Opinion for the court filed by Circuit Judge GRIFFITH.
Dissenting opinion filed by Circuit Judge ROGERS, with whom Chief Judge GINSBURG joins.
GRIFFITH, Circuit Judge:
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, 521 U.S. 702, 720-21, 117 S.Ct. 2258, 138 L.Ed.2d 772 (1997) (quoting Moore v. East Cleveland, 431 U.S. 494, 503, 97 S.Ct. 1932, 52 L.Ed.2d 531 (1977) (plurality opinion)), we affirm the judgment of the district court.
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, [36] containing detailed information establishing that human testing is appropriate, see 21 C.F.R. § 812.23. Once the application for human testing has been approved, see id. § 312.20, several phases of clinical testing begin. The Alliance’s amended complaint alleges that this testing process is an extremely lengthy one, requiring nearly seven years for the average experimental drug.1 Am. Compl. ¶ 15.
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).2 At any time during the clinical trials, a drug sponsor is required to notify the FDA of “[a]ny adverse experience associated with the use of the drug that is both serious and unexpected,” id. § 312.32(c)(1)(A), and the FDA may order a “clinical hold” halting the trials if it determines that safety concerns so warrant, id. § 312.42. To guide the clinical testing process, Congress has directed the FDA to establish “[scientific advisory panels” to “provid[e] expert scientific advice and recommendations to the Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug.” 21 U.S.C. § 355(n)(l). These panels must include scientists from a variety of disciplines. See id. § 355(n)(3).3
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 [37] provide-early access to promising experimental drugs when warranted. For example, under the “treatment IND” program, the FDA may approve use of an investigational drug by patients not part of the clinical trials for the treatment of “serious or immediately life-threatening disease[s]” if there exists “no comparable or satisfactory alternative drug or other therapy,” 21 C.F.R. § 312.34(a), (b)(l)(i)-(ii); if “[t]he drug is under investigation in a controlled clinical trial,” id. § 312.34(b)(l)(iii); and if the drug’s sponsor “is actively pursuing marketing approval of the investigational drug with due diligence,” id. § 312.34(b)(l)(iv). The FDA reserves the right, however, to deny any treatment IND request if (1) the agency believes there is no “reasonable basis” to conclude that the drug is effective; or (2) granting the request “[w]ould ... expose the patient[ ] ... to an unreasonable and significant additional risk of illness or injury.” Id. § 312.34(b)(3). Sponsors may not profit from any approved treatment IND program and may only “recover costs of manufacture, research, development, and handling of the investigational drug.” Id. § 312.7(d)(3).4
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[38] ciáis had reviewed those submissions, the agency concluded that the Alliance “raised several important questions about expanded access that we believe deserve further consideration,” but questioned whether the specific proposal put forward by the Alliance “would have the intended desirable effects for patients.” Letter from Peter J. Pitts, Associate Commissioner for External Relations, Department of Health and Human Services, to Frank Burroughs, President, Abigail Alliance for Better Access to Developmental Drugs 3 (Apr. 25, 2003). The officials concluded that the early access proposed by the Alliance “points to an area of significant range of opinion within the patient and provider communities about the standards that should be met before a drug is marketed.” Id. at 4. Although “some members of the cancer community have suggested that [the] FDA needs to maintain a strong clinical trial system as the basis of the approval of cancer drugs, ... others, like [the Alliance], have criticized [the FDA] for relying too heavily on completing certain trials before approval.” Id. The FDA noted that “[i]n the realm of reviewing medical products to treat serious and life-threatening diseases, there is inevitable tension between early availability of products to patients, especially patients with refractory disease, and the need to obtain sufficient data to provide a reasonable expectation of benefit and lack of excessive harm.” Id.
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. [39]*3903-1601, 2004 WL 3777340, at *1 (D.D.C. Aug. 30, 2004). A divided panel of this Court reversed, concluding 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.” Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 445 F.3d 470, 486 (D.C.Cir.2006). We vacated that decision and granted rehearing en banc. See Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 469 F.3d 129 (D.C.Cir.2006).
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 treatment options to decide, in consultation with his or her own doctor, whether to seek access to investigational medications that the [FDA] concedes are safe and promising enough for substantial human testing.
Appellants’ Br. at 1.5 That is, we must determine whether terminally ill patients have a fundamental right to experimental drugs that have passed Phase I clinical testing. If such a right exists, the Alliance argues that both 21 C.F.R. § 312.34(b)(3) (preventing access to experimental drugs for terminally ill patients where there is insufficient evidence of effectiveness or where there is an unreasonable risk of injury) and 21 C.F.R. § 312.7 (prohibiting drug manufacturers from profiting on the sale of experimental drugs) must be subjected to strict scrutiny because they interfere with a fundamental constitutional right. We do not address the broader question of whether access to medicine might ever implicate fundamental rights.
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 [40] has held that the protections of the Amendment “guarantee[] more than fair process.” Glucksberg, 521 U.S. at 719, 117 S.Ct. 2258. The Court has stated that “[t]he Clause ... provides heightened protection against government interference with certain fundamental rights and liberty interests,” id. at 720, 117 S.Ct. 2258 (citing Reno v. Flores, 507 U.S. 292, 301-02, 113 S.Ct. 1439, 123 L.Ed.2d 1 (1993); Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 851, 112 S.Ct. 2791, 120 L.Ed.2d 674 (1992)), including “the rights to marry, to have children, to direct the education and upbringing of one’s children, to marital privacy, to use contraception, to bodily integrity, and to abortion,” Glucksberg, 521 U.S. at 720, 117 S.Ct. 2258 (citations omitted).
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, 503 U.S. 115, 125, 112 S.Ct. 1061, 117 L.Ed.2d 261 (1992) (citing Regents of Univ. of Mich. v. Ewing, 474 U.S. 214, 225-26, 106 S.Ct. 507, 88 L.Ed.2d 523 (1985)). There is an additional and substantial concern that courts must also consider: “By extending constitutional protection to an asserted right or liberty interest, we, to a great extent, place the matter outside the arena of public debate and legislative action.” Glucksberg, 521 U.S. at 720, 117 S.Ct. 2258. Thus, the Supreme Court has directed courts to “exercise the utmost care whenever we are asked to break new ground in this field, lest the liberty protected by the Due Process Clause be subtly transformed into the policy preferences of the [courts’ members].” Id. (quotation marks and citations omitted); see Moore, 431 U.S. at 502, 97 S.Ct. 1932 (“As the history of the Lochner era demonstrates, there is reason for concern lest the only limits to such judicial intervention become the predilections of those who happen at the time to be Members of this Court.”) (footnote omitted).
In Glucksberg, the Supreme Court described its “established method of substantive-due-process analysis” as having “two primary features.” Glucksberg, 521 U.S. at 720, 117 S.Ct. 2258.
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, 117 S.Ct. 2258 (quotation marks and citations omitted).
We will assume arguendo that the Alliance’s description of its asserted right would satisfy Glucksberg’s “careful description” requirement.6 Looking to whether the Alliance has demonstrated [41] that its right is deeply rooted in this Nation’s history, tradition, and practices, the Alliance’s claim for constitutional protection rests on two arguments: (1) that “common law and historical American practices have traditionally trusted individual doctors and their patients with almost complete autonomy to evaluate the efficacy of medical treatments”; and (2) that FDA policy is “inconsistent with the way that our legal tradition treats persons in all other life-threatening situations.” Appellants’ Br. at 31. More specifically, the Alliance argues that the concepts of self-defense, necessity, and interference with rescue are broad enough to demonstrate the existence of the fundamental right they seek—a right for “persons in mortal peril” to “try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks.” Id. at 32.
A.
“We begin, as we do in all due process cases, by examining our Nation’s history, legal traditions, and practices.” Glucksberg, 521 U.S. at 710, 117 S.Ct. 2258. The Alliance argues that its right can be found in our history and legal traditions because “the government never interfered with the judgment of individual doctors about the medical efficacy of particular drugs until 1962,” i.e., when major amendments were made to the Food, Drug, and Cosmetic Act. Appellants’ Br. at 44 (emphasis added); see id. at 23 (“[T]he common law consistently left judgments about the efficacy of medical treatments in the hands of individual doctors and them patients. Governmental review of the effectiveness of drugs did not exist in this country at all until 1962 ....”) (emphasis added).
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 States7 began with the Colonies and States when [42] the Colony of Virginia’s legislature passed an act in 1736 that addressed the dispensing of more drugs than was “necessary or useful” because that practice had become “dangerous and intolerable.” Edward Kremers, Kremers and Urdang’s History of Pharmacy 158 (4th ed.1976).8 The Territory of Orleans (Louisiana) passed an act in 1808 requiring a diploma and an examination before permitting pharmacists to dispense drugs; Louisiana also prohibited the sale of deteriorated drugs and restricted the sale of poisons. Id. at 182-84, 214; see David L. Cowen, The Development of State Phamaceutical Law, Pharmacy in History, Vol. 37 No. 2, 1995, at 54 (noting that the 1808 act prohibited the sale of drugs that were “injured, moulded, discomposed, or sophisticated” and placed restrictions on the sale of “any suspicious or dangerous remedy”). South Carolina enacted legislation in 1817 requiring pharmacists to obtain licenses, Kremers, supra, at 184, 214, followed by Georgia in 1825 and Alabama in 1852, id. at 214. By 1870, at least twenty-five states or territories had statutes regulating adulteration (impure drugs), and a few others had laws addressing poisons. Id. at 216. In the early history of our Nation, we observe not a tradition of protecting a right of access to drugs, but rather governments responding to the risks of new compounds as they become aware of and able to address those risks. See Cowen, supra, at 56 (“The history of state laws pertaining to pharmacy obviously reflect[s] the development of pharmacy scientifically, professionally, and economically.”).
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 [43] Drug Act of 1818, 59 Food & Drug L.J. 169, 175 (2004) (footnote omitted). Congress acted again when it passed the Biologies Controls Act of 1902, ch. 1378, 32 Stat. 728 (1902), in response to a series of deadly reactions to a tainted diphtheria vaccine that killed children in New Jersey and Missouri. Sue McGrath, Only A Matter Of Time: Lessons Unlearned at the Food and Drug Administration Keep Americans at Risk, 60 Food & Drug L.J. 603, 604 (2005). This Act “secure[d] licensing control over both biological drug laboratories and their products.” Janssen, supra, at 425. Congress followed with the Pure Food and Drugs Act of 1906, which prohibited the manufacture of any drug that was “adulterated or misbranded.” The Pure Food and Drugs Act of 1906, ch. 3915, 34 Stat. 768 (1906).9
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.10 But even assuming arguendo that efficacy regulation began in 1962, the Alliance’s argument ignores our Nation’s history of drug safety regulation described above. Nor can the Alliance override current FDA regulations simply by insisting that drugs which have completed Phase I testing are safe enough for terminally ill patients. Current law bars public access to drugs undergoing clinical testing on safety [44] grounds. The fact that a drug has emerged from Phase I with a determination that it is safe for limited clinical testing in a controlled and closely-monitored environment after detailed scrutiny of each trial participant does not mean that a drug is safe for use beyond supervised trials.11 FDA regulation of post-Phase I drugs is entirely cpnsistent with our historical tradition of prohibiting the sale of unsafe drugs.
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.12
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 [45] premise to support sweeping claims of fundamental rights. For example, one might argue that, because Congress did not significantly regulate marijuana until 1937, relatively late in the constitutional day, see Gonzales v. Raich, 545 U.S. 1, 11, 125 S.Ct. 2195, 162 L.Ed.2d 1 (2005), there must be a tradition of protecting marijuana use. Because Congress did not regulate narcotics until 1866 when it heavily taxed opium, a drug created long before our Nation’s founding, see United States v. Moore, 486 F.2d 1139, 1215-16, 1218 n. 50 (D.C.Cir. 1973) (Wright, J., dissenting), it must be that individuals have a right to acquire and use narcotics free from regulation. Or because speed limits are a recent innovation, we have a fundamental right to drive as fast as we deem fit. But this is most certainly not the law. A prior lack of regulation suggests that we must exercise care in evaluating the untested assertion of a constitutional right to be free from new regulation. But the lack of prior governmental regulation of an activity tells us little about whether the activity merits constitutional protection: “The fact that powers long have been unexercised well may call for close scrutiny as to whether they exist; but if granted, they are not lost by being allowed to lie dormant, any more than nonexistent powers can be prescript-ed by an unchallenged exercise.” See United States v. Motion Salt Co., 338 U.S. 632, 647, 70 S.Ct. 357, 94 L.Ed. 401 (1950). Indeed, creating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state, which, like drug regulation, has increased in scope as changing conditions have warranted.
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.13
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[46] erative, 532 U.S. 483, 490, 121 S.Ct. 1711, 149 L.Ed.2d 722 (2001) (quoting United States v. Bailey, 444 U.S. 394, 410, 100 S.Ct. 624, 62 L.Ed.2d 575 (1980)). The Alliance offers, however, little detail about how necessity would apply to its case. See Appellants’ Br. at 37. (JE.g., would terminally ill patients have a right to force drug companies to provide them with experimental drugs?) Nonetheless, the Supreme Court’s analysis of the common law doctrine of necessity in Oakland leaves little room for the Alliance’s argument that common law necessity could justify overriding the Food, Drug, and Cosmetic Act.
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, 532 U.S. at 490, 121 S.Ct. 1711.14 The Supreme Court rejected that argument because “[ujnder any conception of legal necessity, one principle is clear: The defense cannot succeed when the legislature itself has made a determination of values,” id. at 491, 121 S.Ct. 1711 (quotation marks omitted). Although the Court limited its analysis to the statutory issue and did not address the defendant’s constitutional arguments, see id. at 494, 121 S.Ct. 1711, the learning of Oakland is clear. Congress may limit or even eliminate a necessity defense that might otherwise be available. That is precisely what the FDCA has done. Congress has prohibited general access to experimental drugs, see 21 U.S.C. § 355(a), and has prescribed in detail how experimental drugs may be studied and used by the scientific and medical communities, see id. § 355(i). Given the Supreme Court’s conclusion that the common law defense of necessity remains controversial and cannot override a value judgment already determined by the legislature, the common law doctrine of necessity provides little support to the Alliance’s proposed right.
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.15 Indeed, the [47] Alliance concedes that taking experimental drugs can “involve enormous risks.” Appellants’ Br. at 32. In essence, the Alliance insists on a constitutional right to assume any level of risk. It is difficult to see how a tort addressing interference with providing “necessary” aid would guarantee a constitutional right to override the collective judgment of the scientific and medical communities expressed through the FDA’s clinical testing process. Thus, we cannot agree that the tort of intentional interference with rescue evidences a right of access to experimental drugs.
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 overcome 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, 410 U.S. 113, 152, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973). Instead, the Alliance argues that Roe “recognized another, entirely separate right to abortion: a woman’s right to abort a fetus at any stage of a pregnancy if doing so is necessary to preserve her life or health.” Appellants’ Br. at 39 (emphasis in original).16 “That right,” the Alliance argues, “is grounded in traditional self-defense principles rather than privacy....” Id. Applying that concept here, the Alliance argues that because its terminally ill members are in immediate danger of harm from cancer, they can use whatever medical means are necessary to defend themselves. Thus, they argue, even if a medical treatment might otherwise be prohibited by law, the doctrine of self-defense justifies access to that treatment, just as self-defense justifies an assault victim using physical force otherwise prohibited by law.
This analogy also fails because this case is not about using reasonable force to de[48] fend oneself (as in most cases involving self-defense), nor is it about access to lifesaving medical treatment. This ease is about whether there is a constitutional right to assume, in the Alliance’s own words, “enormous risks,” Appellants’ Br. at 32, in pursuit of potentially life-saving drugs. Unlike the cases in which the doctrine of self-defense might properly be invoked, this case involves risk from drugs with no proven therapeutic effect, which at a minimum separates this example from the abortion “life of the mother” exception. Because terminally ill patients cannot fairly be characterized as using reasonable force to defend themselves when they take unproven and possibly unsafe drugs, the Alliance’s desire that the terminally ill be free to assume the risk of experimental drugs cannot draw support from the doctrine of self-defense.17
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, 545 U.S. at 28, 125 S.Ct. 2195 (“the dispensing of new drugs, even when doctors approve their use, must await federal approval”); United States v. Rutherford, 442 U.S. 544, 552, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979) (“we are persuaded by the legislative history and consistent administrative interpretation of the [FDCA] that no implicit exemption for drugs used by the terminally ill is necessary to attain congressional objectives”); cf. Oakland, 532 U.S. at 490, 121 S.Ct. 1711 (with respect to whether there is an implied “medical necessity” exemption to prosecution for marijuana use under the Controlled Substances Act, generally speaking, “[w]hether, as a policy matter, an exemption should be created is a question for legislative judgment, not judicial inference”) (quotation marks omitted). And other courts have rejected arguments that the Constitution provides an affirmative right of access to particular medical treatments reasonably prohibited by the Government.18
[49] In keeping with those decisions, we conclude that the Alliance has not provided evidence of a right to procure and use experimental drugs that is deeply rooted in our Nation’s history and traditions. To the contrary, our Nation’s history evidences increasing regulation of drugs as both the ability of government to address these risks has increased and the risks associated with drugs have become apparent. Similarly, our legal traditions of allowing a necessity defense, prohibiting intentional interference with rescue, and recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process.19
[50] IV.
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, 521 U.S. at 722, 117 S.Ct. 2258 (noting that “a challenged state action [must] implicate a fundamental right” to avoid rational basis review). The rational basis test requires that the Alliance prove that the government’s restrictions bear no rational relationship to a legitimate state interest. See, e.g., Harrah Indep. Sch. Dist. v. Martin, 440 U.S. 194, 198, 99 S.Ct. 1062, 59 L.Ed.2d 248 (1979); Glucksberg, 521 U.S. at 735, 117 S.Ct. 2258. The challenged policy “need not be in every respect logically consistent with its aims to be constitutional. It is enough that there is an evil at hand for correction, and that it might be thought that the particular legislative measure was a rational way to correct it.” Williamson v. Lee Optical of Okla., Inc., 348 U.S. 483, 487-88, 75 S.Ct. 461, 99 L.Ed. 563 (1955).20
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, 442 U.S. 544, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979). In [51] that case, terminally ill patients sought to prevent the FDA from prohibiting access to the drug laetrile, even though the drug had not been approved for public use. In rejecting a challenge by terminally ill patients claiming that the FDCA’s safety requirement did not apply to them, the Supreme Court held that “[f]or the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit.” Id. at 555-56, 99 S.Ct. 2470; see also id. at 558, 99 S.Ct. 2470 (noting that history has demonstrated that numerous “resourceful entrepreneurs” might try to take advantage of an unregulated market, which “suggests] why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise”).
Although terminally ill patients desperately need curative treatments, as Rutherford holds, their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit. Thus, we must conclude that, prior to distribution of a drug outside of controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug. We therefore hold that the FDA’s policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects.
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, 197 U.S. 11, 30, 25 S.Ct. 358, 49 L.Ed. 643 (1905); see also Gonzales v. Carhart, — U.S. -, 127 S.Ct. 1610, 1636, 167 L.Ed.2d 480 (2007) (“The Court has given state and federal legislatures wide discretion to pass legislation in areas where there is medical and scientific uncertainty.”); cf. Greenwood v. United States, 350 U.S. 366, 375-76, 76 S.Ct. 410, 100 L.Ed. 412 (1956) (“The only certain thing that can be said about the present state of knowledge and therapy ... is that science has not reached finality of judgment---- Certainly, denial of constitutional power ... to Congress in dealing with a situation like this ought not to rest on dogmatic adherence to one view or another on controversial psychiatric issues.”). Consistent with that precedent, our holding today ensures that this debate among the Alliance, the FDA, the scientific and medical communities, and the public may continue through the democratic pro[52] cess. See Glucksberg, 521 U.S. at 735, 117 S.Ct. 2258.
V.
For the foregoing reasons, the judgment of the district court is affirmed.
So ordered.