Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach

ROGERS, Circuit Judge,

with whom

Chief Judge GINSBURG joins, dissenting:

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 Developmental Drugs and a stunning misunderstanding of the stakes. The court shifts the inquiry required by Washington v. Glucksberg, 521 U.S. 702, 117 S.Ct. 2258, 138 L.Ed.2d 772 (1997), 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.

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 protecting 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, 521 U.S. at 720-21, 117 S.Ct. 2258. Contrary to today’s view of the court and the Federal Drug Administration (“FDA”), nothing in the prior opinion of the court would give “total weight” to the interests of the terminal patients or deny the FDA the ability to put its competing governmental interests into the balance. The court was explicit on this point, requiring precisely such weighing and proof of the proposed government concerns, rather than merely accepting, under *53the rubric of rational basis scrutiny, any assertions the FDA chooses to offer. See Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 445 F.3d 470, 486 (D.C.Cir.2006) (‘Abigail Alliance 7”) (vacated upon grant of rehearing en banc).

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, once 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, 521 U.S. at 720-21, 117 S.Ct. 2258, a substantive due process right qualifies as fundamental if it is both “ ‘deeply rooted in this Nation’s history and tradition,’ ” id. at 721, 117 S.Ct. 2258 (quoting Moore v. City of E. Cleveland, 431 U.S. 494, 503, 97 S.Ct. 1932, 52 L.Ed.2d 531 (1977) (plurality opinion)), and “ ‘implicit in the concept of ordered liberty,’ ” id. (quoting Palko v. Connecticut, 302 U.S. 319, 325, 58 S.Ct. 149, 82 L.Ed. 288 (1937)).1 If the Alliance has correctly alleged a fundamental right, then the FDA policy can survive only upon *54proof of a compelling government interest that overcomes the liberty interest.

A.

The Glucksberg analysis begins with a “ ‘careful description’ of the asserted fundamental liberty interest.” 521 U.S. at 721-23, 117 S.Ct. 2258. As the court’s opinion in this case demonstrates, the description of the right is of crucial importance—too broad and a right becomes all-encompassing and impossible to evaluate; too narrow and a right appears trivial. See Abigail Alliance I, 445 F.3d at 477. The court asserts that “[t]his case is about whether there is a constitutional right to assume ... ‘enormous risks’ in pursuit of potentially life-saving drugs.” Op. at 710 (emphasis in original) (citation omitted). This description can be characterized as “careful” only if the objective of Glucksberg analysis is to produce abstractions that shield a court from acknowledging the rights underlying a party’s claims. As the court notes, fundamental rights cannot be “solely based upon ‘abstract concepts of personal autonomy.’ ” Op. at 707 n. 13 (quoting Glucksberg, 521 U.S. at 725, 117 S.Ct. 2258). However, were it impermissible to draw any inferences from a broader right to a narrower right, nearly all of the Supreme Court’s substantive due process case law would be out of bounds. See, e.g., Moore, 431 U.S. at 503, 97 S.Ct. 1932 (extrapolating specific right to determine extended family living arrangements from broader constitutional protection for “the sanctity of the family”); Roe v. Wade, 410 U.S. 113, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973) (identifying specific right to terminate a pregnancy from broader right to privacy); Griswold v. Connecticut, 381 U.S. 479, 484-86, 85 S.Ct. 1678, 14 L.Ed.2d 510 (1965) (inferring specific right to use contraception from general right to be free from intrusion into “sacred precincts of marital bedrooms”). In any event, the Alliance’s liberty claims are not grounded in the abstract notion of personal autonomy but rather in the specific right to act to save one’s own life.

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. --, 127 S.Ct. 1610, 1638, 167 L.Ed.2d 480 (2007), she would have failed to show a fundamental right to an abortion.2 Again, the claimed fundamental right is to attempt to preserve one’s life; whether the risks associated with doing so justify restraining that right is properly considered only after the right is deemed fundamental. Under Glucksberg, the court’s analysis should begin with an assessment of whether the right to attempt to preserve life can be found in the Nation’s history and tradition. See Abigail Alliance I, 445 F.3d at 479. A *55review of this history demonstrates that this Nation has long entrusted in individuals those fundamentally personal medical decisions that lie at the core of personal autonomy, self-determination, and self-defense.

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 three “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, 186 Kan. 393, 350 P.2d 1093, 1104 (1960). Long before regulation of the efficacy of medications was contemplated by the federal government, courts recognized with “universal acquiescence” that “the free citizen’s first and greatest right, which underlies all others,” is “the right to the inviolability of his person, in other words, his right to himself.” Pratt v. Davis, 118 Ill.App. 161, 166 (1905), aff'd, 224 Ill. 300, 79 N.E. 562 (1906). So too, this court has recognized “the concept, fundamental in American jurisprudence, that ‘[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body.’ ” Canterbury v. Spence, 464 F.2d 772, 780 (D.C.Cir.1972) (alteration in original) (quoting Schloendorff v. Soc’y of N.Y. Hosp., 211 N.Y. 125, 105 N.E. 92, 93 (1914) (Cardozo, J.)).

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, 136 N.Y.S. 155, 160 (Magis.Ct.1911). The privilege extends, of course, to repelling the attacks of aggressors, see, e.g., Brown v. United States, 256 U.S. 335, 343-44, 41 S.Ct. 501, 65 L.Ed. 961 (1921); cf. Montana v. Egelhoff, 518 U.S. 37, 56, 116 S.Ct. 2013, 135 L.Ed.2d 361 (1996) (plurality opinion), but also protects incursions into the property of others, see, e.g., Ploof v. Putnam, 81 Vt. 471, 71 A. 188, 189 (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.” (citation omitted)); Mouse’s Case, 12 Co. Rep. 63, 77 Eng. Rep. 1341, 1342 (K.B.1609) (deciding that it is lawful to throw overboard property of another for safety of lives of passengers); Restatement of ToRts § 197 (1934). See generally George C. Christie, The Defense of Necessity Considered from the Legal and Moral Points of Vietv, 48 Duke L.J. 975 (1996). Although the concept of self-defense is most often thought of in terms of the response to an assault by another human being, its premise compels the same response in the face of other forms *56of aggression against life and limb, whether the aggressor be an animal3 or a diseased cell within one’s body. There is, accordingly, no reason to think that the efforts of Alliance members to repel their terminal diseases do not implicate this concept.

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, 497 U.S. 261, 110 S.Ct. 2841, 111 L.Ed.2d 224 (1990), in which the Supreme Court discussed the fundamental right to refuse life-sustaining medical treatment, id. at 278, 110 S.Ct. 2841. When the Court recognized that the common law tort of battery supported the fundamental right to refuse medical treatment, id. at 269, 110 S.Ct. 2841, it did not constitutionalize the tort of battery. Similarly, recognizing that necessity has historically been protected does not constitutionalize the doctrine of necessity. Yet the court resists the implications of the historical protection for actions prompted by necessity out of an unwarranted fear that acknowledging the historical record will constitutionalize the common law. See Op. at 706-07, 709. In so doing, it forgets the second part of the Glucksberg inquiry. A tradition of protection does not alone establish a fundamental right. The subsequent determination of whether a right is “implicit in the concept of ordered liberty” invalidates the court’s fears of a slippery slope.

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, 70 Md. 162, 16 A. 382, 388-84 (1889). The Restatement of Torts, published in 1934, generalized this point of law: “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.” Restatement of Torts § 326; see also id. § 327 (negligence); Restatement (Seoond) of Torts §§ 326, 327; W. Page Keeton et al„ Prosser and Keeton on the Law of Torts 382 (5th ed.1984). This common law rule is firmly grounded.4 By interposing itself *57between a terminally ill patient and her only means of prolonging her life, the FDA’s policy runs counter to the common law’s historical prohibition on interfering with rescue.

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, 469 F.3d 129 (D.C.Cir.2006) {‘Abigail Alliance II”). Thus, the court’s apparent understanding of the meaning of “necessity” is manifestly flawed. See Op. at 708-09 n. 15. By the court’s reasoning, it is not “necessary” for the driver of a car that is hurtling toward a cliff to press the brake because we “cannot know until after” he has done so whether the car will stop in time. Alliance members, like the endangered driver, will perish without remedial steps. The question presented in this case is not whether investigational drugs are necessary to a terminally ill patient who has exhausted conventional treatment options—they are—but who will make the subsequent decision about using these medications, the patient with her doctor or the government. Moreover, as Prosser and Keeton have explained, “[t]he principle [that one may not prevent aid by others] has been carried even to the length of holding that there is liability for interfering with the possibility of such aid.” Keeton et al„ supra, at 382.

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, 410 U.S. at 164-65, 93 S.Ct. 705, and again in Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 846, 880, 112 S.Ct. 2791, 120 L.Ed.2d 674 *58(1992), the Court held that even after fetal viability, a state cannot constitutionally proscribe abortion “where it is necessary, in appropriate medical judgment, for the preservation of the life or health of the mother,” Roe, 410 U.S. at 164-65, 93 S.Ct. 705; Casey, 505 U.S. at 879, 112 S.Ct. 2791 (plurality opinion); accord, Ayotte v. Planned Parenthood of N. New Eng., 546 U.S. 320, 327-28, 126 S.Ct. 961, 163 L.Ed.2d 812 (2006). In so doing, the Court acknowledged the tradition of “ ‘preserving the life of the mother,’ ” Roe, 410 U.S. at 137, 93 S.Ct. 705 (quoting Rex v. Bourne, [1939] 1 K.B. 687 (Crim.App.)), both in the common law, see id., and in early state statutes, see id. at 138, 93 S.Ct. 705 (citing “model” legislation enacted in New York in 1828).

In Stenberg v. Carhart, 530 U.S. 914, 120 S.Ct. 2597, 147 L.Ed.2d 743 (2000), the Supreme Court squarely addressed whether a state may ban a particular medical procedure in cases where a patient’s health or life is endangered. The Court held that “the governing standard requires an exception ‘where it is necessary, in appropriate medical judgment for the preservation of the life or health of the mother.’ ” Id. at 931, 120 S.Ct. 2597 (quoting Casey, 505 U.S. at 879, 112 S.Ct. 2791). There, the State of Nebraska could not constitutionally ban particular abortion procedures, notwithstanding the state’s “interest in the potentiality of human life,” id. at 930, 120 S.Ct. 2597, even though the state claimed that there were adequate alternatives, id. at 931-32, 120 S.Ct. 2597. Here, the situation is even starker: The Alliance’s terminally ill members have no remaining alternatives except the medications to which the FDA denies them access. This Term all nine justices of the Supreme Court agreed that controlling precedents forbid the government from banning an abortion procedure “if it ‘subjected] [women] to significant health risks,’ ” Gonzales v. Carhart, 127 S.Ct. at 1635 (quoting Ayotte, 546 U.S. at 328, 126 S.Ct. 961) (alterations in original); accord id. at 1641-12 (Ginsburg, J., with whom Stevens, Souter, and Breyer, JJ., join, dissenting), and the Court repeatedly emphasized the availability of safe alternative procedures before approving the ban, see id. at 1636, 1637, 1638. The right sought by the Alliance pertains only to those for whom no such alternatives exist.

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.

*59410 U.S. at 130, 93 S.Ct. 705. This approach continued into the modern era. When England imposed criminal sanctions for abortion in 1861, it provided no explicit exception for pregnancies that endanger the life or health of a mother. Offenses Against the Person Act of 1861, 24 & 25 Viet., c. 100, § 59. Nonetheless, an English court determined that the statute could not include procedures necessary to save the woman’s life, because “as in the case of homicide, so also in the ease where an unborn child is killed, there may be justification for the act.” Bourne, [1939] 1 KB. at 690. This history suggests, contrary to the FDA’s view, that a woman’s right to an abortion as an act of medical self-defense is independent from her right to an abortion based upon her right to make deeply personal decisions, see Casey, 505 U.S. at 851, 112 S.Ct. 2791.

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 530 U.S. at 938, 120 S.Ct. 2597. The Court was careful not to require medical unanimity, see id. at 937, 120 S.Ct. 2597, or even “general medical studies,” see id. at 935, 120 S.Ct. 2597, like those required for FDA approval of investigational new drugs for commercial marketing, see 21 C.F.R. pt. 312. Although Gonzales v. Carhart clarifies that government may regulate to some extent “where there is uncertainty over whether the barred procedure is ever necessary to preserve ... health, given the availability of other ... procedures that are considered to be safe alternatives”, 127 S.Ct. at 1638, Stenberg remains good law, and there are no alternatives to preserve life, let alone health, in this case.

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, 460 F.3d 106, 116 (D.C.Cir.2006). Thus, there are situations where a terminally ill patient seeks access to a new medication that has not yet been approved by the FDA for commercial marketing but that has been recognized by the medical community as that patient’s best chance to survive. In such instances, the Fifth Amendment guarantee of due process protects the terminally ill patient’s pursuit of those medications.

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 *60own life with medical advances because medical advances capable of saving lives are a relatively recent phenomenon. Br. of Appellee at 34-35; Op. at 706 & n. 12. As the prior discussion demonstrates, the Alliance correctly disputes the premise of this argument.

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 treatments 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, 445 F.3d at 478 n.9. To deny the constitutional importance of the right to life and to attempt to preserve life is to move from judicial modesty to judicial abdication, as well as confusion, and deprive an express constitutional interest of its due weight in the court’s analysis.

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-American common-law tradition has punished or otherwise disapproved of both suicide and assisting suicide.” 521 U.S. at 711, 117 S.Ct. 2258. In the Court’s words: “[W]e are confronted with a consistent and almost universal tradition that has long rejected the asserted right, and continues explicitly to reject it today, even for terminally ill, mentally competent adults.” Id. at 723, 117 S.Ct. 2258. But the Supreme Court did not say, as the FDA argued and this court appears to agree, that a right can be fundamental only if it has been acknowledged by statute or decisional law. A plurality of the Supreme Court said the opposite in Michael H. v. Gerald D., 491 U.S. 110, 122 n.2, 109 S.Ct. 2333, 105 L.Ed.2d 91 (1989), in observing that historical “protection need not take the form of an explicit constitutional provision or statutory guarantee, but it must at least exclude ... a societal tradition of enacting laws denying the interest.”

*61Third, the court’s concern that “such a premise [would] support sweeping claims of fundamental rights” neglects the existence of the second Glucksberg criterion. Strict scrutiny is not triggered just by a history of protection—otherwise, the entire common law would be constitutionalized. It is the second requirement, that a right be “ ‘implicit in the concept of ordered liberty,’ such that ‘neither liberty nor justice would exist if they were sacrificed,’” 521 U.S. at 702, 117 S.Ct. 2258 (quoting Palko, 302 U.S. at 325, 326, 58 S.Ct. 149), that guards against unwarranted expansion of substantive due process rights. Just as in the context of the necessity defense at common law, the court conflates these two distinct inquiries, and in its haste to acquire a limiting principle, it constructs a significant and unwarranted roadblock to judicial recognition of fundamental rights. This roadblock starts from the Supreme Court’s requirement, in the interest of judicial restraint, that “[substantive due process’ analysis must begin with a careful description of the asserted right.” Reno v. Flores, 507 U.S. 292, 301, 113 S.Ct. 1439, 123 L.Ed.2d 1 (1993). Although the court appropriately assumes the Alliance has satisfied the requirement in this case, the court then errs by effectively holding that the first Glucksberg criterion can be satisfied only by historical evidence involving the exact situation that the Alliance presented to us today. It offers no principled reason for ignoring highly relevant evidence, particularly with respect to the historical record concerning abortion to save the life of the mother.

Fourth, in the alternative, 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, 460 F.3d at 116.5 Furthermore, safety restrictions are appli*62cable to all medicines for any pallative purpose, as well as illegal drugs that serve no pallative purpose, see Abigail Alliance I, 445 F.3d at 478 & n. 9, and therefore tell us little about the regulation of potentially life-saving medicines sought by terminally ill patients who have no alternative treatment options.

By redirecting its inquiry, the court conveniently avoids the sparse history of drug regulation for efficacy. See Abigail Alliance I, 445 F.3d at 481-83. Prior to 1906, there was essentially no drug regulation in the United States save protections against fraud and adulteration.6 In 1906, Congress enacted the Pure Food and Drug Act (“1906 Act”), ch. 3915, 34 Stat. 768 (repealed 1938), which prohibited misbranded and adulterated foods or drugs from entering interstate commerce, id. § 2, 34 Stat. at 768, and prohibited false and misleading labeling, id. § 8, 34 Stat. at 770. For a small number of particularly dangerous drugs, the 1906 Act required the labels to identify the drug’s ingredients and quantities. Id. The statute also authorized the Bureau of Chemistry, a predecessor of the FDA, to seize nonconforming goods and to recommend federal prosecution of those who violated the 1906 Act. Id. § 4, 34 Stat. at 769. The 1906 Act did not, however, limit individual access to new drugs or regulate therapeutic claims by drug manufacturers. Cf. United States v. Johnson, 221 U.S. 488, 31 S.Ct. 627, 55 L.Ed. 823 (1911). 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 by the Harrison Narcotic Act of 1914, ch. 1, 38 Stat. 785.7

*63In 1938, Congress enacted the Federal Food, Drug, and Cosmetic Act (“1938 Act” or “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. See Report of the Seoretary of AGRICULTURE ON DEATHS DUE TO ELIXIR SuLfanilamide-Massengill, S. Doa No. 75-124, at 1-3 (1937) (“1937 REPORT”).8 For the first time, Congress required that drug manufacturers test, and the FDA review, all new drugs for safety prior to their commercial distribution. Ch. 653, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § 301 et seq.); 1937 Report, supra, at 1-3. 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.9 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.10 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 that can be used while under a doctor’s supervision. See Act of Oct. 26, 1951, ch. 578, 65 Stat. 648 (codified at 21 U.S.C. § 353(b)).

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.11 The Kefauver-Harris Amendments, Pub.L. No. 87-781, 76 Stat. 780 (1962) (codified in scattered sections of 21 U.S.C. §§ 301-81), 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.12 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.” 21 U.S.C. § 355(d). 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.13 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.”14 Thus, a doctor may—and *64approximately 21% of the time does—prescribe a drug to a patient for a purpose other than that for which the FDA has approved the use of the drug.15 Such “off-label” use may occur even if the drug is not deemed safe or effective for that use, such as when a drug studied only for adults is prescribed for a child. Further, it appears that the FDA has never prohibited either off-label prescription or off-label use of drugs.16 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.17 See Food and Drug Administration Modernization Act of 1997, Pub.L. No. 105-115, 111 Stat. 2296 (codified in scattered sections of 21 U.S.C. §§ 301-81).

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. None 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, 445 F.3d at 482, the FDA does not regulate physicians, id. at 483, and off-label prescription of medications is a longstanding practice that has not been outlawed, id. Elsewhere the court relies on straw men that are either acknowledged by the court to be irrelevant, Op. at 704 n. 8 (an incident in 1630 not the result of “legislative or regulatory intervention”); or are in fact irrelevant, id. at 710-11 n. 18 (discussing “affirmative access claim[s]” even though the Alliance makes no such claim); or are speculative, id. at 706 n. 12 (noting “a more plausible explanation for the limited efficacy regulation”); see also Amicus Br. for Economists John E. Calfee et al. This analysis hardly overcomes the history and Constitutional recognition of the underlying right to life that the Alliance claims.

The common law traditions protecting necessity, forbidding interference with rescue, and supporting self-defense, and the Supreme Court’s validation of the fundá*65mental right of a pregnant woman to undergo a medical procedure to save her own life demonstrate that the protected liberty interest of the terminally ill to choose whether to pursue prescription medications that may save them lives is deeply rooted in this Nation’s history. Nothing in the history of drug regulation demonstrates otherwise. In view of the common law history, there is no occasion to determine how the first Glucksberg inquiry would be evaluated were there no evidence supporting or refuting a historical basis for a claimed fundamental right.

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, 521 U.S. at 721, 117 S.Ct. 2258 (quoting Palko, 802 U.S. at 325, 326, 58 S.Ct. 149). The Supreme Court has explained that this expression “encompasses and protects the personal intimacies of the home, the family, marriage, motherhood, procreation, and child rearing.” Paris Adult Theatre I v. Slaton, 413 U.S. 49, 65, 93 S.Ct. 2628, 37 L.Ed.2d 446 (1973). It also safeguards the “freedom of thought and speech,” Palko, 302 U.S. at 326, 58 S.Ct. 149, and “[t]he security of one’s privacy against arbitrary intrusion by the police,” Wolf v. Colorado, 338 U.S. 25, 27-28, 69 S.Ct. 1359, 93 L.Ed. 1782 (1949), overruled on other grounds by Mapp v. Ohio, 367 U.S. 643, 81 S.Ct. 1684, 6 L.Ed.2d 1081 (1961). In the context of criminal trials, matters “implicit in the concept of ordered liberty” include “the right to counsel at trial,” Teague v. Lane, 489 U.S. 288, 311, 109 S.Ct. 1060, 103 L.Ed.2d 334 (1989) (plurality opinion) (quoting Mackey v. United States, 401 U.S. 667, 693-94, 91 S.Ct. 1160, 28 L.Ed.2d 404 (1971) (opinion of Harlan, J.)); the presumption that “all are innocent until the state has proved them to be guilty,” United States v. Salerno, 481 U.S. 739, 763, 107 S.Ct. 2095, 95 L.Ed.2d 697 (1987); and “[t]he principle that a State may not knowingly use false evidence, including false testimony, to obtain a tainted conviction,” Napue v. Illinois, 360 U.S. 264, 269, 79 S.Ct. 1173, 3 L.Ed.2d 1217 (1959).

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, 338 U.S. at 27, 69 S.Ct. 1359. As Justice Frankfurter wrote, these rights create “a realm of sanctuary surrounding every individual and infrangible, save in a very limited class of circumstances, by the agents of government.” Monroe v. Pape, 365 U.S. 167, 208-09, 81 S.Ct. 473, 5 L.Ed.2d 492 (1961) (Frankfurter, J., dissenting), maj. op. overruled by Monell v. Dep’t of Soc. Servs., 436 U.S. 658, 98 S.Ct. 2018, 56 L.Ed.2d 611 (1978).

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*66tects an interest in life as well as an interest in refusing life-sustaining medical treatment.” 497 U.S. at 281, 110 S.Ct. 2841. The Court acknowledged that “[t]he principle that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment,” could be inferred from its prior decisions. Id. at 278, 110 S.Ct. 2841. 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, the Alliance seeks only to have the government step aside so as not to interfere with the individual right of self-determination. 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 been determined to be safe for substantial human testing. This reasoning tracks Eisenstadt v. Baird, 405 U.S. 438, 92 S.Ct. 1029, 31 L.Ed.2d 349 (1972), where the Supreme Court noted that the right to be free from unwanted government intrusion into the fundamental decision whether to have children establishes a right of access to contraceptives, id. at 453, 92 S.Ct. 1029.

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, 469 F.3d at 136-37, in the conclusion that the right to save one’s life is unprotected notwithstanding the specific protection afforded life in the Fifth Amendment to the Constitution.

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, 507 U.S. at 302, 113 S.Ct. 1439. Accordingly, I respectfully dissent.

. 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 own 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, 135 F.3d 694, 702 (10th Cir.1998). By the court's reasoning, if parents had come to court claiming a fundamental right to educate their children but acknowledging that if they sent their children to public school, they could do so only full-time, the fundamental right never would have been recognized. But see Meyer v. Nebraska, 262 U.S. 390, 43 S.Ct. 625, 67 L.Ed. 1042 (1923); Pierce v. Soc'y of Sisters, 268 U.S. 510, 45 S.Ct. 571, 69 L.Ed. 1070 (1925).

. A person may assert self-defense rights against animals. See, e.g., People v. Lee, 131 Cal.App.4th 1413, 32 Cal.Rptr.3d 745, 754-55 (Ct.App.2005); Credit v. Brown, 10 Johns. 365 (N.Y.Sup.Ct.1813).

. See, e.g., Beck v. Haik, 377 F.3d 624, 633-34 (6th Cir.2004) (discussing appropriate jury instruction for claim of interference with rescue); Ross v. United States, 910 F.2d 1422 (7th Cir.1990) (holding that a deputy sheriff committed a constitutional tort by interfering with efforts to rescue a drowning boy); United States v. Lawter, 219 F.2d 559, 562 (5th Cir.1955) (holding that the government is liable when it prevents others from attempting a rescue and takes no action itself); Sneider v. Hyatt Corp., 390 F.Supp. 976, 980 & n. 2 (N.D.Ga.1975) (noting that "deliberate interference with rescue efforts by third parties is a traditional basis for imposing liability”); Soldano v. O’Daniels, 141 Cal.App.3d 443, 190 Cal.Rptr. 310, 313, 316-18 (Ct.App.1983) (applying Restatement); Thomas v. Williams, *57105 Ga.App. 321, 124 S.E.2d 409, 414 (1962) (sustaining cause of action for interference with rescue where defendant prevented rescue of inmate from jail cell during fire); Riggs v. Colis, 107 Idaho 1028, 695 P.2d 413, 415 (1985) (applying Restatement); Byrne v. Long Island State Park Comm'n, 66 Misc.2d 1070, 323 N.Y.S.2d 442 (Sup.Ct.1971); see also Commonwealth v. Marcelli, 14 Mass.App.Ct. 567, 441 N.E.2d 270, 271 (1982) (criminal liability); Cal.Penal Code § 148.2(1) (same).

. 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 (March 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*62min., Rezulin To Be Withdrawn from the Market (March 21, 2000), http://www.fda.gov/ bbs/topics/NEWS/NEW00721 .html; Press Release, Food & Drug Admin., FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen) (Sept. 15, 1997), http:// www.fda.gov/cder/news/phen/fenphenpr 81597.htm; Gina Kolata & Edmund L. Andrews, Anticholesterol Drug Pulled After Link With 31 Deaths, N.Y. Times, Aug. 9, 2001, at A12 (Baycol).

. 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, 545 U.S. 1, 11-13, 125 S.Ct. 2195, 162 L.Ed.2d 1 (2005). FDA Historian Wallace F. Janssen writes that prior to 1906 was the “heyday of 'patent medicines,' " a time when "[ajnyone, no matter how ignorant or unqualified, could go into the drug manufacturing business” and when "[m]edicines ... were sold without restriction at almost every crossroads store.” Wallace F. Janssen, Outline of the History of U.S. Drug Regulation and Labeling, 36 Food Drug Cosm L.J. 420, 422 (1981) (hereinafter “Janssen, Outline of the History”). He further recounts that in "colonial days, and long afterward, consumers ... were their own food and drug inspectors,” “there was a striking absence of statutes dealing with drugs,” and, although there were food inspection laws and standards for weights and measures, see id. at 423, 425, "drug laws were virtually non-existent.” Janssen, America's First Food and Drug Laws, 30 Food Drug Cosm L.J. 665, 669, 671 (1975). This suggests that in this Nation's early history there were no restrictions on a patient's access to potentially life-saving medications, regardless of whatever restrictions may have been placed on physicians, pharmacists, apothecaries, poisons, or misbranded or adulterated substances. See id. at 669-72; Janssen, Outline of the History, supra, at 426-28. But cf. Op. at 703-05.

. 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, 256 U.S. 41, 45, 41 S.Ct. 425, 65 L.Ed. 819 (1921).

. 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: *64An Assessment of Legislative and Regulatory Policy, 51 Fla. L.Rev. 181, 189-92 (1999); see Chaney v. Heckler, 718 F.2d 1174, 1180 (D.C.Cir. 1983), rev’d on other grounds, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985).

. 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.