The Food and Drug Administration appears in these excerpts chiefly as an example of what Bob Zadek calls the presumption of regulation: the expectation among legislatures and regulators that any new activity must be regulated somewhere, and that an unregulated activity represents a failure of government rather than a liberty. The agency is discussed across four episodes, in each case as an instance of prior restraint in health and medicine rather than as a subject of a single case or statute.
Origins and the food-freedom critique
In the earliest of the excerpts, Bob Zadek traces the agency’s origin to Upton Sinclair’s The Jungle, an exposé of abuses in the slaughterhouses of the Midwest that awakened the public and ultimately gave rise to the FDA. He cites James Madison, whom he describes as one of the principal draftsmen of the Constitution, observing that banning food was “utter madness,” and notes that the country lived without foods being banned or regulated until 1906. Zadek concedes that no one would disagree that government’s role is to keep food safe in a way that humans cannot — that we cannot inspect the meat we buy, and that the marketplace is probably ineffective at enforcing that clean food reaches grocery counters and butcher shops. But he argues that beyond the case of food that is clearly harmful, the mission bleeds into areas as diverse as salt, cholesterol, sugar and trans fats Baylen Linnekin on the Front lines of the Fight for Food Freedom (2015).
The agency as prior restraint
A later episode uses the FDA as the model of an agency that protects consumers from their own mistakes. Zadek describes the Food and Drug Administration as not permitting new drugs, prescription drugs or over-the-counter drugs to be sold until they are proven safe and effective, and pairs it with the Securities and Exchange Commission, which requires disclosures about the risks and rewards of a security before it is offered in the public securities market. He calls those goals more or less helpful, making life safer and better and helping consumers be more informed. His argument in that episode is that there is no economic FDA and no economic SEC to protect Americans from unsafe and ineffective economic policies — a void, he says, that leaves the average American vulnerable to socialism or democratic socialism Socialism Reincarnated (2019).
Telehealth and licensing
The theme of prior restraint returns in a discussion of innovation with Adam Thierer, who describes health and finance as fields with a very heavily precautionary, preemptive restraint and prior restraint on innovation for the most part, where everything is born into captivity and heavily regulated out of the gate. Thierer points to telehealth as an example: providing doctor’s advice or medical advice over the internet has been discussed in the country for a quarter century, and although COVID taught that it can be done, state and local laws governing the licensure of the medical profession and federal licensing of medical devices through the Food and Drug Administration make it very difficult, if not sometimes impossible, for entrepreneurs to provide such a platform or for doctors to provide such advice. He notes that doctors once made house calls — old-school telemedicine — and asks why a patient in Virginia should have to get on a plane to talk to a cancer specialist in California rather than send X-rays, biopsies or test results over a video chat. He calls the challenge of cleaning up the messes of the past the fundamental challenge for the United States going forward, describing a “set it and forget it” mentality in which government assumes a rule must have had a good intention and must keep being enforced Finding Freedom in the Permission Society (2021).
COVID testing and bureaucratic bias
The most detailed treatment of the agency comes in a conversation with Mike Munger about the federal COVID response. Munger’s thesis is that the United States had an effective vaccine before it had an effective legal test to detect the virus. He notes that Germany developed an effective test by the end of January 2020, and that South Korea and the United States both diagnosed their first case on January 20th of 2020; by February 15th, South Korea had enlisted the aid of the private sector and drugstores to distribute tests people could actually get, while the United States dragged its feet and the CDC made a mistake, producing a two-month delay. Munger cites a National Public Radio exposé comparing the American, South Korean and German governments, which he says found that South Korea and Germany enlisted the private sector while the United States said the CDC knew better than everyone else Troubleshooting the Constitution (2022).
Munger then describes the summer of 2021, when the United States private sector was manufacturing effective rapid tests distributed to the rest of the world: a U.S.-manufactured rapid COVID test could be bought in South America, Africa and Europe but not in the United States, because the Food and Drug Administration said the tests were not as accurate as the PCR genetic test. Munger’s answer is that the PCR test is an entirely different thing — it asks whether you have antibodies in your system, not whether you are contagious — while what people want to know is whether they are contagious and should visit Grandma, which the rapid test does a good job of. He offers two explanations, allowing that Zadek’s is possible, but argues the FDA gets no benefit from approving the tests and gets in trouble if they do not work well, so it has a bureaucratic bias against speed. He cites thalidomide in the ’50s as one example, and the anger in the 1980s on the left at the FDA for not allowing experimental drugs for AIDS patients who were going to die anyway.
Zadek draws two subtexts from the story. The first is a built-in ethos of distrust of the private sector — the assumption that without intense control it will take advantage of the public and has poor and incorrect motivations. The second is that government finds a need to control information and preserve it as a tool for itself rather than share it with the public: with testing, individuals would have had information about their own health to decide whether they needed treatment, ought to self-quarantine or should visit relatives, removing the decision from government and placing it with citizens. Munger responds that he is skeptical of any monocausal explanation and does not think Zadek’s explanation is wrong, but that he does not think the primary goal of government workers is control; rather, government experts honestly think they are smarter than the rest of us and should make choices for us. He argues that a constitution has to prevent that, and that a government has to be limited precisely because experts who want to do good want the power to do it.
Across episodes
The excerpts show no development in the treatment of the FDA across episodes; the same critique — that the agency imposes prior restraint, distrusts the private sector and slows the arrival of information and products — is advanced by Bob Zadek in the 2015 and 2019 episodes and by Adam Thierer in 2021 and Mike Munger in 2022, with the later episodes supplying the concrete cases of telehealth licensing and rapid COVID tests.
What the sources do not cover
The excerpts do not state the FDA’s founding date, its statutory authority, or the name of any bill or case concerning it. They do not describe any court holding or identify which amendment any dispute turned on. They also do not cover the agency’s internal organization, its budget, or its treatment of any specific drug approval beyond the rapid-test and experimental-AIDS examples Munger mentions.