Some Thoughts on Abigail Alliance:

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. . . .

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.

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.

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.

Powered by WordPress. Designed by Woo Themes