DC Circuit Rejects Abigail Alliance Argument on Drug Access

The en banc DC Circuit today rejected the argument that there is a due process right to access certain types of experimental drugs.

In footnote 5 of the opinion, the majority responds to the dissent regarding the scope of the right that is being asserted in this case:

The dissent has recast the Alliance’s proposed right away from the terms used in its briefs and oral argument—a right to access investigational new drugs—into a right “to try to save one’s life,” which has “its textual anchor in the right to life [expressed in the Fifth Amendment].” Dissent at 2-3. Regardless of how it is described, we must examine the proposed right under Glucksberg, which specifically cautions against the type of broad generalization the dissent now employs. See Glucksberg, 521 U.S. at 721 (requiring a “‘careful description’ of the asserted fundamental liberty interest”). 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. The Supreme Court rejected a similar attempt to broadly define the right at issue in Reno v. Flores when it refused to accept the petitioner’s definition as the “freedom from physical restraint” and instead cast the right as the “right of a child who has no available parent, close relative, or legal guardian, and for whom the government is responsible, to be placed in the custody of a willing-and-able private custodian rather than of a government-operated or government-selected child-care institution.” Reno v. Flores, 507 U.S. 292, 302 (1993). The dissent suffers from the same flaw in arguing that this is about the right to save one’s life, because, in the end, this case is about the right to access experimental and unproven drugs in an attempt to save one’s life, which we conclude under Glucksberg is not deeply rooted in our Nation’s history and traditions. By describing too broadly at the outset a proposed right that will cover the Alliance’s more narrow claim, the dissent fails Glucksberg’s threshold requirement of a carefully described right. We need not pursue the arguments that follow that initial misstep.

Emphasis added.

I had noted the importance of the way the right was described in this earlier post. The dissent in today's case says the majority's perspective on this issue betrays "a flawed conception of the right claimed by the Abigail Alliance for Better Access to Developmental Drugs and a stunning misunderstanding of the stakes." 

The court's opinion contains an interesting description of early American drug regulation practices, starting on p. 16. Additionally, it touches on the issue of criminal drug controls, using that issue to attack the Alliance's position:

[O]ne might argue that, because Congress did not significantly regulate marijuana until 1937, relatively late in the constitutional day, see Gonzales v. Raich, 545 U.S. 1, 11 (2005), there must be a tradition of protecting marijuana use. Because Congress did not regulate narcotics until 1866 when it heavily taxed opium, a drug created long before our Nation’s founding, see United States v. Moore, 486 F.2d 1139, 1215-16, 1218 n.50 (D.C. Cir. 1973) (Wright, J., dissenting), it must be that individuals have a right to acquire and use narcotics free from regulation. . . .  But this is most certainly not the law. A prior lack of regulation suggests that we must exercise care in evaluating the untested assertion of a constitutional right to be free from new regulation. But the lack of prior governmental regulation of an activity tells us little about whether the activity merits constitutional protection: “The fact that powers long have been unexercised well may call for close scrutiny as to whether they exist; but if granted, they are not lost by being allowed to lie dormant, any more than nonexistent powers can be prescripted by an unchallenged exercise.”

The dissent, too, musters a bunch of historical arguments about the right to defend one's own life at common law, and these seem just about as compelling as the regulatory arguments put forth by the majority. All of which goes to show, in my opinion, that whether something is a right “deeply rooted in this Nation’s history and tradition” is a standard that is extremely malleable. The outcome of such a test has far less to do with history than either side would like to pretend and far more to do with the pragmatic considerations motivating each side.

At any rate, given the way the majority defines the right, it's no surprise that the court applies rational basis review to the FDA regulatory regime and concludes that the regime survives that review.

Comments

[Lucid Nebula]

It's notable that conservative chief judge Douglas Ginsberg joined the dissent. He was almost on the SCOTUS appointed by Reagan if he hasn't smoked that pot, but possibly in this case the pot he smoked long years ago made him more compassionate and reasonable.

[Rev. Carl E. Olsen]

I found the argument in this case to be unusual. Abigail Alliance was arguing for the court to recognize a "fundamental right" to use a narrow classification of drugs that have completed Phase I testing but have not been finally approved by the FDA.

To make this argument, Abigail Alliance had to concede the FDA's authorite, because the FDA approves the Phase I testing.

They did this to avoid an analysis like laetrile in United States v. Rutherford, 442 U.S. 544 (1979) (finding there is no "fundamental right" to market drugs which have not obtained FDA approval).

The problem is they had to conceded the FDA's authority just to make the argument distinguishable from Rutherford, since the FDA had to approve an IND (investigational new drug) application before the Phase I trials could begin.

I wonder how much money got burned up in legal fees on this one.

[Rev. Carl E. Olsen]

I should clarify that what I mean is that Abigail Alliance was relying on the FDA's acceptance of an IND application and then arguing the final FDA approval should be bypassed for terminally ill patients who accept the risk. This is really the same agument that was made in Rutherford, only weaker because it accepts FDA's authority to decide which drugs should be available without final approve (ones with an IND and Phase I trials completed) and then turns around and says FDA's final approval process should not be accepted.