On August 7, 2007, the U.S. Court of Appeals for the District of Columbia Circuit held in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach in an 8-2 opinion “that there is no fundamental right ‘deeply rooted in this Nation’s history and tradition’ of access to experimental drugs for the terminally ill.” The decision affirmed an August 2004 opinion from the U.S. District Court for the District of Columbia. In May 2006, however, a divided court of appeals ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to investigational new drugs is a “fundamental right” protected under the Due Process Clause of the U.S. Constitution. The appeals court remanded the case to the district court to determine whether FDA’s policy of restricting access to post-Phase 1 investigational new drugs under FDA’s Investigational New Drug (“IND”) regulations was “narrowly tailored” to serve a “compelling governmental interest.” FDA appealed, and the D.C. Circuit agreed to hear the case en banc.
The case stems from a citizen petition Abigail Alliance and the Washington Legal Foundation submitted to FDA in June 2003 requesting that the Agency amend its IND regulations to create a policy “to grant Initial Approval for promising drugs, biologics, and devices intended to treat life-threatening diseases with unmet needs,” and to seek “regulatory changes to permit expanded availability of developmental lifesaving drugs following phase 1 clinical trials and at all subsequent stages of the trial and review process.” Although FDA has not yet substantively responded to the petition, the Agency did respond to earlier Abigail Alliance submissions. Specifically, in an April 2003 letter from FDA to Abigail Alliance, the Agency commented that accepting Abigail Alliance’s proposal “would upset the appropriate balance that [it is] seeking to maintain, by giving almost total weight to the goal of early availability and giving little recognition to the importance of marketing drugs with reasonable knowledge for patients and physicians of their likely clinical benefit and their toxicity.”
The question Abigail Alliance presented to the D.C. Circuit for consideration 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.
The court reviewed the issue under the due process framework established in Washington v. Glucksberg, in which the Supreme Court described its “established method of substantive-due-process analysis” as having “two primary features:”
First, we have regularly observed that the Due Process Clause specially protects those fundamental rights and liberties which are, objectively, 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. Second, we have required in substantive-due-process cases a careful description of the asserted fundamental liberty interest.
Assuming that Abigail Alliance’s description of its asserted right met the second Glucksberg feature, the court focused on Abigail Alliance’s arguments with respect to the first feature; namely that:
the concepts of self-defense, necessity, and interference with rescue are broad enough to demonstrate the existence of the fundamental right they seek —a right for “persons in mortal peril” to “try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks.” (citations omitted).
The court dismissed Abigail Alliance’s arguments, noting that:
The Alliance argues that its right can be found in our history and legal traditions because “the government never interfered with the judgment of individual doctors about the medical efficacy of particular drugs until 1962,” i.e., when major amendments were made to the [FDC Act]. . . . The Alliance has little to say, however, about our Nation’s history of regulating the safety of drugs. The Alliance’s effort to focus on efficacy regulation ignores one simple fact: it is unlawful for the Alliance to procure experimental drugs not only because they have not been proven effective, but because they have not been proven safe. Although the Alliance contends that it only wants drugs that “are safe and promising enough for substantial human testing,” i.e., drugs that have passed Phase I testing, current law bans access to an experimental drug on safety grounds until it has successfully completed all phases of testing. (citations omitted; emphasis in original).
With respect to Abigail Alliance’s arguments that barring access to experimental drugs for terminally ill patients is inconsistent with the common law doctrines of necessity, the tort of intentional interference with rescue, and the right to self-defense, the court again dismissed these arguments, relying, in part, on the Supreme Court’s decision in United States v. Oakland Cannabis Buyers’ Cooperative. The court stated that “the common law doctrine of necessity provides little support to the Alliance’s proposed right,” that “we cannot agree that the tort of intentional interference with rescue evidences a right of access to experimental drugs,” and that “[b]ecause terminally ill patients cannot fairly be characterized as using reasonable force to defend themselves when they take unproven and possibly unsafe drugs, the Alliance’s desire that the terminally ill be free to assume the risk of experimental drugs cannot draw support from the doctrine of self-defense.”
The court also commented, citing, among other Supreme Court cases, the decision in United States v. Rutherford, that:
[W]e find it highly significant that the Supreme Court has rejected several similar challenges to the FDCA and related laws brought on statutory grounds . . . [a]nd other courts have rejected arguments that the Constitution provides an affirmative right of access to particular medical treatments reasonably prohibited by the Government. In keeping with those decisions, we conclude that the Alliance has not provided evidence of a right to procure and use experimental drugs that is deeply rooted in our Nation’s history and traditions. To the contrary, 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.
In affirming the district court’s decision, the circuit court held that Abigail Alliance’s claim of a right of access to experimental drugs is subject to rational basis scrutiny and that:
Although terminally ill patients desperately need curative treatments, as Rutherford holds, their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit. Thus, we must conclude that, prior to distribution of a drug outside of controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug. We therefore hold that the FDA’s policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects.
The two dissenting judges (Chief Judge Ginsberg and Judge Rogers) strongly rebuked the majority opinion in a 29-page dissent. In sum, the judges contend that:
The court’s opinion reflects 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 shifts the inquiry required by [Glucksberg], by changing the nature of the right, by conflating the right with the deprivation, and by prematurely advancing countervailing government interests. The court fails to come to grips with the Nation’s history and traditions, which reflect deep respect and protection for the right to preserve life, a corollary to the right to life enshrined in the Constitution. The court confuses this liberty interest with the manner in which the Alliance alleges that the liberty has been deprived, namely by denying terminally ill patients access to investigational medications under the narrow conditions described by the Alliance. The court conflates the inquiry as to whether a fundamental right exists at all with whether the government has demonstrated a compelling interest, when strictly scrutinized, rendering its restrictive policy constitutional. . . .
In the end, 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 covered, although not always protected, by the Due Process Clause, 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. This alone is reason the court should pause about refusing to put the FDA to its proof when it denies terminal patients with no alternative therapy the only option they have left, regardless of whether that option may be a long-shot with high risks. The court is on even weaker footing when it relies upon the risks entailed in medical procedures to wrest life-and-death decisions that once were vested in patients and their physicians. The court commits a logical error of dramatic consequence by concluding that the investigational drugs are somehow not “necessary.” While the potential cures may not prove sufficient to save the life of a terminally ill patient, they are surely necessary if there is to be any possibility of preserving her life. (citation omitted; emphasis in original).
The immediate effect that this ruling might have on FDA’s plans to move forward with the Agency’s proposed treatment IND regulations and on Senator Sam Brownback’s (R-KS) efforts to pass legislation supported by Abigail Alliance is unclear at this time. We will update you as we learn more information.