Fighting for the "Right To Try" Unapproved Drugs: Law as Persuasion
Over the last several months, five states have passed “Right to Try” laws,1 which are designed to allow terminally ill patients to obtain experimental drugs.2 Often popularly known as “Dallas Buyers Club” laws,3 Right to Try legislation appears to bypass the FDA’s safety procedures—procedures that supporters of Right to Try legislation believe too often prevent the terminally ill from accessing drugs that might save their lives.4
The reality of Right to Try laws, however, is very different. Media descriptions often do not even mention one of the most pressing questions surrounding these laws: do state laws on drug access meaningfully alter the legal regime governing experimental drugs?5 Regardless of the substantive merits of allowing terminally ill patients to use experimental drugs, FDA regulations require drugs to be approved before they can be sold to consumers, and Right to Try laws do nothing to change that. So what is the purpose of these laws?
I suggest that Right to Try laws do not themselves meaningfully alter substantive law but instead serve a different function. By advocating for these reforms, the movement’s leaders6 are seeking to persuade policy makers at other levels of government. Their aim is either to promote federal policy reform through the FDA or Congress, or to convince federal courts to recognize a Right to Try under the Constitution. The laws’ supporters are using state legislatures as forums to draw attention to and legitimate their cause. The Right to Try saga therefore demonstrates an important feature of American federalism: even when federal law ensures that states lack legal power to alter substantive law meaningfully, state actors can still use their legislative processes to promote their desired policies and constitutional interpretations at the federal level.
I proceed in three parts. Part I describes the content of the Right to Try laws and the context surrounding their passage. Part II argues that state Right to Try laws are unlikely to lead directly to wider access to drugs. Finally, Part III argues that Right to Try laws instead serve the purpose of persuading federal decision makers to reform federal law.
Existing Right to Try laws share several common characteristics. Most generally, they codify a position that the state government will not interfere with a terminally ill patient’s attempt to save her life.7 The laws enact this general policy in two ways. First, they permit doctors to prescribe and drug companies to provide any drug, biological product, or medical device that might save an otherwise terminal patient, as long as it has passed the FDA’s Phase 1 testing and some minimal procedures are followed.8 Under FDA regulations, such drugs would not otherwise be available to the general public for several years (though they are sometimes made available to terminal patients through the Administration’s “expanded access” program).9 Second, Right to Try laws shield, at least to some extent, doctors and drug companies from state tort liability for providing experimental drugs.10 However, these laws do not create any requirement or incentive for drug companies to provide the drugs or for insurance companies to cover them.
Advocacy organizations dedicated to the Right to Try have supported these recent laws. We can trace the genesis of the Right to Try movement back to Abigail Burroughs, who died of cancer in 2001.11 Her doctors had advised her that an unapproved drug, Erbitux, might save her life.12 Burroughs’s family launched a media campaign to get her the drug, pressuring both the producers and Congress to allow her access.13 She died without ever getting a chance to try it.14
Burroughs’s father, Frank, then established the Abigail Alliance for Better Access to Developmental Drugs with the mission of facilitating access for future patients in Abigail’s situation.15 The Alliance’s first major effort was to sue the FDA, claiming a constitutional due process right for terminally ill patients to access unapproved drugs.16 In 2006, a divided three-judge panel of the D.C. Circuit found that the Constitution indeed provided this right.17 The panel’s decision would have constitutionalized the putative substance of the current Right to Try laws had the decision stood (at least in the District of Columbia).18 However, in 2007, the D.C. Circuit reheard the case en banc and reversed the panel.19
After a quiet interval of a few years, Right to Try backers turned their attention from federal courts to state legislatures. Recently, five states have adopted Right to Try laws with bipartisan support.20 While the Alliance has long lobbied for Right to Try laws,21 the Goldwater Institute, a libertarian think tank, has been the driving force behind this recent wave of legislation. The Institute wrote and publicized model legislation,22 which the recent bills have largely followed, and it engaged in a broad campaign to establish the Right to Try in state legislatures.23
Right to Try’s supporters have successfully framed the laws as both a boon to personal liberty and a remedy for bureaucratic failure.24 They state that the laws enshrine “the fundamental right of people to try to save their own lives”25 and describe them as “Dallas Buyers Club laws”—that is, laws that might have prevented some of the horrors of the AIDS crisis as portrayed by the 2013 film.26 The fact that laws have been passed in multiple states suggests that these efforts have been by and large successful; it may be unpopular to argue that terminal patients shouldn’t be allowed to try whatever drug their doctor thinks might work.
Beneath the rhetoric, however, the force of these laws is much less certain. It is not clear that the states have power to legislate on this matter in the first place.27
The FDA requires patients seeking access to unapproved drugs to go through its expanded access program.28 This process intends to ensure that the potential benefit to the patient from using a drug is not outweighed by the risks.29 (Experimental drugs have potential downsides even for terminal patients, such as excessive pain or reduced lifespans.)30 Absent approval through the expanded access program, FDA regulations prevent access to drugs that have not completed all three stages of the FDA’s approval process.31
Numerous reports assert that Right to Try laws let patients “bypass” or “circumvent” the FDA expanded access process.32 However, the laws do not explicitly “bypass” federal law; it is more accurate to describe them as establishing a “Right to Try” under state law, irrespective of federal law. Even if a law did attempt to “bypass” the expanded access process, that aspect of the law would be invalid, since it would contradict federal requirements.33 Either way, the result is the same: FDA regulations still prevent drug companies from providing experimental drugs to terminal patients, and Right to Try laws do not protect companies or individuals from liability under federal law.A state Right to Try therefore does not meaningfully change the legal regime to which drug companies are subject and so is unlikely to bring unapproved drugs to more patients.34
That said, it is possible that some patients will obtain unapproved drugs as a direct result of these laws. The FDA has not taken an official position on Right to Try laws,35 and it is possible that political pressures would prevent the agency from actively opposing the laws.36 As the cases of marijuana legalization in Washington and Colorado have shown, the federal government may choose not to enforce federal law where a state has legalized a practice under its own laws.37
Access to experimental drugs, however, differs from marijuana legalization in at least one important respect. Marijuana producers have an obvious financial incentive to sell the drug to consumers.38 In contrast, for Right to Try laws to help anyone, the drug companies must risk FDA enforcement and other issues for financial returns that are likely to be marginal. The number of patients seeking access to experimental drugs is necessarily small,39 since participants must be terminally ill, unable to get into a nearby clinical trial, and unable to find a reasonable alternative—while also desiring to use a drug the FDA has not yet deemed effective. This would limit the financial upside of providing unapproved drugs. Given that it takes, on average, ten years and roughly $1 billion to complete the FDA approval process,40 the money a company might make from such experimental sales would likely be nominal compared to the costs of development. Moreover, even without fear of FDA enforcement, drug companies are often reluctant to provide access to experimental drugs, reasoning that a bad outcome might damage a drug’s chances of being approved,41 or that a company should focus its resources on the approval process.42 While Right to Try laws shield pharmaceutical companies from state tort liability, limiting their exposure significantly, a careful lawyer would still almost certainly advise her client to go through the FDA process.
So long as the Right to Try remains a creature solely of state law, it will be unlikely to get many more drugs to patients. The most likely short-term outcome is that few, and perhaps no, drugs will be provided to patients that would not have been available otherwise.43
If this analysis is correct, do Right to Try laws simply lack a purpose? Some commentators have suggested this is the case,44 but I don’t think so. As toothless as the current laws may be, their passage can support a campaign of persuasion that may ultimately lead to meaningful federal reform.
If a law is passed, it is natural to assume that its primary effect consists in the legal rights it creates or removes. When a legislature passes a law outlawing a particular drug, its undoubted purpose is to deter and punish those who use the drug. Under ordinary circumstances, it would be strange for a politician supporting a bill to say, “I believe this law will not meaningfully create or alter substantive law, but I think we should pass it anyway.”
However, within our federal system, with its multiple sources of law and separate legislative bodies, a state law can also serve to persuade federal decision makers. This is one of the assumptions behind the famous “laboratories of democracy” theory of federalism, which celebrates the way in which state-level legal experiments can become models for nationwide reforms.45 Indeed, it is common for a policy movement to begin by seeking changes to state law on the road to its ultimate aim of changing federal law.46 Such a strategy can have two benefits from a movement’s perspective: first, it can bring the desired policy to a segment of the population before the whole country is prepared to accept it (though not in the case of Right to Try). Second, and more relevant here, it draws greater national attention to the issue47 and conveys the point that respectable public figures believe in the policy. In this sense, state laws can serve to legitimate a policy and help to develop its constituency, even if the laws themselves do not alter the current legal regime in a meaningful way.
State Right to Try laws primarily leverage this second benefit. The movement seeks to influence federal policymakers, from congressmen48 to FDA regulators to federal judges. It increases the salience of the issue for the American public49 and may help to achieve what Jack Balkin calls putting a constitutional argument “on the wall”—that is, convincing elites that the position is legitimate.50Frank Burroughs himself, founder of the Abigail Alliance, has gestured at some of these goals: “[A lawsuit challenging state Right to Try laws] wouldn’t be all bad news because it would further elevate this issue in the public arena and put pressure on Congress and the FDA to make this change.”51
Therefore, while the current Right to Try laws do not create new rights, they are not necessarily futile. The movement behind them is leveraging a facet of American federalism: that state laws can be used to persuade federal actors. In the future, the Right to Try may become an entrenched legal right, and these laws, currently toothless, may very well have made the difference.
Sam Adriance is a member of the Yale Law School Class of 2015. He would like to thank Mike Labson for his helpful suggestions and Zach Arnold and editors of the Yale Law Journal for their thoughtful feedback.
Preferred Citation: Sam Adriance, Fighting for the “Right To Try” Unapproved Drugs: Law as Persuasion, 124 Yale L.J. F. 148 (2014), http://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs.