None of these have been achieved in any sustained way. Both parties have made gestures. Neither has restructured the incentive system.
The Price of Distance
The Anti-Federalists were arguing about architecture, not personalities. They were not claiming the people who would staff the federal regulatory apparatus would be corrupt. They were claiming the structure would produce corrupt outcomes through ordinary human behavior in a system with the wrong incentives.
Nine million pills in a town of 392. Five hundred thousand deaths over two decades. A regulatory apparatus that had the data and the authority and the mandate to prevent it, and did not.
The system worked exactly as it was designed. The design, as Brutus and the Federal Farmer argued in 1787, was the problem.
The citizen in the rural community who learned to distrust federal institutions did not arrive at that distrust irrationally. They arrived at it through evidence. The structure that was built to protect them protected something else instead.
Understanding the mechanism is not a counsel of despair. It is the prerequisite for reform. You cannot fix a structural problem by changing the people. You can only fix it by changing the structure, by building accountability to the people most affected, rather than proximity to the industry most organized.
The Federal Farmer told us this was coming. It came, at the cost that he feared and on the schedule that the structure guaranteed.
Brutus, Letter XII, February 7, 1788. Federal Farmer, Letter III, October 10, 1787. Available at the Avalon Project, Yale Law School, and the Library of Congress American Memory collection.