For more than 20 years, Tasha Ellis worked in a variety of roles within the education system, teaching K–8 in Atlanta public schools, adult literacy, even college classes. She was good at it. But something never quite fit.

“The school system didn’t allow me to be everything that I am,” she explains, “because I had to stay in a certain box, so to speak, or follow a script.”

A Montessori kid herself, she’d always believed in building the whole child and making learning personal. She was tutoring kids after school and thinking about starting a tutoring business. Then a friend sent her information about microschools. “She said, ‘This is your fit,’” Tasha recalls. “And I looked at it and I was like, ‘This is my fit.’”

Tasha took a leap of faith and left her job to create Legacy Learning Loft. There have been bumps along the way. She started with seven students, lost most of them, and had to rebuild from scratch; she converted her downstairs into a classroom so that she wouldn’t have to pay rent. Today she has three full-time students and four tutoring clients, including one adult. “I am growing. I’m eager to grow even more,” she says. 

Legacy Learning Loft serves students in grades K–9. For her older student, Tasha starts the day with “culturally relevant social and emotional learning” using a program she purchased that includes Socratic discussions. “We’re able to talk about the things that we probably wouldn’t normally be able to talk about in a real school,” she says. Current events comes next, including conversations about what’s happening in the world and why it matters to them. Then comes math, ELA, and social studies, differentiated by student. Every week includes a hands-on STEM lesson for everyone. 

For example, over the holidays students designed and built gingerbread houses. But first they had to choose an architectural style, measure materials, and work within a budget. “One student was like, ‘I don’t have enough money,’” Tasha explains. “I said, ‘Well, what do you need to do? Perhaps you can downsize.’ And he was like, ‘Oh my gosh.’ I was like, ‘This is life, kid.’”

One of Legacy Learning Loft’s scholars transferred from one of Atlanta’s most elite private schools. Tasha was intentional about ensuring this student remained appropriately challenged, especially given his advanced academic background. On his beginning-of-year diagnostic, he performed on grade level, with notable strengths in vocabulary and informational text.

When a mid-year diagnostic was administered to measure his growth, the results were impressive—he had advanced from a 7th grade to a 10th grade level in both reading and math. Beyond the academic gains, he also grew in confidence as he saw what he was capable of.

Other scholars who began the year approaching grade level experienced remarkable growth as well. Their diagnostics pinpointed the specific skill areas that needed targeted attention, and months later, those students advanced by two full grade levels.

Scheduling at Legacy Learning Loft is flexible. Tasha has one full-time student and two who come part-time, spending their other days at an outdoor learning school they’ve attended since age three. For families who can’t make a full switch, tutoring remains an option.

The biggest hurdle, Tasha says, isn’t the teaching—it’s helping families understand what a microschool is. When you say personalized instruction, she says a lot of people think the child is just sitting in isolation all day and not socializing at all. One student’s friends told him he wasn’t in a “real school.” His response stuck with her. “He said, ‘It is a real school because I’m getting real results.’”

Despite the challenges, Tasha says that “being able to create my own educational space has been an absolute dream.” For anyone considering starting a microschool, she advises, “Understand your why. And let that define what you’re doing, because you’re creating something that is small but mighty.”

The Trump administration has been scaling back support for clean energy, generating backlash from those concerned about carbon emissions. Which view is more convincing?

Take as given that carbon emissions are a significant externality. Then, in principle, policies that reduce carbon emissions can be beneficial, even if they decrease measured GDP. This is because they might reduce unmeasured, negative components of GDP—the externalities—even more.

Clean energy subsidies, however, are a blunt instrument for reducing carbon emissions. While they lower the cost of non-carbon energy relative to carbon-based energy, they also reduce total energy costs. This incentivizes greater energy utilization, some of which comes from carbon sources. Thus the net effect of clean energy subsidies is ambiguous, and they have other costs that arise from distorted incentives. 

A better approach is carbon (Pigouvian) taxation. 

A Pigouvian tax unambiguously raises the price of carbon-based energy relative to other sources, thus shifting energy use toward a more efficient outcome. This also avoids the unintended costs associated with clean energy subsidies. Carbon taxes are unpopular, however, because their added energy costs are explicit. In addition, setting the tax at the right level can be challenging due to complexities in measuring the social cost of carbon. 

Therefore, in practice, the least bad response to the risks from carbon emissions might be doing nothing, other than eliminating existing subsidies for carbon-based fuels.

Cross-posted from Substack. Isadora Millay, a student at Harvard College, co-wrote this piece.

Early this morning, Senate Majority Leader John Thune (R‑SD) secured cloture on S.4344, Senator Tom Cotton’s (R‑AR) bill to extend Section 702 of the Foreign Intelligence Surveillance Act (FISA) for three years with no reforms. This afternoon, House Speaker Mike Johnson (R‑LA) introduced the latest version of the House GOP leadership’s 702 reauthorization bill. That bill, like the one that never made it to the House floor last week, does not do what its authors claim. 

Both House bills marginally reform the compliance and oversight apparatus while leaving the core Fourth Amendment violation—warrantless access to collected US-person communications—structurally intact. Both are legislative Trojan Horse bills masquerading as something Fourth Amendment compliant. They are, however, exactly what the House and Senate Intelligence Committees and their intelligence community allies are clearly in favor of if the Cotton “clean” 702 reauthorization bill cannot pass (which is likely). 

The reality is and always has been that mandating that the FBI live with a Fourth Amendment warrant requirement to get the digital data of Americans isn’t just what the Constitution requires. It’s absolutely technologically possible to do it in the FISA Section 702 context. What follows is what I believe the public, press, and all members of Congress need to know before they take final action one way or another on this massive and constitutionally dubious surveillance power. 

One Argument Section 702 Defenders Will Make Between Now and Monday—and Why It Collapses

In every Section 702 debate since 2015, defenders of so-called upstream (i.e., internet backbone) collection fall back on the same technical claim: that the National Security Agency (NSA) cannot, as a matter of engineering, reliably differentiate US-person communications from foreign communications in real time on the internet backbone. The claim is offered as a brute fact of physics. Packets are packets. You cannot look inside them at collection time. Therefore incidental collection of Americans’ communications is regrettable but unavoidable.

This argument will likely be repeated during House and Senate floor debates. It has been repeated in Privacy and Civil Liberties Oversight Board (PCLOB) reports, closed-door Hill briefings, Office of the Director of National Intelligence (ODNI) talking points, and the sworn testimony of senior intelligence officials. It is the load-bearing technical premise under the entire upstream-collection regime.

It is also, as anyone who has worked in global banking compliance for the last three decades will tell you, an argument that does not survive contact with the financial sector.

What Wall Street Has Been Doing Since the 1990s

Large global financial institutions have spent more than 30 years building, deploying, patenting, and operating exactly the kind of jurisdictional-tagging and information-barrier architecture that the NSA insists is technically infeasible. They have done this at global trading speeds, across tens of millions of daily communications and transactions, under regulatory frameworks that impose severe penalties for failure.

The driver was not civil liberties. It was Singapore’s Banking Act, Monetary Authority of Singapore technology-risk guidance, EU data-protection regimes, UK FCA rules, US Glass-Steagall and later Gramm-Leach-Bliley requirements, and a long list of jurisdiction-specific bank secrecy and insider-trading statutes. Every major bank operating across borders had to build systems that answered, in real time, a question structurally similar to the one the NSA claims is impossible: Given this communication or transaction, which legal regime governs it and what rules apply?

A recently retired managing director in quantitative risk at a top-three global financial institution—someone who personally oversaw the implementation of such systems over a multidecade career—reached out this week after hearing my recent comments on Section 702. His assessment, in his words: The software “exists in the private sector.” His institution “implemented analogous software for several global compliance needs, some of those requirements existed since the early 1990s e.g. Singapore.” His teams “developed and patented sales and trading tools that had to restrict the types of shareable information based on the geographic location of the originating transaction.”

This is not a civil libertarian making theoretical arguments. This is a senior quantitative-risk executive describing the systems he helped build and patent.

The Patent Evidence

The existence of the underlying capability is documented in the public record. Bank of America alone holds nearly 7,000 granted patents and pending patent applications, the most of any US financial services company, with substantial clusters in information security, data analytics, and compliance domains. JPMorgan, Citi, Goldman, and the other major global institutions hold thousands more. 

As my source put it bluntly: “Banks have a lot of patents: mutually ensured destruction.” The portfolios are defensive—built to ensure that no institution can successfully sue any other for infringement on the compliance and information-handling technologies every major bank had to develop to operate across jurisdictions. That is a tell. You do not build a patent portfolio as mutual deterrence against infringement claims unless the underlying technology is mature, well understood, and in active production use across the industry.

The Privacy Architecture the NSA Won’t Build

Bank of America publicly operates a research arm called the Bank of America Institute, which publishes a monthly Consumer Checkpoint report drawn from the bank’s proprietary transaction data. The Institute’s published methodology is worth quoting in full, because it describes—in plain English, on a public website—an operational privacy architecture of the kind Section 702 critics have spent a decade asking the intelligence community to adopt:

Any household consumer deposit data based on Bank of America internal data is derived by anonymizing and aggregating data from Bank of America consumer deposit accounts in the US and analyzing that data at a highly aggregated level.

That is the public, commercial baseline for handling tens of millions of Americans’ financial transactions. Aggregate and anonymize by default. Disclose methodology. Permit analysis only at the aggregated level. The small cohort of employees with access to identifying transaction data operates under internal “bright lines”—my source’s phrase—about what can be known internally but not shared, even within the bank.

The NSA’s Section 702 upstream posture is the inverse. Collect in the raw. Retain identifying content. Query later under standards the Foreign Intelligence Surveillance Court (FISC) itself has found to be routinely violated. The “minimization procedures” that are supposed to perform a function analogous to the bank’s anonymization step are applied post-collection, by the same agencies whose Section 702 compliance failures triggered the 28-page order Judge Boasberg issued on April 10.

One of these operational models is consistent with the Fourth Amendment. The other is not. The private sector picked the right one 30 years ago, without being asked, because the regulatory environment in which it operates does not permit the alternative.

The Honest Technical Rebuttal

Defenders of Section 702 will object that banking compliance and signals intelligence face different identity-resolution problems. That objection is partially correct, and it is worth stating precisely what is and is not analogous, because precision is what the intelligence community’s argument cannot survive.

Banking compliance systems operate on already-identified parties. Counterparty identity is resolved through KYC records, booking-entity routing, authenticated-endpoint data, and HR-location records before the compliance-labeling layer runs. The NSA’s upstream collection, by contrast, intercepts backbone traffic where endpoint identity is not yet resolved, where IP addresses do not reliably indicate nationality, and where “US person” is a legal status—citizenship or lawful permanent residence—rather than a geography. This is the real technical gap.

Asked directly whether any private-sector tooling could close that gap for the NSA, my source conceded the harder problem—and then offered a professional assessment that Section 702 defenders will not want on the record before a final Section 702 reauthorization vote:

Admittedly easier than the NSA’s identification problem, but I think the bright folks at the NSA or Palantir have already cracked this nut.

That is the considered judgment of a senior quantitative-risk executive who spent his career building adjacent systems at scale—not a civil libertarian, not a critic, not a partisan. His professional read is that the identity-resolution problem the NSA has spent a decade invoking as insuperable has in all likelihood already been solved, either inside the agency or by one of its most prominent contractors.

Either he is right, in which case the NSA’s “technical infeasibility” defense is false on the merits and has been for some time. 

Or he is wrong, in which case the NSA has had three decades, a budget measured in billions of dollars annually, the cryptanalytic and traffic-analysis capabilities of the most sophisticated signals-intelligence agency in human history, and complete control over its own collection endpoints—and has nevertheless failed to solve a problem that an informed industry observer assesses to be tractable. 

In that case, the defense is not technical at all. It is a policy choice not to build what could be built, retained by an agency whose Section 702 compliance failures currently sit largely unproduced on Judge Boasberg’s docket.

What Section 702’s Own Oversight Body Already Directed the NSA to Do

If any of this sounds like an outsider’s wishful thinking about what the NSA should be capable of, consider the directive that the NSA’s own statutory oversight body issued in 2023. The PCLOB—the independent agency Congress established within the executive branch specifically to oversee counterterrorism programs’ compliance with civil liberties and privacy law—published Recommendation 8 of its 2023 Section 702 report in language that deserves to be read verbatim by any senator preparing to vote on Section 702’s fate.

PCLOB asked the NSA to document and formalize measures to:

“a. Screen and collect only traffic likely to contain communications of targeted selectors during upstream acquisition;

b. Remove traffic that is purely domestic or is neither to nor from a targeted selector; and

c. Remove traffic not likely to contain foreign intelligence information.”

Read line (b) again. 

PCLOB, the federal oversight body with statutory responsibility for Section 702, explicitly challenged the NSA in 2023 to develop and document measures to remove purely domestic traffic from its upstream collection. That is precisely the US-person differentiation capability the NSA has historically invoked as technically infeasible. The Board did not accept the infeasibility defense. It said the NSA should build the capability, evaluate its performance annually, submit those evaluations to the FISC as part of the annual certification process, and make them available to appropriate oversight bodies.

That recommendation is now three years old. The question House and Senate members should ask the NSA is simple: Where are the annual PCLOB Recommendation 8 evaluations? 

If the NSA has implemented Rec 8, the evaluations exist, and they would document the capability the intelligence community has spent a decade telling Congress does not exist. 

If the NSA has not implemented Rec 8, it has spent three years in defiance of a formal recommendation from its own statutory oversight body—and the infeasibility defense reduces to an agency saying it will not build what it has been told to build. 

If the NSA has partially implemented Rec 8, the annual reports either have not been filed, have not been declassified, or have been filed in forms that obscure what the NSA is and is not actually doing.

All three branches of that disjunction destroy the technical premise. A House or Senate member who votes “yes” without demanding the PCLOB Rec 8 evaluations is voting to extend, for three years, an authority whose technical justification the executive branch has declined to document to its own oversight body.

The remedy is straightforward and should be noncontroversial on its face. 

No Section 702 reauthorization vote should occur in either chamber until the director of National Intelligence and the director of the NSA have provided, in writing, to every member of the House and Senate, a substantive answer to the following question: Has the NSA implemented PCLOB Recommendation 8, and if so, where are the annual evaluations required under subparagraphs (2) through (4) of that recommendation? 

This is a transparency ask, not a declassification ask. 

The PCLOB recommended that those evaluations be submitted to the FISC as part of the annual certification process; the existence, frequency, and basic scope of those filings can be conveyed to members of Congress without compromising sources or methods. 

If the answer is yes and the evaluations exist, members of both chambers need to see them before they vote on any extension of the authority those evaluations concern. 

If the answer is no, then any reauthorization that does pass must include, as a statutory condition, the formal codification of PCLOB Recommendation 8—the screening, collection-limiting, and purely-domestic-traffic-removal measures the Board directed the NSA to build, along with the annual evaluation, FISC reporting, and oversight-disclosure requirements the Board attached to them. It should also include language mandating Government Accountability Office compliance audits—a practice that has already uncovered massive FBI First Amendment violations involving a separate investigative authority: “Assessments.”

Either the capability exists and the evaluations prove it, or the capability does not exist and Congress should require it to be built. There is no defensible third option, because compliance with the Fourth Amendment should never be optional.

Department of Agriculture Secretary Brooke Rollins made headlines last week when she called rising fertilizer prices an “overarching economic pending disaster” before the House Appropriations Committee. She is not wrong about the disaster part. She is, however, wrong about the cause of the problem and its supposed solution. 

The Trump administration’s answer to soaring input costs for American farmers is to deploy tariff revenue to subsidize domestic fertilizer production. The implication? The government creates problems with trade barriers, collects revenue from Americans hurt by those barriers, and then hands back a portion of the money to a favored industry as a political salve (leaving aside the fact that this new proposal is just another in the administration’s long line of supposed tariff revenue use).[i] To develop the plan, Secretary Rollins convened a meeting at the USDA with Commerce Secretary Howard Lutnick, National Economic Council Director Kevin Hassett, and, notably, US Trade Representative Jamieson Greer, alongside executives from four of the country’s top fertilizer companies. 

The Phosphate Problem Washington Made

Tariffs

To understand how we got here, start with a 2021 decision that deserves more public scrutiny than it has received. At the behest of the Mosaic Company—which controls about 75 percent of US phosphate production—the Department of Commerce imposed a roughly 20 percent countervailing duty (CVD) tariff on phosphate imports from Morocco (the CVD was decreased to 2.12 percent in 2023 after an administrative review, then increased to about 17 percent in 2024 after another review). Mosaic argued that Morocco’s OCP Group, the world’s dominant phosphate producer, received unfair government subsidies. 

Setting aside the legal merits, the economic consequences for American farmers were severe and entirely predictable. Earlier this year, researchers at Texas A&M’s Agricultural and Food Policy Center released a study on the damage. The paper found that the phosphate CVD increased the price of diammonium phosphate—the most common phosphate fertilizer used by American row-crop farmers—by 28.6 percent while the duty was in effect at its original levels. This finding is basically consistent with that of a peer-reviewed 2023 study in the American Journal of Agricultural Economics, which estimated a 34 percent increase in US phosphate fertilizer prices as a result of the CVDs.

The Texas A&M researchers then calculated what this price spike meant for farmers growing corn, soybeans, wheat, cotton, rice, and sorghum (about 90 percent of domestically applied phosphate fertilizer is applied to the first four of these commodities). Their answer: the CVD increased phosphate fertilizer costs for producers of such crops by an estimated $6.9 billion across the 2021–2025 growing seasons. 

Corn farmers absorbed the biggest hit—about $3 billion over that period. Soybean farmers paid an additional $2.5 billion. Wheat growers faced nearly $1 billion in added costs. These are not abstractions. These are real dollars stripped from farm income because Washington decided that protecting a single dominant company’s market share mattered more than keeping input costs manageable for the people who actually grow America’s food.

Prior to the CVD, Morocco supplied roughly 20 percent of US phosphate imports. After the CVD was imposed and imports from Morocco cratered, Peru—not subject to phosphate CVDs—filled the void. 

Yet tariffs are not the only cause of this mess. 

War in Iran 

While the CVDs are bad enough, the Iran war is further exacerbating the problem. According to the United Nations, about 30 percent of all seaborne fertilizer passes through the Strait of Hormuz. As a result, nitrogen fertilizer prices have increased since the escalation of the conflict in the Middle East. 

Researchers at the International Food Policy Research Institute have documented the scale of the problem: The Gulf region accounts for 36 percent of global urea exports, 29 percent of global ammonia exports, and 26 percent of global diammonium phosphate (DAP) exports. Urea is the world’s most widely used nitrogen fertilizer (Iran is the largest urea exporter in the Gulf, according to the International Fertilizer Association). Ammonia is the foundational building block from which urea and other nitrogen fertilizers are made, while DAP is a widely used phosphorus fertilizer. Perhaps the most underappreciated link between the Iran war and phosphate is sulfur. The Gulf supplies about 50 percent of the globally traded sulfur—a by-product of oil and gas refining and a critical input for producing sulfuric acid, which in turn is used to process phosphate rock into fertilizer. In other words, the war is squeezing sulfur at both ends of the supply chain: The CVDs cut off Moroccan imports, and now the Hormuz disruption is throttling the sulfur needed to process what phosphate rock remains available as well as DAP. 

Fertilizer Tariff Crusader to Lower Fertilizer Prices? 

As Reason’s Eric Boehm pointed out earlier this week in an excellent piece, prior to joining the second Trump administration, Jamieson Greer represented Simplot—one of the two firms that control roughly 90 percent of the domestic phosphate market—and lobbied to impose the very fertilizer CVDs now squeezing farmers. His résumé, which was circulated to Congress for his confirmation as USTR, even highlighted his efforts that led, in part, to the current mess. At a 2021 ITC hearing, Greer assured the commission that “there has been no shortage of fertilizer for the American farmer, and there will be no such shortage”—a pledge now measured against a Farm Bureau survey showing 70 percent of farmers cannot buy as much fertilizer as they need this year. As Boehm reported, Simplot and Mosaic have since asked the ITC to raise those tariffs further, while Greer works to “fix” the crisis his private-sector efforts helped create. This is tariff-driven regulatory capture in pure form: A corporate trade lawyer wins protectionist tariffs for his client at the expense of the broader farm economy, then ascends to a government office charged with fixing the resulting damage. The revolving door doesn’t just reward insiders, it locks in bad policy for everyone else.

The fix is not complicated, even if it is politically difficult. The US should revoke the phosphate CVDs—a sunset review is already underway, and over 50 farm and agriculture groups have written to the ITC urging exactly that. Likewise, the Trump administration should reject the impulse to paper over a policy failure with a subsidy program funded by the very revenue that policy created. Recycling protectionist rents back to the industry that lobbied for them is not sound agricultural policy. It is the Washington tariff racket, dressed up in a farmer’s overalls.

New research uses regional per capita tax burdens in 1780s France to examine the relationship between tax burdens and rioting. It finds that

bailliages (administrative districts) with heavier tax burdens experienced significantly more riots between 1750 and 1789.

This association

stemmed primarily from taxes on goods rather than on income or profits.… Taxation created the structural foundations for unrest, while material hardship and ideological forces catalyzed long-standing grievances about fiscal inequality into open revolt.

Also, 

legislators from high-tax constituencies were more likely to demand institutional change, call for the abolition of feudal privileges, … support abolishing the monarchy[,] and … vote for the king’s execution during the National Convention in January 1793.

Oppressive taxation is unpopular, and it can harm the rule of law.

Cross-posted from Substack.

With federal deficits at high and unsustainable levels, there is an urgent need to find ways to cut federal spending. Fortunately, new Cato research has found that a suite of higher education reforms could help reduce the deficit by more than $200 billion over the next 10 years. These reforms emerge from several basic principles of good governance. 

Obsolete Government Programs Shouldn’t Be Immortal 

Perhaps the most straightforward reason to end a government program is that the problem it was intended to address is no longer a problem. Unfortunately, government programs have a tendency to become almost immortal, even after they are obsolete (see mohair subsidies). In higher education, the best example of this problem is the work-study program, which was created during the Great Depression to keep students enrolled and out of the labor force. This was the wrong solution to high unemployment at the time, and it is certainly not an appropriate goal for policy with today’s low unemployment rate. Yet the program is still in operation.

Programs That Fail to Achieve Their Purpose Should Be Ended

The next good reason to end a government program is that it fails to achieve the desired purpose. In higher education, the various tax credits and deductions fall squarely into this bucket. While designed to improve college affordability for the middle class, these tax benefits utterly fail because colleges respond to the programs by raising tuition and cutting other financial aid. When colleges harvest aid intended for students to enrich the institution instead, students are left no better off than they were without the program. 

The Government Should Treat People Equally 

Another principle is that the government should treat people equally, and programs that fail to do so should be terminated. The main offender of this principle in higher education is the Public Service Loan Forgiveness (PSLF) program, which forgives the loan debt of government and nonprofit workers after 10 years of payments. This program exhibits bias in two ways. The first unfair treatment is that of other workers, who need to repay their loans for 30 years before having them forgiven, compared to only 10 years for workers favored by PSLF. The second instance of bias is against the PSLF workers’ colleagues. Government and nonprofit workers who do not take out student loans receive no benefit, while their colleagues who receive PSLF get an average of almost $98,000. 

The Government Should Treat Colleges Equally 

Government policy should not privilege some colleges at the expense of others (other than performance-based rewards or punishments). Unfortunately, the campus-based aid programs (the Federal Supplemental Educational Opportunity Grant program and work-study) violate this principle. Instead of allocating funding based on the number of needy students at each college, these programs disproportionately privilege rich colleges with political power. These favored colleges typically rail against real and perceived instances of unearned privilege and aristocracy yet are conspicuously quiet about these programs. 

Loans Should Charge Interest 

Borrowing money entails an opportunity cost, a cost that is most commonly dealt with by charging interest. Waiving interest doesn’t make this cost disappear, and in practice merely transfers the financial burden from the borrower to the taxpayer. But there is a growing tendency to waive interest on student loans, which should be reversed. In particular, subsidized student loans should be ended, and the interest waiver in the new Repayment Assistance Plan should be scrapped. 

Cost-Plus Contracts Are a Bad Idea

A final source of low-hanging budgetary fruit is to avoid cost-plus contracts. These types of contracts reimburse colleges for whatever they spend, which of course gives the college absolutely zero incentive to control costs while leading to ballooning federal spending. This is the story of research overhead spending for the past few decades, and colleges are currently sitting in a minefield of PR nightmares. The last time Washington dug into the books, it discovered that Stanford University had been recording the depreciation on a yacht as a research expense. There are almost certainly a lot of hidden yachts out there, waiting to be exposed. 

Overall, our new report found reforms that would reduce the deficit by more than $200 billion over the next ten years. 

Two recent Wall Street Journal editorials argue that the Food and Drug Administration’s (FDA) “inexplicable” rejection of RP1, an immunotherapy for melanoma, may cost lives by blocking access to a promising therapy for patients with few remaining options. That critique captures a real frustration. But the deeper problem goes beyond any single FDA decision.

In Your Body, Your Health Care, I wrote:

“Ideally, Congress should end the FDA’s power to deny consumers their right to self-test and self-medicate through its power over the drug and medical device approval process… Private-sector organizations can perform the same function as the FDA in certifying that drugs and devices are safe and effective. The crucial difference is that private certification organizations can provide consumers with the information they need to make educated treatment decisions but cannot deny them access to medical care.”

That principle is most urgent for patients with terminal illness.

These patients are often told that the law protects their right to try investigational treatments. But “Right to Try” laws are largely symbolic. They permit access to experimental therapies, but the system is structured in ways that often prevent patients from obtaining them. 

Existing pathways, such as expanded access and the federal “Right to Try” law, technically allow patients to seek experimental therapies. But access depends on whether manufacturers are willing to provide the drug and whether physicians can navigate a cumbersome process to administer it. The result is a system in which patients may be legally guaranteed the right to try but lack the practical ability to do so. 

Competent adults should be free to decide whether to accept the risks of investigational therapies, even when efficacy is uncertain.

This is not prohibition in the classic sense. But for patients facing terminal illness, it can function much the same way.

The Real Barrier: A System Built for Populations, Not Patients

Consider a patient with metastatic melanoma who has exhausted all approved therapies and has limited time remaining. Obtaining an investigational drug outside a clinical trial, however, typically requires manufacturer agreement, FDA authorization, and institutional review board (IRB) approval (see FDA guidance on expanded access for physicians and how to request single-patient expanded access).

Each step has a rationale. Together, the steps create delays and uncertainty that are incompatible with the realities of terminal illness.

The deeper issue is structural. The system is designed to answer a population-level question—whether a drug is safe and effective for the market—not whether an individual patient, facing imminent death, should take the risk. It answers that question by restricting individual choice.

In that system, time is a feature, not a bug. For patients, it is the opposite.

Why Existing Solutions Fall Short

I have proposed international drug reciprocity as a way to speed access when regulators in different countries reach different conclusions. That approach can be valuable when a therapy is approved abroad but delayed at home. But it offers no help when no regulator has yet approved a therapy. In those cases, the barrier to treatment is not delay—it is uncertainty.

Right to Try has a different limitation. It removes the FDA from the process but leaves the underlying constraints intact: manufacturer willingness, clinical infrastructure, and liability concerns. 

It creates the appearance of access without changing the conditions that prevent access. Right to Try did not fail because it went too far. It failed because it left the existing system intact.

Respecting Autonomy—on Both Sides

Any reform must begin with a basic principle: Autonomy applies not only to patients but also to manufacturers—and to the physicians asked to administer these therapies.

Patients should be free to accept risk in pursuit of potential benefit. But companies cannot be compelled to provide investigational drugs if doing so risks undermining clinical trials, depleting a limited supply, or jeopardizing eventual approval. Physicians likewise face malpractice and regulatory risks when using therapies outside the standard of care. A policy that ignores these constraints would simply replace one form of coercion with another. Meanwhile, the patient—who bears the ultimate risk—remains the least empowered decisionmaker in the process.

The challenge, then, is not to mandate access but to stop systematically discouraging it.

Making Access Possible, Not Theoretical

Expanded access already exists as a pathway. The problem is that it is too slow, opaque, and burdensome to function when patients do not have time.

Policymakers could take several steps to make expanded access viable without compelling participation:

• Preauthorized expanded-access protocols
  Allow manufacturers to establish flexible, standing protocols that physicians can use without case-by-case negotiation, reducing delay and administrative uncertainty.
• Simplified physician attestation
  Replace lengthy applications with a brief certification that the patient has a serious condition, lacks alternatives, and has provided informed consent.
• Centralized IRB review
  Federal rules already allow a single IRB, but institutions often duplicate review. Encouraging reliance on central IRBs—or allowing limited pre-clearance with post hoc oversight—would reduce redundant review and delay.
• Faster FDA response times
  Formalize rapid turnaround (e.g., 24–48 hours) to reduce uncertainty when authorization is required.
• Clearer liability protections
  Current protections are incomplete and ambiguous. Clarifying them would reduce a major deterrent for both physicians and manufacturers while preserving accountability for fraud or gross negligence. 
• Targeted reporting requirements
  Limit reporting to serious and unexpected adverse events and basic outcomes rather than layering on requirements that begin to resemble those of a clinical trial.

These changes would not guarantee access. They would simply ensure that when patients, physicians, and manufacturers are willing to proceed, the system does not stand in their way.

From Legal Rights to Real Choices

For patients with terminal illness, time is the scarcest resource. A system that recognizes their autonomy in principle but withholds it in practice is not neutral—it is making the decision for them.

We do not need to guarantee access to every investigational therapy. But we should stop pretending that a theoretical right is meaningful when the system is built to prevent its use. For patients who are out of time, that distinction is not theoretical.

Ideally, policy should respect the autonomy of patients, manufacturers, and physicians alike. In practice, that means there will be cases where not all parties are satisfied. The goal is not to eliminate those tensions but to ensure that the system does not structurally prevent willing participants from acting.

The right to try is not the same as the ability to try. Until policy reflects that distinction, many patients will continue to have one without the other.