Abigail Alliance for Better Access to Developmental Drugs v. von EschenbachAbigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
Lead Opinion
Opinion for the court filed by Circuit Judge GRIFFITH.
Dissеnting opinion filed by Circuit Judge ROGERS, with whom Chief Judge GINSBURG joins.
This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective. The district court held there is no such right. A divided panel of this Court held there is. Because we conclude that there is no fundamental right “deeply rooted in this Nation’s history and tradition” of access to experimental drugs for the terminally ill, see Washington v. Glucksberg,
I.
A.
The Abigail Alliance for Better Access to Developmental Drugs (the “Alliance”) is an organization of terminally ill patients and their supporters that seeks expanded access to experimental drugs for the terminally ill. The Food, Drug, and Cosmetic Act (“FDCA” or “Act”), however, generally prohibits access to new drugs unless and until they have been approved by the Food and Drug Administration (“FDA”). See 21 U.S.C. § 355(a). Gaining FDA approval can be a long process. First, an experi-’ mental drug’s sponsor (e.g., a drug company) must submit an application for approval. See id. § 355(a). Because no drug may be approved without a finding of “substantial evidence that the drug will have the effect it purports or is represented to have,” id. § 355(d)(5), an application must contain “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use,” id. § 355(b)(1)(A). Such reports rely in large measure on clinical trials with human subjects.
But before a sponsor can even begin human testing, it must submit for the FDA’s approval an investigational new drug application (“IND”), see id. § 355(i)(l); see also 21 C.F.R. pt. 312,
Clinical testing for safety and effectiveness requires three or sometimes four phases. See 21 C.F.R. § 312.21. Phase I involves the initial introduction of a new drug into human subjects. A Phase I study usually consists of twenty to eighty subjects and is “designed to determine the metabolism and pharmacologic actions of the [new] drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.” Id. § 312.21(a)(1). Although gathering data on effectiveness may be part of Phase I, its primary focus is to determine whether the drug is safe enough for continued human testing. See id. Phase II studies are “well controlled” and “closely monitored” clinical trials of no more than several hundred subjects, used to evaluate both the “effectiveness of the drug for a particular indication” and its “common short-term side effects and risks.” Id. § 312.21(b).
Phase III studies are expanded clinical trials of several hundred to several thousand subjects designed to “gather ... additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.” Id. § 312.21(c).
Terminally ill patients need not, however, always await the results of the clinical testing process. The FDA and Congress have created several programs designed to
B.
Concluding that the FDA’s current process for early access to new drugs was inadequate to meet the needs of its terminally ill members, the Alliance submitted its own proposals to the FDA. Those proposals culminated in a “citizen petition” to the FDA, see 21 C.F.R. § 10.25, arguing that there is a “different risk-benefit tradeoff facing patients who are terminally ill and who have no other treatment options.” Abigail Alliance Citizen Petition, In re Tier 1 Initial Approval Program to Expedite the Availability of Lifesaving Drugs 9 (June 11, 2003). Although the Alliance agreed that “[ejxtensive marshalling of evidence regarding drug interactions, dose optimization, and the like” is “appropriate for new drugs to treat patients with other alternatives ...[,] these steps may well entail a delay that is fatal” for terminally ill patients. Id. The Alliance contended that these patients “should have the ability to opt for a new treatment that has met a lower evidentiary hurdle with respect to safety and efficacy.” Id. The Alliance’s proposal suggested that the FDA allow early access based upon “the risk of illness, injury, or death from the disease in the absence of the drug.” Id. at 4. Accordingly, the Alliance requested that the FDA promulgate new regulations that would allow sponsors to market experimental drugs, under some circumstances, after the completion of Phase I trials.
The FDA never responded to the Alliance’s citizen petition, but did respond to the Alliance’s earlier submissions. After noting that a number of senior FDA offi
Relying upon its experience exercising its scientific and medical judgment in creating its regulations for experimental drugs and, in certain circumstances, exceptions to those regulations for the terminally ill, the FDA noted that “a reasonably precise estimate of response rate” and “enough experience to detect serious adverse effects” are “critical” in determining when experimental drugs should be made available. Id. For example, most experimental cancer drugs “have potentially lethal toxicity, with potentially large effects on a patient’s remaining quality of life.” Id. Accordingly, “it does not serve patients well to make drugs too widely available before there is a reasonable assessment of such risks to guide patient decisions, and experience in managing them.” Id. at 4-5. The FDA concluded that accepting the 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.” Id. at 5.
Having thus been rejected by the FDA, the Alliance turned to the courts, arguing that the United States Constitution provides a right of access to experimental drugs for its members. In a complaint that mirrored much of its earlier submissions to the FDA, the Alliance argued that the FDA’s lengthy clinical trials, combined with the “FDA’s restrictions on pre-approval availability[,] amount to a death sentence for these [terminally ill] patients.” Am. Compl. ¶¶ 15-17. Nor, the Alliance argues, are the FDA’s exceptions to the clinical testing process sufficient to provide the terminally ill the access they need because they “are small, when they exist at all,” and the ban on profits prevents many drug sponsors from participating. Id. ¶ 18.
“Terminally ill patients,” in the Alliance’s view, “are typically willing to assume risks____” Id. ¶ 19. Before the district court, the Alliance argued that the Constitution guarantees them the right to do so. The district court rejected that argument, holding that “there is no constitutional right of access to unapproved drugs.” Abigail Alliance for Better Access to Developmental Drugs v. McClellan, No.
As framed by the Alliance, we now consider:
Whether the liberty protected by the Due Process Clause embraces the right of a terminally ill patient with no remaining approved treаtment 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.
Appellants’ Br. at 1.
II.
The Due Process Clause of the Fifth Amendment provides that “[n]o person shall be ... deprived of life, liberty, or property, without due process of law.” U.S. Const, amend. V. The Supreme Court
As such rights are not set forth in the language of the Constitution, the Supreme Court has cautioned against expanding the substantive rights protected by the Due Process Clause “because guideposts for responsible decisionmaking in this unchartered area are scarce and open-ended.” Collins v. Harker Heights,
In Glucksberg, the Supreme Court described its “established method of substantive-due-process analysis” as having “two primary features.” Glucksberg,
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.
Id. at 720-21,
We will assume arguendo that the Alliance’s description of its asserted right would satisfy Glucksberg’s “careful description” requirement.
A.
“We begin, as we do in all due process cases, by examining our Nation’s history, legal traditions, and practices.” Glucksberg,
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,” id. at 1, 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. See 21 C.F.R. § 312.21(b) (requiring that Phase II studies examine “common short-term side effects and risks ” of new drugs) (emphasis added); id. § 312.21(c) (requiring Phase III studies to “gather ... additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug”) (emphasis added). Thus, to succeed on its claim of a fundamental right of access for the terminally ill to experimental drugs, the Alliance must show not only that there is a tradition of access to drugs that have not yet been proven effective, but also a tradition of access to drugs that have not yet been proven safe.
Examining, as we are required to do under Glucksberg, our Nation’s history, legal traditions, and practice with respect to the regulation of drugs for efficacy and safety, we conclude that our Nation has long expressed interest in drug regulation, calibrating its response in terms of the capabilities to determine the risks associated with both drug safety and efficacy.
Drug regulation in the United States
Nor were the States the only regulators of access to drugs. Although early federal regulation was not extensive, perhaps because “[n]ot until interstate commerce began its great expansion after the Civil War did the need for Federal rule-making become widely realized,” Wallace F. Janssen, Outline of the History of U.S. Drug Regulation and Labeling, 36 Food Drug Cosm. L.J. 420, 425 (1981), there are early examples of federal government intervention. In 1848, the Import Drug Act, ch. 70, 9 Stat. 237 (1848), banned “imported adulterated drugs” after a Congressional committee concluded that “this country had become the grand mart and receptacle of all the refuse [drug] merchandise ..., not only from the European warehouses, but from the whole Eastern world.” Wesley J. Heath, America’s First Drug Regulation Regime: The Rise and Fall of the Import
The current regime of federal drug regulation began to take shape with the Food, Drug, and Cosmetic Act of 1938. See Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § 301 et seq.). The Act required that drug manufacturers provide proof that their products were safe before they could be marketed. See id. The new Act also prohibited false therapeutic claims. Id. Notably, the drug industry “strenuously objected” to the 1938 Act “ostensibly on the ground that it would deprive the American people of the right to self-medication,” Harry A. Toulmin, Jr., Law of Foods, Drugs and Cosmetics 8-9 (2d ed.1963)—an argument not unlike the Alliance’s position of today.
We end our historical analysis where the Alliance would prefer it begin—with the 1962 Amendments to the FDCA. Undoubtedly, as the Alliance argues at length, Congress amended the FDCA in 1962 to explicitly require that the FDA only approve drugs deemed effective for public use. See Drug Amendments of 1962, Pub.L. No. 87-781, § 102, 76 Stat. 780, 781 (1962). Thus, the Alliance argues that, prior to 1962, patients were free to make their own decisions whether a drug might be effective.
But even setting the safety issue to one side, the Alliance’s argument that effectiveness was not required before 1962 also fails under closer scrutiny. First, as a matter of history, at least some drug regulation prior to 1962 addressed efficacy. More importantly, an arguably limited history of efficacy regulation prior to 1962 does not establish a fundamental right of access to unproven drugs. The amendments made to the FDCA by Congress throughout the twentieth century demonstrate that Congress and the FDA have continually responded to new risks presented by an evolving technology. Recent government efficacy regulation has reflected Congress’s exercise of its well-established power to regulate in response to scientific, mathematical, and medical advances.
True, a lack of government interference throughout history might be some evidence that a right is deeply rooted. But standing alone, it cannot be enough. If it were, it would be easy to employ such a
B.
The Alliance next turns to several common law doctrines, arguing that barring access to experimental drugs for terminally ill patients is “inconsistent with the way that our> legal tradition treats persons in all other life-threatening situations.” Appellants’ Br. at 31. Specifically, the Alliance argues that three doctrines—(1) the doctrine of necessity; (2) the tort of intentional interference with rescue; and (3) the right to self-defense—each support the recognition of a right to self-preservation. Such a right to self-preservation, the Alliance believes, would permit “persons in mortal peril ... to try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks.” Id. at 32. Specifically, in this case, the Alliance believes that a right to self-preservation would give the terminally ill a constitutionally protected right of access to experimental drugs.
Looking first to the Alliance’s necessity argument, the Alliance invokes the common law doctrine, which “ ‘traditionally covered the situation where physical forces beyond the actor’s control rendered illegal conduct the lesser of two evils.’ ” United States v. Oakland Cannabis Buyers’ Coop
In Oakland, a group of patients seeking access to marijuana for medicinal purposes argued that “because necessity was a defense at common law, medical necessity should be read into the Controlled Substances Act.” Oakland,
The Alliance next invokes the tort of intentional interference with lifesaving efforts, which the Restatement of Torts defines as “intentionally preventing] a third person from giving to another aid necessary to his bodily security.” Restatement (First) of Torts § 326 (emphasis added). But that is not this case. The Alliance seeks access to drugs that are experimental and have not been shown to be safe, let alone effective at (or “necessary” for) prolonging life.
Finally, the Alliance looks to traditional self-defense principles to support its proposed constitutional right. The common law doctrine of self-defense provides that “[o]ne who is not the aggressor ... is justified in using a reasonable amount of force against his adversary when he reasonably believes (a) that he is in immediate danger of unlawful bodily harm from his adversary and (b) that the use of such force is necessary to avoid this danger.” 2 Wayne R. LaFave, Substantive Criminal Law § 10.4 (2d ed.2003). Self-defense typically arises when a victim is being attacked by an aggressor and uses reasonable force to оvercome immediate danger. The Alliance argues that self-defense permits victims to assume two types of risk: (1) the risk that the victim will kill the attacker; and (2) the risk that “[flighting back may dramatically increase the ... harm” to the victim. Appellants’ Br. at 35-36. So, the argument goes, if victims of crimes are allowed to assume these risks in defending their lives, terminally ill patients should also be allowed to assume the risk that an experimental drug may hasten their deaths.
That self-defense principles should be applied in the medical context is evidenced, the Alliance argues, by the Supreme Court’s abortion jurisprudence. The Alliance does not look to the “right of personal privacy” addressed in Roe v. Wade,
This analogy also fails because this case is not about using reasonable force to de
III.
Although it has not addressed the precise constitutional argument urged by the Alliance, we find it highly significant that the Supreme Court has rejected several similar challenges to the FDCA and related laws brought on statutory grounds. See, e.g., Raich,
Because the Alliance’s claimed right is not fundamental, the Alliance’s claim of a right of access to experimental drugs is subject only to rational basis scrutiny. See Glucksberg,
The Alliance acknowledges the risk inherent in taking experimental drugs. See Am. Compl. ¶ 19 (“Terminally ill patients are typically willing to assume risks.... ”). The Alliance would rather that individual patients make decisions about this risk than have the FDA decide which drugs are safe enough for limited access to the terminally ill. The FDA counters that “[without a requirement of FDA approval, patients could be exposed to unreasonable risks from investigational drugs that may be neither safe nor effective.” Appellees’ Br. at 55-56.
Applying the rational basis standard to the Alliance’s complaint, we cannot say that the government’s interest does not bear a rational relation to a legitimate state interest. That conclusion is compelled by the Supreme Court’s decision in United States v. Rutherford,
Although terminally ill patients desperately need curative treatments, as Rutherford holds, their deaths can certainly be hastened by the use of a potentiаlly 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.
Although in the Alliance’s view the FDA has unjustly erred on the side of safety in balancing the risks and benefits of experimental drugs, this is not to say that the FDA’s balance can never be changed. The Alliance’s arguments about morality, quality of life, and acceptable levels of medical risk are certainly ones that can be aired in the democratic branches, without injecting the courts into unknown questions of science and medicine. 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 the Supreme Court has held:
We must assume that, when the statute in question was passed, the legislature ... was not unaware of these opposing theories, and was compelled, of necessity, to choose between them. It was not compelled to commit a matter involving the public health and safety to the final decision of a court or jury. It is no part of the function of a court or a jury to determine which one of two modes was likely to be the most effective for the protection of the public against disease.
Jacobson v. Massachusetts,
V.
For the foregoing reasons, the judgment of the district court is affirmed.
So ordered.
Notes
. In FDA parlance, experimental drugs that have not yet been approved for public use are deemed "investigational drug[s]." See 21 C.F.R. § 312.3(b).
. In some circumstances, a Phase IV review is conducted, which "delineale[s] additional information about the drug’s risks, benefits, and optimal use.” 21 C.F.R. § 312.85.
. Section 355(n)(3) of Title 21, United States Code, provides:
The Secretary shall make appointments to each panel ... so that each panel shall consist of—
(A)members who are qualified by training and experience to evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as clinical and administrative medicine, pharmacy, pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;
(C) a representative of consumer interests, and a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel; and
(D) two or more members who are specialists or have other expertise in the particular disease or condition for which the drug under review is proposed to be indicated.
. The FDA has several other regulatory programs designed to hasten research of the safety and effectiveness of drugs for terminally or severely ill patients and allow early access where scientifically and medically warranted. For example, under its “Fast Track" program, the agency has "established procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists." 21 C.F.R. § 312.80. Fast Track allows the FDA to waive its IND application requirement if it is “unnecessary or cannot be achieved," id. § 312.10, and even allows a waiver request to be made “[i]n an emergency ... by telephone or other rapid communication," id. The “Accelerated Approval” program provides a truncated approval process for “certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” Id. § 314.500. The FDA categorizes some new drugs, including nearly all cancer drugs, as "priority drugs” and seeks to accelerate their availability.
. 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 714-15. 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,
. We nonetheless have serious doubt about whether the Alliance's description of its proposed constitutional right could ever pass constitutional muster. The Alliance's claimed right depends on a regulatory determination that the drug is safe for testing, prompting an obvious question: How can a constitutional right be defined by an administrative regulation that is subject to change? Would an FDA decision requiring increased testing for safety and efficacy before the commencement of human clinical trials affect the Alliance’s constitutional right? Moreover, we find it difficult to imagine how a right inextricably entangled with the details of shifting administrative regulations could be “deeply rooted in this Nation's history and tradition and implicit in the concept of ordered liberty.” Glucksberg,
. Drug regulation also has a long history in England, beginning no later than Henry Vi's royal decree in 1447 that gave grocers the power to inspect “anis, wormseed, rhubarb, scammony, spikenard, senna and all sort of drugs belonging to medicine, so as not, in the buying of these to be hurt in their bodily health.” Edward Kremers, Kremers and Ur-
. Although not an example of legislative or regulatory intervention, in 1630 Nicholas Knopp of Massachusetts was "fined five pounds, or was whipped, for vending as a cure for scurvy ‘a water of no worth nor value,’ which he 'soldé att a very deare rate.' ” James Harvey Young, The Toadstool Millionaires: A Social History of Patent Medicines in America Before Federal Regulation 16 (1961) (quoting Records of the Governor and Company of the Massachusetts Bay in New England (Boston, 1853), I, 83).
. As the Alliance notes, “the Supreme Court held that the 1906 Act did not prohibit a drug manufacturer from marketing an ineffective cancer remedy with false therapeutic claims, so long as it was not adulterated.” Appellants’ Br. at 45 (citing United States v. Johnson,
. Looking to Lawrence v. Texas, the FDA argues that "[tjhe history of the FDCA over the past seventy years is entitled to particular weight in the substantive due process calculus,” Appellees' Br. at 31, because, in determining the constitutionality of a Texas statute prohibiting certain intimate sexual conduct between members of the same sex, the Supreme Court looked to the Nation's "laws and traditions in the past half century ” as having the "most relevance” to the constitutional dispute in that case. Lawrence v. Texas,
. In fact, the FDA cites numerous examples in which drugs have been pulled from the market pоst-Phase I due to safety concerns. See, e.g., Alex Berenson, End of Drug Trial Is a Big Loss for Pfizer and Heart Patients, N.Y. Times, Dec. 4, 2006, at A1 (highlighting Pfizer's decision to pull torcetrapib from a clinical trial of more than 15,000 patients because tnose Laking the drug were dying at a greater rate than those taking a placebo); Milton Packer et ah, Effect of Oral Milrinone on Mortality in Severe Chronic Heart Failure, 325 New Eng. J. Med. 1468 (1991) (concluding after expanded clinical trials that milrinone therapy was "associated with a 28 percent increase in mortality”); Debra S. Echt et ah, Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo, 324 New Eng. J. Med 781 (1991) (concluding after expanded clinical trials that “[tjhere was an excess of deaths ... in patients treated with encainide or flecainide”).
. In exercising the caution the Supreme Court demands when analyzing claims of fundamental rights, see Glucksberg,
It was not just advances in statistics and clinical trials, however, that improved governments' ability to regulate access to drugs. The ability of scientists to "detect, identify, and understand” the components of various drugs has contributed to "new regulatory approaches [that] would not have been feasible and could never have oсcurred” without these scientific advances. Peter Barton Hutt, The Importance of Analytical Chemistry to Food and Drug Regulation, 38 Vand L.Rev. 479, 487 (1985). Further, the need for efficacy regulation became more pressing "[a]fter World War II[as] the number of drugs available, the range of diseases and conditions amenable to drug therapy, and the power of drugs all increased dramatically.” Peter Temin. Taking Your Medicine- Drug Regulation in the United States 5 (1980).
. The Supreme Court in Glucksberg specifically disapproved of recognizing new fundamental rights solely based upon "abstract concepts of personal autonomy.” Glucksberg,
. As an initial matter, the Oakland Court noted that "it is an open question whether federal courts ever have authority to recognize a necessity defense not provided by statute." Id. (emphasis added). "Even at common law, the defense of necessity was somewhat controversial. And under our constitutional system, in which federal crimes are defined by statute rather than by common law, it is especially so.” Id. (internal citations omitted). The Court did "not decide, however, whether necessity can ever be a defense when the federal statute does not expressly provide for it,” Oakland,
. The lynchpin of the dissent's argument that preventing access to experimental drugs implicates a right to preserve one’s own life is that we have confused “what is necessary with what is sufficient.” Dissent at 715, 718. Because terminally ill patients have no other approved treatment options, so the argument goes, any drug having passed Phase I, no matter the remaining unexplored risk, is "necessary” for prolonging a patient's life. But the dissent ignores the fact that when these treatment decisions are being made, the safety and efficacy records of experimental drugs are not fully known. We thus cannot know until after the clinical testing process has been completed that these drugs are in fact necessary. This argument also defies reality as the great majority of experimental drugs ultimately provide no benefit, and we fail to see how an ineffective and unsafe drug can be classified as necessary. See, e.g., Peter D. Jacobson & Wendy E. Parmet, A New Era
. See also Casey,
. To be sure, we do not suggest that the law can never strike the balance between access to experimental drugs and risk that the Alliance suggests. We limit our analysis to whether the Constitution demands the balance they desire. The Alliance can, of course, advocate its position vigorously before Congress and the FDA, and convince our Nation's democratic branches that the values the Alliance favors should be protected. In fact, within the last year, the political branches have responded to the concerns of the Alliance and others. The FDA recently issued a notice of proposed rulemaking that:
propos[ed] to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The proposed rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies.
Expanded Access to Investigational Drugs, 71 Fed.Reg. 75,147-01, 75,147 (Dec. 14, 2006).
. No circuit court has acceded to an affirmative access claim. See, e.g., Mitchell v. Clayton,
. As there exists no deeply rooted right, we need not examine whether a right of access to experimental drugs is " 'implicit in the concept of ordered liberty,’ such that 'neither liberty nor justice would exist if they were sacrificed.' " Glucksberg,
. We are mindful of the fact that this case is before us pursuant to the FDA’s motion to dismiss, brought under Federal Rule of Civil Procedure 12(b)(6). The Seventh Circuit has noted some tension between the Rule 12(b)(6) standard and rational basis review. See Wroblewski v. City of Washburn,
Dissenting Opinion
with whom
Today, the court rejects the claim that terminally ill patients who have exhausted all government-approved treatment options have a fundamental right to access investigational new drugs. The court’s opinion reflects a flawed conception of the right claimed by the Abigail Alliance for Better Access to Dеvelopmental Drugs and a stunning misunderstanding of the stakes. The court shifts the inquiry required by Washington v. Glucksberg,
These missteps lead the court to rely upon how rights and liberties have been limited and restricted—addressing regulations to prevent fraud in the sale of misbranded and adulterated medications or safety restrictions applicable to all medicines for any palliative purpose—which says little about the historic importance of the underlying right of a person to save her own life. Likewise, in its treatment of the common law doctrines of necessity, interference with rescue, and self defense, the court points to evolved limitations on those doctrines while ignoring the core concerns that animate them, namely the special importance of life and attempts to preserve it. That the ultimate protection of such varying attempts to save life is cabined by the precedents—regarding what constitutes “necessity,” the related “necessity” of any aid being given to a third party, and the “reasonable” and “necessary” limitations on any force used in self-defense—does not suggest the absence of an underlying right to attempt to protect life, but rather the recognition of competing governmental interests that in various circumstances justify the deprivation of or a limitation upon the right.
The common law doctrines remain good evidence of a history and tradition of prоtecting life and attempts to preserve life as a deep-seated personal right. That the right may be and has been denied in the face of compelling governmental interests is no reason for conflating the two stages of the analysis and looking only to the results of past cases in order to avoid the analysis prescribed by the Supreme Court in Glucksberg,
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 them physicians. The court commits a logical error of dramatic consequence by concluding that the investigational drugs are somehow not “necessary.” Op. at 708 & n. 15; accord id. at 709. 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.
It bears outlining the history and common law basis for the Alliance’s claim in order to demonstrate, оnce again, that the history and traditions of this Nation support the right of a terminal patient, and not the government, to make this fundamentally personal choice involving her own life. Because judicial precedents and the historical record require strict scrutiny before upsetting rights of this magnitude, the FDA must demonstrate a compelling governmental interest before its policy restricting access can survive. Accordingly, I would remand the case to the district court to make the initial determination as to whether FDA has met its burden, and I respectfully dissent.
I.
The Fifth Amendment of the Constitution proscribes the “deprivation] of life, liberty, or property.” U.S. Const, amend. V. The Alliance claims a corollary to the right to life itself, namely the right to attempt to preserve it. As alleged by the Alliance, this right is deprived without due process of law when the FDA makes it practically impossible for Alliance members for whom conventional treatments have failed to access investigational new drugs that have been approved for substantial human testing. Under Glucksberg,
A.
The Glucksberg analysis begins with a “ ‘careful description’ of the asserted fundamental liberty interest.”
The court fundamentally misunderstands the right claimed by the Alliance and trivially casts it as a function of the regulatory scheme. See Op. at 702 n. 6. But the Alliance should not be penalized for anticipating a justification for infringing the right that might survive strict scrutiny. Applying the court’s reasoning today, had “Jane Roe” been prescient enough to claim a right to abort a previable fetus by a procedure that is demonstrably safer than all other alternatives, cf. Gonzales v. Carhart, — U.S. --,
1. The heritage of this right predates the Founding. Samuel Adams referred to “the duty of self preservation” as “the first law of nature.” Samuel Adams, The Rights of the Colonists: Report of the Committee of Correspondence to the Boston Town Meeting, 7 Old South Leaflets 417 (No. 173) (Burt Franklin 1970) (1772). The common law’s eminent commentator, William Blackstone, wrote of thrеe “principal or primary articles” historically comprising “the rights of all mankind.” First among these was “[t]he right of personal security ... in a person’s legal and uninterrupted enjoyment of his life, his limbs, his body, [and] his health.” William BlaCkstone, 1 Commentaries *129. Blackstone described the guarantee of “[t]he preservation of a man’s health from such practices as may prejudice or annoy it.” Id. at *134. This right included the right to self-defense and the right to self-preservation. “For whatever is done by a man to save either life or member, is looked upon as done upon the highest necessity and compulsion.” Id. at *130.
This principle is of early vintage, for “Anglo-American law starts with the premise of thorough-going self determination.” Natanson v. Kline,
2. This historical entitlement recognized in the legal tradition of this Nation is reflected in rights recognized at common law that are retained by an individual. Most notably, the right of self-defense enforces the right of a person facing death to take reasonable steps to protect her own life. Although this right is not unqualified, self-defense has been described as “an inherent right of man, older than states or Constitutions.” People v. Pignatoro,
Aside from asserting that this case is not about efforts to preserve one’s life, but rather the “right to assume any level of risk,” the court further avoids the doctrines of self-defense and necessity by asserting that Congress can override the common law. See Op. at 709. This is true but irrelevant. It was also true in Cruzan v. Director, Missouri Department of Health,
The common law also recognized the right of protection against interference with rescue. This right is infrequently invoked, but as early as 1889, it was acknowledged by the highest court of the State of Maryland, which explained that even prolongation of a fading life was not to be obstructed:
Surely the law does not authorize the husband to say to his wife; “You shall die of the cancer; you cannot be cured, and a surgical operation affording only temporary relief, will result in useless expense.” The husband had no power to withhold from his wife the medical assistance which her case might require.
State v. Housekeeper,
The common law protection, of course, is for rescues that are reasonably necessary. In an effort to distinguish this historical protection, the court relies upon the fact that the new investigational drugs “have not been shown to be safe, let alone effective at (or ‘necessary’ for) prolonging life.” Op. at 708. But this confuses what is necessary with what is sufficient. This is not a case about elective medical treatments. Without access, Alliance members will die. No doubt the deceased members of the Alliance who were denied access to experimental drugs that were subsequently approved by the FDA would have been surprised to learn that these drugs, under the court’s analysis, were unnecessary to the preservation of their lives. See Br. of Appellants at 31 n. 15; Reply Br. of Appellants at 23. See generally Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach,
Throughout its discussion of self-defense and interference with rescue, the court recognizes that common law rights are not unlimited but fails to acknowledge that the evolved limitations on hallowed rights do not undercut the core concerns that animate them—here, the special importance of life and attempts to preserve it. That the ultimate protection of such varying attempts to save life is cabined by precedents discussing “necessity” speaks not to the absence of an underlying right to attempt to protect life but rather to the recognition of competing governmental interests that in various circumstances justify the deprivation of or a limitation upon the right. .Whether similar countervailing interests exist in this case is a question bearing on the resolution of strict scrutiny analysis, not on whether it should apply.
3. Although the Supreme Court has not squarely addressed the right to use potentially life-saving medications, it has developed a sizable body of law regarding the right to a potentially life-saving medical procedure when the life or health of a pregnant woman is on the line. In Roe,
In Stenberg v. Carhart,
Consequently, for the court to conclude that the Supreme Court has not already decided that medical self-preservation is fundamental, the court is forced to conclude that when a patient’s life is on the line, medical procedures like abortion are to be analyzed differently than medical treatments consisting of prescription medications. To draw this distinction, the FDA offers only the empty assertion that “the right to abort a fetus to save the life or health of the mother is simply an aspect of the underlying constitutional right of abortion recognized in Roe.” Brief for Appellees at 39. This ipse dixit cannot be reconciled with the fact that a woman’s right to end a life-threatening pregnancy has long been uncontroversial in the face of state statutory prohibitions against abortion and distinct from the considerations that otherwise bear on the procedure. “The criminal abortion laws passed in every state by 1880 made exceptions for therapeutic abortions performed in order to save a woman’s life.” Leslie J. Reagan, When AboRtion Was a CRIME 5 (1997). Reaching farther back into history, as the Supreme Court discussed in Roe:
The Ephesian, Soranos, often described as the greatest of the ancient gynecologists, appears to have been generally opposed to Rome’s prevailing free-abortion practices. He found it necessary to think first of the life of the mother, and he resorted to abortion when, upon this standard, he felt the procedure advisable.
The court chooses not to distinguish the abortion cases on this flimsy basis but its approach is no less startling. The court holds that because the Alliance seeks access only to “potentially life-saving drugs,” Op. at 710 (emphasis in original), the abortion cases are distinguishable. Nowhere in the Supreme Court’s jurisprudence has it intimated that the government may ban procedures that represent a patient’s only chance of survival because they might not be successful. The fundamental right does not accrue only upon a demonstration of surefire actualization; the trigger is the necessity, which is crucially different from the sufficiency to which the court repeatedly refers. Indeed, in Stenberg, the Supreme Court addressed the level of medical consensus needed for a procedure to become protected, holding that procedures supported by “substantial medical authority” could not be proscribed. See
Although the FDA does not contend that its approval process reflects the Stenberg standard, the court nonetheless makes the wholly unsupported assertion that “the collective judgment of the scientific and medical communities [is] expressed through the FDA’s clinical testing process.” Op. at 709. To the contrary, the Alliance specifically alleges in attachments to its complaint that the FDA has denied terminally ill Alliance members access to investigational new drugs “reported to have great potential,” Decl. of Carole Steele ¶ 3, and acknowledged by the “medical community” as “far and away ... superior to anything then available,” Decl. of Victoria Jean Doran ¶ 2. At this stage of the proceedings, the court is required to accept the Alliance’s allegations as true. See, e.g., Broudy v. Mather,
There is, then, no merit to the FDA’s suggestion adopted by the court that in the medical context there can be no deeply rooted privilege to attempt to save one’s
B.
Against this substantial historical record demonstrating the deep roots of the right to preserve one’s own life, it is no coincidence that neither the court nor the FDA can marshal evidence from the early history of the Nation demonstrating that the federal government or any state thought to restrain the terminally ill from accessing medical treatmеnts and procedures that had not proven unsafe but were of unknown efficacy. Still, the court asserts that “a lack of government interference ... cannot be enough” to demonstrate that a right is deeply rooted. This reasoning is misguided.
First, the most fundamental rights are those that no government of the people would contemplate abridging—it is doubtful that many courts or legislatures have discussed whether the government can determine whether we are allowed to breathe air, but this does not make our access to oxygen any less grounded in history. Cf. U.S. Const, amend. IX (stating that “[t]he enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people”). In considering whether the terminally ill patient’s interest in self-preservation is protected by the Due Process Clause, the court overlooks the most fundamental evidence of the protection that the Alliance claims, namely that the words “life” and “liberty” are in the Due Process Clause itself. The right to life, and the asserted corollary right to attempt to preserve life, is not a second derivative species of “liberty” whose protection by the Constitution should be approached with skepticism. Insofar as courts should be skeptical of interfering with the legislative debate and ongoing democratic discussions about fundamental issues of life and death, that skepticism is better applied to the latter portion of the strict scrutiny analysis—the evaluation of the competing government interests and the greater or lesser narrowness of the tailoring required in the face of scientific uncertainty and conflicting opinions. See Abigail Alliance I,
Second, the Supreme Court’s statements on fundamental rights do not support the court’s conclusion. In Glucksberg itself, the Supreme Court determined that the claimed right to assisted suicide was not deeply rooted because “for over 700 years, the Anglo-Americаn common-law tradition has punished or otherwise disapproved of both suicide and assisting suicide.”
Fourth, in the altеrnative, the court shifts the target and looks to historical evidence of regulation for safety. The court claims that post-Phase I testing is designed not only to test a drug’s efficacy but also to continue monitoring its safety. Op. at 703. As support, the court lists instances in which drugs have been removed from the market after Phase I because of safety concerns. See id. at 706 n. 11. This inquiry confuses the right—to save one’s life—with the alleged deprivation, which here occurs by means of an agency policy. Whether the FDA policy actually impermissibly infringes upon the asserted right is a factual question that is not properly resolved at the motion-to-dismiss stage when all reasonable inferences must be drawn to the plaintiffs benefit, see, e.g., Broudy,
By redirecting its inquiry, the court conveniently avoids the sparse history of drug regulation for efficacy. See Abigail Alliance I,
Only in 1962 did Congress require drug manufacturers to provide empirical evidence of the effectiveness of a drug as opposed to evidence of the drug’s safety.
Despite the increased federal scrutiny of new drugs, important aspects of patient access to drugs are unregulated by the government and appear always to have been unregulated. The “FDA’s regulatory authority ... extends to manufacturers of drugs but not to the physicians who dispense them.”
For more than half of this Nation’s history, then, until the enactment of the 1906 Act, a person could obtain access to any new drug without any government interference whatsoever. Even after enactment of the FDCA in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs’ efficacy. Rather, at that time, the FDA could interrupt the sale of new drugs only if it determined that the new drug was unsafe. Government regulation of such drugs premised on concern over a new drug’s efficacy, as opposed to its safety, is of very recent origin. Even today, a patient may use a drug for unapproved purposes where the drug may be unsafe or ineffective for the off-label purpose. In short, encumbrances on the treatment decisions of a patient and her physician lack the historical pedigree of the rights that the Alliance seeks to vindicate.
Instead of confronting this history, the court relies on statutory restrictions that address misbranded or adulterated drugs, sales of poisons, and fraudulent curative claims, see Op. at 704-05 & n. 8, government restrictions that are not inconsistent with the right of a person to attempt to save her own life. Nоne of the cited restrictions, focusing largely on the licensing of pharmacists, suggest a physician could not prescribe a new medication for a terminal patient. While Congress has imposed increased responsibilities on the drug industry and the FDA upon evidence of tragic consequences of some new drugs as a result of new technology, see Abigail Alliance I,
The common law traditions protecting necessity, forbidding interference with rescue, and supporting self-defense, and the Supreme Court’s validation of the fundá
II.
For a right to be fundamental, the Glucksberg analysis requires that it also be “ ‘implicit in the concept of ordered liberty,’ such that ‘neither liberty nor justice would exist if they were sacrificed,’ ” Glucksberg,
Unlike Glucksberg's historical inquiry, this step assesses whether the Alliance’s claimed right is a component of the “compendious expression for all those rights which the courts must enforce because they are basic to our free society.” Wolf,
Setting aside the textual anchor of the Alliance’s claim in the right to life, the claimed right also falls squarely within the realm of rights implicit in ordered liberty. The core of liberty is autonomy. As Professor Charles Fried writes, “[ljiberty is the exercise of our powers as self-conscious, judging individuals, individuals who in making our own lives cannot be responsible to anyone ... else except as we choose to be.” ChaRles Fried, Modern Liberty 180 (2007). It is difficult to imagine any context in which this liberty interest would be stronger than in trying to save one’s own life. Cf. Brian Clark, Whose Life Is It Anyway? (1978).
The Supreme Court engaged in similar analysis in Cruzan. In evaluating the claim that due process protects a person’s right to refuse life-sustaining treatment, the Court reasoned that “it cannot be disputed that the Due Process Clause pro
In summary, there is no logic to be found, in view of oft-limited rights considered inherent in the nature of ordered liberty, see Abigail Alliance II,
III.
For these reasons, I have serious disagreements with the court’s assessment of the Alliance’s claim to a fundamental right protected by the Fifth Amendment to the Constitution. It is no more than tragic wordplay to suggest that the Alliance’s liberty claim to potentially life prolonging medications, when no other government approved alternatives exist, does not involve a corollary to the right to life enshrined in the Fifth Amendment to the Constitution. See Op. at 701 n. 5. Denying a terminally ill patient her only chance to survive without even a strict showing of governmental necessity presupposes a dangerous brand of paternalism. As the court phrases it, because “[w]e ... cannot know until the clinical testing process has been completed that these drugs are necessary,” Op. at 708-09 n. 15 (emphasis added), the terminally ill patient, informed by her physician, is denied a right to decide whether to bear those risks in an attempt to preserve her life. Such intervention is directly at odds with this Nation’s history and traditions giving recognition to individual self-determination and autonomy where one’s own life is at stake and should extend no further than the result in this case. Because the right of a terminally ill patient to access potentially life-saving investigational medications satisfies the Glucksberg test, I would remand this case for the district court to assess in the first instance whether there exists a compelling governmental interest, narrowly tailored, to overcome the Alliance’s interest. Flores,
. The Glucksberg framework arose from a situation involving a non-literal liberty interest. Although, as described below, the right to act to preserve one's оwn life passes the test laid down in that case, the healthy skepticism that Glucksberg prescribed for new-fangled non-literal liberty interests may be unduly restrictive as applied to a claim with a firm textual anchor in the right to life expressly protected by the Fifth Amendment to the Constitution.
. Similarly, the Tenth Circuit has held that although parents have a fundamental constitutional right to direct the education and upbringing of their children, this right does not "allow parents to dictate that their children will attend public school for only part of the school day.” Swanson ex rel. Swanson v. Guthrie Indep. Sch. Dist. No. I-L,
. A person may assert self-defense rights against animals. See, e.g., People v. Lee,
. See, e.g., Beck v. Haik,
. Although the FDA does not stop examining drug safety after Phase I, nor does it stop after drugs receive full marketing approval. The FDA has pulled approved such drugs from the market, but it does not follow that the FDA can take any action abridging any right, related or not, on the basis of its legitimate interest in safety. At a certain point, the FDA determines that a drug is safe enough for widespread testing, and the Alliance alleges that this marker is Phase I approval, where the FDA authorizes expanded testing in up to "several hundred subjects,” Am. Compl. ¶ 14; 21 C.F.R. § 312.21. In fact, between 1997 and 2000, 5.34 percent of fully approved new drugs were pulled from the market. Kris Hundley, Drug’s Chilling Path to Market, St. Petersburg Times, May 27, 2007, at 1A. Since then, many more approved drugs have been withdrawn. See, e.g., Press Release, Food & Drug Admin., FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons (Mаrch 30, 2007), http://www.fda. gov/bbs/topics/NEWS/2007/NEW01597.html; Press Release, Food & Drug Admin., FDA Announces Voluntary Withdrawal of Pergolide Products (March 29, 2007), http://www. fda.gov/bbs/topics/NEWS/2007/NEW01596. html (Permax); Press Release, FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons (July 13, 2005), http://www.fda.gov/ bbs/topics/news/2005/NEW01205 .html; Press Release, Food & Drug Admin., FDA Issues Public Health Advisory on Tysabri, A New Drug for MS (Feb. 28, 2005), http://www.fda. gov/bbs/topics/news/2005/NEW01158.html; Press Release, Food & Drug Admin., FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product (Sept. 30, 2004), http://www.fda.gov/ bbs/topics/news/2004/NEW01122.html; see also, e.g., Press Release, Food & Drug. Ad
. See Charles J. Walsh & Alissa Pyrich, Rationalizing the Regulation of Prescription Drugs and Medical Devices: Perspectives on Private Certification and Tort Reform, 48 Rutgers L.Rev. 883, 890-91 (1996); Lois K. Perrin, Note, The Catch-22 for Persons with AIDS: To Have or Not To Have Easy Access to Investigational Therapies and Early Approval for New Drugs, 69 S. Cal. L.Rev. 105, 109 (1995); see also Gonzales v. Raich,
. See Steven R. Salbu, Regulation of Drug Treatments for HIV and AIDS: A Contractarian Model of Access, 11 Yale J. on Reg. 401, 406-09 (1994); James L. Zelenay, Jr., The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?, 60 Food & Drug L.J. 261, 263-64 (2005); cf. Minnesota ex rel. Whipple v. Martinson,
. See Salbu, supra note 7, at 407.
. See Zelenay, supra note 7, at 264-65.
. Id.
. See Michael D. Greenberg, AIDS, Experimental Drug Approval, and the FDA New Drug Screening Process, 3 N.Y.U. J. Legis. & Pub. Pol'y 295, 295, 300 & n. 23 (1999-2000).
. See Salbu, supra note 7, at 408 n. 41. See generally Harvey Tefp & Colin R. Munro, Thalidomide: The Legal Aftermath 1-10 (1976); Janssen, Outline of the History, supra note 6, at 438.
. See Walsh & Pyrich, supra note 6, at 901; see also Zelenay, supra note 7, at 266.
. Steven R. Salbu, Off-Label Use, Prescription, and Marketing of FDA-Approved Drugs:
. See David C. Radley et al., Off-Label Prescribing Among Office-Based Physicians, 166 Archives Internal Med. 1021 (2006) (studying 2001 data of office-based physicians).
. See Salbu, supra note 14, at 189-92.
. See id. at 211.