Here are some of my initial thoughts and reactions to the majority opinion in today's decision in Abigail Alliance v. Eschenbach. Next I'll post some thoughts and reactions on the dissent.
Abigail Alliance argues that terminally ill patients are typically willing to assume the risks of taking drugs that have not gone all the way through the approval process, and that this choice should be theirs to make, not the government’s. I am exceptionally sympathetic to this claim as a policy matter, but I have trouble making the leap to their constitutional claim. 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 by strong libertarian leanings, I am more reluctant than many libertarians to read rights into the Constitution.
The question before the court, as framed by Abigail Alliance, was:
Whether the liberty protected by the Due Process Clause embraces the right of a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor, whether to seek access to investigational medications that the [FDA] concedes are safe and promising enough for substantial human testing.At one level, Abigail Alliance’s claim is for a constitutional right to life – or right to take actions that may save one’s life – that imposes limits on the government’s ability to prohibit a patient’s access to new drugs. On the other hand, it is the drug company that must submit itself to the approval process, and terminally ill patients certainly have no constitutional right to drugs that have not yet been placed on the market by their manufacturers. If due to liability concerns or for some other reason manufacturers were not willing to make unapproved drugs available even if the FDA lifted its rules, terminally ill patients would be out of luck. Furthermore, 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. Nonetheless, such rules are quite common today.
In what strikes me as an important footnote (fn5), the majority rejects the dissent’s effort to frame the issue as whether there is a “right to save one’s life,” as opposed to a”right to access experimental and unproven drugs in an attempt to save one’s life.” Accepting the former would be problematic, the majority maintains, because
If the asserted right is so broad that it protects a person’s efforts to save his life, it might subject to strict scrutiny any government action that would affect the means by which he sought to do so, no matter how remote the chance of success.Perhaps, but all this would mean is that such government actions are subject to strict scrutiny. Insofar as the government can demonstrate that FDA drug regulation is still necessary to protect the public at large from unsafe drugs, the regulatory scheme could still be upheld.
I think the majority is on fiarly strong legal ground in suggesting that it is a bit late in the game to suggest that the federal government’s power to regulate pharmaceuticals is constrained by a fundamental right to potentially life-saving medical treatment.
our Nation’s history evidences increasing regulation of drugs as both the ability of government to address these risks has increased and the risks associated with drugs have become apparent. Similarly, our legal traditions of allowing a necessity defense, prohibiting intentional interference with rescue, and recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process. . . .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.Our Nation’s history and traditions have consistently demonstrated that the democratic branches are better suited to decide the proper balance between the uncertain risks and benefits of medical technology, and are entitled to deference in doing so.
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. One of the things that is interesting about this litigation is that it raises the questions the extent to which the Constitution constrains how a regulatory agency balances these trade-offs.
Related Posts (on one page):
- Abigail Alliance and therapeutic cloning
- Abigail Alliance -- The Practitioners Respond:
- Roger Pilon on Abigail Alliance:
- A Practitioner's Perspective on Abigail Alliance:
- More on Abigail Alliance:
- Judge Rogers' Abigail Alliance Dissent:
- Jessie Hill on Abigail Alliance:
- Some Thoughts on Abigail Alliance:
- No Constitutional Right to Drugs:
Hobbes agrees that the condemned man has the "natural right" to resist the sovereign and escape the gallows; he just doesn't think the man should kid himself that the sovereign is bound to respect that right.
You argue:
"On the other hand, it is the drug company that must submit itself to the approval process, and terminally ill patients certainly have no constitutional right to drugs that have not yet been placed on the market by their manufacturers. If due to liability concerns or for some other reason manufacturers were not willing to make unapproved drugs available even if the FDA lifted its rules, terminally ill patients would be out of luck."
Under that reasoning, since a private employer can voluntarily fire someone for their speech without violating the First Amendment, the government could force them to fire employees for their speech.
But that is not the rule. The courts have held to the contrary. See Korb v. Lehman (4th Cir. 1990) (government could not pressure private employer to fire employee based on employee's speech); see Truax v. Raich (U.S. Supreme Court, 1916) (holding that the fact that employee was an at-will employee and private employer was free to fire him for discriminatory reasons did not mean that the government could force the employer to fire him); Merritt v. Mackey (9th Cir. 1987) (although private employer can fire employee without due process, government cannot pressure private employer to do so without violating the constitution's due-process clause).
Your reasoning contradicts the state-action doctrine the underlies constitutional law. The essence of the state-action doctrine is that the state is often forbidden from doing (directly or indirectly) what private entities are perfectly free to do, precisely because it is the state, and most constitutional limitations only apply to the state.
Yes, because federal laws survive strict scrutiny all the time
/sarcasm
But that argument, made in passing the above post, has some parallel in the court majority's opinion.
The court majority attempted to distinguish away other medical rights recognized by the courts, like the right to refuse unwanted medical treatment even when that results in one's death, by claiming that a ban on experimental drugs involves "affirmative access" to a "commercial good" rather than the "freedom" from "forced medical treatment."
That is an absurd distinction. If the judges in the court majority were denied the right to buy food, and thus condemned to starvation, no one would argue that their right to live was not infringed merely because buying food involves "affirmative access" to a "commercial good."
Most constitutional rights necessarily involve "access" to a "commercial good." A newspaper can't exercise its First Amendment right to publish unless it is allowed to buy "commercial goods" like newsprint and paper. A political candidate can't communicate with voters without spending money on ads. And it is well-established that the First Amendment protects "access" to such "commercial goods."
And the fact that no private seller has an obligation to sell a newspaper newsprint, ink, or paper, hardly means that the government could step in and ban a newspaper from buying such things.
Similarly, the fact that a drug company might or might not sell a drug even absent a federal ban, for liability or other reasons, does not mean that the government can ban it from doing so.
I think I was unclear. I agree with you on the state action doctrine, and I was not arguing that the government regulation is okay just because companies might refuse to sell.
I was simply observing that Abigail Alliance is claiming a right of patients to access drugs, but that it is the manufacturer who is the primary subject of regulation here. Just because I have a right to acquire or use something does not mean others will sell it, or that I will actually obtain it. Further, I am not sure that, as a Constitutional matter, it is always the case that my right to possess something means that others must also have the right to sell it.
JHA
As I post on the following thread, I agree with this as a matter of due process law. However, at the same time, this sentence so well captures the real nanny state problem with the FDA approval process. I believe in the scientific method. I believe in doctors exercising medical judgment. But (other than in instances where there is some sort of epedimiological issue with allowing widespread use of the drug that could end up harming others, or where allowing widespread use could make it impossible to fill clinical trials) when did terminal cancer patients delegate to the wise and all-knowing government the decision as to what risks are worth running?
As a matter of polcy-- not constitutional law-- I see no reason why people who are terminally ill shouldn't be permitted to run any level of risk they want, so long as they don't throw a risk onto others. And I certainly don't trust the FDA to make that call. This is almost a textbook example of Lord Acton's dictum. The FDA was granted the power to take drugs off the market for a very good reason-- to protect the public from unsafe and ineffective drugs, false claims, and quackery. The agency then leverages that power to a point where it gets to decide what sorts of risks people should be entitled to run.
1) Are a person who has been informed that he has X months to live
2) Can participate in a double blind drug trial where his chances of getting a potentially effective drug are 1 in 2 or less
3) Can buy that same drug and self dose
The logical person would choose to buy the drug and not take a 50:50 chance. Are so who would participate in the drug trials? No data would be collected and we would never know if the drugs were effective.
Furthermore I believe that there have been cases where the FDA has given case by case approval for patients to use unapproved drugs but they often are unable to obtain the drugs since quantities are limited and producing the drugs in small batch quantities is very expensive.
Insurance companies refuse the pay for the drugs, no surprise. So if this ever was approved the next battle would be to force insurance companies to fund the drug purchases.
Not really. The elected branches claim to be good at lots of things, that doesn't mean they've demonstrated it to be true.
If the asserted right is so broad that it protects a person’s efforts to save his life, it might subject to strict scrutiny any government action that would affect the means by which he sought to do so, no matter how remote the chance of success.
I'm not sure I see how subjecting government interference in my right to protect my own life to strict scrutiny is a bad thing. A prohibition on actions that would harm another individual or violate other basic laws (like property or contract) could easily survive the strict scrutiny test. The "no matter how remote the chance of success" argument is moot if you're talking about a drug that has made it to clinical trials. Most of the general consumer safety arguments become comparatively trivial in the case of a terminally ill patient.
I understand the argument that the government should not be able to force the drug company to sell an unapproved drug, but that's an easily distinguishable question.
If the government can establish that people won't participate in the trials, that's one thing. I am not sure that has been shown.
Even with such a showing, though, it would seem to me that an outright ban isn't the way to go forward. Rather, allow everyone who wants in into the "clinical trial", i.e., at least give them the 50-50 chance. (The reason I put "clinical trial" in quotes is because you could still limit the actual study to those people who were going to be studied anyway.)
The idea is to get the drugs out to the maximum number of people who want them. A restriction consistent with that philosophy is not a nanny state regulation but a legitimate regulation to ensure that drugs get tested. But when the government's interest morphs into making sure that nobody gets the drugs as long as, in the government's opinion, risks exceed benefits, then you have the nanny state.
Who pays for the drugs for all these people and for the added personnel required to run a greatly expanded study?
The patients pay for the drugs / placebos, and there are no added personnel needed because they are not actually being studied. All you have to do is give them the same probability of getting the drug as the people in the study do, and there's nothing wrong with selling them a lottery ticket so long as they are fully informed.
That sounds fine to me but probably won't to Read &Pelosi
How is that implication a problem?
Also, this is necessary reading: http://www.reason.com/news/show/120763.html
Soylent Green, anyone?
On a more serious note, Abigail Burroughs grew up in my neighborhood, and her father, Frank Burroughs, lived there until just a couple years ago. It's easy to look at terminally ill patients as available test subjects/economic commodities when you don't know them personally; it's not that way for some of us. But why should an individual life be devalued and commoditized because of the random appearance of a fatal disease?
Further, I think that the suggestion of irrationality is a good one -- a terminally ill patient has no additional risk from the use of an unapproved or experimental drug -- she's going to die imminently anyway, by definition. There is no need to protect her, and I don't see why society (the government) should have a right to appropriate her life for experimental purposes in the name of protecting others.
Looking at the other side of the issue, I would suggest that if, say, a parent of a terminally ill child were to steal such a drug, there would be an arguable defense of necessity that should go to the jury in a criminal trial. How then can we rationally prohibit the sale of the drug? Would we send Jean Valjean to the galleys today? I guess in the DC Circuit we might, but most places not.
If the FDA actually could show that the widespread dissemination were harming the trial, then you'd need to make the odds of receiving the drug the same inside and outside the trial. But I doubt that will really happen. That's just the excuse that is being offered for placing the informed decision to take drugs in the government's hands rather than in the citizens'.