Whether physician-assisted suicide serves a "legitimate medical purpose" under the Drug Enforcement Administration's regulations implementing the Controlled Substances Act.

You have asked for our opinion whether a physician who assists in a patient's suicide by prescribing a controlled substance has a "legitimate medical purpose" within the meaning of a regulation of the Drug Enforcement Administration (DEA), 21 C.F.R. [section] 1306.04(a) (2000), (1) if the physician is immune from liability under a state law such as the Oregon "Death with Dignity Act" for assisting in a suicide in such a manner. (2) In our view, assisting in suicide, even in a manner permitted by state law, is not a "legitimate medical purpose" under the DEA regulation, and accordingly dispensing controlled substances for this purpose violates the Controlled Substances Act, which the DEA regulation implements.

Background

The Oregon "Death with Dignity Act," which legalized physician-assisted suicide under [page 2] certain circumstances, was originally approved by Oregon voters on November 8, 1994, and went into effect on October 27, 1997. (3) Prior to the effective date of the Oregon law, Representative Henry J. Hyde, Chairman of the House Judiciary Committee, and Senator Orrin G. Hatch, Chairman of the Senate Judiciary Committee, wrote to the Administrator of the DEA, Thomas A. Constantine, requesting a determination whether the CSA prohibits the use of controlled substances for the purpose of assisting in a suicide. (4)

Administrator Constantine replied on November 5, 1997, concluding "that delivering, dispensing or prescribing a controlled substance with the intent of assisting a suicide would not be under any current definition a `legitimate medical purpose'" and thus would violate the CSA. (5)

Within a month, the Oregon Deputy Attorney General, David Schuman, wrote to the United States Department of Justice on December 3, 1997, arguing that "the CSA is addressed to the problems of the abuse and trafficking of controlled substances. In enacting and later amending the CSA, Congress had no intention of regulating medical practices that are legal under state law and that have no relation to drug abuse or trafficking." (6) Deputy Attorney General Schuman concluded that the DEA had no authority to regulate medical practices authorized by state law and unrelated to drug abuse or trafficking.

On June 5, 1998, Attorney General Janet Reno reversed the interpretation of DEA Administrator Constantine, concluding that "the CSA does not authorize DEA to prosecute, or to revoke the DEA registration of, a physician who has assisted in a suicide in compliance with Oregon law." Specifically, Attorney General Reno stated: "There is no evidence that Congress, in the CSA, intended to displace the states as the primary regulators of the medical profession, or to override a state's determination as to what constitutes legitimate medical practice in the [page 3] absence of a federal law prohibiting that practice." (7)

Physicians Are Regulated Under the Controlled Substances Act

The basic domestic drug trafficking provision of the CSA, 21 U.S.C. [section] 841, governs physicians' prescriptions of controlled substances. Section 841 (a)(1) makes it unlawful for "any person knowingly or intentionally ... to ... dispense, a controlled substance." The term "dispense" is defined to "mean[] to deliver a controlled substance to an ultimate user ... by, or pursuant to the lawful order of, a practitioner...." 21 U.S.C. [section] 802(10). A "practitioner" includes a "physician ... licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices ... to ... dispense ... a controlled substance in the course of professional practice." Id., [section] 802(21).

Although section 841(a)(1) generally prohibits the dispensing of controlled substances, the statute does permit such action if "authorized by this subchapter." 21 U.S.C. [section] 841(a). One such form of authorization is found in the CSA's provisions dealing with physician "registration." See id., [section] 822(b) ("Persons registered by the Attorney General ... to ... dispense controlled substances ... are authorized to ... dispense such substances ... to the extent authorized by their registration and in conformity with the other provisions of this subchapter."). Physicians may apply to the DEA (which acts here as the Attorney General's delegate) for registration permitting them to prescribe and administer controlled substances. Section 823(b) provides that the DEA shall register qualified applicants unless it "determines that ... such registration is inconsistent with the public interest." This determination is to be based on any of five factors identified in the statute, including "such other factors as may be relevant to and consistent with the public health and safety." Id., [section] 823(b)(5).

"[T]he scheme of the [CSA], viewed against the background of the legislative history, reveals an intent to limit a registered physician's dispensing authority to the course of his `professional practice.' ... Implicit in the registration of a physician is the understanding that he is authorized only to act `as a physician.' ... [R]egistration is limited to the dispensing and use of drugs `in the course of professional practice or research.' Other provisions throughout the Act reflect the intent of Congress to confine authorized medical practice within accepted limits." United States v. Moore, 423 U.S. 122, 140-42 (1975). Although section 841(a) does not, in terms, state that a physician is authorized to dispense controlled substances only for a legitimate medical purpose, that limitation appears to be implicit in the statute, see Moore, 423 U.S. at 137, [page 4] n. 13, and has been made explicit by DEA regulation. (8) The relevant regulation reads:

A prescription issued for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.... An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorize research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [section] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 21 C.F.R. [section] 1306.04(a) (emphasis added).

Where a physician dispenses controlled substances without a "legitimate medical purpose" under 21 C.F.R. [section] 1306.04(a), the physician violates several provisions of the CSA, including [subsections] 829 and 841(a)(1). If such dispensing without a legitimate medical purpose is proven in a criminal case, the physician may be subject to criminal penalties under 21 U.S.C. [subsections] 841(a)(1) (felony) and 842(a)(1) (misdemeanor). See Moore (holding that registered physician can be prosecuted and convicted under [section] 841(a)(1) for dispensing controlled substances outside the usual course of professional practice). Even without a criminal prosecution or conviction, the DEA may initiate administrative proceedings to suspend or revoke the registration of a physician based on evidence that the physician dispensed controlled substances without a legitimate medical purpose under 21 C.F.R. [section] 1306.04(a). In an administrative proceeding, the Government must prove, by a preponderance of the evidence, that the physician dispensed in violation of [section] 1306.04(a), and that, as a result, the physician's continued registration would be inconsistent with the public interest. See 21 U.S.C. [section] 824(a)(4) (applying public interest standard of [section] 823(f) to administrative proceedings for suspension or revocation of registration granted under [section] 823); see generally Robert G. Hallermeier, M.D., Continuation of Registration with Restrictions, 62 Fed. Reg. 26, 818 (1997) (administrative proceeding in which DEA sought revocation of physician's federal registration). (9) Nothing in the language of the CSA or of the relevant DEA [page 5] regulations requires that the physician be shown to have violated state law in order to be subject to criminal sanctions under [subsections] 829 or 841(a), or to suspension or revocation of federal registration under [section] 824(a)(4). Indeed, of the five separate grounds listed in [section] 824(a)(4) for adverse administrative action, only two directly concern state law sanctions. (10) Further, as we shall discuss in detail below, see infra at 17-19, Congress added the "public interest" standard in [section] 824(a)(4) in order to permit the Attorney General to take adverse administrative action against a registrant in cases in which the registrant's wrongful conduct might not have been sanctioned or sanctionable under state law.

Dispensing Controlled Substances to Assist in Suicide Does Not Serve a "Legitimate Medical Purpose"

We understand that physician-assisted suicide typically involves the use of a lethal dose of a combination of drugs, including controlled substances. First, the patient is sedated using either a barbiturate (e.g., sodium pentothal), or an opiate (e.g., morphine). Then, one or more drugs are used to paralyze the muscles and/or to stop the heart. The sedatives involved in these procedures are controlled substances under the CSA. Most lawfully available opiates and barbiturates are in Schedule II of the CSA, the most strictly regulated category of substances available for non-research purposes. See 21 C.F.R. [section] 1308.12(b), (c), (e) (2000).

In our opinion, assisting in suicide is not a "legitimate medical purpose" within the meaning of 21 C.F.R. [section] 1306.04(a) that would justify a physician's dispensing controlled substances. That interpretation, which the DEA itself originally adopted before being overruled by Attorney General Reno, is the best reading of the regulatory language: it is firmly supported by the...