The D.C. Circuit announced a new fundamental constitutional right today in Abigail Alliance for Access to Better Drugs v. Eschenbach. I assume you would like to know what your fundamental constitutional rights are, so here is the new one:
the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient.
First, some background. The FDA has a policy forbidding the sale of of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently safe for expanded human testing (Phase II of the approval process) but are not yet approved. A group of terminally ill patients wanted the FDA to permit them to use the investigational drugs even if they are risky and not approved. They sued the FDA, claiming that the the FDA’s policy violated their constitutional right to take drugs. The district court dismissed the complaint on the ground that the patients had no such constitutional right.
The D.C. Circuit reversed in a divided opinion by Judge Bazelon Judith Rogers. The court held that that the FDA policy infringed a fundamental constitutional right and remanded to the district court to determine if the FDA’s regulatory scheme could survive strict scrutiny. As I understand the opinion, the basic reasoning of the opinion is as follows:
(1) The right to control one’s body is fundamental, Cf. Cruzan, and also implies a right to preserve oneself.
(2) If you have a right to preserve oneself, you have a right to access medications that you think you need to preserve oneself.
(3) Regulating drugs interferes with your right to access medications which you think you need to preserve yourself.
(4) Regulating drugs is a historically recent practice.
(5) The historical absence of drug regulation implies an “individual liberty deeply rooted in our Nation’s history and tradition” to be free of drug regulations.
(6) The FDA’s ban on the sale of unapproved but initially tested life-saving drugs infringes that liberty interest in the case of terminally ill patients.
(Cites to articles by Larry Tribe and Robert Post along the way, natch.) The opinion’s holding:
We conclude, upon applying the Glucksberg analysis and heeding the protected liberty interests articulated by the Supreme Court, that where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient’s informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause.
Douglas “Constitution in Exile” Ginsburg joined the majority opinion; Judge Griffith dissented. Hat tip: Howard.
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I thought this was a joke. Wow. Put this in the obvious cert pile. This bumps right up against Raich.
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You are a tease, Prof. Kerr.
The title of this post promised more. Much more.
On topic: do you think this will get to SCOTUS, or will the D.C. Circuit reverse this en banc. My money is that given the present climate, the Circuit won’t let this decision stand. Unenumerated rights are just not that popular at present, methinks. Especially kinda goofy ones like this.
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I’m not sure this is as goofy as marghlar suggests.
While the courts has been very down on fundamental rights arguments about *ending* one’s own life, they’ve been far less hostile to claims involving the knowing preservation of one’s own life.
This may be seen as a potential end-run around Washington v Glucksberg. Take unapproved experimental drugs that might suddenly reverse late-stage cancer, with a risk of respiratory suppression, voila.
I predict that the courts either leave it alone, or carve out the tiniest of narrow exceptions for this precise set of facts: the patient is dying but conscious, desperate and there’s a drug that promises some hope but is not yet approved.
Could you please explain the reference to Judge Bazelon.
I cannot imagine what justifies the sneering criticism of this plainly correct decision by the D.C. Circuit to save the lives of the terminally ill (i.e., the false comparison of Judge Rogers with the late radical judge David Bazelon).
It is so much less radical than the Roe v. Wade line of cases, which support it by recognizing that the mother has an interest in her health and life (and unlike in those cases, in this case, there is no competing fetal life at stake).
If the constitutional liberty interest in mere health prevents the government from regulating late term abortion procedures that a respectable minority of physicians believes is the best course of treatment (as the Supreme Court held in the partial-birth abortion case of Stenberg v. Carhart), even when many physicians think otherwise, then surely the far-greater constitutional liberty interest in one’s life should prevent the FDA from banning access to drugs which a respectable minority of physicians believes is the best course of treatment for a terminally ill patient (or indeed, the only way to save a terminally patient’s life).
Surely the right to save one’s own life (at no one else’s expense) should be given as much protection as the right to merely preserve one’s mental health (as in Roe v. Wade and Stenberg v. Carhart), as the abortion cases did even at the expense of competing (fetal) life.
Why should the right to an abortion be broader than a terminally ill person’s right to live?
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Practical problems with this decision abound. How will anyone be persuaded to enter into a placebo study, when they have a right to take the medication? This will undercut the FDAs ability to protect the public in really drastic ways.
The problem is that a Phase I study just doesn’t seem adequate to support a reasonable belief that a drug is both safe and effective — and it is pretty extreme to impose a constituitonal redrawing of where that line ought to be. If the government has no right to withhold treatment until it can satisfy that a drug is safe and effective, why not just go ahead and declare that anyone who is terminally ill has the right to ingest anything that they subjectively believe will help them get better? (A position I’d respect from a policy point of view, but hardly one to be found in the constitution.)
I think that at the very least, this regulatory practice should satisfy strict scrutiny on remand. But I’m drastically unsure that having a bunch of judges look over the shoulders of health regulators and decide when medicines are safe or not, can possibly be good for the public welfare.
This will undercut the FDAs ability to protect the public in really drastic ways.
Does it make sense to say that the FDA needs to protect terminally-ill people from unsafe drugs? They’re going to die. They just want a chance.
As a matter of policy, one might reasonably support the FDA’s role in regulating drugs for people who aren’t on their death beds. But, come on, these people are going to die unless they try something. Why prevent them from making last-ditch efforts to save their own lives?
(Of course, whether the decision is sound as a matter of law is a different issue. But please stop pretending that we need the FDA to save soon-to-be-dead people from experimental drugs.)
Mike:
Even terminally-ill people can have their deaths hastened. The FDA is still relevant in such situations — because only carefully controlled, double-blinded placebo trials are going to tell us whether medications are helping rather than hurting.
If the courts decide that they need to look over the FDA’s shoulder about these decisions, I hope that they’ll at least be deferential. But if we hamstring our ability to conduct placebo trials on the terminally ill, we drastically impair our ability to develop new and effective cures for their diseases.
Marghlar,
You overstate the problem somewhat.
First, people do not sign up for “placebo trials”. They sign up for a double-blind trial. Nobody is supposed to know who is getting what treatment until after the fact.
Secondly, and much more importantly, patients in trials do not have to pay for the drugs. A patient taking an experimental drug outside of a trial has almost no chance of persuading his insurance company to foot the bill.
The desperately ill and very rich may be willing to pay that extra fee for the certainty of getting the possibility of better treatment, but by no means will this ruling eliminate clinical trials.
Dustin, you might be right that it won’t totally undercut placebo trials. However, I do think it will enter into someone’s calculations — having decent odds of not getting any medicine at all will surely discourage people from getting involved, when they can now get an assured chance at getting the drug.
Also, by characterizing this as something primarily for the benefit of the affluent, you undercut any characterization of it as a fundamental right. Why should the constitution protect the right of rich people to get privileged access to drugs of questionable utility?
I have difficulty accepting that the benefits of judicial review in this arena will outweigh the costs.
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Well, I can’t say that’s not a legitimate ethical question.
I can say that it’s not entirely dissimilar from what happens now. Phase 1 trials (which look at toxicity in healthy individuals) generally occur by offering low-income individuals (often students) money in exchange for taking a medication of unknown safety. This is not an area that’s entirely ethically pure.
Of course, the flipside is that: yeah, the rich have it better. They have it all over me in most aspects of life. That doesn’t affect the question of whether experimental drugs should be widely available. Anything available in a limited quality will be more available to the right; that’s just economics.
What you’re asking, Marghlar, is basically a question of more-universal health care (and yes, I read Eugene Volokh’s post this morning–I even forwarded it to someone). While I would love to see everyone taken care of with state of the art care, that would require a massive paradigm shift in hospital economics to be feasible.
It’s a shame. The Alliance’s core argument — that terminally ill patients with no options for treatment ought to be able to assume the risks of taking drugs that have made it through the FDA’s Phase I trials — is certainly decent and may even deserve a hearing before Congress (as the dissent points out). But I have no idea how any principled jurist can extend a substantive due process right to “terminally” ill people as opposed to “seriously” ill people or “chronically” ill people. After all, if there is a right to “self-preservation,” why should you have to wait until you are on death’s doorstep? Isn’t this “right” present the minute a doctor diagnoses a patient with a particular illness?
Instead of discussing the FDA’s testing system and inquiring how it could be altered to better serve sick people, we will now spend months (years?) litigating questions such as whether the right to self-preservation exists, whether it extends beyond terminally ill patients and how this rule actually applies in real life (how sick do you have to be to be “terminally ill”? when are there “no alternative” drugs available?). This is a victory for lawyers — not for sick people.
The problem, Dustin, is that this is a very ethically dicey area, and the cost/benefits are hard to balance without a medical degree. Ergo, I distrust the assertion of court authority over the process. Why are courts more qualified, or better positioned, to make this call than the FDA? What interest group is distorting the political process here? This seems like a good faith effort by the FDA to balance competing concerns. I’m not sure that I think developing a whole constitutional law around clinical trials will improve the quality of health care.
My point about this decision potentially making clinical trials more difficult to conduct is only one cost of this decision.
Trust me, the M.D.s are in the dark as we are (I’m working on my Ph.D, so I see thing as a researcher–I’m not involved in drug research, so I’m not biased in that respect).
Just because the FDA acts in good faith doesn’t mean it’s *right*. Here’s a question: suppose that I and my physician have concluded that we want to gamble on an unproven drug, because *some* hope of life is better than none. Suppose that I am willing to go into debt to try and save my life. Suppose that I am not eligible for a clinical trial (my hospital isn’t involved, I have some other condition, whatever). Why should some nameless beuracrat keep me from trying to save my own life?
Dustin: you’re point on liberty is well taken, and if I were making the rules, I’d probably give it more due than the FDA currently does.
The problem is, the constitution doesn’t always require exactly whatever I might want it to. I don’t think it embodies such a strong libertarian impulse as this decision implies. Unenumerated rights are tricky things, because it is a thin line between protecting unwritten “understandings” and thwarting the political process based upon a whim.
You keep assuming that this is a decision that is without risks — but trying an untested drug might well worsen a terminal illness, causing an earlier death, or a more painful one, etc. Drug regulation exists to prevent these sort of risks. You can say that there should never be mandatory drug regulation (and if I was writing the rules, there might not be), but I doubt that it is a right that can reasonably be read into the constitution.
It seems like the question isn’t whether the FDA might be wrong here — it’s whether the courts are more likely to be right than is the FDA. I don’t see the argument that a court is better postitioned to make this call than is the FDA.
Why do you think that the courts are likely to draw a better line than the FDA?
marghlar: your argument rests on the shaky moral ground that the aggregate utilitarian benefit of more rigorous FDA testing (i.e. placebo testing on the terminally ill) outweighs the right to autonomous self-determination. That’s a non-obvious and hotly contested position.
As for the issue of why we draw the line for terminally ill people and not for other ill people, that is to answer marghlar’s other point: normally, it is the role of the FDA to balance risks, but when you get to the point of being terminally ill, the risk calculus becomes so overwhelmingly in favor of taking risks with even a small probability of success and even a high probability of harm that no rational agency could forbid it.
Consider the following empty numbers: if you have a month to live, wouldn’t you say that it’s perfectly rational to take a drug that has a 1% chance of saving you and a 99% chance of causing you to die more painfully, and in only a week? The 1% chance for a full life dramatically outweighs the 99% chance of losing 3 weeks and suffering more pain.
(As for the bottom level antimajoritarian argument, see the standard cookie-cutter replies. At the end of the day, the issue isn’t whether the courts are likely to draw a better line than the FDA, it’s providing as much breathing space for the individual to draw their line without interference from the community.)
I’m not assuming that taking a drug is without risks. If anything, the valid arguments you make about the dangers of experimental drugs are reasosn why people would participate in clinical trials–they might be more comfortable under the closer supervision that one affords. But I am saying that, from an ethical/philosophical perspective, I might want to gamble with my future. Life is high stakes, after all.
I don’t know if the courts are more *right* than the FDA. I do think that courts will draw a more “free” line, for the sole reason that the FDA loses if it approves a drug that is harmful and gains nothing if it doesn’t approve a helpful drug. It has a vested interest in conservatism that the courts don’t.
That’s not a legal argument. I’m not a lawyer, so others are far more qualified than I do discuss whether the grounds for the ruling are solid. I am attempting to analyze reality and understand the realities of what this ruling means, and to discuss what we perceive the ideal situation to be.
I don’t know Dustin — I’d say the FDA gets a lot of pressure to approve drugs — from the public, from industry, etc. To say that it has a vested interest in conservatism is to obscure the point that it also has a vested interest in drug development — and that there is a public interest in some conservatism when analyzing the effects of new bio-active chemicals.
One very real consequence of this decision is that the FDA is going to have to spend a lot more time in court justifying its decisions. That takes up budget that could be being used to test more drugs.
Paul: I grant you that the entire concept of drug regulation is in its essence utilitarian and not libertarian. What I dispute is that your version of libertarianism is a constituitonal principle. (Nor would I say that my version of utilitarianism is a constiutional principle.)
But the fact is, you are the one arguing that the courts have power to thwart the will of the polity on this one. I generally distrust such extensions when the political process should adequately protect the interest at hand. I think the resources that have been spent on this court battle would be better spent petitioning the FDA to change its rule, or getting Congress to pass a law. If the equities are as clear as you suggest, it shouldn’t be hard.
I have sympathy for your position, I really do. A former job of mine involved advocacy on behalf of clients with AIDS who needed access to experimental drugs. But I think that what you are seeking stretches the constitution beyond reasonable limits. It should be a document that regulates how our political system works, not a trump card in any political argument when you can’t get what you want out of the democratic process.
marghlar: The problem with your constitution-is-not-a-trump-card argument, for practical purposes, is that it ends discussion — the whole “constitutional litigation versus the democratic process” is so played out, and it can be applied to anything.
The issue isn’t one of regulating the political process, it’s one of the proper scope of the political process. The position of those who favor an aggressive constitution (yes, Virginia, there really are penumbral emanations) is that there are some things that the political process isn’t rightly entitled to interfere with.
Paul, all you’re really saying is that those you want to see certain political preferences immunized from challenge through democratic processes. The question becomes one of who is rightly entitled to make that determination. I don’t think it’s unreasonable to suggest that the best answer isn’t “two judges on the D.C. Circuit” (or, for that matter, “five justices of the Supreme Court”).
Paul, I don’t think it ends discussion, I think it returns it to the proper forum — the FDA. What you are seeking is not discussion, but compulsion by the judiciary.
Nor do I advocate for universal constitutional deference to the elected branches. I want strong equal protection enforcement and strong protection for the rights of criminal defendants, because such groups tend to be disabled and vulnerable in the political process. Likewise, I tend to want a very strong first amendment with regard to political speech, because communication is the foundation of political decisionmaking.
Terminal illness seems to be a great social equalizer. We all die, and most of us have a family member who has been very ill. Nor does anyone have much to gain by discriminating against the very ill. I think the FDA has been acting in good faith, and trying to reach what it thinks is the best result, with these rules. I very much doubt the utility of court interference in this area. I think that health regulators are better equipped to reach the right answer in these cases.
You assert that a concern for judicial restraint is “so played out,” but I think that such a concern has to be implicated in any substantial extension of judicial authority, and is very much alive in modern jurisprudence.
Excellent commentary, everyone. We at the Abigail Alliance are glad this issue is being discussed by such intelligent people, after being ignored for so long.
I’m not a lawyer, but I don’t believe this case will replace administrative deference and put the courts in the place of scientists. The FDA will need to create regulations that define a threshold for “potentially life-saving drugs” — there are many examples to draw upon, from Gleevec to Revlimid to Tysabri, where it was absolutely clear that people’s lives were saved in the Phase I trial (and, for some, fatal toxicity was a known risk as well). There are also many Phase I trials where efficacy and survival are not studied and/or determined, and those would not meet the threshold.
When I first started as a cancer patient advocate, I was told that placebo trials in terminal patients were rare-to-nonexistant — control arm patients always get the best available care. When I go on the Hill to talk to congressional staff about these issues, most of them think that’s true as well. It’s the party line, echoed by everyone from commissioned registrars to Cokie Roberts. A placebo is, by definition, “no treatment at all.”
But marghlar above told us the reality of the status quo today: “only carefully controlled, double-blinded placebo trials are going to tell us whether medications are helping rather than hurting.” If that’s true, we need better science because, constitutional right or not, compassionate use programs or not, it’s nearly impossible to get unhealthy patients to enroll in those trials with fully-informed consent.