Abigail Alliance v. von Eschenbach
October 29, 2007
Questions and Answers:
The crux of the matter in Abigail Alliance is whether the right the Alliance is asserting is a "fundamental" right, the FDA's restriction of which must pass "strict scrutiny," or merely a liberty interest, subject to restriction under the "rational basis" test. That bifurcation of rights and judicial review was institutionalized in footnote four of Carolene Products (1938), of course, although its roots can be traced to O'Gorman & Young, Inc. v. Hartford Fire Ins. Co. (1931), as Randy Barnett shows in an article forthcoming in the Michigan Law Review, "Scrutiny Land." Invented from whole cloth to make the world safe for the New Deal's regulation of economic liberties, those distinctions today are the stuff of modern "constitutional law," which connects with the Constitution only occasionally. And as Abigail Alliance shows, it's not economic liberty alone that is at risk in the regulatory world that unfolded after 1938.
Judge Judith Rogers, joined by Chief Judge Douglas Ginsburg, constituted the majority on the DC Circuit panel that found the right of terminally-ill patients to access potentially life-saving drugs that had passed FDA Phase I testing to be "fundamental," deriving it from the Fifth Amendment's right to life, the entailed right to self-preservation, and the classic common law right against interference with the exercise of those rights, which the FDA restrictions were arguably doing (see commentary here). Writing in dissent, Judge Thomas Griffith, who would later write the en banc decision reversing the panel (see commentary here), sought refuge in the "two-step method" for identifying fundamental rights set forth in Washington v. Glucksburg (1997): substantive due process analysis requires, Chief Justice Rehnquist wrote there, that fundamental rights be "deeply rooted in this nation's history and tradition" and "implicit in the concept of ordered liberty" such that "neither liberty nor justice would exist if they were sacrificed;" and the rights must be "carefully described."
But the Rogers majority sought refuge in Glucksburg too, for what could be more fundamental and "deeply rooted in this nation's history and tradition" than the rights to life, to self-preservation, and to the control of one's body. Indeed, it was only in 1951 that Congress created a category of restricted prescription drugs. For most of our history, self-medication was the rule.
And so Glucksburg, which purports to help us distinguish "fundamental" from "nonfundamental" rights, is the lynchpin on which Abigail Alliance turns. In truth, its second step should come first. But what does it mean to "carefully" describe a right? There are countless ways to describe any right, owing to the invention of language. Moreover, careful description presupposes not simply, or even mainly, attention to history, but to theory -- to the theory of rights and correlative obligations -- as the old common law judges understood. Otherwise rights are a function merely of will, existing at the pleasure of the sovereign. That is not the foundation for American rights. We come thus to the question of presumptions. Fundamental rights, so called, presuppose liberty, which is America's presumption. What kind of jurisprudence is it that can undermine that presumption, shifting the burden from the government to justify any restriction to the individual to justify his right, simply by redefining the right? What kind? A result-oriented jurisprudence, that's what kind, with a methodology tailored to its end.
Does the Constitution confer a right for terminally ill persons to have access to experimental drugs that have passed the FDA’s Phase I clinical testing? That’s the question that the en banc D.C. Circuit, by a vote of 8 to 2, answered in the negative—correctly, in my judgment—in Abigail Alliance v. von Eschenbach.
I share Roger Pilon’s aversion to the Supreme Court’s concocted distinction between fundamental rights and liberty interests. But Roger, if I’m reading his post correctly, accepts the proposition that the courts have broad authority to denominate various wants or interests as fundamental rights, and his complaint is that the courts have misclassified which wants or interests should be so classified. I, by contrast, believe that the Constitution creates a system of representative government in which American citizens have broad power to establish and revise, through their elected representatives, the policies that will govern themselves and their communities—and that judges need a firm basis in the Constitution in order to recognize a right that overrides the laws and policies that flow from representative government.
To make the contrast more concrete: Roger cites with approval dissenting Judge Rogers’s conclusion that a right for terminally ill persons to have access to experimental drugs that have passed the FDA's Phase I clinical testing derives from (in Roger’s summary) the “Fifth Amendment’s right to life, the entailed right to self-preservation, and the classic common law right against interference with the exercise of those rights.” But it’s quite a stretch to equate preventing a person’s access to unapproved experimental drugs with depriving a person of his right to life, and, what’s more, the Fifth Amendment does not establish a general “right to life” but only a right not to “be deprived of life … without due process of law.” Where, I wonder, is the violation of due process?
At bottom, the posited right strikes me as quite fanciful. If judges have such freewheeling authority to invent rights, then we are living in a system of government by judiciary, in which representative government operates only at the sufferance of, and within the bounds allowed by, judges. That’s not the system established by our Constitution.
As a policy matter, I am exceedingly sympathetic to the Abigail Alliance’s claims. The Alliance argues that terminally ill patients should be allowed to take potentially life-saving drugs that have not gone all the way through the FDA’s drug approval process if they so choose. The decision about whether to assume the risk such drugs may pose should be theirs to make, not the government’s. Accordingly, the Alliance has called for legislative reform of the FDA’s drug approval process and policies with regard to potentially life-saving drugs. So far so good. Sign me up.
My problem is with the Alliance’s effort to turn their policy arguments into constitutional claims. Try as I might, I am unable to find their legal arguments convincing. Any regulatory scheme that limits the ability of producers to sell or market products without government approval necessarily limits the ability of consumers to purchase such goods. Both parties to the potential transaction have their liberty constrained by such a rule. As much as I might like it if the federal government were barred from adopting regulatory schemes to protect us consumers from ourselves, such a principle would cut a whole swath out of the federal regulatory state. It is a bit late in the day for such a move, particularly given the Supreme Court’s precedents concerning when, if ever, courts should discover previously unrecognized constitutional rights.
It is tempting to adopt a “presumption of liberty” in cases like this, but such a presumption carries a risk of its own. Every time a court holds that a fundamental right is protected by the Constitution, it effectively removes this issue from the democratic process – indeed, that is the point. This serves to protect rights, but it also functions to insulate erroneously recognized rights from correction. So, despite my strong libertarian leanings, I am more reluctant than some to read rights into the Constitution even where, as here, I find both the practical and moral arguments quite compelling.
Let me reiterate where my sympathies lie. Rejecting Abigail Alliance’s claims necessarily means that there are people whose lives would have been saved had they had access to unapproved drugs. We don’t know how many, but we can be quite certain the number is greater than zero. (Whether the net number of lives saved is negative or positive, however, is a separate question.) The delay between when a new drug is developed and when it is finally approved necessarily has consequences. If there are people who will be helped by a newly approved drug, then there are people who were not helped during the time it took for the drug to be approved. In the case of a life-saving drug, this means that there will be people whose lives could have been saved had the drug been approved earlier. More extensive testing and a prolonged approval process may help avoid the approval of a dangerous drug, but it also delays the benefits of a beneficial drug. There are health costs – and potentially lives lost – on both sides of the equation. I agree with those who argue the FDA is too “conservative” in its approach, but I am not ready to believe that drug approval decisions are a matter of constitutional law.
I doubt there’s anything I could add to the debate over the precise meaning of the Ninth Amendment or the limits on substantive due process. But surely there are some rights that are so fundamental, and thus so obvious, that the Founding Fathers did not see the need to enumerate them in the Bill of Rights. Judge Rogers, in dissent, alludes to one such right – the right to breathe air.
In general, I agree with Ed that "judges need a firm basis in the Constitution in order to recognize a right that overrides the laws and policies that flow from representative government." But that proposition clearly has its limits. After all, there is no firm basis in the Constitution for a right that prevents the state from killing people merely to achieve some governmental interest, as long as the state provides due process in determining the killing policy’s application to particular individuals. Yet I would imagine that Ed and Jonathan believe that such a right exists.
The right at stake in Abigail Alliance is not much different than the right to breathe air. Whether the state is denying you air or access to the only drug with a chance of saving your life, the state is handing you a death sentence. The only differences are that breathing usually involves fewer risks and a higher probability of prolonging life, and not breathing results in a much quicker death. While the imminence of death has a psychological impact on our intuition about whether a fundamental right to life is implicated, it’s difficult to make a logical argument that its implication hinges on the speed of death. As for risks and probability of success, they would seem to go to determining whether the required level of scrutiny is met, not to what the level of scrutiny should be, i.e., not to whether a right is fundamental.
I’ll concede that, in some cases, the benefits of an experimental drug could be so tenuous and speculative that a fundamental right is no longer plausibly implicated. But that was not the case with Abigail Burroughs, whose oncologist concluded that the experimental drugs at issue had a very significant chance of saving her life. Under those conditions, I disagree with Ed that "it’s quite a stretch to equate preventing a person’s access to unapproved experimental drugs with depriving a person of his right to life."
It’s true that there was hardly a guarantee that the drugs would save Abigail’s life. Similarly, there is hardly a guarantee that running 3 miles a day will prevent you from having another heart attack and dying. But can the state prohibit you from running, despite a doctor’s recommendation to do so, until it has fully evaluated the risks and efficacy of running? I use this example because I’m trying to tease out the degree to which Jonathan and Ed accept the intrusion of the regulatory state in Abigail’s case simply because the regulation falls under a traditional and constitutional area of state authority, namely regulation of interstate commerce. In contrast, running probably doesn’t fall under that authority unless you step on the nest of an endangered species. The distinction has a certain psychological appeal, but the government’s authority to regulate tells us nothing about whether the regulation impinges on a fundamental right.
On a similar note, Jonathan points out that "any regulatory scheme that limits the ability of producers to sell or market products without government approval necessarily limits" the liberty of buyer and seller. But again, that begs the question of whether the liberty is fundamental and thus off limits to the regulatory scheme, absent a compelling interest.
I conclude by arguing that, at very least, the terminally ill have a fundamental right of access to experimental drugs under the current state of constitutional law. Judge Rogers puts this argument in a nutshell when she says "[It] is startling that the oft-limited rights to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body even if it results in one's own death or the death of a fetus have all been deemed fundamental rights . . . , but the right to try to save one's life is left out in the cold despite its textual anchor in the right to life."
It would be particularly startling if the state, which is constitutionally prohibited from regulating abortion procedures when it risks the health of the mother, were free to regulate pharmaceuticals when the regulation ensures the death of the patient.In sum, if there is no fundamental right preventing the state from handing out death sentences to achieve some governmental interest – as the FDA did in the case of Abigail Burroughs – then it is hard for me to imagine that any right can be fundamental. But under the current state of the law, there clearly are fundamental rights. Thus, I must conclude that the antecedent is false as well and the terminally ill do have a fundamental right of access to experimental drugs.
Unlike Ed, who shares my aversion to the Supreme Court’s “concocted distinction between fundamental rights and liberty interests,” Curt seems to accept the distinction, concluding with a modus tollens argument: If there’s no fundamental right here, then there are no such rights; but the Court has held otherwise; thus, there is a fundamental right here. Curt’s premise amounts to a reductio ad absurdum: doubting this right would lead to contradiction.
Fine, but the life of the law has not been logic, as Holmes the jurist amply demonstrated. Were the court to have done the right thing here, Jonathan says, it would have “cut a whole swath out of the federal regulatory state,” but it’s “a bit late in the day for such a move.” That’s a practical, not a legal, point. If that’s the court’s rationale, let’s hear it, not this fundamental rights/judicial scrutiny nonsense. Jon adds, more deeply, that adopting a “presumption of liberty” risks removing an issue from the democratic process, serving thus “to insulate erroneously recognized rights from correction.” True, but adopting a “presumption of constitutionality” is risky too, tending to insulate erroneously recognized powers from correction – precisely Jon’s practical point.
And so we come to Ed’s response to my initial post and to the question of just what the constitutional presumption is. Ed believes the Constitution gives representatives “broad power” to govern – and judges need a “firm basis” in the Constitution to override that power. That’s the post-New Deal view, certainly, held today by both conservatives (Scalia) and liberals (Breyer). It amounts to a presumption of constitutionality, not liberty – save the liberty to vote periodically, with millions of others. It privileges not simply “self-government” but broad self-government – which means majoritarianism, at best, but rule by factions, in reality, as Public Choice economics demonstrates. And it’s utterly inconsistent with Madison’s assurance in Federalist 45 that federal powers would be “few and defined” (Abigail Alliance is a federal case), implying broad liberty, not power.
Thus, Ed is a modern, not an originalist. And that’s borne out by his discussion of due process. The Fifth Amendment, he says, “does not establish a general ‘right to life’ but only a right not to ‘be deprived of life … without due process of law’” – adding, in wonder, where is the violation of due process? There was none. Abigail Alliance was fairly adjudicated. The problem is in the substantive law. The Due Process Clause does not establish “a general right to life.” It merely recognizes that right – in the course of recognizing the further right not to be deprived of it without due process of law. There is, in short, a whole body of natural and common law that stands behind the Constitution (see the Seventh Amendment), to be drawn upon as cases or controversies require. The document is not a closed body of positive law.
Thus, when Congress regulates in a way that deprives individuals of their right to take medicines that might save their lives, as individuals were free to do before 1951, not only does it exceed its limited power to ensure the free flow of commerce among the states, but it deprives us of one of the rights we retained when we granted Congress that power in the first place. That extension of its power is neither necessary nor, more important still, proper. This is not “inventing” rights, as Ed charges, or “reading rights into the Constitution” – Jonathan’s phrase. It’s reading the Constitution as it was meant to be read.
It’s a pleasure to be in a debate in which being called “a modern, not an originalist” is meant as condemnation. But it is the modern judicial activist who imagines that any law he regards as stupid or evil must be unconstitutional, even if it doesn’t violate a right set forth in, or fairly inferable from, the Constitution.
As I read him, Roger is making two interrelated claims: first, that Congress lacks power under the Commerce Clause to prevent individuals from having access to medicines that might save their lives, and, second, that exercise of such power “deprives us of one of the rights we retained when we granted Congress [the Commerce Clause] power in the first place.” I’m extremely skeptical of the first claim, but would gladly entertain any supporting evidence and argument.
The second claim, by contrast, seems to me to rest on an understanding of the Constitution that I reject in toto—namely, that there are certain unenumerated rights that are of constitutional dimension and that are judicially enforceable but that are not in fact inferable from the text of the Constitution itself. This understanding seems to me incompatible with the principles of representative government that undergird the Constitution, and it finds no support in the text of the Constitution. (As for misplaced reliance on a misreading of the Ninth Amendment, I’ll refer the reader to this previous exchange I’ve had with Roger.)
Curt assumes, as I understand it, that there must be a constitutional “right to breathe air.” I believe in breathing air as much as the next fellow, and I also believe that human beings have a natural right to breathe. But I see no reason to believe that such a constitutional right exists. If our legislators were ever so stupid or evil as to enact a law barring people from breathing air, the response that our constitutional system contemplates is that we citizens should engage in massive civil disobedience, compel the legislators to repeal the law, and, failing that, revolt. (The same goes for all the other spectacles in the parade of horribles.) That’s not a perfect remedy, but, as the Framers understood, a constitutional republic isn’t a perfect system—nor, of course, is any other form of government.
Unconstrained reliance on the courts to rescue us from our follies isn’t legitimate. Nor, in any event, would it be prudent: as history amply shows, judges are all too ready to impose their own follies on citizens whose values they disfavor.
Ed partly misunderstands my argument and thus misstates it. It’s not the folly (or wisdom) of a law that makes it unconstitutional (or not). It’s the law’s promulgation absent constitutional authority or in derogation of rights, enumerated or unenumerated alike, as Ed, correctly, has me saying.
Thus my two interrelated claims. First, I’m hardly alone in thinking the modern reading of the Commerce Clause wrong. Put it this way, would the document have been ratified had that reading been understood originally? Recall how quickly Congress shelved Hamilton’s 1791 Report on Manufactures. The evidence Ed requests is voluminous.
Second, the proposition Ed rejects in toto is “that there are certain unenumerated rights that are of constitutional dimension and that are judicially enforceable but that are not in fact inferable from the text of the Constitution itself.” I never said that those rights were not inferable from the text. To the contrary, the text of the Ninth Amendment, with emphasis, states plainly that “The enumeration in the Constitution of certain rights shall not be construed to deny or disparage others retained by the people.” One cannot “retain” what one does not first have to retain. And if the text alone were not enough to cement constitutional recognition of rights retained by the people, the well-known history behind the Ninth Amendment only buttresses that recognition. Once it became clear that a Bill of Rights would be needed to ensure ratification, the problem posed by the inability to enumerate all of our rights had to be addressed; for the interpretive canon expressio unius est exclusio alterius would be invoked, Federalists feared, to limit the rights protected to those that were enumerated. Indeed, that result largely has come to pass, precisely as the Federalists feared, notwithstanding their having added the amendment to guard against it. And it has because people like Ed have ignored both text and history.
Thus, the misreading Ed mentions is by him and those in his camp. To be sure, the Ninth Amendment does not specify rights; but beyond a certain level of generality, neither do other amendments. There, too, judicial understanding of the theory of the Constitution – its theory of legitimacy, grounded in the background theory of rights – is essential if the document and its principles are to be applied correctly. Indeed, few are the provisions of the document that can be applied without such understanding.
But the deeper problem with Ed’s approach, so common among conservatives today, is his belief that this understanding, as he puts it, is “incompatible with the principles of representative government that undergird the Constitution.” To the contrary again, the Preamble, grounded in state-of-nature theory, makes it clear that the people created and empowered the federal government – but only limited government, as the rest of the document reveals, not a government of “broad powers,” as Ed said in his first post. That’s what makes him a modern, as I said in my response, and the charge remains unanswered.
To my surprise, I am now hopeful that there is a broader realm of violent agreement between Roger and me than I expected.
I agree with Roger that the text of the Ninth Amendment presupposes the existence of “other [rights] retained by the people.” I also agree with him that those other rights include the freedoms that are the correlative of the limited powers of the national government. (In other words, the Framers understood that the fact that a power had limits meant that rights not to be subjected to an exercise of that power existed beyond those limits. See my point 2 here, which post is modified in somewhat related respects here.)
It also now appears to me (though I apologize in advance to Roger if I am mistaken) that Roger is arguing only that Congress lacks power under the Commerce Clause to prevent individuals from having access to medicines that might save their lives—and that this argument about power, consistent with the usage in the Ninth Amendment, is tantamount to saying that individuals have a right to have access to medicines that might save their lives. If that is Roger’s argument—if, that is, that what I previously understood as his second claim (about “rights”) is just a recasting of his Commerce Clause argument—then my previous criticism of his second claim is inapplicable (and, I think, Roger’s countercriticism is also inapplicable).
Alas, I’m still not sure that I know what Roger’s actual Commerce Clause claim is. Perhaps I’m missing something, but I also understand the Abigail Alliance dissent to rest on a theory of unenumerated rights that is divorced from Commerce Clause limits.
I think it is worth stepping back for a moment to clarify the issue. Observing the truism that the federal government is one of limited and enumerated powers or asserting that there are unenumerated fundamental rights is not enough to resolve the question in Abigail Alliance. What has to be shown is that this exercise of federal power exceeds the scope of enumerated powers or contravenes a fundamental right that is subject to vindication in the courts. I do not think that Roger or Curt has done that here.
Starting with the question of enumerated powers, Roger may wish to argue that a federal regulatory scheme placing conditions on the sale of pharmaceuticals violates Congress’ commerce clause power (as supplemented by the necessary and proper clause), but it is worth noting that this claim was not made in Abigail Alliance, if for no other reason than an intermediate court could not vindicate such a claim consistent with prevailing precedent. We may all agree that Gonzales v. Raich was wrongly decided, but an intermediate appellate court, such as the D.C. Circuit, is not entitled to disregard such precedents. Moreover, even if Raich was wrong (as I believe), that does not mean that a prohibition on the sale and distribution (as opposed to possession) of certain pharmaceuticals exceeds the commerce power.
Of course, even were a Court to find that the regulations at issue here exceed the scope of the commerce power, that would only mean that the federal government may not adopt such regulations. It would not be enough to establish to the Abigail Alliance dissenters’ more ambitious claim, embraced by Roger and Curt, that there is fundamental right as against government regulation at all levels. As Justice John Marshall observed in Gibbons, state governments may adopt all sorts of quarantine and inspection laws that would lie beyond the scope of federal power.
But what if Roger and Curt are right, and there is a fundamental right at issue here that should be vindicated in court. What, precisely, is that right? Does the right to seek to preserve one’s life require that any and all government actions that could conceivably interfere with someone’s ability to take potentially life-saving actions be subject to the strictest judicial scrutiny? Clearly this would be an absurdity, for at the extreme virtually any government action – from environmental regulations to marginal tax rates – could have some conceivable marginal effect that might inhibit a potentially life-saving choice.
If Roger and Curt’s claim is not so ambitious – and I suspect it is not – then where is the line to be drawn? It cannot simply be at self-defense, as Abigail Alliance claimed something more – not merely the right to autonomy or self-help but the right to purchase medicines from a third party. If the fundamental right at issue here is simply to have access to those drugs that have proceeded a sufficient way through the FDA drug approval process, this is an odd right indeed for an originalist to defend. After all, how could an originalist claim that the contours of a fundamental right are determined, in part, by federal administrative action. Yet that seems to be the claim Abigail Alliance pressed, and two members of the D.C Circuit accepted.
To conclude for the plaintiffs, I’m glad Ed seems to see “a broader realm of violent agreement” with me than he’d expected. His last post captures the essence of my argument, if not its underlying rationales. He concludes, however, by noting that the Abigail Alliance dissent rested not on the limits of the commerce power but on a theory of unenumerated rights. Jon then expands on that point in his post.
It’s fitting that this exchange should end on those points, because they take us to the heart of the matter. Yes, the Abigail Alliance dissent sought to derive a “fundamental” right from the Due Process Clause. That’s because the modern reading of the Commerce Clause deprived it of a more straightforward constitutional argument based on the absence of a power. Jon notes that the D.C. Circuit, as an inferior court, is bound by Supreme Court precedent. That did not stop the Fifth Circuit in Lopez, of course. But I quite agree that the battle here to re-limit the commerce power would be markedly more challenging, even though reading “regulate” functionally (the methodology Marshall urged in the first part of Gibbons, before he abandoned it in the second part, focusing instead on “commerce” and “among”) would limit use of the commerce power to its original end – to ensure the free flow of goods and services.
(But even if federal power were thus limited, Jon adds, the “fundamental” right at issue would not be established since states could still prohibit access to potentially life-saving drugs under their general police power. Well that depends on the scope of the power, just as in the federal case. Properly, the police power is little more than Locke’s “Executive Power,” the power to secure our rights in the state of nature, which we delegated to government in the original position. As such, it is bounded by the rights to be secured. Whose rights are violated, requiring police power protection, if Abigail Burroughs has access to drugs? To be sure, mere positive law might expand the power, but might does not make right, not even majoritarian might.)
And so we come to Jon’s second main point, the point at which this discussion began, concerning the difficulty of defining the right in question. Notice that this is the difficulty with which we must end when we abandon the original design. The Framers saw clearly the problem of defining our rights. That’s why they spoke mostly of powers, which they tried to limit by making them “few and defined.” When they had to add a bill of rights, two years later, their “list” was essentially illustrative. It included “certain rights,” but in no way was doing so meant to be construed as denying or disparaging “others retained by the people.” Those who read the Ninth Amendment as a mere rule of construction diminish the fundamental theory of the Constitution, its theory of legitimacy.
I fully grant that the Court, by its own hand, is in a difficult position today – trying to define rights to spare us from the awful consequences of effectively unlimited power. The idea that the Constitution authorizes a government with the power to prevent people from accessing potentially life-saving drugs would appall the Framers. That that proposition can be seriously entertained is a mark of how far we have strayed from our principles. As it has evolved, our “living” Constitution has led, ironically, to the death of Abigail Burroughs.
I think we all agree that the Supreme Court has strayed far from the original public meaning of the Constitution, and that many government actions upheld today would have been struck down in earlier eras (if they were even enacted it the first place). But this agreement can only carry us so far, and it does not resolve the central question in this debate: Whether the terminally ill have a fundamental constitutional right to access medications that might save their lives. However much I may agree with Roger and Curt that FDA restrictions on the sale of potentially life-saving drugs is offensive and unwise, I cannot agree that federal courts should subject such restrictions to the strictest judicial scrutiny under the Due Process Clause, and I find somewhat fanciful the suggestion that such a right could be derived from the Commerce Clause.
Federal courts do not possess the roving authority to strike down or scrutinize any and all government actions that transgress some 18th century understandings of natural right, nor does the Ninth Amendment confer such authority upon them. Unless Roger and Curt wish to embrace that position, and subject any and all government actions that could conceivably interfere with someone’s ability to take potentially life-saving actions to the strictest judicial scrutiny, the right at issue in any given case must be identified and defined with sufficient particularity to allow for judicial review. Roger’s preferred alternative construction, embracing a presumption of liberty against which government actions must be judged, cannot avoid this difficulty where, as here, the federal government acts within the general scope of its enumerated powers (under current precedent if not the original meaning as well). Even clearly permissible exercises of the commerce clause power have the potential to inhibit life-protecting actions on the margin.
In Abigail Alliance v. Eschenbach, a divided three-judge panel of the U.S. Court of Appeals for the D.C. Circuit held that terminally ill patients had a fundamental constitutional right to access potentially life-saving drugs approved by the FDA for post-Phase I testing on human subjects. Defining a fundamental constitutional right so narrowly makes the right at issue dependent upon government action, in this case Phase I FDA approval. Defining it more broadly – as a right to take any and all actions that may save one’s own life – would necessarily require that federal courts inject themselves into all manner of administrative and legislative decision-making.
Reviewing Abigail Alliance en banc, the D.C. Circuit thought better of the original panel’s decision, refusing to find a fundamental constitutional right of either formulation. However much I support the Alliance’s claims as a matter of policy, and would like to see their claims vindicated by the legislature, I do not see how the Constitution can compel this result in a court of law.