The Food and Drug Administration is treated across two episodes of the show as an agency whose defining feature is not the products it approves but the products and patients it holds back. In the April 2020 episode, economist Alex Tabarrok and host Bob Zadek examine the agency’s mission and its role in the early pandemic testing failure. In the May 2022 episode, Guy Bentley describes how the same regulatory structure, extended to tobacco products, now governs e-cigarettes and a proposed menthol ban.
The “safe and effective” mission
Bob Zadek frames the FDA’s mission as the phrase “safe and effective,” which he calls a relatively new addition, and proposes removing the words “and effective” so that the agency would apply to drugs the same standard it applies to food: making sure a product is not going to kill somebody. He argues that “and effective” is meaningless, that telling people the FDA has not found a drug to be effective is sufficient information, and that after that anyone can make an informed decision about what goes into their body. FDA (2020)
Tabarrok agrees that the addition came only after 1962 and says that overall the change would be better, while conceding the tradeoff: there would be more ineffective drugs on the market, but drugs would arrive sooner and more would be available. He describes the FDA as having put itself up as the gold standard, allowing a drug onto the market only once it is both safe and effective, and issuing a permit without which a drug cannot be produced. FDA (2020)
Drug lag, drug loss, and medical self-defense
Tabarrok analogizes the case to self-defense: as a person has the right to defend against an intruder, so there should be a right to medical self-defense — to use whatever tools are available to fight a virus, bacteria or cancer that breaks into the body — and the FDA stands in the way. He identifies two costs of the current regime. Drug lag is the time the FDA takes to approve drugs. Drug loss is the research and development that never happens because the testing the FDA requires is expensive; it takes over a billion dollars to get a new drug on the marketplace, and if the patient population is not big enough a firm will decide it is not worth researching the drug at all. FDA (2020)
Bob Zadek connects this to Right to Try, which he calls a very important issue for libertarians. He describes the case of a person diagnosed with a fatal disease and a shortened life, with a drug available that may save their life, whom the FDA will not allow to try an unproven drug absent the compassionate use doctrine. To protect a dying person from a bad drug, he argues, is absurd, and the individual should be able to say they want to take a chance when they have no hope otherwise. FDA (2020)
The Consumer Reports model
Asked how he would structure the FDA, Tabarrok proposes what he calls a Consumer Reports model. Consumer Reports evaluates, tests, ranks and rates products but does not tell consumers they cannot buy one; it provides information. He says he is glad when the NIH runs randomized controlled trials and reports the effects of drugs, and argues the FDA should be much more like that agency — providing information to physicians and patients rather than permitting, and should not be allowed simply to say a drug may not be produced or sold. Physicians and patients should make their own choices about what tradeoffs are reasonable. FDA (2020)
The invisible graveyard
Tabarrok attributes the FDA’s slowness to its incentives. If the agency approves a drug that turns out to have bad side effects, people die, there is congressional oversight, and the agency is in trouble. If it delays and orders another test, people also die — those who would have lived had the drug been available sooner — but they lie in what he calls an invisible graveyard, because relatives do not know that a loved one would have lived. The visible graveyard is what causes the FDA problems, so it is more concerned about approving a bad drug than about delaying a good drug, with the consequence that more people die than should. FDA (2020)
Bob Zadek ties this to Frédéric Bastiat’s writing on the seen and the unseen, and to public choice theory: the visible effects of a policy are criticized while the unseen are never a problem for someone seeking to hold on to a job. He argues the FDA made decisions whose harm might be greater because it was unlikely people would know the additional deaths were at the agency’s feet. FDA (2020)
Pandemic testing and exponential risk
Tabarrok says the CDC, whose entire job is to prepare for pandemics, failed first: it produced a botched test that did not work, and the FDA enhanced that failure by not allowing private labs to run their own tests. He describes the agency’s ordinary bureaucratic behavior — risk-averse, insisting on safety protocols and efficacy testing, requiring private labs to be checked — including the requirement that a lab mail the FDA a CD with test results and a printout. Only weeks later did the FDA allow private labs to make their own tests, and that is when testing capacity began to increase. FDA (2020)
Asked about the FDA’s risk-taking, Tabarrok agrees with Bob Zadek’s point that the agency’s decisions turned out to be the most risky. He explains that the virus, unchecked, doubles about every three days, so that starting with a thousand infected people, ten doublings in thirty days brings a million; acting early is critical because eliminating a single doubling saves 500,000 people from infection. The FDA does not usually deal with exponentials, and its usual procedure is to fear approving a drug with bad side effects more than delaying a good one. FDA (2020)
Tobacco, e-cigarettes, and the Baptists and the bootleggers
In the 2022 episode, Guy Bentley describes how smoking rates came down: people learned from a young age that smoking is bad for them, ever since the Surgeon General’s report in the 1960s, and cigarette taxes drove consumption down to an extent but are far less effective than often claimed because cigarettes are an inelastic good. What has been really effective, he says, is e-cigarettes. He contrasts the United Kingdom, which massively embraced e-cigarettes in the late noughties and early 2010s after a unit inside Number 10 Downing Street advised the Prime Minister that they seemed less harmful than cigarettes, and which now officially promotes harm reduction, with the United States. FDA’s New Rules Against Smoking (2022)
Bentley says that around 2009 Congress passed the Tobacco Control Act under the Obama administration, making the FDA responsible for regulating all tobacco products and erecting an enormous regulatory barrier for new products. The two groups who worked most closely on the legislation, he says, were the Campaign for Tobacco-Free Kids and Philip Morris — the world’s biggest cigarette company and the United States’ biggest anti-smoking group — an alliance he calls the Baptists and the bootleggers, after Prohibition, because Philip Morris thought it could comply with FDA regulation and hurt its competitors. E-cigarettes were deemed tobacco products in 2016 and brought under FDA regulation, where the agency must determine whether each application is beneficial to public health as a whole, a standard that includes users and non-users and which Bentley calls completely irrational. E-cigarettes are also forbidden from informing the public that they are safer unless they pass a separate modified risk tobacco product application. FDA’s New Rules Against Smoking (2022)
The menthol ban
Bentley describes the FDA’s proposed rule to ban the sale of menthol cigarettes and flavored small cigars, with the main prohibition against menthol. He says the FDA claims menthol cigarettes are more appealing to youth, harder to quit and easier to start, and disproportionately used by African Americans, leading to health disparities. He disputes each claim: he says the vast majority of the roughly 1.5% of kids who smoke use non-menthol cigarettes, that a study his organization conducted found states with the highest menthol consumption have the lowest youth smoking rates, that menthol smokers smoke fewer cigarettes per day, and that a Vanderbilt University study found no difference in quit rates between menthol and non-menthol smokers or between African American and white smokers. He calls it gross for the FDA to cloak a prohibition in the language of equity, noting that Black and white adults smoke at similar rates and that African American youth are less likely to smoke than whites or Hispanics. FDA’s New Rules Against Smoking (2022)
Bentley says both Grover Norquist of Americans for Tax Reform and Al Sharpton and the American Civil Liberties Union have spoken out against the ban — the former on libertarian and public health grounds, since alternatives like e-cigarettes make prohibition unnecessary, the latter because prohibitions are disproportionately targeted at minorities. He predicts more police interactions, with illicit menthol sales used as a pretext to investigate people for guns, drugs and other things, and the illicit market concentrated in African American communities. FDA’s New Rules Against Smoking (2022)
Across episodes: the same agency, two products
The two episodes treat the same structural question — an agency that permits rather than informs — against different products, and the later episode does not revisit the earlier one’s proposals. In 2020, Tabarrok advances the Consumer Reports model and the distinction between drug lag and drug loss, and Bob Zadek proposes removing “and effective” from the mission; in 2022, Bentley describes the Tobacco Control Act’s regulatory barrier and the modified risk application as the mechanism by which the same permitting architecture throttles e-cigarettes. The 2022 excerpts do not mention Tabarrok, the right to try, or the invisible graveyard, and the 2020 excerpts do not mention tobacco, e-cigarettes or menthol.
What the sources do not cover
The excerpts do not state the FDA’s founding date, its current commissioner, or the text or section numbers of the Tobacco Control Act. They do not give the outcome of any litigation over the menthol rule or the e-cigarette applications, nor the final disposition of the proposed ban. The 2022 excerpt ends mid-exchange, with Bob Zadek’s final line unattributed and incomplete, so no conclusion from that exchange is recorded here.