ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS and Washington Legal Foundation, Appellants v. Andrew von ESCHENBACH, In His Official Capacity as Commissioner, Food and Drug Administration and Michael O. Leavitt, In His Official Capacity as Secretary, U.S. Dept. of Health and Human Services, Appellees, 495 F.3d 695

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 experimental 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, containing detailed information establishing that human testing is appropriate, see 21 C.F.R. § 312.23. 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. 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).

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 “[sjcientific 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). 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 provide early access to promising experimental drugs when warranted.

For example, under the “treatment IND” program, the FDA may approve use of an investiga-tional 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). 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 “[e]xtensive 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 officials 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. 08-1601, 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 in-vestigational 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 l.

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 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 unchart-ered 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.

Looking to whether the Alliance has demonstrated 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 their 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, ie., drugs that have passed Phase I testing, current law bans access to an experimental drug on safety grounds until it has successfully completed all phases of testing.

See 21 C.F.R. § 312.21(b) (requiring that Phase II studies examine “common short-term side effects and risks ” of new drugs) (emphasis added); id. § 312.21(c) (requiring Phase III studies to “gather ... additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug”) (emphasis added).

Thus, to succeed on its claim of a fundamental right of access for the terminally ill to experimental drugs, the Alliance must show not only that there is a tradition of access to drugs that have not yet been proven effective, but also a tradition of access to drugs that have not yet been proven safe.

Examining, as we are required to do under Glucksberg, our Nation’s history, legal traditions, and practice with respect to the regulation of drugs for efficacy and safety, we conclude that our Nation has long expressed interest in drug regulation, calibrating its response in terms of the capabilities to determine the risks associated with both drug safety and efficacy. Drug regulation in the United States began with the Colonies and States when 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). 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 Pharmaceutical Law, Pharmaoy 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 reflects] 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 Drug Act of 1848, 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). The current regime of federal drug regulation began to take shape with the Food, Drug, and Cosmetic Act of 1938. See Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § 301 et seq.). The Act required that drug manufacturers provide proof that their products were safe before they could be marketed. See id.

The new Act also prohibited false therapeutic claims. Id. Notably, the drug industry “strenuously objected” to the 1938 Act “ostensibly on the ground that it would deprive the American people of the right to self-medication,” Harry A. Toulmin, Jr., Law of Foods, Drugs and Cosmetics 8-9 (2d ed.1963) — an argument not unlike the Alliance’s position of today. We end our historical analysis where the Alliance would prefer it begin — with the 1962 Amendments to the FDCA.

Undoubtedly, as the Alliance argues at length, Congress amended the FDCA in 1962 to explicitly require that the FDA only approve drugs deemed effective for public Use. See Drug Amendments of 1962, Pub.L. No. 87-781, § 102, 76 Stat. 780, 781 (1962). Thus, the Alliance argues that, prior to 1962, patients were free to make their own decisions whether a drug might be effective. But even 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 grounds. The fact that a drag 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.

FDA regulation of post-Phase I drugs is entirely consistent with our historical tradition of prohibiting the sale of unsafe drags. But even setting the safety issue to one side, the Alliance’s argument that effectiveness was not required before 1962 also fails under closer scrutiny. First, as a matter of history, at least some drug regulation prior to 1962 addressed efficacy. More importantly, an arguably limited history of efficacy regulation prior to 1962 does not establish a fundamental right of access to unproven drugs.

The amendments made to the FDCA by Congress throughout the twentieth century demonstrate that Congress and the FDA have continually responded to new risks presented by an evolving technology. Recent government efficacy regulation has reflected Congress’s exercise of its well-established power to regulate in response to scientific, mathematical, and medical advances. True, a lack of government interference throughout history might be some evidence that a right is deeply rooted. But standing alone, it cannot be enough.

If it were, it would be easy to employ such a 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. Morton 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. 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 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. (E.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. 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. Indeed, the 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). “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 defend oneself (as in most cases involving self-defense), nor is it about access to lifesaving medical treatment.

This case 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. 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. 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. 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). 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 “[w]ithout 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 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 “suggest[s] 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 process. 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. ROGERS, Circuit .

In FDA parlance, experimental drugs that have not yet been approved for public use are deemed “investigational drug[s].” See 21 C.F.R. § 312.3(b). . In some circumstances, a Phase IV review is conducted, which "delineate[s] additional information about the drug’s risks, benefits, and optimal use.” 21 C.F.R. § 312.85. .

Section 355(n)(3) of Title 21, United States Code, provides: The Secretary shall make appointments to each panel ... so that each panel shall consist of— (A)members who are qualified by training and experience to evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the development, manufacture, or utilization of such drugs; (

B) members with diverse expertise in such fields as clinical and administrative medicine, pharmacy, pharmacology, pharmacoe-conomics, biological and physical sciences, and other related professions; (

C) a representative of consumer interests, and a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel; and (

D) two or more members who are specialists or have other expertise in the particular disease or condition for which the drug under review is proposed to be indicated. . The FDA has several other regulatory programs designed to hasten research of the safety and effectiveness of drugs for terminally or severely ill patients and allow early access where scientifically and medically warranted.

For example, under its "Fast Track" program, the agency has "established procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists." 21 C.F.R. § 312.80. Fast Track allows the FDA to waive its IND application requirement if it is "unnecessary or cannot be achieved," id. § 312.10, and even allows a waiver request to be made "[i]n an emergency ... by telephone or other rapid communication,” id.

The "Accelerated Approval” program provides a truncated approval process for "certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” Id. § 314.500. The FDA categorizes some new drugs, including nearly all cancer drugs, as "priority drugs” and seeks to accelerate their availability. .

The dissent has recast the Alliance's proposed right away from the terms used in its briefs and oral argument—a right to access investigational new drugs—into a right "to try to save one’s life,” which has “its textual anchor in the right to life [expressed in the Fifth Amendment].” Dissent at 714-15. Regardless of how it is described, we must examine the proposed right under Glucksberg, which specifically cautions against the type of broad generalization the dissent now employs. See Glucksberg, 521 U.S. at 721, 117 S.Ct. 2258 (requiring a " ‘careful description’ of the asserted fundamental liberty interest”).

If the asserted right is so broad that it protects a person’s efforts to save his life, it might subject to strict scrutiny any government action that would affect the means by which he sought to do so, no matter how remote the chance of success. The Supreme Court rejected a similar attempt to broadly define the right at issue in Reno v.

Flores when it refused to accept the petitioner’s definition as the "freedom from physical restraint” and instead cast the right as the "right of a child who has no available parent, close relative, or legal guardian, and for whom the government is responsible, to be placed in the custody of a willing-and-able private custodian rather than of a government-operated or government-selected child-care institution.” Reno v. Flores, 507 U.S. 292, 302, 113 S.Ct. 1439, 123 L.Ed.2d 1 (1993).

The dissent suffers from the same flaw in arguing that this is about the right to save one’s life, because, in the end, this case is about the right to access experimental and unproven drugs in an attempt to save one’s life, which we conclude under Glucksberg is not deeply rooted in our Nation’s history and traditions. By describing too broadly at the outset a proposed right that will cover the Alliance’s more narrow claim, the dissent fails Glucksberg's threshold requirement of a carefully described right. We need not pursue the arguments that follow that initial misstep. .

We nonetheless have serious doubt about whether the Alliance's description of its proposed constitutional right could ever pass constitutional muster. The Alliance's claimed right depends on a regulatory determination that the drug is safe for testing, prompting an obvious question: How can a constitutional right be defined by an administrative regulation that is subject to change? Would an FDA decision requiring increased testing for safety and efficacy before the commencement of human clinical trials affect the Alliance’s constitutional right?

Moreover, we find it difficult to imagine how a right inextricably entangled with the details of shifting administrative regulations could be "deeply rooted in this Nation’s history and tradition and implicit in the concept of ordered liberty.” Glucksberg, 521 U.S. at 721, 117 S.Ct. 2258 (quotation marks and citations omitted). .

Drug regulation also has a long history in England, beginning no later than Henry Vi’s royal decree in 1447 that gave grocers the power to inspect “anis, wormseed, rhubarb, scammony, spikenard, senna and all sort of drugs belonging to medicine, so as not, in the buying of these to be hurt in their bodily health.” Edward Kremers, Kremers and Ur-dang's History of Pharmacy 111 (4th ed.1976).

The Pharmacy Wares Drugs and Stuffs Act in 1540 allowed inspectors to search apothecaries' [¿.e., pharmacists’] shops for drugs that were “defective, corrupted and not meet nor convenient to be ministered in any medicines for the health of man's body.” John P. Griffin, Venetian Treacle and the Foundation of Medicines Regulation, 58 Brit. J. of Clinical Pharmacology 317, 319 (2004); see also John P. Griffin & Rashmi R. Shah, History of Drug Regulation in the United Kingdom, in The Textbook of Pharmaceutical Medicine 457 (John P. Griffin & John O'Grady eds., 2006).

"[W]hen the Society of Apothecaries was chartered independently ([in] 1617), its master and wardens were empowered to inspect any pharmacy and to burn before the offender’s door all drugs and preparations they deemed corrupt or unwholesome.” Kremers, supra, at 111. “In the 18th century, power to examine the shops of apothecaries, chemists and druggists was given to the College of Physicians ([in] 1723), and cases involving questionable drugs were judged by a court composed partly of physicians and partly of apothecaries ([in] 1730).” Id. at 111-12. .

Although not an example of legislative or regulatory intervention, in 1630 Nicholas Knopp of Massachusetts was "fined five pounds, or was whipped, for vending as a cure for scurvy 'a water of no worth nor value,' which he ‘soldé att a very deare rate.’ ” James Harvey Young, The Toadstool Millionaires: A Social History of Patent Medicines in America Before Federal Regulation 16 (1961) (quoting Records of the Governor and Company of the Massachusetts Bay in New England (Boston, 1853), I, 83). .

As the Alliance notes, “the Supreme Court held that the 1906 Act did not prohibit a drug manufacturer from marketing an ineffective cancer remedy with false therapeutic claims, so long as it was not adulterated.” Appellants' Br. at 45 (citing United States v. Johnson, 221 U.S. 488, 31 S.Ct. 627, 55 L.Ed. 823 (1911)). But Johnson was merely a question of statutory

interpretation, and the Court specifically noted that it would “say nothing as to the limits of constitutional power.” Johnson, 221 U.S. at 498, 31 S.Ct. 627. Johnson therefore cannot be read to support the recognition of a constitutional right to access experimental drugs or consume any drugs regardless of the risks. . Looking to Lawrence v.

Texas, the FDA argues that "[t]he history of the FDCA over the past seventy years is entitled to particular weight in the substantive due process calculus,” Appellees’ Br. at 31, because, in determining the constitutionality of a Texas statute prohibiting certain intimate sexual conduct between members of the same sex, the Supreme Court looked to the Nation’s “laws and traditions in the past half century ” as having the “most relevance” to the constitutional dispute in that case. Lawrence v. Texas, 539 U.S. 558, 571-72, 123 S.Ct. 2472, 156 L.Ed.2d 508 (2003) (emphasis added).

We need not determine today whether recent history is particularly relevant in measuring the scope of rights under the Due Process Clause. In this case, there is no evidence of a deeply rooted right of terminally ill patients to gain access to experimental drugs — either throughout our Nation’s history or during the past half century. . In fact, the FDA cites numerous examples in which drugs have been pulled from the market post-Phase I due to safety concerns. See, e.g., Alex Berenson, End of Drug Trial Is a Big Loss for Pfizer and Heart Patients, N.Y.

Times, Dec. 4, 2006, at Al (highlighting Pfizer’s decision to pull torcetrapib from a clinical trial of more than 15,000 patients because those taking the drug were dying at a greater rate than those taking a placebo); Milton Packer et al.. Effect of Oral Milrinone on Mortality in Severe Chronic Heart Failure, 325 New Eng. J. Med. 1468 (1991) (concluding after expanded clinical trials that milrinone therapy was “associated with a 28 percent increase in mortality''); Debra S. Echt et al., Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo, 324 New Eng. J.

Med. 781 (1991) (concluding after expanded clinical trials that "[t]here was an excess of deaths ... in patients treated with encainide or flecainide”). .

In exercising the caution the Supreme Court demands when analyzing claims of fundamental rights, see Glucksberg, 521 U.S. at 720, 117 S.Ct. 2258, we note a more plausible explanation for the limited efficacy regulation — the government was not previously able to systematically regulate effectively for efficacy: "The history of the effectiveness requirement in drug regulation is inextricably linked to the advent of the randomized, controlled clinical trial as the cornerstone of medical research ..., [which] would not become widely recognized until the twentieth century.” Jennifer Kulynych, Will FDA Relinquish the “Gold Standard" for New Drug Approval?

Redefining Substantial Evidence" in the FDA Modernization Act of 1997, 54 Food & Drug L.J. 127, 131 (1999) (footnotes omitted). In fact, "World War II ushered in the era of the modern clinical trial, when the U.S. military undertook large-scale, systematic testing of tuberculosis remedies and antimalarial agents on groups of enlisted soldiers.” Id. Ironically, the Alliance would use the recent development of tools such as modern clinical trials to bolster its claim of exemption from regulation made possible by these very tools.

It was not just advances in statistics and clinical trials, however, that improved governments’ ability to regulate access to drugs. The ability of scientists to "detect, identify, and understand” the components of various drugs has contributed to "new regulatory approaches [that] would not have been feasible and could never have occurred” without these scientific advances. Peter Barton Hutt, The Importance of Analytical Chemistry to Food and Drug Regulation, 38 Vand. L.Rev. 479, 487 (1985).

Further, the need for efficacy regulation became more pressing "[a]fter World War II[as] the number of drugs available, the range of diseases and conditions amenable to drug therapy, and the power of drugs all increased dramatically.” Peter Temin, Taking Your Medicine: Drug Regulation in the United States 5 (1980). . The Supreme Court in Glucksberg specifically disapproved of recognizing new fundamental rights solely based upon “abstract concepts of personal autonomy." Glucksberg, 521 U.S. at 725, 117 S.Ct. 2258.

The FDA argues that the Alliance’s effort to create a new fundamental right based upon these three doctrines amounts to precisely this type of reasoning forbidden by Glucksberg, that is, amounts to the creation of a right based solely upon abstract concepts of liberty. The Alliance insists that "reasoning by analogy, and a search for broader principles, are the only available tools” in cases where there is a “tradition of non-regulation.” Reply Br. at 3.

In those circumstances, the Alliance argues, "there often will be no common law cases precisely on point simply because the common law never confronted the precise problem.” Id. We need not address this FDA argument because none of the common law doctrines upon which the Alliance relies supports its proposed right. . As an initial matter, the Oakland Court noted that "it is an open question whether federal courts ever have authority to recognize a necessity defense not provided by statute.” Id. (emphasis added). “Even at common law, the defense of necessity was somewhat controversial.

And under our constitutional system, in which federal crimes are defined by statute rather than by common law, it is especially so.” Id. (internal citations omitted). The Court did "not decide, however, whether necessity can ever be a defense when the federal statute does not expressly provide for it,” Oakland, 532 U.S. at 491, 121 S.Ct. 1711, because, as in this case, the federal statute at issue in Oakland had specifically reached the value judgment the proponents of an implied necessity defense sought to override. .

The lynchpin of the dissent’s argument that preventing access to experimental drugs implicates a right to preserve one's own life is that we have confused "what is necessary with what is sufficient.” Dissent at 715, 718. Because terminally ill patients have no other approved treatment options, so the argument goes, any drug having passed Phase I, no matter the remaining unexplored risk, is "necessary" for prolonging a patient's life. But the dissent ignores the fact that when these treatment decisions are being made, the safety and efficacy records of experimental drugs are not fully known.

We thus cannot know until after the clinical testing process has been completed that these drugs are in fact necessary. This argument also defies reality as the great majority of experimental drugs ultimately provide no benefit, and we fail to see how an ineffective and unsafe drug can be classified as necessary. See, e.g., Peter D. Jacobson & Wendy E.

Parmet, A New Era of Unapproved Drugs: The Case of Abigail Alliance v. von Eschenbach, 297 JAMA 205, 206 (2007) (noting that only five percent of all cancer drugs beginning clinical trials are ultimately approved for use and that less than a third that pass Phase I advance from Phase II to Phase III).

The dissent's position is further compromised by the fact that the Supreme Court rejected a similar argument in a statutory challenge to the FDCA because “[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." United States v. Rutherford, 442 U.S. 544, 555-56, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979). .

See also Casey, 505 U.S. at 879, 112 S.Ct. 2791 (reaffirming exception); Roe, 410 U.S. at 173, 93 S.Ct. 705 (Rehnquist, J., dissenting) ("If the Texas statute were to prohibit an abortion even where the mother's life is in jeopardy, I have little doubt that such a statute would lack a rational relation to a valid state objective....”). . To be sure, we do not suggest that the law can never strike the balance between access to experimental drugs and risk that the Alliance suggests. We limit our analysis to whether the Constitution demands the balance they desire.

The Alliance can, of course, advocate its position vigorously before Congress and the FDA, and convince our Nation's democratic branches that the values the Alliance favors should be protected. In fact, within the last year, the political branches have responded to the concerns of the Alliance and others. The FDA recently issued a notice of proposed rulemaking that: propos[ed] to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use.

Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The proposed rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies. Expanded Access to Investigational Drugs, 71 Fed.Reg. 75,147-01, 75,147 (Dec. 14, 2006). .

No circuit court has acceded to an affirmative access claim. See, e.g., Mitchell v. Clayton, 995 F.2d 772, 775 (7th Cir.1993) (“most federal courts have held that a patient does not have a constitutional right to obtain a particular type of treatment or to obtain treatment from a particular provider if the government has reasonably prohibited that type of treatment or provider”); N.Y. State Ophthalmological Soc'y v.

Bowen, 854 F.2d 1379, 1389 (D.C.Cir.1988) ("We disagree that the constitutional right to privacy comprehensively protects all choices made by patients and their physicians or subjects to 'strict scrutiny’ all government interference with choice of medical treatment. There is no basis under current privacy case law for extending such stringent protection to every decision bearing, however indirectly, on a person's health and physical well-being.”), cert. denied, 490 U.S. 1098, 109 S.Ct. 2448, 104 L.Ed.2d 1003 (1989); Carnohan v.

United States, 616 F.2d 1120, 1122 (9th Cir.1980) ("Constitutional rights of privacy and personal liberty do not give individuals the right to obtain [the cancer drug] laetrile free of the lawful exercise of government police power.”); Rutherford v. United States, 616 F.2d 455, 457 (10th Cir.1980) ("[T]he patient[’s] ... selection of a particular treatment, or at least a medication, is within the area of governmental interest in protecting public health. The premarketing requirement of the [FDCA], 21 U.S.C. § 355, is an exercise of Congressional authority to limit the patient's choice of medication.

This is clear under the [Supreme Court's] decisions ....”), on remand from 442 U.S. 544, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979), cert. denied, 449 U.S. 937, 101 S.Ct. 336, 66 L.Ed.2d 160 (1980); see also Sammon v. N.J. Bd. of Med. Exam’rs, 66 F.3d 639, 645 n. 10 (3d Cir.1995); United States v. Burzynsld Cancer Research Inst., 819 F.2d 1301, 1313-14 (5th Cir.1987); cf. Lambert v.

Yellowley, 272 U.S. 581, 588, 590, 596-97, 47 S.Ct. 210, 71 L.Ed. 422 (1926) (where Congress determined, in implementing Prohibition, that “practicing physicians differ about the value of malt, vinous and spirituous liquors for medicinal purposes, [and] that the preponderating opinion is against their use for such purposes,” the Court rejected a physician's claim of a constitutional right to "use ... such medicines and medical treatment as in his opinion are best calculated to effect [his patients'] cure and establish their health,” holding that “there is no right to practice medicine which is not subordinate ... to the power of Congress to make laws necessary and proper....

High medical authority being in conflict as to the medicinal value of spirituous and vinous liquors taken as a beverage, it would, indeed, be strange if Congress lacked the power to determine that the necessities of the liquor problem require a limitation of permissible prescriptions....”); Watson v. Maryland, 218 U.S. 173, 176, 30 S.Ct. 644, 54 L.Ed. 987 (1910) ("It is too well settled to require discussion at this day that the police power of the States extends to the regulation of certain trades and callings, particularly those which closely concern the public health.

There is perhaps no profession more properly open to such regulation than that which embraces the practitioners of medicine.”). . As there exists no deeply rooted right, we need not examine whether a right of access to experimental drugs is " ‘implicit in the concept of ordered liberty,' such that 'neither liberty nor justice would exist if they were sacrificed.' ” Glucksberg, 521 U.S. at 720-21, 117 S.Ct. 2258 (quoting Palko v. Connecticut, 302 U.S. 319, 325, 326, 58 S.Ct. 149, 82 L.Ed. 288 (1937)).

While we need not and do not address all of the Alliance's arguments regarding whether their proposed right is implicit in our Nation's system of ordered liberty, we note a crucial difference between this case and one of the cases relied upon by the Alliance in making that argument, Cruzan v. Director, Mo. Dep’t of Health, 497 U.S. 261, 110 S.Ct. 2841, 111 L.Ed.2d 224 (1990).

In Cruzan, the Supreme Court "assume[d] that the United States Constitution would grant a competent person a constitutionally protected right to refuse lifesaving hydration and nutrition,” although the Court indicated that "the dramatic consequences involved in [a particular] refusal of [life-sustaining] treatment would inform the inquiry as to whether the deprivation of that interest is constitutionally permissible.” Id. at 279, 110 S.Ct. 2841.

Looking to Cruzan, the Alliance argues that "[i]f a patient has a fundamental right to medical self-determination that gives them the right to starve themselves to death, then surely they have a right to choose to fight for their lives even if that means taking a drug that has not yet met the FDA's full approval standards.” Appellants' Br. at 27.

Cruzan’s assumption that there is a right to refuse lifesaving treatment in some circumstances was predicated upon "the common-law rule that forced medication was a battery[] and the long legal tradition protecting the decision to refuse unwanted medical treatment.” Glucksberg, 521 U.S. at 725, 117 S.Ct. 2258 (discussing Cruzan); see also Cruzan, 497 U.S. at 269, 110 S.Ct. 2841. But a tradition protecting individual freedom from life-saving, but forced, medical treatment does not evidence a constitutional tradition of providing affirmative access to a potentially harmful, and even fatal, commercial good. .

We are mindful of the fact that this case is before us pursuant to the FDA’s motion to dismiss, brought under Federal Rule of Civil Procedure 12(b)(6). The Seventh Circuit has noted some tension between the Rule 12(b)(6) standard and rational basis review. See Wroblewski v.

City of Washburn, 965 F.2d 452, 459 (7th Cir.1992) ("The rational basis standard requires the government to win if any set of facts reasonably may be conceived to justify its classification; the Rule 12(b)(6) standard requires the plaintiff to prevail if relief could be granted under any set of facts that could be proved consistent with the allegations. The rational basis standard, of course, cannot defeat the plaintiff’s benefit of the broad Rule 12(b)(6) standard.”) (quotation marks and citations omitted).

In this case, however, we need not worry about the outer realm of Rule 12(b)(6) protection because, as we explain below, the Alliance's pleadings themselves make our rational basis determination straightforward. Cf. Trudeau v. FTC, 456 F.3d 178, 193 (D.C.Cir.2006) (noting that it "is possible for a plaintiff to plead too much; that is, to plead himself out of court by alleging facts that render success on the merits impossible” (quoting Sparrow v. United Air Lines, Inc., 216 F.3d 1111, 1116 (D.C.Cir.2000))).