Bad Policy, Good Constitutional Law
Just need to weigh in with my two cents on the Abigail Alliance case just ruled on by the D.C. Circuit Court of Appeals. Essentially, the court rejected a plaintiff's claim that terminally ill patients should be allowed access to potentially life saving drugs, even if those drugs had not yet met all FDA approvals. (Specifically, the plaintiff's were asking for access to drugs which had met Phase I approval and were about to begin or were in the process of conducting clinical trials.) Predictably, libertarians are not very happy.
I was going to write of a defense of the decision from a constitutional perspective, but Jonathan Adler beats me to it, here and here.
For those of you who are link-averse, allow me to explain, in brief, why the decision makes constitutional sense. First, this was not a challenge to the authority of the FDA to regulate drugs and drug risks - I'd entertain such a challenge, but other then myself, I think the only people interested in considering it would be Clarence Thomas, Randy Barnett, and an odd array of libertarians. Therefore, like the Raich case of a few years ago, what the plaintiffs were asking for was an exemption to a generally applicable law. Now I do have sympathy for terminal patients and I'd grant them access to whatever drugs they wanted if I were a legislator, but the question here is whether the Constitution provides such a right.
The problem with this right is constructing it - what does terminally ill mean? And more importantly, what is a life saving drug? What do the chances of success have to be? What risks are permissible? The complexities of such a right begin to sound like abortion rights to the hundredth power. And meanwhile, it would be odd if an exception applied to patients who were dying, but not to those in horrible pain. I can't think of a basis in the Constitution for this distinction, nor can I find any basis for determining a right based upon some sort of scientific or medical opinion about a physical condition. As I said, it just gets really messy, and would drag the courts into all sorts of political debates.
Policy wise, this is a horrible move by the FDA, and yet another indication of the organization's incompetence and incompatibility with the realities of life. Yet this is our monster- we created it and if we want to change it, we have to do so politically.
I also wanted to remark, briefly, on the comments left by someone named Hans Bader over at the Volokh Conspiracy (in the first Volokh comment thread above).
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."
Just a few comments- first, everyone in the country is denied access to certain drugs, so much of the above discussion is somewhat irrelevant. The fact that the government can't stop people from selling food, or paper, or newsprint to certain groups or individuals is just as much a question of Equal Protection as it is one of basic rights. The equivalent sort of law needed by this example would be a law banning the sale of food to everyone, or a law banning all sales of newsprint and newspapers, to anyone and everyone. Forgetting the ridiculousness of the all-out ban on food for a minute, I would imagine that a ban on newsprint could well be considered to be Constitutional today as a time, place and manner restriction, if for instance the purpose of the ban was environmental concerns and alternative avenues of publication existed. As I've said above, the problem in finding a right for terminally ill patients is that you're looking for an exception to a neutral law that is applicable to everyone.
I was going to write of a defense of the decision from a constitutional perspective, but Jonathan Adler beats me to it, here and here.
For those of you who are link-averse, allow me to explain, in brief, why the decision makes constitutional sense. First, this was not a challenge to the authority of the FDA to regulate drugs and drug risks - I'd entertain such a challenge, but other then myself, I think the only people interested in considering it would be Clarence Thomas, Randy Barnett, and an odd array of libertarians. Therefore, like the Raich case of a few years ago, what the plaintiffs were asking for was an exemption to a generally applicable law. Now I do have sympathy for terminal patients and I'd grant them access to whatever drugs they wanted if I were a legislator, but the question here is whether the Constitution provides such a right.
The problem with this right is constructing it - what does terminally ill mean? And more importantly, what is a life saving drug? What do the chances of success have to be? What risks are permissible? The complexities of such a right begin to sound like abortion rights to the hundredth power. And meanwhile, it would be odd if an exception applied to patients who were dying, but not to those in horrible pain. I can't think of a basis in the Constitution for this distinction, nor can I find any basis for determining a right based upon some sort of scientific or medical opinion about a physical condition. As I said, it just gets really messy, and would drag the courts into all sorts of political debates.
Policy wise, this is a horrible move by the FDA, and yet another indication of the organization's incompetence and incompatibility with the realities of life. Yet this is our monster- we created it and if we want to change it, we have to do so politically.
I also wanted to remark, briefly, on the comments left by someone named Hans Bader over at the Volokh Conspiracy (in the first Volokh comment thread above).
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."
Just a few comments- first, everyone in the country is denied access to certain drugs, so much of the above discussion is somewhat irrelevant. The fact that the government can't stop people from selling food, or paper, or newsprint to certain groups or individuals is just as much a question of Equal Protection as it is one of basic rights. The equivalent sort of law needed by this example would be a law banning the sale of food to everyone, or a law banning all sales of newsprint and newspapers, to anyone and everyone. Forgetting the ridiculousness of the all-out ban on food for a minute, I would imagine that a ban on newsprint could well be considered to be Constitutional today as a time, place and manner restriction, if for instance the purpose of the ban was environmental concerns and alternative avenues of publication existed. As I've said above, the problem in finding a right for terminally ill patients is that you're looking for an exception to a neutral law that is applicable to everyone.
2 Comments:
Just one small argument...
"I would imagine that a ban on newsprint could well be considered to be Constitutional today as a time, place and manner restriction, if for instance the purpose of the ban was environmental concerns and alternative avenues of publication existed."
Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.
I'm a little hazy on some specific court cases that I learned about in class, but you pretty much can't prevent publication of any kind unless there is "imminent danger".
And as a libertarian, wouldn't you be against a law that would force a business to do something they didn't want to do? That's what you said during our smoking ban argument.
I think the law student in me sort of took over without realizing I'm usually writing for a non-legal audience.
First, about the speech issue, I'm not talking about banning publication or banning speech, only banning certain methods of speech, which the Supreme Court has usually found to be constitutional, provided that the law is content neutral and is applied in a content neutral manner. As a matter of comparison, most towns have noise ordinances, which would cover speech that is too loud and time restrictions to prevent people from loud protests in quiet neighborhoods in the middle of the night. The newsprint thing is a similar sort of restriction- content neutral and applying to all papers. Obviously it's a dumb idea, but I think it could pass First Amendment scrutiny. An interesting question would be a ban, say, on all paper publications, but that would probably a bit more complicated of an analysis. (And as to your imminent danger comment your basically right, but again, that applies to preventing specific individuals from publishing.)
As to the other part of your comment, no, I don't believe in forcing businesses to sell a product or service they don't want to sell. If drug companies have doubts about their products they shouldn't have to sell them - My only point is that the government shouldn't get in the way of a drug company wanting to sell a potentially life saving drug to a terminally ill patient. In reality, the only real reason not to sell such a drug would be the liability issues, which could hopefully be dealt with through some form of contractual waiver.
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