ROGERS, Circuit Judge: The Abigail Alliance for Better Access to Developmental Drugs ("the Alliance") seeks to enjoin the Food and Drug Administration ("FDA") from continuing to enforce a policy barring the sale of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently safe for expanded human testing (hereafter "post-Phase I investigational new drugs"). More specifically, the Alliance seeks access to potentially life-saving post-Phase I investigational new drugs on behalf of mentally competent, terminally ill adult patients who have no alternative government-approved treatment options (hereafter "terminally ill patients"). The Alliance contends that the FDA's policy violates the substantive due process rights to privacy, liberty, and life of its terminally ill members. The complaint presents the question of whether the Due Process Clause protects the right of terminally ill patients to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational new drugs that the FDA has yet to approve for commercial marketing but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing on a substantial number of human beings.

Upon applying the Supreme Court's test for addressing substantive due process claims . . . , we [recognize] . . . the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor's advice, even where that medication carries risks for the patient. . . .

I.

A.

The Food, Drug, and Cosmetic Act ("FDCA") prohibits drug manufacturers from introducing any "new drug" into interstate commerce until manufacturers have applied for, and received, FDA approval.  Before a new drug is eligible for full approval and marketing, the Secretary of the U.S. Department of Health and Human Services must find "substantial evidence that the drug will have the effect it purports or is represented to have."  Exempted from this general ban are new drugs "intended solely for investigational use by experts . . . ."

The FDCA directs the Secretary to promulgate regulations for testing new drugs.  Pursuant to this authority, the FDA has promulgated regulations that require three phases of government testing on humans before investigational new drugs can receive FDA approval and enter the commercial marketplace.  In Phase I, new drugs are tested on 20 to 80 human subjects to determine "the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness."  It takes approximately one year to conduct Phase I testing.  FDA counsel acknowledged at oral argument that drugs that survive this phase have been deemed "sufficiently safe for substantial human testing, but [are] not yet proven to be safe and effective to the satisfaction of the FDA [to be commercially marketed]."  Phase II involves targeted, controlled clinical studies of up to several hundred human subjects "to evaluate the effectiveness of the [Phase I investigational new] drug . . . and to determine the common short-term side effects and risks associated with the drug."  Phase III expanded trials, which can include several thousand human subjects, are "performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug . . . ."  With narrow exceptions, FDA regulations require informed consent to be obtained from clinical trial participants.

B.

On January 16, 2003, the Alliance submitted a proposal to the FDA for new regulations to render post-Phase I investigational new drugs available to terminally ill patients who were not admitted to the FDA's clinical trials. The FDA rejected the proposal by letter dated April 25, 2003, outlining the FDA's policy. . . .

The Alliance filed suit against the FDA Commissioner and the Secretary of the Department of Health and Human Services, seeking to enjoin the FDA from enforcing the policy barring the sale of post-Phase I investigational new drugs to terminally ill patients not in Phase II clinical trials. Noting that the FDA has administrative discretion to define several stages for human testing of new drugs after animal testing has been conducted, the complaint alleges that it takes, on average, just under seven years for investigational new drugs to complete the three phases of clinical human trials and receive FDA approval for commercial marketing and thus become eligible for purchase by persons not in FDA clinical trials. The complaint also alleges that non-commercial options provide relief only to a very small number of terminally ill patients as spaces in clinical trials are "very limited . . . in relation to the need."  The Alliance asserts that clinical human trials are limited in number and by type of patient who qualifies.  Further, the FDA's "compassionate use" programs, which permit drug companies voluntarily to provide new drugs at cost during the pre-approval period, are available only to "a fraction of those in desperate need."  Although the FDA may permit "treatment use" of unapproved new drugs, and has allowed access for limited groups of persons with AIDS,  the FDA has refused as a general matter to allow terminally ill patients to have access to investigational new drugs that have successfully completed Phase I trials. Consequently, the complaint alleges, the effect of the FDA policy, as illustrated by the examples of the deaths of four terminally ill patients, has been to deny terminally ill patients the choice to use post-Phase I investigational new drugs despite the patients' willingness "to assume risks if their physicians advise them that a treatment may save or prolong their lives and if they have no other viable options.". . .

II.

The Due Process Clause of the Fifth Amendment to the United States Constitution provides that "no person shall be . . . deprived of life, liberty, or property, without due process of law."  The Supreme Court has held that the Clause "guarantees more than fair process" and accords substantive protection to the rights it guarantees. . . . 

  Although the Supreme Court has never explicitly said so, and we need not decide the matter here, it appears the Supreme Court has employed two distinct approaches when faced with a claim to a fundamental right. In some cases, the Court has discerned the existence of fundamental rights by probing what "personal dignity and autonomy" demand.  In other cases, the Court has derived fundamental rights by reference to the Nation's history and legal tradition. . . .  The [first] approach is succinctly captured by Casey's characterization of substantive due process rights as those that involve "the most intimate and personal choices a person may make in a lifetime, choices central to personal dignity and autonomy." Casey, 505 U.S. at 851.

The other approach for determining whether a claimed right warrants substantive due process protection, which appears to be more restrictive, has two "features." Under Glucksberg, courts must inquire whether the fundamental right asserted is "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 [it] were sacrificed,"  Additionally, in order to ensure that courts do not multiply rights without principled boundaries, courts must provide a "careful description of the fundamental liberty interest."  If a court concludes that the claimed right is a fundamental right entitled to protection under the Due Process Clause, then the burden shifts to the government to show that its encroachment upon the right "is narrowly tailored to serve a compelling [governmental] interest."

Because we conclude, upon applying the seemingly more restrictive analysis of Glucksberg, that the claimed right warrants protection under the Due Process Clause, we need not decide whether the line of cases construing the concept of "personal dignity and autonomy" would also lend protection to the claimed right.

III.

. . . .  

A.

One feature of the Glucksberg analysis requires courts to compose a "careful description" of the asserted fundamental liberty interest before extending due process protection to it.  The Supreme Court has not settled on how precisely formulated the right must be. Two Justices have interpreted the "careful description" requirement as indicating that courts should identify fundamental rights at the "most specific level at which a relevant tradition protecting, or denying protection to, the asserted right can be identified." Michael H., 491 U.S.  at 127 n.6  (1989) (Scalia, J., with Rehnquist, C.J., concurring). Two other Justices have indicated that asserted rights not expressed at "'the most specific level' [of generality] available" can nonetheless be recognized. Id. at 132 (O'Connor and Kennedy, JJ., concurring) . . . .

The Alliance's complaint contains the careful description we seek, allowing this court to consider whether the challenged FDA policy impinges upon one or more of the interests protected by the Due Process Clause. The FDA characterizes the Alliance's claimed right as a broadly stated prerogative to access post-Phase I investigational new drugs and to receive treatment, but the Alliance has defined the right more narrowly. The Alliance claims neither an unfettered right of access to all new or investigational new drugs nor a right to receive treatment from the government or at government expense. The Alliance's claim also does not challenge the Controlled Substances Act, 21 U.S.C. § §  801 et seq., or the government's authority to regulate substances deemed harmful to public health, safety, and welfare. Rather, the Alliance contends that the fundamental due process rights to privacy, liberty, and life include the right of terminally ill patients, acting on a doctor's advice, to obtain potentially life-saving medication when no alternative treatment approved by the government is available. Recognizing that the effectiveness and side effects of the investigational new drugs may still be in question after the Phase I trials have been completed, the Alliance asks only that the decision to assume these known or unknown risks be left to the terminally ill patient and not to the FDA. This description of the claimed right conforms to the demands of even the narrowest interpretation of the Glucksberg "careful description" requirement.

B.

The other feature of the Glucksberg inquiry requires courts to determine whether there exists a long-standing tradition in our Nation that would protect individual access to potentially life-saving medication. . . .  Although it is relevant to the substantive due process analysis that the government has never proscribed the desired conduct, this is not dispositive. The absence of regulation could be attributable to a liberty interest that is deeply rooted in this Nation's history and tradition, and therefore characterized by a history of liberty from governmental interference, but there may be another explanation. For example, a lack of regulation might indicate only that the technology of yesteryear did not warrant it.

The FDA's discussion of the merits of this question consists of a single sentence: "[The] FDA has had statutory authority to regulate drugs for almost a century, and that authority is now firmly ingrained in our understanding of the appropriate role of government."  We offer the following observations, mindful of the fact that the Alliance is complaining only of obstacles to post-Phase I investigational new drugs erected by the FDA and not obstacles that might be erected by state consumer protection or other laws.

A right of control over one's body has deep roots in the common law. The venerable commentator on the common law William Blackstone wrote that the right to "personal security" includes "a person's legal and uninterrupted enjoyment of his life, his limbs, his body, [and] his health," as well as "the preservation of a man's health from such practices as may prejudice or annoy it."  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."  As recognized throughout Anglo-American history and law, when a person is faced with death, necessity often warrants extraordinary measures not otherwise justified. Indeed the principle holds even when that action impinges upon the rights of others. See, e.g., Ploof v. Putnam, 71 A. 188 (1908) ("This doctrine of necessity applies with special force to the preservation of human life. . . . One may sacrifice the personal property of another to save his life or the lives of his fellows.") . . . .  Barring a terminally ill patient from the use of a potentially life-saving treatment impinges on this right of self-preservation.

Such a bar also puts the FDA in the position of interfering with efforts that could save a terminally ill patient's life. Although the common law imposes no general duty to rescue or to preserve a life, it does create liability for interfering with such efforts. Section 326 of the Restatement (First) of Torts, first published in 1934, explained that

one who, without a privilege to do so, intentionally prevents a third person from giving to another aid necessary to his bodily security, is liable for bodily harm caused to the other by the absence of aid which he has prevented the third person from giving.

While infrequently invoked, this common law rule is of venerable vintage.

In contrast to these ancient principles, regulation of access to new drugs has a history in this country that is of recent origin. Prior to 1906, there was essentially no drug regulation in the United States.  In that year Congress enacted the Pure Food and Drug Act ("1906 Act"), which prohibited misbranded and adulterated foods or drugs from entering interstate commerce and prohibited false and misleading labeling. . . .  The 1906 Act did not, however, limit individual access to new drugs or regulate therapeutic claims by drug manufacturers.  It thus appears that a patient still could obtain access to any new drug for medicinal use, even if the drug had no therapeutic benefit, albeit subject to the controls placed on narcotics in 1914 by the Harrison Narcotic Act.

In 1938, Congress enacted the FDCA in response to the deaths of more than one hundred people, many of them children, from ingesting Elixir Sulfanilamide, which had been marketed as an antibiotic.  For the first time, Congress required that drug manufacturers test, and the FDA review, all new drugs for safety prior to their commercial distribution.  Under the 1938 Act, a new drug could be commercially marketed only after the manufacturer filed a New Drug Application ("NDA") with the FDA that set forth medical and scientific information attesting to the drug's safety. The 1938 Act did not, however, require drug manufacturers to receive affirmative FDA approval before marketing the drug.  Rather, an NDA became automatically effective within a time frame set by the FDA unless the FDA determined that the drug was unsafe and barred its commercial distribution.  It was not until 1951, in the Durham-Humphrey Amendment, that Congress created the category of prescription drugs, i.e., drugs that are unsafe for self-medication but which can be used while under a doctor's supervision.

    Only in 1962 did Congress require drug manufacturers to provide empirical evidence of the effectiveness of a drug as opposed to merely the drug's safety.  The Kefauver-Harris Amendments were enacted in response to the rash of birth defects discovered in babies whose mothers had taken Thalidomide to ease morning sickness caused by pregnancy.  The Kefauver-Harris Amendments transformed drug regulation and the approval process in several respects. First, the Amendments required the FDA to review a new drug for both safety and effectiveness and specified that to demonstrate effectiveness manufacturers were required to submit data from "adequate and well-controlled investigations.”  Second, the Amendments authorized the FDA to approve human clinical trials, regulate drug advertising, inspect drug-manufacturing facilities, and promulgate good manufacturing practices.  The Amendments also required drug manufacturers to disclose to the FDA any information they received regarding the adverse consequences of approved drugs.  This legislation set the framework for the system of drug regulation currently in place.

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."  Thus, a doctor may prescribe a drug to a patient for a purpose other than that for which the FDA has approved the use of the drug.  Such "off-label" use may occur even if the drug is not deemed safe or effective for that use.  Further, it appears that the FDA has never prohibited either off-label prescription or off-label use of drugs.  In recent years, the FDA has been moving to permit drug manufacturers to promote the use of their drugs for off-label purposes in limited circumstances.

For over half of our 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' effectiveness.  Rather, at that time, the FDA could only interrupt the sale of new drugs based on its determination that a new drug was unsafe. Government regulation of drugs premised on concern over a new drug's efficacy, as opposed to its safety, is of recent origin. And even today, a patient may use a drug for unapproved purposes even where the drug may be unsafe or ineffective for the off-label purpose. Despite the FDA's claims to the contrary, therefore, it cannot be said that government control of access to potentially life-saving medication "is now firmly ingrained in our understanding of the appropriate role of government" so as to overturn the long-standing tradition of the right of self-preservation.

C.

The Alliance's claim also falls squarely within the realm of rights the Supreme Court has held are "implicit in the concept of ordered liberty."  Specifically, the claimed right is implied by the Court's conclusion in Cruzan that due process protects a person's right to refuse life-sustaining treatment.  Writing for the Court, Chief Justice Rehnquist noted in examining the origins of the doctrine of informed consent that the Court had observed early on that "no right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority of law.”. . .   Without qualification, the Court stated: "It cannot be disputed that the Due Process Clause protects an interest in life as well as an interest in refusing life-sustaining medical treatment."

A similar analysis leads to the conclusion that the Due Process Clause protects the liberty interest claimed by the Alliance for its terminally ill members.  The text of the Due Process Clause refers to protecting "liberty" and "life." Although there is no similarly clear textual basis for a "right to die" or refusing life-sustaining medical treatment, the Supreme Court in Cruzan recognized, in light of the common law and constitutionally protected liberty interests based on the inviolability of one's body, that an individual has a due process right to make an informed decision to engage in conduct, by withdrawing treatment, that will cause one's death.  The logical corollary is that an individual must also be free to decide for herself whether to assume any known or unknown risks of taking a medication that might prolong her life.

   Like the right claimed in Cruzan, the right claimed by the Alliance to be free of FDA imposition does not involve treatment by the government or a government subsidy. Rather, much as the guardians of the comatose patient in Cruzan did, the Alliance seeks to have the government step aside by changing its policy so the individual right of self-determination is not violated.  The Alliance claims that there is a protected right of terminally ill patients to choose to use potentially life-saving investigational new drugs that have successfully cleared Phase I.  If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded "life."  Our reasoning is not unlike that of the Supreme Court in Eisenstadt where the Court held that the right to be free from unwanted government intrusion into the fundamental decision whether to have children establishes a right of access to contraception. . . .

[With respect to prior cases denying a right of terminally ill persons to bypass FDA approval,] the terminally ill patients in [those cases] sought access to laetrile, a new cancer drug that had not cleared FDA's Phase I safety hurdle and thus had not been approved for expanded testing on humans in ongoing clinical trials. . . .  In this case, . . . the Alliance seeks only access to investigational new drugs that the FDA, after Phase I human trials, has deemed sufficiently safe for human testing on a substantial number of human beings. In other words, the Alliance seeks for its members the same right of access enjoyed by those terminally ill patients lucky enough to secure a spot in Phase II trials.

Accordingly, we hold that the district court erred in dismissing the Alliance's complaint pursuant to Rule 12(b)(6) for failure to state a claim. We conclude, upon applying the Glucksberg analysis and heeding the protected liberty interests articulated by the Supreme Court, that where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient's informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause.  The prerogative asserted by the FDA - to prevent a terminally ill patient from using potentially life-saving medication to which those in Phase II clinical trials have access - thus impinges upon an individual liberty deeply rooted in our Nation's history and tradition of self-preservation.  The district court never reached the question of whether the challenged FDA policy violates this protected liberty interest, and we therefore remand the case to the district court to determine whether the FDA's policy barring access to post-Phase I investigational new drugs by terminally ill patients is narrowly tailored to serve a compelling governmental interest.

Dissent by Judge Griffith omitted.