Paternalism and Public Health

Jessica Flanigan

DOI:10.1093/oso/9780190684549.003.0002

Abstract and Keywords

Since medical paternalism is wrong in the clinical context, it should be rejected in public policy as well. But even if paternalistic public health policies were permissible, it is not clear that prohibitive pharmaceutical regulations are necessary to promote public health. Prohibitions could undermine health in some cases, for example, if prescription requirements make patients more deferential to physicians and tolerant of medical risks. Premarket testing requirements cause people to suffer and die waiting for new drugs to get approved, and they discourage new drug development. This is not to say that regulation serves no purpose. Pharmaceutical regulators provide a valuable pubic good by overseeing testing for new drugs and by certifying drugs that they deem generally safe and effective. But the benefits of regulation do not require that the regulations be prohibitive, and prohibitive regulations not only violate patients’ rights, they may also cost lives.

Keywords:   pharmaceutical regulation, drug lag, drug loss, off-label prescribing, pediatrics

In the fall of 1937, more than one hundred people died slow and painful deaths after taking Elixir Sulfanilamide. Many of the victims were children who were given the drug to treat streptococcal infections. The drug caused abdominal pain and vomiting, renal failure, agonizing convulsions, and death.¹Before 1937, Sulfanilamide was safely and effectively used in tablet and powder form, but the manufacturer, S.E. Massengil Co., reformulated it to be taken in liquid form. The new elixir formulation dissolved Sulfanilamide in diethylene glycol, a sweet poisonous substance that is similar to antifreeze. Harold Watkins, the chemist who developed the solvent for S.E. Massengil Co. did not test the mixture on animals or humans, or even review the medical literature that demonstrated the toxicity of diethylene glycol. Without any testing or oversight, the company distributed 633 shipments of the poisonous elixir.

Physicians reported the deadly effects of Elixir Sulfanilamide within a month of distribution, and members of the American Medical Association (AMA), the FDA, and S.E. Massengil Co. acted quickly to complete a national recall of the drug. The news media also participated in publicizing the dangers of the drug. As the recall continued, newspapers reported poisonings and near-poisonings, the shockingly minimal legal ramifications of S.E. Massengil Co.’s negligence, the CEO’s seeming indifference to patients’ deaths, and Harold Watkins’s suicide in the wake of the tragedy.

One particularly powerful description of the Elixir Sulfanilamide tragedy was a widely publicized letter to President Roosevelt from Maise Nidiffer, a mother whose six-year-old daughter Joan died from taking the drug. Nidiffer wrote:

The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see (p.33) her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. … It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight.²

Nidiffer’s letter was included in a widely publicized report by Secretary of Agriculture Henry A. Wallace and FDA Commissioner Walter Campbell. The report called for unprecedented reforms to drug regulation, including premarket testing requirements, administrative authority to prohibit and recall drugs, the authority to regulate labels, and the requirement that manufacturers disclose all known properties of a drug.³ These and other accounts of the disaster fortified public support for greater pharmaceutical regulation. In 1938, Congress passed the Food, Drug, and Cosmetic Act, which set the standards of drug regulation worldwide since its passage.

Maise Nidiffer’s letter is one of the most compelling reasons to support pharmaceutical regulation. Drugs can be dangerous. Manufacturers cannot always be trusted. Someone should keep the public protected by ensuring that drugs are safe and effective. Premarket testing requirements and the prescription drug system were designed in part to ensure that patients do not unknowingly harm themselves by using dangerous drugs. However, prohibitive drug regulations, which violate patients’ rights of self-medication, are not necessary to this end. If patients were adequately informed that a drug was not tested, if manufacturers disclosed the dangers of a drug, then patients could safely avoid dangerous drugs, like Elixir Sulfanilamide, even if such drugs were available.

There are other compelling reasons in favor of prohibitive drug regulations too. As in the case of informed consent, patients who are not sufficiently informed or mentally competent cannot give meaningful consent to treatment. If it were impossible to sufficiently inform people about drugs, or if people were not mentally capable of making choices about pharmaceuticals, then that could be grounds for prohibition as well.

Or, paternalists may argue that even if patients are capable of making choices about pharmaceuticals, prohibitive regulations are nevertheless permissible for the sake of public health. There are two versions of this defense of paternalism. Some paternalists argue that even competent citizens can rightly be prohibited from making self-destructive and unhealthy choices. Others argue in favor of (p.34)paternalism on the grounds that unhealthy choices are burdensome to the political community, which bears the cost of providing medical care to all citizens.

Proponents of prohibitive regulations must show not only that it is permissible to limit people’s pharmaceutical choices for the sake of their health, they must also show that prohibitive policies promote public health on balance and that they are necessary to do so. Yet paternalistic arguments for drug regulation fail at each step. I argued in the previous chapter that it is not permissible to limit a person’s treatment options on the grounds that she might make a bad choice. In this chapter I will argue further that the public health context is not morally different from the clinical context with respect to paternalism.

Furthermore, even if paternalistic policies were permissible, it is not clear that prohibitive pharmaceutical regulations are necessary to promote public health. In fact, prohibitions may actually undermine health, at least in some cases. Prescription requirements might not prevent accidental overdoses, for example, if the requirements make patients more deferential to physicians and tolerant of medical risks. Premarket testing requirements cause people to suffer and die waiting for new drugs to get approved, and they discourage new drug development.

This is not to say that regulation serves no purpose. Pharmaceutical regulators provide a valuable pubic good by overseeing testing for new drugs and by certifying drugs that they deem generally safe and effective. But the benefits of regulation do not require that the regulations be prohibitive, and prohibitive regulations not only violate patients’ rights, they may also cost lives.

2.1 Prohibition and Protection

When S.E. Massengil Co. sold Elixir Sulfanilamide, the company did not disclose that the solvent was wholly untested. Patients who used the drug were led to believe that it was as safe as the previously available tablet and powder Sulfanilamide. The subsequent deaths were used to justify giving regulatory agencies the power to prohibit and recall drugs, but the 1938 Congress was also explicit that the new requirements ought not extend to prohibitions of existing and approved medicines. Rather, the initial legislation aimed to require that manufacturers show the FDA that new drugs were safe for use and appropriately labeled. The Act states it is “not intended to restrict in any way the availability of drugs for self-medication. On the contrary, it is intended to make self-medication safer and more effective.”⁴

(p.35) Yet the 1938 Act did permit the FDA to prohibit new drugs until they were approved. Then, in 1951, Durham-Humphrey amendments to the 1938 Act introduced further limits on self-medication by allowing the FDA to require prescriptions for certain approved drugs.⁵ Prescription-grade drugs were defined as those that are potentially toxic or harmful if used without authorization and supervision from a medical professional.⁶

The FDA’s prohibitive power expanded again in 1962 when Congress passed the Kefauver-Harris amendments to the 1938 Act, which required that all manufacturers submit to safety and efficacy testing overseen by the FDA. Like the 1938 Act, the Kefauver-Harris amendments were passed after a public health crisis, when thousands of children in Europe were born with deformed limbs as a result of mothers’ consumption of the morning sickness treatment thalidomide. The United States was spared from the thalidomide crisis because an FDA official, Dr. Francis Kelsey, delayed the manufacturer’s application for approval. Kelsey became a national hero for protecting American families from the dangerous drug. Her story buoyed support for stronger drug regulations, though Kelsey acknowledged that an expansion of the agency’s power was not necessary to prevent the marketing of dangerous drugs like thalidomide.⁷ Finally, the US Congress passed the Comprehensive Drug Abuse Prevention and Control Act in 1970, which enabled the DEA to enforce prohibitions of prescription drugs and to distinguish between legitimate medical uses and illegitimate recreational drug use.⁸

Tragic incidents like the Elixir Sulfanilamide deaths and the thalidomide crisis heightened public support for the expansion of prohibitive pharmaceutical regulations from 1938–1970. But were prohibitive policies necessary to avoid these disasters? In both cases, had patients known that the drugs they were using were untested and potentially toxic, they most likely would not have used them. When patients died because they used these toxic medicines, the problem was not that people had access to a dangerous substance. After all, even today people can purchase antifreeze, bleach, and many other chemicals that would be toxic if ingested.

(p.36) To achieve the 1938 legislation’s purpose of making self-medication more effective, pharmaceutical regulators could have implemented a drug certification program rather than prohibitive requirements. Such a system could prevent accidental poisonings from dangerous drugs, but it would do so by providing information about the effects of a drug rather than by barring access to the drugs. The US Consumer Product Safety Commission (CPSC) is an example of a certification program that does not primarily prohibit people from purchasing dangerous products. The Commission regulates most consumer products that are not food, drugs, tobacco, medical devices, or firearms. It oversees some premarket safety testing to some extent, but this testing is mostly aimed at informing consumers about whether children’s toys contain toxic materials.⁹ In 2011, the CPSC launched an online database that catalogues and monitors consumer safety complaints, dangerous defects, and risks for all products, so that consumers can access the information necessary to make an informed choice. The CPSC also oversees voluntary recalls of dangerous products but has rarely used the legal system to force a manufacturer to comply with a recall.¹⁰

Despite the CPSC’s apparent toothlessness, it promotes consumer safety through limited testing, voluntary recalls, information campaigns that discourage consumers from buying unsafe products, and labeling and safety disclosure requirements.¹¹ The CPSC works in part because companies are also legally liable for known but undisclosed safety hazards posed by their products. Anticipating CPSC oversight and potential liability encourages manufacturers to test products for safety and voluntarily disclose risk and warnings.¹²The CPSC’s example demonstrates that protective policies needn’t be prohibitive. If the risks associated with a product are disclosed, consumers can avoid products that are untested and refrain from purchasing products that they deem too dangerous.

So while access to dangerous drugs is a necessary condition for major drug disasters to occur, that fact does not imply that patients’ access to drugs (p.37) should be limited to avoid drug disasters. Perhaps pharmaceutical policies that promote informed decision-making by certifying drugs and publicizing risks could also avoid drug disasters without violating patients’ rights of self-medication.

2.2 Soft Paternalism and Drug Regulation

One may respond to my call for certification by arguing that patients are not capable of understanding the consequences of using dangerous drugs, even if the risks of using a drug are disclosed. Paternalism that coercively interferes with someone’s choice on the grounds that she is incapable of choosing is called soft paternalism. For some patient populations, soft paternalism is a valid reason to limit choice. For example, young children and mentally incompetent adults cannot give informed consent to treatment in the clinical context, in part due to their inability to understand the consequences of treatment decisions. In these cases, surrogate decision-makers ought to paternalistically choose a treatment on their behalf. Young children and mentally incompetent adults may also be unable to understand the consequences of using dangerous medications as well. And similarly, physicians, pharmacists, and public officials can also permissibly constrain treatment options for people who cannot make an informed and competent choice.

Yet prohibitive regulations apply to all citizens, including adults who are capable of making informed medical choices. For example, prescription drug laws forbid informed adult patients from using dangerous drugs without authorization from a physician. However, some philosophers doubt that even informed adult patients are capable of making medical decisions. For example, Sarah Conly defends a soft-paternalistic rationale for prescription requirements on the grounds that medicine is particularly complicated and even educated consumers cannot really understand information about prescription drugs. Conly writes:

While [prescription requirements are] occasionally frustrating, there hasn’t been any groundswell movement to eliminate the necessity for a doctor’s visit for certain medications. … The idea seems to be that this isn’t a judgment we can reliably make ourselves: the costs of a bad decision are great, expert knowledge is necessary and available, and we are thus, on the whole, better off having the decision taken out of our hands.¹³

(p.38) And though people are generally capable of researching medications and learning about their effects, Conly is skeptical that research can substitute for the knowledge of a medical expert.

Following John Stuart Mill’s claim that it would be permissible to stop someone from unknowingly trying to cross a broken or dangerous bridge, she suggests that prescription requirements can be defended on similar grounds. Yet, even if we grant Mill’s claim that paternalism in emergency situations may be warranted, it would not establish that paternalism is justified whenever a person is irrational in a particular situation. Interference is only permissible in the broken bridge case because the bridge-crosser is not making an autonomous choice due to her lack of information. So, just as it is permissible to interfere with fundamentally incompetent decision-makers, such as children, it is permissible to interfere with temporarily incompetent bridge crossers. However, if she was informed and decided to cross anyhow, then paternalistic interference would be impermissible. Turning to prescription requirements, it is possible to inform people of the risks of using drugs. So Mill’s argument in favor of emergency paternalism would not support paternalism in this case. This explains why Mill agreed that it was permissible to interfere with an uninformed choice, yet he opposed prescription requirements.¹⁴

But perhaps this is too quick. Conly suggests that the line between a competent person and an incompetent person is blurry, and that even competent adults can be irrational in some situations such that paternalistic interference could be warranted.¹⁵ Steven Wall develops an argument like this too. Wall is skeptical that those who ground rights against interference in the value of autonomy can reject hard paternalism, for example, a policy that prevents competent and informed adults from using drugs, without those same considerations against hard paternalism also counting against soft paternalism, for example, stopping the person from crossing a broken bridge.¹⁶ And whatever considerations one might cite in favor of soft paternalism would also count in favor of hard paternalism.

Wall’s argument against my view goes like this. People make lots of non-autonomous choices that are not self-harming or destructive, so if interference were warranted whenever a person’s choice fell short of full autonomy then “respect for the choices of idealized agents can go hand in hand with insufficient respect for the actual choices of people.”¹⁷ In this way, arguments in favor of soft paternalism can also be cited in favor of hard paternalism. On (p.39) the other hand, if only minimal autonomy is necessary to ground a duty of noninterference, then it is difficult to justify interfering with the uninformed crosser, since, except for her ignorance, she is generally an autonomous person. Wall then considers the possibility that a person’s rights against interference vary with her autonomous capacity and notes that this response would still permit a lot of paternalistic interference that would strike us as hard paternalism.

In response, I think an anti-paternalist should deny the claim that the uninformed bridge crosser is sufficiently autonomous and adopt the view that a person’s autonomous choices command our respect when her decision-making abilities exceed a certain threshold. It is permissible to treat people whose autonomous capacities are below the requisite threshold level of autonomy in order to promote their autonomy and bring them into a moral relationship. That is, people who lack the capacity to participate in a reciprocal moral relationship of mutual respect may be interfered with because their decisions are not the kinds of autonomous choices that people have a duty to respect. In contrast, when people are capable enough to make informed and autonomous decisions, paternalism for the sake of promoting their autonomy is wrong because they have rights against paternalistic interference in virtue of the value of their existing autonomy.

Tamar Schapiro defends a similar view regarding the paternalistic deception of children, and the analogy may serve as a useful illustration of this point.¹⁸ Schapiro claims that nonautonomous beings that are capable of autonomy, such as children, should be brought into the moral relationship.¹⁹ In some cases, bringing a person into the moral relationship may require paternalism that violates the norms that would govern a moral relationship between two autonomous people. For example, if lying to children about Santa Claus facilitated greater self-control and improved their ability to reason about morality, then it would be permissible to lie about Santa even though lying is generally wrong. When we interact with children, the context that usually gives norms of honesty their authority is deficient because the child is not autonomous. In these cases, the most choice-worthy action may be paternalism. Yet, as Schapiro notes, even when paternalism is warranted, it still makes sense to regret this way of realizing the moral relationship because it stems from a deficiency in one person’s circumstances.

I will elaborate on children’s medical rights in the next section. For now, the lesson to take from Schapiro’s justification of paternalistic deception is that paternalism is warranted when a person’s circumstances make autonomous (p.40) choice impossible. And in those cases, paternalistic interference should aim foremost to enable autonomous choice going forward, not to promote a person’s well-being. This framework enables critics of paternalism to meet Wall’s challenge and draw a line regarding paternalistic drug policy and soft-paternalistic interference with the bridge crosser. So if the bridge crosser were sufficiently autonomous, then interference would not be warranted. If she were not sufficiently autonomous, then paternalism should aim to enable autonomous choice.

At this point, one may reply that more people live below the threshold of autonomous decision-making than I seem to recognize. For example, Conly is skeptical about whether people really are autonomous and experts on their own well-being, as I have suggested. Conly cites evidence of cognitive biases, the fact that people are overly optimistic about their ability to make a choice, and the evidence that many people seem to regret their free choices when they are allowed to make them. And Conly is also skeptical that education and information can solve these problems. She argues that it is generally ineffective to teach people about the dangers of smoking or overeating and that it is more difficult still to convince people they are misinformed or in the grip of a bias. For these reasons, Conly thinks it is permissible to prohibit adult citizens from making bad decisions because they are incapable of making the right decisions on their own. She then concludes that public officials therefore ought to prohibit people from making bad decisions as long as the benefits outweigh the costs of doing so.

Say we grant Conly’s pessimistic picture of human decision-making. For an argument like Conly’s to succeed against rights of self-medication, one must show not only that patients and consumers reliably fail to be fully informed and that attempts to inform them are unsuccessful but also that public officials have an advantage in knowing what is best and that the benefits do not outweigh the costs. It is not at all clear that the health benefits of prohibitive pharmaceutical regulations outweigh the costs. But even if one could show that prescription requirements and other pharmaceutical regulations benefited people’s health on balance, it would be even more difficult to show that they benefited people’s overall well-being. Regulators who make decisions for a heterogeneous population are unlikely to understand patients’ interests better than patients, if only because they lack information about each patient’s values. And regulators and public officials are people too, so they are also subject to cognitive biases and deficiencies in decision-making such as risk-aversion and political incentives that could put patients at risk.

This argument also revives the arguments from the previous chapter. If it were true that public officials and physicians knew which decisions about drugs each patient ought to make and had the authority to prevent patients from choosing otherwise, then these arguments in favor of coercive paternalism would also justify some breaches of informed consent. For example, imagine that physicians adopted a policy of secretly removing tonsils, adenoids, appendices, wisdom (p.41) teeth, and other unnecessary but potentially problematic parts whenever a patient was under anesthesia and would be unlikely to find out. If the benefits of covert paternalism outweighed the costs, it seems that Conly’s arguments would support such a policy, even though it consists in removing body parts without patients’ consent.

Conly is correct, however, to point out that some people do make terrible decisions because they lack information. But paternalistic policies do not remedy patients’ lack of information. Even if a paternalistic policy prevents the bad effects of ignorant decision-making, it may cause patients to become even less informed as they develop learned helplessness in the face of restrictive policies.

Alternatively, public officials could work to promote medical literacy and to make information about treatment options more accessible and available. Pharmacists and physicians could still recommend drugs and answer patients’ questions. Public officials could still certify drugs and recommend drugs. Technological advances such as online databases of drug information and websites that give targeted health advice can inform patients as well. Until patients are given the chance to access information and exercise their rights of self-medication, it is premature, even for a defender of paternalism, to cite patient ignorance as grounds for prohibition.

An analogy to financial literacy illustrates this point. In the nineteenth-century United States, married women were forbidden to own property or make contracts. This legal doctrine was called coverture, and it was justified in part on the grounds that women lacked the necessary education, status, and intelligence to manage finances, and that they were better off if a male patriarch handled money on their behalf. Institutions that prevented women from making financial decisions reinforced the sexist assumptions about women that justified those institutions. Defenders of coverture may even have been correct that women were less capable of managing money, but only because they had never been given the chance.

Similarly, institutions that prevent patients from making medical decisions may render patients incapable of making medical decisions. But prohibitive policies are not the solution to patients’ seeming inability to make informed choices any more than coverture was the solution to women’s seeming financial illiteracy. More generally, we should be reluctant to infer that members of marginalized or powerless groups are incapable of making decisions simply because they have not proven themselves as capable when they were subject to oppressive policies.

2.3 Children and Incompetent Adults

The Elixir Sulfanilamide and thalidomide disasters predominately affected children. Yet the system of pharmaceutical regulation that developed in (p.42) response to these disasters limited the rights of everyone. I have argued that these policies violate competent, adult patients’ rights of self-medication. But the initial impulse to protect the well-being of children was justified. Young children do not have rights of self-medication, and pharmaceutical policies should prevent children from using dangerous drugs. Similarly, some adults with severe cognitive disabilities have autonomous capacities that are relevantly similar to children. Policies that aim to protect these vulnerable groups are also justifiable.

In clinical and policy contexts, guardians or expert surrogates should make medical decisions on behalf of nonautonomous children. Where do we draw the line between children and autonomous people who have rights of self-medication? I propose that a person has rights of self-medication at the point that she has rights to make her own medical decisions in accordance with the doctrine of informed consent. As a rough guide, pediatricians sometimes use a “rule of sevens” to allocate decisional authority for minors. For children under the age of seven, pediatricians seek only parental permission for treatment. For children seven to fourteen years old, pediatricians seek parental permission and their patient’s assent to treatment. If patients in this age range refuse treatment, there is a strong ethical presumption against forcing treatment or diagnosis unless the child’s life is at stake and treatment cannot be deferred without substantial risk. And the AAP maintains that adolescents older than fourteen may have the same decisional capacities as adults and would therefore be entitled to the same medical rights that are protected by the doctrine of informed consent.²⁰

According to this standard, there is no presumption in favor of parental rights to make medical decisions for their children. Parents may have important insight into their child’s interests, but they may not decide in their child’s interests, and parents do not have the authority to consent on behalf of their children.²¹ As Tim Dare argues, even though parents may feel they know their child better than anyone, they may systematically fail to know what is in their child’s overall interests for several reasons.²² First, parents often project their values and preferences as their child’s, but those values may not be the child’s. Children may misrepresent their values and adopt a different disposition around their parents than they do around other caregivers and physicians. These family dynamics may distort parents’ understanding of their children’s interests. (p.43) Parents’ partiality toward their own children may also obscure their judgment about treatment, meaning that parents could refuse treatment that is in a child’s interest out of concerns about side effects, or they might overestimate their child’s tolerance for treatment that is not in the child’s interest.

Instead, the American Academy of Pediatrics approaches responsibility for a child’s well-being as a duty that is shared by medical professionals, public officials, the courts, parents, and the child. I would add that people deciding in the interest of a child should not only aim to promote a child’s well-being but her capacity to decide as well. The duty to develop a child’s capacity to make medical decisions may require treating the child as if she has the authority to decide, informing her about the risks and benefits of treatment, and teaching her how to communicate with health professionals about her symptoms, medical history, and values.

Turning to self-medication, this framework can be used to justify prescription requirements for young children. As above, pharmacists and physicians should not presume that parents have the sole authority to medicate their children. Though parents do provide and administer pharmaceuticals to their children, paying for medical treatment does not generally entitle people to put their children in harm’s way by making risky pharmaceutical choices. The prescription drug system is a model of the shared responsibility approach to medical decision-making because it requires that pediatricians and parents support the decision to use pharmaceuticals.²³

As with children, physicians and patient representatives should make medical decisions in the interest of adults who are not capable of exercising their rights of informed consent. The possibility that children or incompetent adults could access dangerous pharmaceuticals may warrant designating some drugs as behind the counter so that pharmacists can screen for capacity when they sell drugs. In these ways, the right of self-medication is limited to only a subset of the patient population. Yet, just as the presence of some people who are incapable of giving informed consent for medical treatment does not support violations of autonomous patients’ medical rights in general, the presence of some people who are incapable of informed medical decision-making does not support paternalistic limits on self-medication for the general population.

(p.44) 2.4 Hard Paternalism and Drug Regulation

Granting that most adult patients are capable of choosing which medications to use, paternalists may nevertheless oppose rights of self-medication on the grounds that some pharmaceuticals are unacceptably dangerous. Paternalism that coercively interferes with an adult’s capable, informed choice is called hard paternalism. Several political philosophers have argued that while autonomy is valuable, it is not an absolute constraint on what public officials can permissibly do and that hard paternalism can be justified in some cases.

If we accept that most adult citizens are capable of making self-regarding medical choices, then defenders of paternalistic policies must show why physicians and public officials are nevertheless entitled to paternalistically interfere with people’s drug choices. What is it about their roles as doctors and regulators that permit them to coercively limit treatment options? Citizens do not consent to public officials’ coercion. Patients do not contractually entrust physicians to prevent them from making regrettable choices. Some paternalists write that “we” are entitled to enforce paternalistic policies. This language conflates citizens in a democratic society with public officials; ordinary citizens are not entitled to paternalistically coerce each other. Agents of the state enforce hard paternalism, so defenders of paternalism must explain why public officials are uniquely entitled to coerce.

In this section I will consider three justifications for hard paternalism that appeal to the idea that public officials should not be held to the same moral standards as other people. First, some political philosophers argue that while individuals are not permitted to paternalistically coerce each other, public officials can coerce people if a democratic majority authorizes them or if they can justify their conduct to reasonable citizens. Another alleged asymmetry between private individuals and public officials is that public officials collectively decide to enforce laws based on many reasons, and paternalism may only be one among them.²⁴ Therefore, diverse bodies like legislatures or electorates cannot be paternalistic because they do not act on a unified set of reasons that expresses disrespect for people. This seeming asymmetry addresses the expressive harms of paternalism to an extent—policies that benefit people by limiting their freedom needn’t express any disrespectful judgments of their abilities to make decisions, but those policies could still be unjustified because they violate rights or have other costs.

Democratic theorists may claim that paternalistic prescription drug requirements and approval policies are permissible as long as they are democratically (p.45) passed. Such an argument may go like this. First, imagine that a majority of citizens preferred to prevent themselves and others from making self-harming choices and a minority preferred unregulated access to pharmaceuticals. In these cases, democratic majorities may legitimately impose paternalistic policies on citizens who oppose paternalism.²⁵ If majorities were not entitled to enforce coercive paternalistic policies, then a single anti-paternalist’s preferences would effectively veto everyone else in society who favors a paternalistic law.²⁶ Such a libertarian regime of strict anti-paternalism would only be attractive to libertarians, who would then force everyone else in society from satisfying their desire to protect themselves from their own bad judgment.²⁷In these cases, proponents of paternalism suggest that anti-paternalists must compromise for the sake of the enormous good that paternalism can bring to society as a whole.²⁸

This argument is at risk of proving too much. Democratic majorities are and ought to be constrained by their duty to respect people’s rights. And the scope of a person’s rights does not depend on how many of her compatriots are willing to recognize those rights. For example, if people have rights against surveillance, then the government acts unjustly by spying on them, even if a majority of citizens do not believe in privacy rights. Though people may overwhelmingly prefer limits on the rights of pharmaceutical users, the distribution of preferences in a society is irrelevant to a patient’s claim to self-medication if she indeed has a right to use pharmaceuticals. In this way, democratic justifications of hard paternalism assume the conclusion they seek to establish. It only seems plausible that voters and their representatives are permitted to enforce pharmaceutical regulations if we already assume that people do not have rights of self-medication.

Say we concede that proponents of self-medication are mistaken about the scope of patients’ rights and that people are not entitled to risk their safety in this way. Some people defend paternalism on the grounds that public officials and voters have epistemic advantages, relative to individuals deciding for themselves, because they can better assess the aggregate costs and benefits of regulations without being blinded by an individual’s self-interested perspective.²⁹ For (p.46) example, Robert Goodin argues that impersonality is a virtue of public officials, who ought to decide on the basis of consequentialist considerations rather than person-affecting principles when they are crafting policy.³⁰

But taking an impersonal perspective is not impartial. Just as public officials and voters deciding on public policy are also subject to cognitive biases, they also systematically favor the median voter’s self-interest and decide against marginalized minority groups. Plausibly, pharmaceutical regulators are more likely to focus a lot on the people who are killed by using dangerous pharmaceuticals, especially when these vivid tragedies are reported in the media. And officials are likely to overlook the costs of regulation that are disproportionately borne by a minority of anti-paternalists, sick patients who are seeking unapproved treatments, and people who want to use prescription drugs without a medical need. And cynically, we might also consider that health professionals have financial incentives to maintain a system of legal requirements that ensures patients consult with physicians and pharmacists before using pharmaceuticals.

Alternatively, one may defend pharmaceutical regulation from a broadly contractualist framework.³¹ For example, drawing on Thomas Scanlon’s arguments for contractualism, Peter deMarneffe writes:

To value each other properly as rational beings is to act towards each other only in ways that we can justify to each other. We can justify our actions to each other if they are permitted by principles none of us could reasonably reject. … Because [paternalistic] reasons sometimes outweigh any reasons we have to insist on a principle that prohibits all forms of paternalistic interference, no one could reasonably reject a principle that permits some forms of paternalism.³²

Like the soft-paternalist arguments for pharmaceutical regulation, by claiming that it would be unreasonable to use drugs against medical advice, this justification for paternalism asserts that there is some objective ideal of reasonableness (p.47) or an ideal of full information and rationality that a person must meet, and that when people fall short of that ideal interference can be warranted. But contractualists needn’t show that consumers of pharmaceuticals are not sufficiently autonomous. Even if one were to accept my claim that most adults are sufficiently autonomous, to justify paternalism on contractualist grounds, one must only show that they are unreasonable.³³

Two responses. First, consider a conception of reasonableness that deems people who desire to use unapproved or prescription medicines without authorization as unreasonable. Such a conception of reasonableness may hold that unauthorized pharmaceutical users fail to promote their own interests or well-being, according to some objective conception of well-being or interests. As such, this standard of reasonableness would be perfectionistic because it would appeal to a conception of value that at least some people would reject. Namely, anyone who subjectively values self-medication would fall short of this perfectionistic standard.

On its own, perfectionism is not fatal to a liberal justification for paternalism, though many liberals think that there are at least pro tanto reasons against perfectionistic public policy.³⁴ But even if we were to accept standards of reasonableness that are based on an objective conception of people’s interests, people may still reasonably reject pharmaceutical paternalism. To see why, we must distinguish between two questions. Is it reasonable to use unauthorized pharmaceuticals? And, is it reasonable to reject a mandate that requires authorization for pharmaceutical use? As evidence of the claim that pharmaceutical users have reason to act in accordance with paternalistic regulations, one may point to the fact that most people would defer to the judgments of their physicians and pharmaceutical regulators if they were acting in accordance with their idealized, fully informed, and rational desires. Thus, most people have reasons to comply with pharmaceutical regulations, so it is permissible to coerce their non-ideal actual selves into complying with these regulations. Danny Scoccia, for example, develops an argument like this. Scoccia claims that interference does not violate a person’s autonomy if, based on his values, he would consent to it were he informed and rational.³⁵ Conly also argues that everyone has a reason to support coercive paternalism because we have reason to support policies that effectively get us what we really want, even if we fail to recognize it.³⁶

(p.48) So say we grant that thinking of our more reasonable selves in light of some objective theory of well-being can give us guidance about what is good for a person and shed light on what we think people have reason to do. It is plausible enough that we ought to do either what our idealized selves would do or what they would advise us to do. Nevertheless, whether a fully informed and rational person would consult with a physician or regulatory agency before making drug choices is quite a separate question from whether he would endorse being coerced to comply with experts’ recommendations. A pharmaceutical user, were he fully informed and rational, would plausibly consult with experts and his physician and advise his non-ideal self to do the same. But even an ideally informed pharmaceutical user would neither necessarily prefer coercive regulations (because he already consults with experts and would rationally desire to keep his options open) nor necessarily advise his non-ideal self to support pharmaceutical regulations (because his non-ideal self might not always comply with regulations, so he would be susceptible to penalties under a mandate).

One may reply that in some cases, people do have reasons not only to comply with whatever a paternalistic law would require but also to prefer a mandate as well. Peter de Marneffe argues that this kind of argument may justify prostitution regulations, prohibitive drug laws, and laws that prohibit suicide.³⁷ For example, de Marneffe argues that motorcycle helmet laws are permissible even if some people would have reason to reject the paternalistic law because the reasons for people to want the government to adopt a helmet law have greater weight.³⁸ So de Marneffe may grant that the relevant question is not whether a person could reasonably refuse to wear a helmet but whether a person could reasonably reject helmet laws. But de Marneffe claims that a paternalistic law can meet this standard if the reasons cited by the intended beneficiaries of a paternalistic law have greater weight than the reasons of those who oppose it. Similarly, one could argue that sex workers do not have very strong reasons to want the legal freedom to sell sexual services compared with the reasons that people have to prefer a legal environment that subjects them to a lower risk of engaging in sex work.³⁹

Turning to drug prohibitions, de Marneffe’s argument in favor of prohibiting heroin can illustrate how his defense of paternalism could apply to other drugs. De Marneffe claims that heroin and the social environment that would result from legal heroin are extremely destructive to young people’s overall well-being. Therefore, “the reasons of at least one person to prefer her situation in a (p.49) prohibition environment outweigh everyone else’s reasons to prefer his or her situation in a legalization environment.”⁴⁰

Can a similar case be made for prohibitive pharmaceutical policies? Some prescription drugs are similar to heroin and some are more powerful. But most drugs are not as destructive as heroin. Moreover, while de Marneffe may plausibly sustain his claim that everyone else’s reasons to prefer legalization are not very weighty with respect to heroin, those who seek access to therapeutic drugs generally have much weightier reasons than those who want to use drugs recreationally. Moreover, as some commentators have pointed out, de Marneffe’s view seemingly allows a single individual’s objectively weighty interest in the enforcement of a paternalistic policy to prevail even if that individual and all other citizens would prefer a non-paternalistic policy regime.⁴¹

A final justification for paternalism along these lines is James Wilson’s claim that all public policy consists in coercing people in ways that would be impermissible if done by ordinary citizens. Wilson argues that there is nothing uniquely objectionable about a policy that coerces people for the sake of their own good and a policy that coerces people in order to provide public goods.⁴² Elsewhere, I argued in response to Wilson’s argument that for the same reasons that public health paternalism is often morally objectionable, so too are other coercive public policies.⁴³ Perhaps rejecting hard paternalism would have revisionary implications for how people see other coercive laws. Perhaps people should accept these revisionary implications and reconsider whether some non-paternalistic coercive policies are wrong too.

2.5 The Health Effects of Approval Requirements

I have argued that existing philosophical defenses of coercive paternalism cannot justify prohibitive pharmaceutical regulations, even if such regulations effectively promoted people’s health and well-being. But perhaps the more compelling reason to reject paternalistic pharmaceutical regulations is that they are ineffective. By this I do not mean that public officials cannot effectively prevent people from accessing unapproved and prescription drugs. Rather, there is reason to believe that when public officials do effectively prevent people from accessing medicine, they do not promote people’s health and well-being on balance.

(p.50) Though prohibitive pharmaceutical regulations are justified on the grounds that they make people safer, the empirical record does not clearly support this claim. Consider first the effects of prohibitive approval policies, such as premarket safety and efficacy requirements. These requirements raise the price of drug development and thereby discourage manufacturers from creating new drugs. This phenomenon is known as drug loss. It refers to the drugs that are never invented because it would be too expensive and risky to bring them to market. People also die while waiting for new drugs to be approved. This is called drug lag. Furthermore, it is especially unlikely that prohibitive efficacy-testing requirements are necessary for protecting the public’s health since many drugs are sold off-label, meaning they are prescribed for conditions for which they have never been tested for efficacy. There is also reason to believe that even safety requirements may not be necessary to protect the public from dangerous drugs. Reflecting on large-scale tragedies associated with dangerous drugs, prohibitive regulations did not protect citizens from drug disasters.

Drug regulation discourages innovation because it is very expensive to attain approval. The process can take up to fifteen years and cost up to $2 billion.⁴⁴ To test whether prohibitive policies discouraged innovation, economist Sam Peltzman developed a model to predict how many new drugs would have been introduced to the market were it not for the introduction of efficacy-testing requirements, which were established in 1962.⁴⁵ He found that two and a half times more drugs would have been introduced on average each year after 1962 (forty-one), than the average number of drugs that were actually introduced (sixteen). This hypothesis was subsequently supported by additional studies.⁴⁶ For example, when economists compared research and development productivity in the United States and UK, they found that productivity declined sixfold (p.51) in the United States and only threefold in the UK after the introduction of the 1962 testing requirements in the United States.⁴⁷ Economist Elizabeth Jensen later found more generally that regulatory stringency is inversely related to the expected number of new drug discoveries.⁴⁸ This hypothesis is supported by evidence that less regulated drug classes are more innovative, so it is plausible that less regulation for all drugs would increase innovation.⁴⁹

In response to worries about drug lag, the US Congress passed the Orphan Drug Act (ODA) in 1983, to encourage companies to develop and seek approval for drugs for rare conditions, affecting fewer than 200,000 Americans. The ODA established tax incentives to develop drugs for rare conditions and seven-year market exclusivity provisions for approved drugs. The ODA worked, but it also confirmed that prohibitive regulations discouraged drug development. Significantly more drugs were developed for patients with rare diseases, and patients with rare diseases were significantly more likely to access and benefit from newly available drugs.⁵⁰ The success of the ODA illustrates that costly approval processes adversely affect pharmaceutical innovation and that efforts to mitigate the costs of approval positively affect innovation. Yet the ODA only helped patients with moderately rare diseases. For extremely rare diseases, even the benefits established by the ODA do not offer manufacturers enough of an incentive to invest in development and approval.

In response to these concerns, policymakers could encourage innovation by compensating manufacturers for high-development and approval costs, but this policy would be costly for citizens who would be asked to subsidize the research costs of for-profit corporations. Or policymakers could encourage drug development through deregulation, which would also lower the cost of development and approval. Nobel-winning economist Gary Becker argued in favor of deregulation for this reason. Becker wrote:

A return to a safety standard alone would lower costs and raise the number of therapeutic compounds available. In particular, this would include more drugs from small biotech firms that do not have the deep (p.52) pockets to invest in extended efficacy trials. And the resulting increase in competition would mean lower prices—without the bureaucratic burden of price controls.⁵¹

Drug lag costs lives because people suffer and die from diseases that might be treatable, if only there were more investment in finding a cure. Today, patient advocates privately organize to raise funds to subsidize the costs of drug development for rare diseases. Requirements that raise the cost of development make it less likely that they will succeed. Premarket testing requirements also cost lives because patients with conditions that could be treated or cured by unapproved drugs suffer and die while they are waiting for approval. We can see evidence of drug lag by comparing approval times between countries and across time. Both methods of comparison indicate that longer approval times are extremely costly but do not save lives.

The average drug took seven months to gain approval in 1962. Five years later, it took thirty months because of efficacy-testing requirements. Drug lag was first raised as a concern in the 1970s when pharmacologists William Wardell and Louis Lasagna estimated that tens of thousands of American patients’ deaths could have been prevented if the FDA had approved available lifesaving drugs sooner and faster.⁵² By then drugs took up to ten years to gain approval. In the late 1970s, American patients began traveling to European countries to buy pharmaceuticals that were awaiting approval in the United States, and the National Cancer Institute (NCI) clashed publically with the FDA over the agency’s oversight of clinical trials for cancer treatments, which they alleged undermined potentially lifesaving research and subjected oncologists to unnecessary bureaucratic requirements.⁵³ In 1988, the HIV/AIDS advocacy organization AIDS Coalition to Unleash Power (ACT UP) staged large protests to encourage the FDA to expedite approval for medications that could fight opportunistic infections like HIV.⁵⁴

In response to these concerns from the medical community and the public, Congress passed the Prescription Drug User Fee Act (PDUFA) in 1992 that, among other things, implemented expedited approval process for drugs that could potentially treat life-threatening diseases and relaxed premarket prohibitions for terminally ill patients. The PDUFA shortened the approval process, and today, the United States has one of the fastest approval processes in the world. (p.53) In 2012, the Congress created a new category of expedited approval for breakthrough therapies, which encouraged the FDA to allow greater access to drugs that treat serious diseases and are likely to be effective based on preliminary evidence.⁵⁵

Still, every month that an unapproved drug remains inaccessible to patients, people suffer and die because they lack access to treatment.⁵⁶ In light of the cost of withholding access to drugs, due to drug loss and drug lag, defenders of prohibitive requirements give three kinds of justifications for mandatory premarket efficacy testing. First, prohibitive requirements are intended to prevent manufacturers from selling drugs that do not effectively treat patients’ conditions. Second, efficacy requirements may be justified on the grounds that consumers and physicians would otherwise be unable to learn about new drugs. Third, efficacy requirements may be used to further establish whether a drug is safe.

The first justification for efficacy-testing requirements is that they are necessary to prevent “snake oil” salesmen from selling useless potions that do not effectively treat anything. Patients are harmed when they forgo effective treatment and use an ineffective treatment instead. However, the evidence does not support the claim that efficacy-testing requirements prevent manufacturers from selling ineffective drugs or patients from taking them. For example, when efficacy requirements were introduced in the 1960s, the market share of ineffective drugs did not change.⁵⁷ Additionally, the practice of off-label prescribing has now grown to account for more than 20 percent of all prescriptions written, which means that more than 20 percent of all drugs are prescribed for conditions that they were not approved to treat on the basis of efficacy-testing requirements. And though off-label uses of drugs are not subject to efficacy testing, off-label prescriptions are no more dangerous than on-label prescriptions.⁵⁸

(p.54) The off-label market is foundational to current prescribing practices for the treatment of adults, though the practice is not uncontroversial.⁵⁹ In some cases, off-label prescribing practices are not supported by causal research and may be harmful.⁶⁰ But even critics of off-label prescribing acknowledge the substantial benefits of the practice and do not propose that each drug undergo efficacy-testing requirements for every patient-type and condition. The pervasive, broadly successful practice of off-label prescribing indicates that manufacturers are capable of providing effective drugs to patients even when those drugs have not been officially approved for their conditions. So, efficacy testing is not required to deliver effective drugs to patients.⁶¹

A second defense of efficacy-testing requirements is offered by Patricia M. Danzon and Eric L. Keuffel, who argue that premarket testing solves the pharmaceutical market’s failure to provide consumers and physicians with enough information about new drugs.⁶² The idea is that drug companies will not disclose information about drugs on their own, so they must be compelled to do so by testing their drugs in publically available clinical trials. Data sharing is a legitimate concern about the current clinical trial system. Even with efficacy-testing requirements, the FDA does not release the data they gain during the drug approval process. More generally, manufacturers are not required to publish negative or compromising results of registered clinical trials, and published results do not include participant-level data. These practices leave patients and physicians in the dark about the effects of drugs. In a recent report by the Institute of Medicine, a committee of public and private stakeholders argued that the current system of clinical trials, which are overseen by the government, could be used to encourage more data sharing. Yet prohibitive policies, such as efficacy-testing requirements, are not necessary to ensure that patients and physicians have access to information about new drugs.⁶³ In addition to data (p.55) sharing, pharmaceutical regulators could also certify and recommend drugs for particular uses, as they do when they expand the list of approved uses for previously approved drugs.

The third defense of prohibitive efficacy-testing requirements is that faster drug approval makes drugs less safe. This empirical claim is controversial. One study shows that, as drug approval times decreased since 1992, there have also been more black-box warnings associated with new drugs and more market withdrawals.⁶⁴ But another study shows that the 1992 legislation did not cause a corresponding increase in drug recalls or public health crises that resulted from dangerous drugs.⁶⁵ A comparison between different countries’ approval processes before 1992 suggests that a shorter approval process was not less safe.⁶⁶Even if a faster approval process does cause more drug recalls, longer approval requirements also cost lives. In order to defend lengthy efficacy requirements for the sake of safety, one would need to show that the harm of faster approval was greater than the harm of prohibition. The harm of prohibition is clear—patients die waiting for drugs to be approved. The same cannot be said about the harm of a faster approval process.

These arguments against prohibitive efficacy requirements should prompt us to reconsider prohibitive safety requirements as well. When people use drugs that they do not know to be unsafe, drug disasters occur. For example, patients who used Elixir Sulfanilamide died because they were not aware that the drug’s solvent had not been tested. If the manufacturer had been required to disclose its untested status, or if there was a system of certification, the disaster could have been avoided without prohibition. The thalidomide disaster in the 1950s (p.56) and 1960s is also cited as a justification for a longer approval process and greater safety regulation on the grounds that the FDA spared the United States from the crisis because the drug was awaiting approval.

Despite this narrative, however, it is unclear whether prohibitive regulations should be credited for avoiding the thalidomide crisis. First, recall that the thalidomide tragedy occurred before the 1962 amendments that required efficacy testing. Therefore, the tragedy cannot be cited as a triumph of the current standards of regulation because thalidomide was one of the motivations for extensive and prohibitive safety and efficacy-testing requirements; it was not a product of them.⁶⁷ Furthermore, clinical trials are not usually conducted on pregnant women, so government testing even today could not have detected the adverse effects of thalidomide. At the time, thalidomide approval was delayed because of concerns that had nothing to do with pregnancy or birth defects but rather because of potential neurological effects, even though birth defects were the primary problem with thalidomide. Today, thalidomide is still available as an approved treatment for cancer patients and people with leprosy, so it is technically still available off-label as a morning sickness drug. The drug’s legal status is thereby effectively the same as when it was prescribed in the 1950s, since all morning sickness drugs are off-label. Of course, no pregnant women would take thalidomide knowing the risks, despite the fact that it bears the same approval status as other morning sickness drugs that are widely used, such as Zofran. Therefore, if patients and physicians have access to information about drugs, they can avoid unsafe drugs even if the drugs are not prohibited.

Premarket testing requirements also cannot protect patients from the risks associated with long-term risks associated with drugs. For example, in the 1960s more than 3,500 children in Europe and Australia died after long-term continued use of the asthma drug Isoproterenol. The drug was also approved and sold in the United States and Canada, but manufacturers marketed safer inhalers in these countries for reasons unrelated to the approval system.⁶⁸ Similarly, when more than 27,000 American patients suffered heart attacks and sudden cardiac death between 1999 and 2003 after taking the popular arthritis treatment Vioxx, premarket testing requirements could not have effectively prevented the drug-related deaths because they resulted from long-term use.⁶⁹

My claim is not that safety testing never saves lives. It is plausible that strict approval requirements prevented Japan’s clioquinol tragedy from occurring in (p.57) the United States. From 1956 to1970, more than 11,000 patients in Japan were severely disabled after using clioquinol as an over-the-counter treatment for intestinal problems.⁷⁰ In other countries, such as the United States, over-the-counter sales of clioquinol were banned, and the drug’s use was discouraged as early as 1961 because of concerns about toxicity. This example illustrates that regulations can prevent deaths. The questions at hand, though, are whether the costs of drug lag and drug loss are justified for the sake of avoiding drug disasters, and whether drug disasters can be prevented in less costly ways.

Paternalists who defend prohibitive premarket testing requirements must show that limiting the right of self-medication does in fact promote citizens’ health or well-being on balance, not just that prohibitive requirements have saved lives in some cases. Defenders of premarket testing requirements must also show that prohibitions are necessary to protect people from dangerous drugs. If giving patients access to quality information about drugs could also prevent drug disasters, then approval policies cannot be justified by an appeal to paternalistic concerns for people’s well-being.

2.6 The Health Effects of Prescription Policies

Proponents of pharmaceutical regulation also speculate that greater access to prescription drugs would have disastrous consequences for patients. The prescription drug system is sometimes cited, along with helmet laws and seatbelt requirements, as paternalistic policies that are so uncontroversial they demonstrate the more general plausibility of all coercive paternalism.⁷¹ But unlike helmet laws and seatbelt requirements, the prescription drug system does not clearly save lives. Rather, in some cases, its prescription requirements may endanger patients.

We can assess the health effects of prescription requirements by comparing public health outcomes before and after prohibitive prescription requirements between countries that do and do not enforce prohibitive requirements and between drugs that change from prescription-only to over the counter. For example, if a prescription drug system did prevent unsafe drug choices, then we would expect to see fewer medicine-related mortality rates after the introduction of prescription requirements. Yet an analysis of time-series data from the United States found that the introduction of a prescription drug system did not reduce overall mortality from accidental or suicidal poisonings, which suggests that prescription requirements did not clearly protect people from the risks of (p.58) drug use.⁷² Rather, prescription requirements were correlated with more fatal poisoning incidents, perhaps because consumers were more likely to use potent and risky drugs when a physician endorsed their choice or suggested that they use a drug.

Another explanation for this result is that prescription-only designation coincided with an explosion of new and dangerous drugs. Perhaps fatal poisonings would have increased were it not for a prescription-only system. Yet international comparisons, between middle-income countries that enforced prescription drug regulations and those that did not, have similar results. Poisoning-related mortality did not increase in countries without prescription requirements. Instead, states that enforced prescription-only drug regulations had higher rates of poisoning than non-prohibitive countries.⁷³

Prescription requirements also make drugs more expensive and limit access to potentially beneficial treatment. For example, one study of prescription requirements found that switching the approval status of cough and cold medicines and topical hydrocortisones from prescription-only to over the counter significantly lowered the costs of medical care for patients, expanded access, and improved health outcomes for people with colds.⁷⁴ The fiscal cost of prescription requirements may be paid either by pharmaceutical users or their insurance providers. If consumers directly bear the cost of visiting a physician for a prescription and paying a pharmacist to administer it, then the worst-off are likely to be harmed the most by the added expense of prescription requirements. If members of insurance-risk pools or taxpayers pay the cost of a prescription system, then people without access to insurance or publically financed healthcare may find it difficult to access affordable medicine. In contrast, if (p.59) officials did not enforce prescription requirements, people could still pay to consult with physicians and pharmacist about their treatment options, they just would not be required to.

Proponents of coercive paternalism may reply that prescription requirements have good health effects because they prevent people from abusing controlled substances, such as prescription stimulants and painkillers. I will address this possibility in more detail in a later chapter, but for now, note that prescription requirements for high cholesterol, asthma, heartburn, allergies, diabetes, neutropenia, multiple sclerosis, arthritis, and hypertension treatments surely cannot be justified for the sake of preventing abuse.

And even prescription requirements for stimulants and painkillers could only be justified on these grounds if the health effects of prohibitive policies and criminal sanctions were on balance positive. But criminal prohibitions of prescription drugs not only have devastating effects on users and communities, they also prevent patients with a legitimate need for painkillers and stimulants from accessing them.⁷⁵ When prescription requirements do effectively prevent people from accessing prescription drugs for recreational use, some users respond by switching to even more dangerous opioids, such as heroin. To justify the prohibitive prescription requirements in these cases, it isn’t enough to point to overdose and abuse statistics. One must also show that prohibiting recreational prescription drug use is the best way to do promote public health despite the costs. In light of the negative effects of prohibitive policies, this burden of proof remains unmet. So even though people recreationally use some pharmaceuticals in dangerous ways, prescription requirements cannot be justified on the grounds that they promote the public’s health.

2.7 The Regulatory Reversal Test

Public officials have made some progress in acknowledging that patients with urgent claims to investigational drugs should have access. For example, compassionate access programs and accelerated approval policies aim to give more patients earlier access to potentially lifesaving drugs. The FDA’s current compassionate access program approves most requests for early access from patients who meet the criteria. Each year, about one thousand patients are permitted to access unapproved drugs, and the FDA grants more than 99 percent of (p.60) compassionate use requests.⁷⁶ In 2015, the agency streamlined the process for patients to get access to experimental drugs and promised faster approval for compassionate use requests. Additionally, the FDA is approving all drugs faster than ever and offers accelerated approval for drugs that could potentially treat cancer, HIV, and rare conditions. Health Canada and EMA have similar programs. Regulatory agencies have also redesignated some drugs to over-the-counter or behind-the-counter status and, in doing so, have given patients more affordable access to safe and beneficial drugs.

Regulatory agencies also allow over-the-counter access for drugs that once required a prescription. Today more than seven hundred products contain active ingredients that once required a prescription in the United States.⁷⁷ Agencies like the FDA move drugs over the counter on the grounds that expanded access to relatively safe or well-understood drugs benefits the public’s health on balance. The decision to move drugs over the counter is increasingly common, as European agencies aim to lower the costs associated with providing medications and the FDA aims to expand patients’ access to preventive medicines and drugs that treat chronic conditions.⁷⁸

These policies recognize that the previous approval policies and prescription requirements caused unjustified harm to patients who were waiting for better access to drugs. Yet public officials are reluctant to deregulate further in order to prevent other patients from suffering the same harm on the grounds that the consequences of deregulation would be worse on balance. The evidence I presented in the previous sections suggest otherwise, though this evidence is not decisive. However, we should be suspicious of the hypothesis that deregulation would be harmful because this approach to regulation is plausibly informed by status quo bias.

When people overstate the risks of a change in the future while acknowledging that similar changes in the past have been for the good, their assessments of the risks may reflect a bias to endorse the status quo. Nick Bostrom and Toby Ord developed a useful heuristic called the Reversal Test, which can be used to diagnose whether resistance to new technologies or policies is a result of status quo bias or whether a preference for the status quo is justified.⁷⁹ The Reversal (p.61) Test asks defenders of the status quo to explain why changing a parameter (e.g., approval times or patient access) was good in the past but is unlikely to be good in the future. This test shifts the argument from justifying a change to justifying the status quo. In order to justify resistance to faster approval times or patient access, proponents of the current system must show that while expanding access has been beneficial so far, even more access would be harmful.

Proponents of the current approval system agree that existing compassionate access and accelerated approval programs are morally better than a more restrictive system. Reclassifying some pharmaceuticals as over the counter has also meaningfully expanded access without causing great harm. Therefore, one must either agree that the system should become even less restrictive going forward or show that the current system is optimal. If the current system should become less restrictive then the scope of compassionate access should expand to include even more patients. Approval times should become shorter for all drugs, not just breakthrough therapies. And regulatory agencies should consider making more drugs available without a prescription.

Or, if the current system is optimal, then it was wrong to prevent patients from compassionate access programs in the past, but allowing more patients to have compassionate access today would also be wrong—and the current balance of prescription to over-the-counter drugs is just right. There is little reason to believe that the current system is optimal, even on consequentialist grounds. Patients continue to die waiting for drug approval. People cannot access beneficial drugs because of paternalistic prescription policies, even if those drugs are relatively safe and going without them is not. Though the empirical evidence is not decisive, it does indicate that the costs of existing regulations outweigh the benefits. The existing system is also coercive, and if coercion requires justification to those who are coerced then this is a further normative reason that the burden of proof should lie with defenders of the status quo to justify the current system of regulation. Policymakers should be less concerned about unsubstantiated empirical predictions about the potentially disastrous consequences of less regulation and more concerned about the costs of the current system.

2.8 Certification Versus Approval

Imagine a world without gatekeepers for pharmaceuticals. Imagine a world where most drugs are available over or behind the counter. In such a world, people would be able to access pharmaceuticals without authorization from a physician. People could purchase experimental medicines with unknown risks. But imagine that other parts of pharmaceutical policy stayed the same. In such a world, regulatory agencies could still test and certify drugs as safe and effective (p.62) for particular conditions. Physicians could still recommend treatment plans and advise patients about their options. Manufacturers would still be required to disclose the known and unknown risks associated with every product. Patients could still know the anticipated effects of drugs, whether regulators deem a drug safe and effective, and if their physicians recommend it.

Unlike other consumer choices, the decision to use a pharmaceutical is generally motivated by concern for one’s health. People use pharmaceuticals to make themselves healthier. Given that patients are motivated by their health, they should ask medical experts, such as physicians and regulators, about health effects of pharmaceuticals, even if they can access pharmaceuticals without authorization from experts. This is especially true if drugs carry warnings that they are potentially very dangerous, or if patients know they have medical conditions that make using pharmaceuticals risky.

In such a world, where drugs are properly labeled and certified and patients have access to expert advice from physicians and regulators, should we expect that patients would knowingly choose to take drugs that are diluted with untested solvents or drugs that have never been tested on humans? Would patients self-medicate with toxic and risky drugs without ever talking to a pharmacist or a physician? Would people ignore the certification of regulatory bodies in favor of their own judgment about drugs? Would patients use incredibly dangerous painkillers recreationally? Would you? People who are concerned with their health would realize that it is prudent to only use certified drugs in most cases, to consult with a physician, and to avoid the risks associated with recreational painkiller use.

For the majority of patients who value their health, not much would change if they could purchase and use pharmaceuticals without a prescription. People probably would not visit physicians as often if physicians were not required to prescribe medicine, but many drug-related choices are so complicated or dangerous that it would still be justified to consult with an expert before choosing to use a drug. And for the minority of patients who have other values, removing gatekeepers between pharmaceuticals and users would enable them to access experimental treatments when all other options have failed. Patients would be empowered to learn more about their drug choices and tailor their medications to fit their values. Patients would not be required to spend money paying an expert to tell them what they already knew. Allowing access to medications would not harm the patients who currently value the expertise of physicians and regulators because they would still have access to all that expertise. But allowing access would provide patients with an additional set of options for those circumstances when their own values and priorities depart from experts’ judgments.

If prohibitive forms of paternalism are ever permissible, it is because prohibitions are necessary to protect people from making dangerous choices. But this thought experiment illustrates that prohibitions are not necessary to protect (p.63) people. A certification system would be sufficient to warn patients about the dangers of using pharmaceuticals. The drug disasters that motivated public officials to increasingly limit citizens’ rights of self-medication throughout the twentieth century could have been avoided had the risks of dangerous drugs been discovered and disclosed. More generally, simply disclosing the dangers of a drug can prevent people from using a deadly medicine.

Paternalists who are concerned that patients would harm themselves if given access to risky drugs should ask whether the harm is due to access or uninformed access. When dangerous drugs harm or kill patients, it is often because someone misunderstood the risks of the drug. Giving patients the option to use drugs against medical advice would not make patients worse off as long as patients still have access to medical advice. If the risks of a drug were disclosed, people who are interested in mitigating risks to their health would avoid using a drug that was more likely to be harmful than helpful. For this reason, certification of drugs is a worthwhile goal for public officials. But approval policies are not necessary to protect health for patients who value their health and they limit the options of patients whose judgment or values departs from those of experts. Therefore, even if paternalism were a permissible justification for some prohibitive policies, when it comes to pharmaceuticals, certification is sufficient.

2.9 Conclusion

When public officials pass prohibitive laws to protect citizens’ health by preventing people from making unhealthy choices, those laws are paternalistic. I am skeptical that prohibitive forms of paternalism are ever permissible. But even if the strongest arguments in favor of paternalism could justify some prohibitive polices, they could not justify prohibiting most pharmaceuticals because pharmaceutical regulations do not clearly protect the public health and they are not necessary to promote informed self-medication.