Brief for the Petitioners Gonzales v. State of Oregon*

OPINIONS BELOW

The opinion of the court of appeals is reported at 368 E3d 1118. The order of the district court granting respondents' motion for summary judgment is reported at 192 E Supp. 2d 1077.

SUMMARY OF ARGUMENT

The court of appeals acknowledged that the Controlled Substances

Act prohibits practitioners from prescribing or dispensing controlled substances except for a "legitimate medical purpose" and "in the usual course of professional treatment." Pet. App. 5a (quoting 21 C.ER. 1306.04). Respondents nonetheless seek to overturn the Attorney Generals determination that the prescription of controlled substances, not for ordinary treatment, but for the express purpose of ending an individual's life, does not constitute a legitimate medical purpose or treatment under federal law. Respondents essentially submit that the Attorney General's interpretation of federal law would frustrate the purposes of a state-law voter initiative, and so the federal law must yield. Thus, the issue presented in this case is "who gets to decide," id. at 9a, whether a practitioner's conduct comports with this requirement of federal law-the Attorney General, pursuant to a uniform national standard, or each of the 50 States, according to 50 different views regarding the proper use of controlled substances. The text and structure of the CSA, as well as general principles of federalism, make clear that the Attorney General's interpretation of federal law need not yield to Oregon's contrary policy choices.

It is well established that the federal government, rather than the States, normally defines the terms in federal laws, giving them a single, nationwide definition. see Mississippi Band of Choctaw Indians v. Holyfield, 490 U.S. 30 (1989). There is no basis to depart from this general rule in interpreting the terms "legitimate medical purpose" and "treatment" in the context of the CSA. To the contrary, it is clear that Congress intended the CSA to set uniform nationwide minimum standards for controlled substances, and, in light of the centrality of the "legitimate medical purpose" and "treatment" limitations to the entire federal scheme, those terms must also be given a uniform federal meaning.

Indeed, decisions of this Court already recognize that the CSA establishes national rules that do not yield to contrary medical policy that an individual State might seek to follow as a matter of state law. In United States v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 483 (2001), the Court made clear that the federal determination that marijuana has no "accepted medical use in treatment in the United States" foreclosed the assertion of a "medical necessity" defense to a federal prosecution under the CSA, despite a California law purporting to recognize a valid medical use of marijuana and to permit its use in certain circumstances.

There is no reason to believe that a different result is required when federal law determines that a drug has a legitimate medical purpose, but that not all uses of that drug are legitimate. This Court, for example, upheld a CSA conviction based on a physician's prescription of a schedule II drug-one that has a recognized and accepted medical use-for illegitimate purposes and did so on the basis of a national standard for medical practice. see United States v. Moore, 423 U.S. 122 (1975).

The conclusion that the Attorney General reached on this issue-that assisting suicide is not a legitimate medical purpose-finds overwhelming support in tradition, history, law, and medical expertise. The Attorney General's conclusion is consistent with the laws of 49 States, other laws and policies of the federal government, and leading associations of the medical profession. These facts alone demonstrate that the Attorney General's conclusion is reasonable and therefore must be upheld in light of the deference to which his views are entitled.

In the decision below, the court of appeals majority ignored the Mississippi Band line of cases, and declined to follow Oakland Cannabis and Moore in upholding the uniform national scope of the CSA. The court concluded that in order for the federal government to regulate controlled substances in a way that limits the practice of medicine in Oregon, a clear Congressional statement of its intent to do so was necessary. Pet. App. Ua. Citing Gregory v. Asheroft, 501 U.S. 452, 460 (1991), the court of appeals held that a clear statement is necessary whenever federal law impacts upon an area within the traditional regulatory authority of the States, such as the practice of medicine. Pet. App. 11a. But Gregory applies only to federal laws that have an impact upon essential aspects of State sovereignty, such as the tenure of judges and location of a State's Capital. To expand Gregory to all areas of private conduct traditionally regulated by the States, as the court of appeals did here, would dramatically expand the clear statement requirement to encompass virtually all areas of federal regulation, in light of the breadth of the States' traditional police powers. The Loehner-era authority that the court of appeals cited for the proposition that certain categories of activity are presumptively beyond the authority of the federal government has long ago been rejected by this Court as both unworkable and unfounded, and there is no basis for resurrecting it now.

The court of appeals' belief that the Attorney General's ruling implicates the presumption against preemption, Pet. App. 14a-15a, was similarly misplaced. It is not "preemption" for the federal government to prohibit conduct as a matter of federal law that a particular State would deem permissible under its own laws. Oregon is free to decriminalize assisted suicide as a matter of Oregon law, as it has done. But Oregon could not displace contrary federal law by prefacing its state statutes with the phrase "notwithstanding any provision of federal law," and no presumption against preemption allows it to exempt its physicians from compliance with federal directives sub silentio. Federal law does not yield even when it frustrates the purposes of state law.

There is no basis in the statutory language or purpose of the CSA for subordinating the Attorney General's ability to administer the Act's comprehensive national scheme for controlling dangerous substances to the views of each of the States regarding those substances' permissible uses.

ARGUMENT

I. THE CONTROLLED SUBSTANCES ACT ESTABLISHES A COMPREHENSIVE AND UNIFORM NATIONAL SYSTEM FOR REGULATING CONTROLLED SUBSTANCES, AND THE ATTORNEY GENERALS INTERPRETIVE RULING IMPLEMENTING THE ACT IS SUPPORTED BY THE OVERWHELMING WEIGHT OF AUTHORITY

A. The Prohibition On Dispensing Controlled Substances For Other Than A "Legitimate Medical Purpose" In The "Usual Course Of Professional Treatment" Is Central To The Regulatory Scheme Established By The Controlled Substances Act

The CSA prohibits a practitioner from prescribing controlled substances except "for a legitimate medical purpose" and "in the usual course of professional treatment." Pet. App. 5a (quoting 21 C.ER. 1306.04). Those limitations appear throughout the CSA, reflecting their centrality to the comprehensive national scheme Congress established to regulate controlled substances. The starting point of the Act (indeed, its first provision) is the recognition that "[m]any of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people." 21 U.S.C. 801(1). And the entire federal scheme for regulating controlled substances is built upon the dual principles that the dispensing of controlled substances should be allowed for such "legitimate medical purpose [s]," but that their distribution for illegitimate purposes should be prohibited. Ibid.

The Attorney General is charged under the CSA, 21 U.S.C. 811 (a), with assigning controlled substances to the appropriate "schedule" according to whether they have a "currently accepted medical use in treatment in the United States," 21 U.S.C. 812(b), and other factors. A substance for which the Attorney General has determined there is "no currently accepted medical use in treatment in the United States" is placed in schedule I, 21 U.S.C. 812(b)(l)(B), and may not be prescribed or dispensed except pursuant to a research protocol specifically approved by the Attorney General and the secretary of Health and Human Services to ensure the substance will not be diverted from "legitimate medical or scientific use," 21 U.S.C. 823(0. Substances in other schedules may be dispensed by practitioners only because they have "a currently accepted medical use in treatment in the United States," 21 U.S.C. 812(b)(2)(B), (3)(B), (4)(B), and (5)(B), thereby underscoring the centrality of "medical use" in "treatment" as a necessary condition for allowing a scheduled substance to be dispensed at all.

Other provisions of the Act similarly confine a practitioners latitude in dispensing drugs in schedules II through V to legitimate medical uses in the course of treatment. The CSA makes it unlawful for "any person" to "dispense" a controlled substance "[e]xcept as authorized" by the CSA. 21 U.S.C. 841 (a) and (a)(l). The Act defines "dispense" to include the "prescribing" of a controlled substance by a "practitioner," 21 U.S.C. 802(10), and defines "practitioner" to include a professionally-licensed physician dispensing controlled substances "in the course of professional practice," 21 U.S.C. 802(21). The CSA reiterates the "in the course of ... professional practice" limitation in other provisions concerning the misuse of federal order forms, 21 U.S.C. 828(e), and unlawful possession of controlled substances, 21 U.S.C. 844(a). The "legitimate medical purpose" requirement is also reiterated in 21 U.S.C. 823(a)(l), which requires the Attorney General to ensure that there is an "adequate . . . supply" of schedule I and schedule II substances "for legitimate medical, scientific, research, and industrial purposes."

Consistent with those various provisions of the Act, the Attorney General's regulation confirms that a prescription for a controlled substance "must be issued for a legitimate medical purpose" and that "[a]n order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription" within the meaning of the CSA. 21 C.ER. 1306.04(a).

This court has similarly recognized and enforced the CSAs prohibition on the prescription of controlled substances for other than legitimate medical purposes. In United States v. Moore, 423 U.S. 122 (1975), the court unanimously held that physicians violate the CSA "when their activities fall outside the usual course of professional practice." Id. at 124; see id. at 141-142 ("provisions throughout the Act refleet the intent of congress to confine authorized medical practice within accepted limits"). In so holding, the court noted that "[t]he medical purpose requirement," which is explicit in 21 U.S.C.. 829(c), could be implicit in 21 U.S.C.. 829(a) and (b) and is, in any event, made explicit with respect to those provision by the Attorney General's regulation, now codified at 21 C.ER. 1306.04(a). 423 U.S. at 137 n. 13. Following Moore, the courts of appeals have consistently applied a "legitimate medical purpose" standard in CSA prosecutions of physicians and pharmacists. see, e.g., United States v. Daniel, 3 E3d 775, 778 (4th Cir. 1993), cert, denied, 510 U.S. 1130 (1994); United States v. Kaplan, 895 F.2d 618, 619 (9th Cir. 1990); United States v.Jamieson, 806 E2d 949, 951 (10th Cir. 1986); United States v. Chin, 795 E2d 496, 503 (5th Cir. 1986); United States v. Hammond, 781 E2d 1536, 1537 (11th Cir. 1986); United States v. Plesons, 560 E2d 890, 896-897 & n.6 (8th Cir. 1977); accord United States v. Hughes, 895 E2d 1135, 1143 (6th Cir. 1990) ("legitimate medical practice").6

In fact, Congress has adopted a statutory definition of "valid prescription" that mirrors the Attorney General's. In 2000, Congress revised the reporting requirements for distributions of certain listed chemicals. see Children's Health Act of 2000, Pub. L. No. 106-310, Tit. XXXVI, Div. B, 3652, 114 Stat. 1239 (21 U.S.C. 830(b)(3)). In so doing, Congress exempted from the reporting requirements "[distributions . . . pursuant to a valid prescription." 21 U.S.C. 830(b)(3)(D)(iv). Congress defined the phrase "valid prescription" in terms almost identical to those used by the Attorney General regarding the requirement for a "prescription" under 21 U.S.C. 829(a) and (b), as one "issued for a legitimate medical purpose by an individual practitioner . . . acting in the usual course of the practitioner's professional practice," 21 U.S.C. 830(b)(3)(A)(ii).

B. The Attorney General's Conclusion That Facilitating An Individual's Suicide Is Not A "Legitimate Medical Purpose" In "Treatment" For Purposes Of The Controlled Substances Act Is Supported By The Overwhelming Weight Of Authority

The overwhelming weight of authority supports the Attorney General's conclusion that dispensing drugs for the purpose of hastening a person's death is outside "the usual course of professional treatment" and not a "legitimate medical purpose" under the federal regulatory scheme. 21 C.ER. 1306.04. The Attorney General's conclusion is supported by the ordinary meaning of the CSAs text and by centuries of almost uniform opposition to the practice of assisted suicide, including the current opposition of leading medical societies, federal law, and the law of 49 of the 50 States. In light of the deference owed to the Attorney General's construction of the CSA, this broad consensus amply supports the reasonableness of his conclusion.

1. The language of the CSA demonstrates that Congress did not authorize physicians to prescribe controlled substances for the purpose of ending their patients' lives

As explained above, the operative requirements for a "prescription" to be valid under the CSA are that it be issued for a "legitimate medical purpose" and "in the usual course of professional treatment." 21 C.ER. 1306.04(a). see 21 U.S.C. 830(b)(3)(A)(ii). Because the CSA and implementing regulations do not specifically define those terms, they should be given their "ordinary meaning." see, e.g., Asgrow seed Co. ? Wmterboer, 513 U.S. 179, 187 (1995); FDICv. Meyer, 510 U.S. 471, 476 (1994). The ordinary meaning of the term "medical" is "[p]ertaining or related to the healing art or ... to 'medicine," 9 Oxford English Dictionary 546 (2d ed. 1989), and the term "medicine" refers to "[t]hat department of knowledge and practice which is concerned with the cure, alleviation, and prevention of disease in human beings, and with the restoration and preservation of health," id. at 549; see Webster's Third New International Dictionary 1402 (1966) ("the science and art dealing with the maintenance of health and the prevention, alleviation, or cure of disease"); The Random House Dictionary of the English Language 1194 (2d ed. 1987) ("the art or science of restoring or preserving health or due physical condition"). Whatever else the provision of controlled substances for the express purpose of hastening death may constitute, it clearly crosses a line and involves something other than the restoration or preservation of health, i.e., involves something other than medicine. Indeed, in one of this Court's first decisions to construe the Harrison Act of 1914, ch. 1, 38 Stat. 785 (Harrison Act)-the precursor to the CSA-the Court held that the term "prescription" by itself plainly connoted a requirement that the physician be attempting to "treat[]" or "cure" an illness. see Webb v. United States, 249 U.S. 96, 99-100 (1919) (To call a doctor's order for morphine that was . "not . . . issued ... in the course of professional treatment in the attempted cure of the habit" "a physician's prescription would be so plain a perversion of meaning that no discussion of the subject is required."). Assisting an individual's suicide does not fit within the ordinary meaning of the phrases "legitimate medical purpose" or "usual course of professional treatment," 21 C.ER. 1306.04(a), because it does not aim to preserve the patient's health or to cure, alleviate, prevent, or "treat" the disease or its symptoms in the patient. To the contrary, it aims to bring about the patient's death.

Moreover, the context within which these phrases are used within the CSA confirms that Congress intended them to be construed according to their ordinary usage. For example, the legislative findings that accompany the CSA reflect that Congress associated "legitimate medical purpose" with "maintain [ing] the health and general welfare of the American people."21U.S.C. 801(1). Similarly, Congress's direction that controlled substances be scheduled according to whether they have a "currently accepted medical use in treatment" and an "accepted safety for use . . . under medical supervision," 21 U.S.C. 812(b) (emphasis added), reflects Congress's intent that physicians dispense controlled substances to preserve and enhancenot end-their patients' lives. It certainly makes no sense to talk about the "safety for use" of drugs when they are dispensed to end a person's life. "A doctor who assists a suicide . . . 'must, necessarily and indubitably, intend primarily that the patient be made dead.'" Vacco v. Quill, 521 U.S. 793, 802 (1997) (quoting Assisted Suicide in the United States: Hearing Before the Subcomm. on the Constitution of the House Comm. on the Judiciary, 104th Cong., 2d Sess. 367 (1996) (testimony of Dr. Leon R. Kass)). The CSAs repeated use of the word "medical" in conjunction with the words "treatment," "health," and "safety" confirms that suicide is not a "legitimate medical purpose" under the CSA, because any procedure intended to cause the death of a patient is not "treatment" and does not promote the patient's "health" or "safety."7

2. The Attorney General's interpretation of the phrases "legitimate medical purpose" and "professional treatment" to exclude physician-assisted suicide is supported by historical tradition and the near-unanimity of state and federal authority

Even if the provisions of the CSA were not themselves clear, deference is owed to the Attorney General's construction of the Act and the implementing regulation describing what constitutes a valid prescription for purposes of federal law. see Chevron U.S.A. Inc. v. NRDC, inc., 467 U.S. 837, 843-844 (1984). The Attorney General, and his delegee the Administrator of the DHA, are, after all, the federal officers with primary responsibility for enforcing the CSA. see Alliance for Cannabis Therapeutics v. DEA, 930 E2d 936, 939 (D.C. Cir. 1991) ("neither the statute nor its legislative history precisely defines the term 'currently accepted medical use'; therefore, we are obliged to defer to the Administrator's interpretation of that phrase if reasonable"); Trawick v. DEA, 861 E2d 72, 75-76 (4th Cir. 1988) (deferring to DEA Administrator's determination that registrant's actions were inconsistent with the public interest and that his registration should be revoked). Indeed, the Attorney General's interpretation of his own regulation, 21 C.ER. 1306.04, is entitled to particular deference under Auerv. Robbins, 519 U.S. 452, 461 (1997), and Thomas Jefferson University v. Shalala, 512 U.S. 504, 512 (1994).

The Attorney General's conclusion-that the provision of drugs for the express purpose of ending life is something other than legitimate medical treatmentis consistent with the position adopted by 49 States, the federal government in other contexts, and leading associations of the medical profession. As the Court noted in Washington v. Glucksberg, 521 U.S. 702 (1997):

In almost every State-indeed, in almost every western democracy-it is a crime to assist a suicide. The States' assisted-suicide bans are not innovations. Rather, they are longstanding expressions of the States' commitment to the protection and preservation of all human life.

Id. at 710. see id. at 710 n.8 (citing compilation of state authorities); id. at 776 n.14 (Souter, J., concurring) (citing state statutes expressly prohibiting assisting a suicide).8 The laws of all 49 states, apart from Oregon, express their disapproval in one form or another of assisted suicide. see ibid.; Vacco, 521 U.S. at 805-806 &n.9 (collecting health-care and living-will statutes of 49 States and two territories disapproving of suicide and assisted suicide). It is Oregon's physician-assisted suicide statute that is contrary to longstanding historical practices as well as to the contemporary state of the law. Glucksberg, 521 U.S. at 710-719; id. at 723 ("[W]e are confronted with a consistent and almost universal tradition that has long rejected [a right to physician-assisted suicide], and continues explicitly to reject it today, even for terminally ill, mentally competent adults.").9 Oregon is free to change its state law; but doing so does not require the Attorney General to change his interpretation of federal law.

The Attorney General did not ignore the laws of the States in interpreting the CSA to bar the dispensing of controlled substances to facilitate suicide. To the contrary, his interpretation is consistent with the position of the overwhelming majority of the States. In light of the historical unanimity of opinion on this issue, and the fact that the CSA predated Oregon's DWDA by several decades, it is inconceivable that Congress, in enacting the CSA, regarded assisted suicide as a legitimate "medical" practice in the "treatment" of disease.

Numerous health care experts have likewise agreed that physician-assisted suicide is not a legitimate medical treatment. In Glucksberg, the Court noted that New York State's Task Force on Life and the Law-a group including doctors, ethicists, lawyers, religious leaders and interested laypersons-had unanimously concluded that "[!legalizing assisted suicide and euthanasia would pose profound risks to many individuals who are ill and vulnerable .... [T] he potential dangers of this dramatic change in public policy would outweigh any benefit that might be achieved." 521 U. S. at 719 (quoting New York State Task Force on Life and the Law, When Death is Sought: Assisted Suicide and Euthanasia in theMedical Context 120 (May 1994)). Likewise, as OLC noted in the memorandum on which the Attorney Generals interpretive ruling was based, the American Medical Association (AMA), American Nurses Association, and American Psychiatric Association filed a joint brief in Glucksberg taking the position that physician-assisted suicide is "fundamentally incompatible with the physician's role as healer." Pet. App. 124a (quoting AMA Br. at 5, Washington v. Glucksberg, 521 U.S. 702 (1997) (No. 96-11O)); see Glucksberg, 521 U.S. at 731 (quoting same). The ethical guidelines of the AMA continue to state that "[pjhysician assisted suicide is fundamentally incompatible with the physician's role as healer." AMA, Current Opinions of the Council of Ethical and Judicial Affairs, Opinion No. E-2.211, Physician-Assisted Suicide (last visited Apr. 28, 2005) <http :// www.ama-assn. org/ama/pub/category/print/8459.html>.

In other federal laws and programs as well, physician-assisted suicide is not regarded as a legitimate medical practice. In 1997, Congress passed a broad ban on the federal funding of assisted suicide. see Assisted Suicide Funding Restriction Act of 1997, Pub. L. No. 105-12, 3(a), 111 Stat. 23. Administratively, the Department of Health and Human Services's Health Care Financing Administration (now the Centers for Medicare and Medicaid Services) similarly has determined that physician-assisted suicide is not eligible for reimbursement under Medicare because it is "not reasonable and necessary to the diagnosis and treatment of disease or injury." Pet. App. 121a (internal quotation marks omitted); Medicare Benefit Policy Manual ch. 16, 20 (2003).

There can be no question, then, that the Attorney General's interpretive ruling is consistent with the prevailing legal and medical views regarding medical practice and on that basis is, at the very least, a reasonable interpretation of federal law, which is entitled to deference.

C. The Controlled Substances Act Has A Uniform Meaning, Determined By Federal Law, Throughout The United States

As the court of appeals recognized, the principal question presented by this case is "who gets to decide," Pet. App. 9a, whether particular conduct comports with the federal requirement under the CSA that a prescription be issued for a "legitimate medical purpose" and in the "usual course of professional treatment," 21 C.ER. 1306.04(a). Although Congress presumably could develop a statutory scheme that depended entirely on state law and varied across the Nation, it did not do so in the CSA. The text and structure of the CSA, as reinforced by general principles of federalism, make clear that a uniform federal standard determines what constitutes a legitimate medical purpose under this federal statute.

1. There is a presumption in favor of a uniform national standard. It is a wellestablished principle of statutory construction that, "in the absence of a plain indication to the contrary, . . . Congress when it enacts a statute is not making the application of the federal act dependent on state law." Mississippi Band of Choctaw Indians v. Holy field, 490 U.S. 30, 43, 47 (1989) (quoting Jerome v. United States, 318 U.S. 101, 104 (1943), and holding that the word "domicile" used in the Indian Child Welfare Act, 25 U.S.C. 1911(a), should have a uniform meaning rather than vary according to state law). Rather, "[b]ecause federal law applies nationally," the assumption is "that Congress desires national uniformity in the application of its laws." SaZt Lake Tribune PuWg Co. v. Management Planning, Inc., 390 E3d 684, 688 (10th Qr. 2004). Accordingly this Court has repeatedly adopted uniform national definitions for the terms in federal laws and refused to make the definitions of those terms dependent upon the vagaries of state law. see, e.g., Reves v. Ernst &> Young, 494 U.S. 56, 71 (1990) (the meaning of the word "maturity" in the securities Exchange Act of 1934, 15 U.S.C. 78c(a)(10), "is a question of federal law" and does not differ from State to State based on differences in state law); United States v. Turley, 352 U.S. 407 (1957) (same for the word "stolen" in the National Motor Vehicle Theft Act, 18 U.S.C. 2312); United States v. Pelzer, 312 U.S. 399 (1941) (same for the phrase "future interests" in the Revenue Act of 1932, ch. 209, 504(b), 47 Stat. 247). Because nothing in either the CSA or its implementing regulations makes the definition of "legitimate medical purpose" or "treatment" depend upon state law, this Court's decisions in Mississippi Band and similar cases mandate that those phrases be given uniform federal definitions and not vary from State to State.

Indeed, the Mississippi Band presumption is particularly appropriate with respect to the CSA, which establishes a "comprehensive federal scheme" for regulating controlled substances. Goading v. United States, 416 U.S. 430, 449 (1974). The CSA contains numerous provisions reflecting the need for uniform minimum federal standards. Congress emphasized that when employed for a "legitimate medical purpose," controlled substances are "necessary to maintain the health and general welfare of the American people," 21 U.S.C. 801(1), but that "illegal. . . distribution . . . and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people," 21 U.S.C. 801(2). And Congress specifically found that "[federal control" of all incidents of the traffic in controlled substances, including intrastate incidents, is "essential to the effective control" of such substances. 21 U.S.C. 801(6) (emphasis added). Accordingly, the core provisions of the CSA prohibit the dispensing of controlled substances "[e]xcept as authorized by this subchapter" 21 U.S.C. 841 (a) (emphasis added), and authorize registered physicians to prescribe controlled substances only "to the extent authorized by their registration and in conformity with the other provisions of this subchapter," 21 U.S.C. 822(b) (emphasis added). The repeated cross-references to the provisions of the CSA itself, without any comparable references to state law, demonstrate Congress's intent to create a comprehensive federal system of regulation.

Other provisions of the CSA confirm that the requirement of a legitimate "medical" purpose in "treatment" cannot be construed as a delegation to the States to determine what constitutes legitimate medical practices for purposes of the CSA. The CSA authorizes the Attorney General to assign controlled substances to particular schedules, 21 U.S.C. 811(a), depending on whether they have "accepted medical use in treatment in the United States" 21 U.S.C. 812(b) (emphasis added). The CSA's scheduling provisions plainly contemplate a single national determination of accepted "medical" use; there is no such thing as a controlled substance that appears in schedule 1 in those States that do not recognize any accepted "medical" use for the substance but appears in a different schedule in other States that do recognize such a use. Moreover, the fact that Congress itself initially put certain drugs on schedule I-subject to rescheduling based on the judgments of federal, not state, officials-is a particularly strong indication that the Congress that enacted the CSA believed medical judgments could and should be made on the national level. see pp. 28-30, infra.

2. Judicial decisions interpreting the CSA confirm that it provides a uniform federallaw standard. This Court's decisions confirm that the minimum standards established by the CSA for dispensing controlled substances are uniform throughout the Nation and are not subject to revision by the States.10 As the Court has recognized, "the application of federal legislation is nationwide and at times the federal program would be impaired if state law were to control." Dicherson v. New Banner ImL, Inc., 450 U.S. 103, 119-120 (1983). The determination whether a drug has a "currently accepted medical use in treatment in the United States," for purposes of scheduling the substance under 21 U.S.C. 812(b), is such an instance in which the need for federal uniformity precludes resort to 50 different state laws.

a. In Oakland Cannabis, for example, the Court considered a ballot initiative passed by California voters that established, for purposes of state law, that seriously ill Californians could "use marijuana for medical purposes." 532 U.S. at 486 (quoting CaI. Health & Safety Code Ann. 11362.5(b)(l)(A) (West 2004 Supp.)). Nonetheless, this Court rejected a marijuana cooperative's reliance on the state law as supporting a "medical necessity" defense to a federal prosecution under the CSA. The Court held that such a defense would be inconsistent with Congress's finding, in classifying marijuana in schedule I, that the substance has "no currently accepted medical use in treatment in the United States." Id. at 492, see id. at 493 (notwithstanding the California law, "Congress has made a determination that marijuana has no medical benefits worthy of an exception," and neither the State nor the Court could "override a legislative determination" to that effect).

Although Congress, rather than the Attorney General, had made the initial determination that marijuana has no generally accepted medical use in treatment in the United States, that distinction makes no difference as to the determination's binding effect on the States. Indeed, the Court expressly rejected the converse argument-that Congressional determinations were entitled to less deference-in Oakland Cannabis, 532 U.S. at 492-493, and the CSA expressly grants the Attorney General authority to assign substances to the appropriate schedule, and to move substances (including those originally classified by Congress) among schedules. 21 U.S.C. 811(a).

b. Just as California's ballot initiative purporting to recognize, as a matter of state law, a permissible "use [for] marijuana for medical purposes," CaI. Health & Safety Code 11362.5(b)(l)(A), did not compel recognition in Oakland Cannabis of an exception to the generally applicable federal rule under the CSA that a schedule I substance has no "generally accepted medical use in treatment in the United States," such a state law would not compel the Attorney General to reclassify marijuana to a different schedule under the CSA. Rather, such a reclassification requires an independent federal assessment of the medical and scientific evidence and, if supported by substantial evidence, would bind the entire Nation for purposes of the CSA. see Alliance for Cannabis Therapeutics v. DEA, 15 E3d 1131 (D.C. Cir. 1994) (upholding DEAs refusal to reschedule marijuana as supported by substantial evidence); see also Gettman v. DEA, 290 E3d 430, 432 (D.C. Cir. 2002) (explaining CSA procedures for rescheduling a controlled substance). As the D.C. Circuit held in Alliance for Cannabis, "only rigorous scientific proof can satisfy the CSAs 'currently accepted medical use' requirement." 15 E3d at 1137. There is no basis in the CSA for substituting a ballot initiative, such as California voters' approval of medical marijuana or Oregon voters' endorsement of physician-assisted suicide, for the "rigorous scientific proof required by the CSA for a substance to be found to have an "accepted medical use." Ibid.

Nor is there any reason to conclude, as the court of appeals did in this case, that the Attorney General's determination whether a particular use of a controlled substance qualifies as a "legitimate medical purpose" "in the usual course of professional treatment" for CSA purposes, 21 C.ER. 1306.04(a), is any less binding in the States than his determination whether a substance has any accepted medical use. Oakland Cannabis makes clear that the Attorney General could reclassify the schedule II substances typically used by Oregon physicians to assist suicide11 to schedule I if the medical and scientific evidence warranted-despite Oregon's assisted suicide initiative. There is no reason he should have less authority to determine that, while those schedule II substances have other generally accepted medical uses in treatment, deliberately assisting a person to commit suicide is not one of them.

The Attorney General imposed just that type of limitation on the use of a schedule II substance when he transferred the substance dronabinol (which was approved by the FDA in a particular form marketed under the brand name Marinol) from schedule I to schedule II. Dronabinol is an isomer of tetrahydrocannabinols (THC), which is the principal psychoactive substance in marijuana. 51 Fed. Reg. 17,476 (1986). After the FDA determined that Marinol has a legitimate medical use in alleviating nausea associated with cancer treatment, id. at 17,477, DEA issued a rule transferring the substance from schedule I to schedule II-as a drug with "a currently accepted medical use with severe restrictions," 21 U.S.C. 812(b)(2)(B); 51 Fed. Reg. at 17,476. In so doing, however, DEA recognized the significant risk that Marinol would be dispensed by physicians for improper purposes, rather than the accepted use recognized by the FDA, and that practitioners might "attempt to justify illegal or improper distribution or dispensing by claiming unique knowledge of [the] drug's effectiveness for a broad range of medical indications." Id. at 17,477. For that reason, at the same time DEA moved Marinol to schedule II, it also made clear that a physician who dispenses Marinol "for medical indications outside the approved use associated with cancer treatment, except within the confines of a structured and recognized research program," would be subject to revocation of his or her registration and possible criminal prosecution. Ibid.12

c. This Court's decision in Moore also strongly supports the conclusion that the CSA establishes a uniform federal standard for the permissible dispensing of substances regulated under the Act. Moore involved the prosecution of a physician who prescribed large quantities of methadone tablets with little or no medical assessment or supervision. See 423 U.S. at 126. He was convicted under the CSA for prescribing controlled substances outside the usual course of professional practice. The Court held that the CSA was intended to limit a physician's distribution of controlled substances to actions "as a physician" and in the course of "professional practice." id. at 140, 141.

The opinion in Moore makes clear that Moore's conviction, which the Court affirmed, was based on a uniform nationwide standard for determining the lawfulness of the prescriptions under the CSA: Whether the prescriptions were "in accordance with a standard of medical practice generally recognized and accepted in the United States." 423 U.S. at 139 (quoting jury instructions) (emphasis added). The Court recognized that one of Congress's objectives in replacing the Harrison Act with the CSA was precisely to establish clear and consistent federal "limits on free experimentation with drugs" by physicians, id. at 143, and to clarify that "physicians who go beyond approved practice," as determined by the secretary of Health, Education and Welfare (now Health and Human Services) and the Attorney General, are subject to criminal prosecution, id. at 144. See ibid, (noting that the CSA "requires the Secretary . . . , after consultation with the Attorney General and national addict treatment organizations, to 'determine the appropriate methods of professional practice in the medical treatment of . . . narcotic addition' " (quoting 42 U.S.C. 257a (1970), recodified at 42 U.S.C. 290bb-2a (2000)), and that those federal officials would "clarify for the medical profession . . . the extent to which they may safely go in treating narcotic addicts as patients" (quoting House Report 14, 15)).

With the exception of the decision below, the courts of appeals have followed Moore and applied a national standard for professional practice under the CSA. See United States v. Vamos, 797 E2d 1146, 1151, 1153 (2d Cir. 1986) (CSA incorporates the standard of professional practice "generally recognized and accepted in the United States"), cert, denied, 479 U.S. 1036 (1987); United States v. Hay es, 794 E2d 1348, 1351-1352 (9th Cir. 1986) ("the standard of medical practice generally recognized in the country"), cert, denied, 479 U.S. 1086 (1987); United States v. Norris, 780 E2d 1207, 1209 & n.2 (5th Cir. 1986) (same as Vamos) United States v. Daniel, 3 E3d 775, 778 (4th Cir. 1993) (same), cert, denied, 510 U.S. 1130 (1994); Kevin E O'Malley et al, Federaljury Practice and Instructions (Criminal) 64.16, at 428 (5th ed. 2000) (same). Indeed, several courts, including the court below, have specifically rejected arguments by practitioner-defendants that their federal-law obligations under the CSA should depend on state law. In United States v. Rosenberg, 515 E2d 190, 198 (1975), the Ninth circuit affirmed the conviction of a California doctor under the CSA and rejected as "singularly unpersuasive" his contention that "the determination of whether or not he was acting in the course of his professional practice must be determined by the state of California." Similarly, in United States v. Leal, 75 E3d 219 (1996), the Sixth circuit rejected a pharmacist's defense against prosecution for violating the CSA that state law imposed no duty to identify suspicious prescriptions. Id. at 226-227.13 As the Sixth circuit held, "[w]hether state law imposes an equivalent civil or criminal duty is irrelevant" to whether the pharmacist had violated his "federal duty . . . to be vigilant in filling prescriptions." Id. at 227.

3. The CSA's legislative history confirms that there is a uniform federal-law standard. The CSAs legislative history reflects Congress's understanding that the Harrison Act, the predecessor to the CSA, created a federal standard for determining what constitutes a legitimate medical practice and its intent to clarify that federal standard, not to cloud that standard by overlaying potentially disparate state standards. The House Report noted that "for the last 50 years" physicians had been subject to federal prosecution under the Harrison Act if their "methods of prescribing narcotic drugs have not conformed to the opinions of Federal prosecutors of what constitutes appropriate methods of professional practice." House Report 15.14 The House Report states an intent "to clarify for the medical profession in the United States the extent to which they may safely go in treating narcotic addicts as patients," id. at 14, and the CSA directed the secretary, working together with the Attorney General, to do so, 42 U.S.C. 290bb-2a (2000) (formerly codified at 42 U.S.C. 257a (197O)). The House Report leaves no doubt that Congress intended to establish a uniform federal standard for the use of narcotics in medical treatment, rather than to confuse standards by incorporating varying state law duties. See House Report 14-15; Moore, 423 U.S. at 144 (discussing same).15

Moreover, in subsequent amendments to the CSA, Congress has diminished the relevance of state law in the one area where the Act refers to it. As originally enacted, the CSA incorporated state law only with respect to the standards for obtaining a registration. See Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 303(f), 84 Stat. 1253; Moore, 423 U.S. at 138 n. 15 ("Registration was mandatory for practitioners with state licenses."). But Congress modified those standards in 1984 to allow the Attorney General to make practitioner registration determinations on independent federal grounds, see 21 LJ.S.C. 823(0 (making compliance with state law only one of several factors in determining whether the public interest would be served by registering a physician), precisely because States were not adequately regulating abuses by physicians of their prescription-writing authority. See, e.g., S. Rep. No. 225, 98th Cong., 1st Sess. 262 (1983) (noting that it "may clearly be contrary to the public interest" to require the Attorney General to grant a practitioner's registration application to any practitioner licensed under state law); 130 Cong. Rec. 25,849 (1984) (statement of Rep. Fish) ("State laws regarding the dispensing of controlled substances are . . . inadequate."); id. at 1586 (statement of Sen. Laxalt) (Congress intended to "expand [] the standards for practitioner registration beyond the . . . exclusive reliance upon authorization by the practitioner's own jurisdiction"); see also id. at 25,850 (statement of Rep. Hughes) (drugs "prescribed by physicians . . . account for about 60 percent of the overdoses each year"); id. at 25,851 (statement of Rep. Gilman) (physician prescriptions are responsible for the diversion of "close to 1 million doses of dangerous drugs per year" from legitimate channels to illegitimate channels). Congress wanted to "make it easier" for DEA "to suspend or revoke the authority of physicians and pharmacists who write or dispense prescriptions in a way that is threatening to the public health or safety." Ibid. Thus, even where the CSA had incorporated state law by reference, Congress has revised the Act to make the federal regulation of controlled substances less dependent on the varying determinations of state authorities, and thereby even more uniformly applied throughout the Nation.

The court of appeals' ruling could have a significant adverse impact on federal prosecutions of physicians under the CSA outside the context of assisted suicide and would provide even less clarity and uniformity than under the Harrison Act regime that Congress desired to replace. As noted above, the courts of appeals have, until now, recognized that the "standard of medical practice generally recognized and accepted" for purposes of the CSA, Moore, 423 U.S. at 139, is a national one. If, however, the Court were to hold that the CSA implicitly incorporates the views of each of the 50 States regarding acceptable practice with respect to the dispensing of controlled substances, the prosecution of physicians would become much more difficult. In most instances, there would be no state statutory law governing the particular matter in question, and defendants would be free to assert their own view of accepted medical practice in that State. see Rosenberg, 515 F.2d at 198 n.14 (physician's attempted defense that prescription of the drugs at issue in limited quantities was permissible under state law); Leal, 75 F.3d at 226-227 (pharmacist's attempted defense that state law permitted pharmacist to fill prescription without inquiring into its appropriateness).

Ironically, the court of appeals' decision presumes that Congress intended to make federal requirements under the CSA dependent upon the 50 States' different views of medical practice at precisely the same time that the States were moving away from local practice standards in favor of national ones. By 1970, when Congress enacted the CSA, the States were in the process of abandoning the "locality rule" that doctors were to be judged according to the standard of care "in the same or similar locality." Jon R. Waltz, The Rise and Gradual Fall of the Locality Rule in Medical Malpractice Litigation, 18 DePaul L. Rev. 408, 409 (1968-1969); see id. at 410 (noting that the rule "is about to disappear almost completely"); Theodore Silver, One Hundred Years of Harmful Error: The Historical Jurisprudence of Medical Malpractice, 1992 Wis. L. Rev. 1193, 1234 ("[s]ince the 1960s, conventional wisdom has characterized the locality rule as an obsolete doctrine"). Some of the chief reasons that the States abandoned the locality rule were that it required plaintiffs to produce local experts, who might be unwilling to testify against a colleague, and that it effectively immunized doctors who, however low their standards, were the only ones in the community. Waltz, supra, 18 DePaul L. Rev, at 420; Silver, supra, 1992 Wis. L. Rev, at 1227; Robbins v. Footer, 553 E2d 123, 128, 130 (D.C. Cir. 1977) (rejecting locality rule in the District of Columbia for similar reasons and, on that basis, vacating and remanding district court's disqualification of an expert witness who was not adequately expert in local practices). Where, as in most instances, no state statute specifies the standard of practice at issue, federal prosecutors would have to contend with all the problems that led to the rejection of the locality rule in malpractic actions. There is nothing in the CSA, however, that supports such a result.

CONCLUSION

For the foregoing reasons, the judgment of the court of appeals should be reversed, and the case remanded with instructions to dissolve any injuctions and dismiss.

Respectfully submitted.

FOOTNOTE

* In the Supreme Court of the United States, Alberto R. Gonzales, Attorney General, et al, Petitioners ?. State of Oregon, et al., No. 04-623, On Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit, Brief for the Petitioners, May 2005.

Petitioners are Alberto R. Gonzales, Attorney General of the United States, Karen Tandy, Administrator of the Drug Enforcement Administration, Kenneth W McGee, Assistant Special Agent-InCharge of the Portland Office of the Drug Enforcement Administration, the United States of America, the United States Department of Justice, and the Drug Enforcement Administration.

Respondents are the State of Oregon, Peter A. Rasmussen, David Malcolm Hochhalter, John Doe # 1, and Don W James.

6 The phrases "legitimate medical purpose," 21 C.ER. 1306.04(a), and "in the course of professional practice," 21 U.S.C. 802(21), both reflect a concern for allowing only legitimate or professionally appropriate uses of controlled substances and reflect essentially the same standard. see, e.g., Daniel, 3 E3d at 778 (allegation that drug distributions were not "for a legitimate medical purpose" was sufficient to allege that they fell "outside the boundaries of the registrant's professional practice"); United States v. Kirk, 584 E2d 773, 784 (6th Qr.) ("[T]here is no difference in the meanings of the statutory phrase, 'In the usual course of professional practice' and the regulations' phrase, 'legitimate medical purpose."), cert, denied, 439 U.S. 1048 (1978); Plesons, 560 E2d at 897 n.6 (same); United States, v. Rosenberg, 515 E2d 190, 196-197 (9th Qr.) (phrases "not 'in the usual course of professional practice' and not 'for any legitimate medical or research purposes'" "have essentially the same meaning"), cert, denied, 423 U.S. 1031 (1975); United States v. Nelson, 383 E3d 1227, 1231 (10th Qr. 2004) (noting that "there is considerable room to doubt" whether the phrases "outside the usual course of medical practice" and "without legitimate medical purpose" have different meanings). Cf. United States v. Tran Trong Cuong, 18 E3d 1132, 1138 (4th Cir. 1994) (stating the "legitimate medical purpose" standard is, if anything, more favorable to the defendant than the standard stated in Moore).

7 The Altorney General's interpretive ruling distinguishes between a physician who intentionally brings about his patient's death and one who treats the pain associated with illness, even though such treatment may have the unintended consequence of hastening the patient's death. Pet. App. 103a. See Vacco, 521 U.S. at 802 (noting the significance of this distinction).

8 Since Glucksberg was decided, Maryland and South Carolina have passed statutes expressly prohibiting assisted suicide. see Md. Code, Crim. Law 3-102 (Michie 2002); S.C. Code Ann. 16-31090 (2003). In addition, West Virginia and Wyoming have adopted new statutes that expressly provide that laws permitting the withdraw of medical treatment do not authorize assisted suicide. see W. Va. Code 16-30-15 (Mlichie 2001); 2005 Wyo. Laws ch. 161 (H.13. 107) (to be codified at Wyo. Stat. 35-22-414(c)). Virginia and Ohio have passed statutes declaring their opposition to assisted suicide and authorizing their courts to enjoin the assistance of suicide. Va. Code Ann. 8.01-622.1 (Michie 2000); Ohio Rev. Code Ann. 3795.02 (Page 2003 Supp.).

9 Indeed, Oregon as well criminalizes assisting another's suicide if done by anyone other than a physician acting pursuant to the DWDA. See Or. Rev. Stat. 163.125(1)(b) (2003); Kanev. Kulongoski, 871 P2d 993, 998 (Or. 1994).

10 The fact that the CSA sets national minimum standards as a matter of lederal law does not mean that it preempts the entire field of controlled substances regulation. It does not. see 21 U.S.C. 903; House Report 29. The CSA does expressly preempt state law when there is a "positive conflict between [a] provision of [the CSA] and [a] State law so that the two cannot consistently stand together." 21 U.S.C. 903. In that event, however, it is state law, not federal law, that must yield. The CSA clearly creates a uniform minimum federal regulation of controlled substances; States may relax or eliminate their own state regulatory schemes or impose stricter slate limits on controlled substances, but they are not free to revise the uniform federal standard.

11 According to the Oregon Department of Human Services, the three drugs that have been dispensed pursuant to the DWDA are secobarbital, pentobarbital, and amobarbital, all of which are schedule II depressants. See Patients' Br. in Opp. 29a-30a; 21 C.ER. 1308.12(e).

12 DEA subsequently retransferred Marinol to schedule III under the CSA. See 64 Fed. Reg. 35,92835,930 (1999). The Federal Register notice of the final rule moving Marinol to Schedule III noted that the FDA had expanded the indications for Marinol's use to include the treatment of anorexia associated with weight loss in patients with AIDS, but that notice did not expressly continue the prior policy statement concerning restrictions on prescribing Marinol.

13 Leal was later overruled on other grounds. see United Slates v. Kennedy, 107 Fed. Appx. 518 (6th Cir. 2004).

14 Congress's understanding of the Harrison Act was clearly correct. "What ensued soon after passage of the act can fairly be described as the most comprehensive general criminal enforcement of any law against medical professionals in U.S. history." Kurt Hohenstein, Just What the Doctor Ordered: The Harrison Anti-Narcotic Act, the Supreme Court, and the Federal Regulation of Medical Practice, 19151919, 26 J. Sup. Ct. Hist. 231, 231-232 (2001). See, e.g., United States v. Webb, 249 U.S. 96 (1919); United States v. Doremus, 249 U.S. 86 (1919).

15 The parts of the 1970 Act specific to the treatment of narcotics addiction were superseded by the Narcotic Addict Treatment Act of 1974, Pub. L. No. 93-281, 88 Stat. 124. The 1974 law also prescribed specific and uniform federal standards with respect to the use of controlled substances in the treatment of narcotics addiction. It requires federal registration for narcotic treatment programs, 21 U.S.C. 823(g), which is "predicated on the demonstrated ability to comply with medical standards established by the FDA and security standards established by DEA," H.R. Rep. No. 884, 93d Cong., 2d Sess. 4 (1974) (emphasis added).

AUTHOR_AFFILIATION

PAUL D. CLEMENT

Acting Solicitor General

PETER D. KEISLER

Assistant Attorney General

EDWIN S. KNEEDLER

Deputy Solicitor General

GREGORY G. KATSAS

Deputy Assistant Attorney General

DOUGLAS HALLWARD-URIEMEIER

Assistant To The Solicitor General

MARK B. STERN

JONATHAN H. LEVY

Attorneys