[Senate Report 105-372]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 607
105th Congress                                                   Report
                                 SENATE
 2d Session                                                     105-372
_______________________________________________________________________


 
                    LETHAL DRUG ABUSE PREVENTION ACT

                                _______
                                

  October 6 (legislative day, October 2), 1998.--Ordered to be printed

_______________________________________________________________________


Mr. Hatch, from the Committee on the Judiciary, submitted the following

                              R E P O R T

                             together with

                     ADDITIONAL AND MINORITY VIEWS

                         [To accompany S. 2151]

    The Committee on the Judiciary, to which was referred the 
bill (S. 2151) to amend provisions of chapter 13 of title 21, 
United States Code, amending the Controlled Substances Act to 
clarify Federal law to prohibit the dispensing or distribution 
of a controlled substance for the purpose of causing or 
assisting in causing the suicide or euthanasia of any 
individual, having considered the same, reports favorably 
thereon with an amendment in the nature of a substitute and 
recommends that the bill (as amended) do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and summary..............................................4
 II. Background and need for the legislation..........................6
III. Section-by-section analysis.....................................12
 IV. Legislative history and votes in committee......................13
  V. Explanation of the legislation and committee views..............16
 VI. Cost estimate...................................................24
VII. Regulatory impact statement.....................................27
VIII.Administration views............................................27

 IX. Additional views of Senator Orrin G. Hatch......................32
  X. Minority views..................................................34
 XI. Changes in existing law.........................................49

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Lethal Drug Abuse Prevention Act of 
1998''.

SEC. 2. FINDINGS; PURPOSES.

  (a) Findings.--Congress finds that--
          (1) the use of certain narcotics and other drugs or 
        substances with a potential for abuse is strictly regulated 
        under the Controlled Substances Act;
          (2) the dispensing and distribution of certain controlled 
        substances only by properly registered practitioners only for 
        legitimate medical purposes are permitted under the Controlled 
        Substances Act and implementing regulations;
          (3) the dispensing or distribution of controlled substances 
        to assist suicide or euthanasia are not legitimate medical 
        purposes and are not permissible under the Controlled 
        Substances Act;
          (4) the dispensing or distribution of certain controlled 
        substances for the purpose of relieving pain and discomfort are 
        legitimate medical purposes and are permissible under the 
        Controlled Substances Act;
          (5) inadequate treatment of pain, especially for chronic 
        diseases, irreversible diseases such as cancer, and end-of-life 
        care, is a serious public health problem affecting hundreds of 
        thousands of patients every year; physicians should not 
        hesitate to dispense or distribute controlled substances when 
        medically indicated for those conditions; and
          (6) for the reasons set forth in section 101 of the 
        Controlled Substances Act (21 U.S.C. 801), the dispensing and 
        distribution of controlled substances for any purpose, 
        including that of assisting suicide or euthanasia, affect 
        interstate commerce.
  (b) Purposes.--The purposes of this Act are--
          (1) to provide explicitly that Federal law is not intended to 
        allow the dispensing or distribution of any controlled 
        substance with the purpose of causing, or assisting in causing, 
        the suicide or euthanasia, of any individual; and
          (2) to encourage practitioners to prescribe, dispense, 
        distribute, and administer controlled substances as medically 
        appropriate in order to relieve pain and discomfort, by 
        reducing unwarranted concerns that their registration to 
        prescribe controlled substances will thereby be put at risk, if 
        there is no intent to assist in causing a patient's death.

SEC. 3. LETHAL DRUG ABUSE PREVENTION.

  (a) Additional Ground for Denial of Registration.--Section 303 of the 
Controlled Substances Act (21 U.S.C. 823) is amended by adding at the 
end the following:
  ``(i) The Attorney General shall determine that registration of an 
applicant under this section is inconsistent with the public interest 
if--
          ``(1) during the 5-year period immediately preceding the date 
        on which the application is submitted under this section, the 
        registration of the applicant under this section was suspended 
        or revoked under section 304(a)(4); or
          ``(2) the Attorney General determines, based on clear and 
        convincing evidence, that the applicant is applying for the 
        registration with the intention of using the registration to 
        take any action that would constitute a violation of section 
        304(a)(4).''.
  (b) Suspension or Revocation of Registration.--
          (1) In general.--Section 304(a) of the Controlled Substances 
        Act (21 U.S.C. 824(a)) is amended--
                  (A) by redesignating paragraphs (4) and (5) as 
                paragraphs (5) and (6), respectively; and
                  (B) by inserting after paragraph (3) the following:
          ``(4) has intentionally dispensed or distributed a controlled 
        substance with the purpose of causing, or assisting in causing, 
        the suicide or euthanasia of any individual, except that this 
        paragraph does not apply to the dispensing or distribution of a 
        controlled substance--
                  ``(A) for the purpose of alleviating pain or 
                discomfort (even if the use of the controlled substance 
                may increase the risk of death), so long as the 
                controlled substance is not also dispensed or 
                distributed for the purpose of causing, or assisting in 
                causing, the death of an individual for any reason; or
                  ``(B) for the purpose of carrying out a sentence of 
                death under Federal or State law;''.
          (2) Conforming amendment.--Section 304(a)(5) of the 
        Controlled Substances Act (21 U.S.C. 824(a)(5)) (as 
        redesignated by paragraph (1) of this subsection) is amended by 
        inserting ``other'' after ``such'' the first place the term 
        appears.
  (c) Pain Relief.--Section 304(c) of the Controlled Substances Act (21 
U.S.C. 824(c)) is amended--
          (1) by striking ``(c) Before'' and inserting the following:
  ``(c) Procedures.--
          ``(1) Order to show cause.--Before''; and
          (2) by adding at the end the following:
          ``(2) Assisted suicide.--
                  ``(A) Findings.--
                          ``(i) In general.--Prior to any proceeding 
                        under paragraph (1), where an order to show 
                        cause may be based on subsection (a)(4) for 
                        denial, revocation, or suspension of 
                        registration, the Attorney General shall make a 
                        finding that the applicant or registrant--
                                  ``(I) has dispensed or distributed a 
                                specific controlled substance that was 
                                directly responsible for the death of 
                                an individual; and
                                  ``(II) did not dispense or distribute 
                                the specific controlled substance as 
                                medically indicated.
                          ``(ii) Consultation.--In making any finding 
                        under clause (i)(II), the Attorney General may 
                        consult with the Secretary of Health and Human 
                        Services, as the Attorney General, in 
                        consultation with the Secretary, determines to 
                        be appropriate.
                  ``(B) Burden of proof.--At any proceeding under 
                paragraph (1), where the order to show cause is based 
                on subsection (a)(4) for denial, revocation, or 
                suspension of registration, the Attorney General shall 
                have the burden of proving, by clear and convincing 
                evidence, that the practitioner's intent was to 
                dispense or distribute a controlled substance with a 
                purpose of causing, or assisting in causing, the 
                suicide oreuthanasia of any individual. In meeting such 
burden, it shall not be sufficient to prove that the registrant knew 
that the use of the controlled substance may increase the risk of 
death.
                  ``(C) Request for review by medical advisory board on 
                pain relief.--At any proceeding under paragraph (1), 
                where the order to show cause is based on subsection 
                (a)(4) for denial, revocation, or suspension of 
                registration, the practitioner may request, within 30 
                days after the receipt of the order to show cause, that 
                the Medical Advisory Board on Pain Relief review, in 
                accordance with paragraph (3), the administrative 
                record of such proceeding as it relates to subsection 
                (a)(4).
          ``(3) Medical advisory board on pain relief.--
                  ``(A) In general.--The Secretary of Health and Human 
                Services, in consultation with the Attorney General, 
                shall by regulation establish a board to be known as 
                the Medical Advisory Board on Pain Relief (referred to 
                in this subsection as the `Board').
                  ``(B) Membership.--
                          ``(i) In general.--Subject to clause (ii), 
                        the Secretary of Health and Human Services, in 
                        consultation with the Attorney General, shall 
                        appoint the members of the Board--
                                  ``(I) from among individuals who by 
                                reason of specialized education or 
                                substantial relevant experience in pain 
                                management, are clinical experts with 
                                knowledge regarding standards, 
                                practices, and guidelines concerning 
                                pain relief; and
                                  ``(II) after consultation with the 
                                American Medical Association, the 
                                American Academy of Pain Medicine, the 
                                American Pain Society, the American 
                                Academy of Hospice and Palliative 
                                Medicine, the National Hospice 
                                Organization, the American Geriatrics 
                                Society, and such other entities with 
                                relevant expertise concerning pain 
                                relief, as the Attorney General 
                                determines to be appropriate.
                          ``(ii) Prohibition.--No member of the Board 
                        may be an officer or employee of the Federal 
                        Government.
                  ``(C) Duties of board.--If, in accordance with 
                paragraph (2)(B), an applicant or registrant requests a 
                review by the Board of the record of a proceeding under 
                paragraph (1), the Board shall review the 
                administrative record of such proceeding as it relates 
                to subsection (a)(4) and issue to the Secretary of 
                Health and Human Services and the Attorney General an 
                advisory opinion as to whether the dispensing or 
                distribution of the controlled substance at issue in 
                the proceeding was for the purpose of alleviating pain 
                or discomfort in a manner that does not constitute a 
                violation of subsection (a)(4). The opinion of the 
                Board under this subparagraph shall be part of the 
                administrative record and shall be considered by the 
                Attorney General in determining whether to deny, 
                revoke, or suspend the registration involved.
                  ``(D) Compensation of members.--Each member of the 
                Board shall be compensated at a rate equal to the daily 
                equivalent of the annual rate of basic pay prescribed 
                for level IV of the Executive Schedule under section 
                5315 of title 5, United States Code, for each day 
                (including travel time) during which such member is 
                engaged in the performance of the duties of the Board.
          ``(4) No additional investigative authority.--Nothing in 
        section 303(i), subsection (a)(4) of this section, or this 
        subsection may be construed to provide the Attorney General 
        with any additional investigative authority in any State, to 
        the extent that the law of the State prohibits assisted suicide 
        or euthanasia.''.

SEC. 4. DESIGNATION OF LIAISON.

  Not later than 30 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall designate an officer of 
the Department of Health and Human Services to serve as a liaison 
between the Secretary of Health and Human Services and the Attorney 
General in carrying out this Act and the amendments made by this Act.

SEC. 5. DIVERSION CONTROL FEE ACCOUNT.

  Notwithstanding any other provision of law, for purposes of section 
111(b) of the Departments of Commerce, Justice, and State, the 
Judiciary, and Related Agencies Appropriations, Act, 1993 (21 U.S.C. 
886a), the operation of the diversion control program of the Drug 
Enforcement Administration shall be construed to include carrying out 
section 303(i) of the Controlled Substances Act (21 U.S.C. 823(i)), as 
added by this Act, and subsections (a)(4), (c)(2), and (c)(3) of 
section 304 of the Controlled Substances Act (21 U.S.C. 824), as 
amended by this Act.

SEC. 6. APPLICABILITY; CONSTRUCTION.

  (a) Applicability.--The amendments made by this Act shall apply with 
respect to any controlled substance dispensed or distributed on or 
after the date of enactment of this Act.
  (b) Construction.--Nothing in this Act or amendments made by this Act 
shall be construed to imply that the dispensing or distribution of a 
controlled substance before the date of enactment of this Act for the 
purpose of causing, or assisting in causing, the suicide or euthanasia 
of any individual is or is not a violation of the Controlled Substances 
Act (21 U.S.C. 801 et seq.).
  (c) Incorporated Definitions.--In this section, the terms 
``controlled substance'', ``dispense'', and ``distribute'' have the 
meanings given those terms in section 102 of the Controlled Substances 
Act (21 U.S.C. 802).

                         I. PURPOSE AND SUMMARY

    This legislation is intended to provide explicit 
clarification that the dispensing or distribution of controlled 
substances to assist with a suicide, that is, certain narcotics 
and other drugs or substances with a potential for abuse, is 
not a legitimate medical purpose and thus is not permissible 
under the Federal Controlled Substances Act. At the same time, 
the legislation is proposed in order to encourage medical 
practitioners to continue to prescribe, dispense, distribute 
and administer controlled substances as medically appropriate 
in order to relieve pain and discomfort. As the bill notes, 
inadequate treatment of pain is a serious public health problem 
affecting hundreds of thousands of patients a year.
    Thus, this legislation is premised on the principle that 
the Controlled Substance Act contemplates use of controlled 
substances to alleviate human pain and suffering and that this 
purpose cannot be turned on its head by allowing controlled 
substances to become intentional agents of death.
    Under the Lethal Drug Abuse Prevention Act, as amended, 
Congress finds that the strict regulation of controlled 
substances allows the dispensing and distribution of controlled 
substances only by properly registered practitioners for 
legitimate medical purposes. The bill finds that the dispensing 
and distribution of controlled substances, acts which affect 
interstate commerce, are not legitimate medical purposes when 
used to assist in a suicide or euthanasia. At the same time, 
the measure recognizes the key role that controlled substances 
can play in legitimate medical purposes, relieving pain and 
discomfort, both before and after enactment of S. 2151.
    The Lethal Drug Abuse Prevention Act requires the Attorney 
General to determine that the registration of an applicant 
(most commonly a physician, retail pharmacy, hospital/clinic or 
teaching institution) is inconsistent with the public interest 
in either of two cases. In the first, the Attorney General 
would make the determination if the applicant's registration 
has been suspended or revoked in the past 5 years because the 
applicant intentionally dispensed a controlled substance to 
cause or assist in causing a suicide. In the second case, if 
the Attorney General determines that the applicant intends to 
use the registration in connection with an assisted suicide. In 
the second case, the Department of Justice's determination must 
be based on a ``clear and convincing evidence'' standard.
    Prior to starting any action to investigate a suspected 
assisted suicide, the Attorney General must make two findings. 
First, she must make an evidentiary-based finding that the 
registrant had dispensed or distributed a controlled substance 
which was directly attributable to the death of an individual. 
Second, she must find that the registrant did not use the 
controlled substance as medically indicated in accordance with 
this Act.
    These two provisions were inserted by the Committee as a 
``screen,'' to make certain that the Drug Enforcement 
Administration does not undertake unwarranted investigations 
which might have the dual negative effects of impeding proper 
pain management as well as unnecessarily subjecting registrants 
to the time-consuming and costly proceedings with serious 
implications for the registrant and the community served by the 
registrant, especially in small, rural single practitioner 
towns.
    The requirement that the Department of Justice make these 
two findings prior to any investigation, combined with the 
``clear and convincing evidence'' standard cited above, 
attempts to allay fears that enactment of S. 2151 would provide 
the DEA with unreasonable, expanded authority which could 
result in innocent practitioners be unjustly charged. Rather, 
this Act explicitly affirms, which was not done in the 
Controlled Substances Act, the need for practitioners to use 
pain medications as medically indicated, in fact, even if the 
use of those medications may increase the risk of death.
    As a further safeguard, the amended bill makes explicit 
that nothing in this legislation shall be construed to grant 
the Attorney General additional investigative authority in any 
State, to the extent that the law of the State prohibits 
assisted suicide or euthanasia.
    This Act--consistent with the existing framework of the 
Controlled Substances Act--contemplates a strong relationship 
between the Department of Justice and the Department of Health 
and Human Services (HHS), so that HHS may serve as the Drug 
Enforcement Administration's chief medical adviser in carrying 
out this Act. For example, S. 2151, as amended, requires that 
within one month of enactment the Secretary of HHS designate an 
officer to serve as a liaison with the Attorney General in 
implementing the Act.
    In addition, the bill requires HHS (in consultation with 
the Department of Justice) to establish a Medical Advisory 
Board on Pain Relief which may be used by any applicant subject 
to license revocation proceedings to review the administrative 
record and provide guidance on whether the controlled substance 
had been used for a legitimate medical purpose. The bill 
enumerates the type of membership envisioned for the Board, 
including individuals who are by reason of specialized 
education or substantial relevant experience in pain management 
considered clinical experts in pain relief and practice. The 
Board shall be operated consisted with the Federal Advisory 
Committee Act and will be funded from the Diversion Control Fee 
Account, consistent with that account's traditional use in 
connection with registration issues.
    Finally, the bill includes language to make certain that 
the amendments to the Controlled Substances Act made therein 
will apply only with respect to any controlled substance 
dispensed or distributed on or after the date of enactment.

              II. BACKGROUND AND NEED FOR THE LEGISLATION

    The ability of modern medicine to extend life has moved far 
from the 16th century,when Montaigne observed: ``To die of old 
age is a death rare, extraordinary, and singular * * * a privilege 
rarely seen.''
    As science yields its astounding, life-extending 
discoveries, our Nation faces the stark reality that many of 
its citizens will develop chronic, often painful conditions 
such as arthritis, or perhaps acute, life-threatening diseases 
such as cancer.
    Medicine's ability to treat these illnesses and extend life 
brings with it new challenges, including the task for providing 
the best care and treatment for our loved ones as they move 
toward the end of life.
    A number of recent events have sparked a national debate 
over the tremendously intertwined moral, legal and ethical 
issues surrounding end-of-life care, and more specifically, the 
idea of physician-assisted suicide. Several converging factors 
have raised our national consciousness with respect to end-of-
life issues, including two recent Supreme Court cases on 
assisted suicide, Vacco v. Quill 1 and Washington v. 
Glucksberg 2, enactment of Oregon's Measure 16 (the 
``Death with Dignity Act''),3 and Presidential 
signature of the Assisted Suicide Funding Restriction Act of 
1997 (P.L. 105-12).4 America's conviction that 
physicians are healers is underscored by the fact that 36 
States outlaw assisted suicide under criminal law, and nine 
others do so through common law.5
---------------------------------------------------------------------------
    \1\ 117 S.Ct. 2293 (1997).
    \2\ 117 S.Ct. 2258 (1997).
    \3\ Or. Rev. Stat. Sec. Sec. 127.800-127.995.
    \4\ The Assisted suicide Funding Restriction Act of 1997, 111 Stat. 
23, April 30, 1997.
    \5\ Merritt, Dick; Fox-Grage, Wendy; and Rothouse, Marla of the 
National Conference of State Legislatures, and Lynn, Joanne; Cohn, 
Felicia; and Forlini, Janet Heald of The Center to Improve the Care of 
the Dying, The George Washington University, ``State Initiatives in 
End-of-Life Care: Policy Guide for State Legislators'', National 
Conference of State Legislatures, 1998, p. 40.
---------------------------------------------------------------------------
    In 1997, the Congress voted overwhelming by a 99-0 vote in 
the Senate, and a decisive 398-16 vote in the House of 
Representatives, to adopt the Assisted Suicide Funding 
Restriction bill, which safeguarded from legal challenge the 
long-standing Federal practice which barred the use of Federal 
funds to assist in suicide or euthanasia. The bill, which was 
signed into law by President Clinton on April 30, 1997 (Pub.L. 
105-12), prohibits the use of appropriated funds to provide or 
pay for any health care item or service or health benefit 
coverage for the purpose of causing or assisting to cause the 
death of any individual.
    Shortly after enactment of P.L. 105-12, on July 25, 1997, 
the Chairmen of both the House and Senate Judiciary Committees 
wrote to Drug Enforcement Administrator Constantine inquiring 
whether delivering, distributing, dispensing, prescribing, 
filling a prescription, or administering a controlled substance 
in the deliberate assistance of a suicide would violate the 
Controlled Substances Act, despite enactment of any State laws 
which might appear to be in conflict.
    As noted in the July, 1997, letter to Mr. 
Constantine,6 under existing regulations (21 CFR 
1306.04), a controlled substance must be used ``for a 
legitimate medical purpose by an individual practitioner acting 
in the usual course of his professional practice.'' Drugs 
reported to be used in assisted suicide include such controlled 
substances as amobarbital, codeine, diazepam, flurazepam, 
glutethimide, chloral hydrate, hydromorphone, meprobamate, 
methyprylon, meperidein, methadone, morphine, phenobarbital, 
secobarbital, and pentobarbital.7
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    \6\ Hon. Henry J. Hyde,
    Congress of the United States,
    Washington, DC.

    Thomas A Constantine,
    Administrator, Drug Enforcement Administration,
    Washington, DC.

        Dear Mr. Constantine: As chairmen of the House and Senate 
      Judiciary Committees we write seeking the Drug Enforcement 
      Administration's view as to whether delivering, 
      distributing, dispensing, prescribing, filling a 
      prescription, or administering a controlled substance with 
      the deliberate intent of assisting in a suicide would 
      violate the Controlled Substance Act, applicable 
      regulations, rulings, or other federal law subject to DEA 
      enforcement, notwithstanding the enactment of a state law 
      such as Oregon's Measure 16 which rescinds state penalties 
      against such prescriptions for patients with a life 
      expectancy of less than six months.
        Drugs used to assist in a suicide include such controlled 
      substances as amobarbital, codeine, diazepam, flurazepam, 
      glutethimide, chloral hydrate, hydromorphone, meprobamate, 
      methyprylon, meperidine, methadone, morphine, 
      phenobarbital, secobarbital, and pentobarbital. Derek 
      Humphrey, Final Exit: The Practicalities of Self-
      Deliverance and Assisted Suicide for the Dying (Hemlock 
      Society 1991), at 117-120. Under existing regulations, a 
      prescription for a controlled substance ``must be issued 
      for a legitimate medical purpose by an individual 
      practitioner acting in the usual course of his professional 
      practice.'' 21 C.F.R. Sec. 1306.04. Case law indicates 
      ``that the physician must have some therapeutic purpose to 
      prescribe lawfully.'' George J. Annas, ``Death By 
      Prescription: The Oregon Initiative,'' New Eng. J. of Med. 
      1240, 1242 (Nov. 3, 1994).
        The Health Care Financing Administration has stated that 
      physician-assisted suicide is not ``reasonable and 
      necessary'' to the diagnosis and treatment of disease or 
      injury and is therefore barred from reimbursement under 
      Medicare. See enclosed letter of May 1, 1996 from Debbie I. 
      Chang, Director of HCFA's Office of Legislative and Inter-
      Governmental Affairs. The American Medical Association, the 
      American Nurses Association, the American Psychiatric 
      Association, and at least 43 other national specialty and 
      state medical societies have condemned assisted suicide, 
      stating that it has ``[l]ong [been] viewed as outside the 
      realm of legitimate health care'' and is ``fundamentally 
      incompatible with the physician's role as healer * * *.'' 
      See Briefs of Amici of the American Medical Association, et 
      al., at 4-5, in Washington v. Glucksberg, No. 96-110 (U.S.) 
      and Vacco v. Quill, No. 95-1858 (U.S.), citing Code of 
      Medical Ethics, sec. 2.211 (App. 11a).
        In our view, assisting in a suicide by prescribing or 
      filling a prescription for a controlled substance cannot be 
      a ``legitimate medical purpose'' under DEA regulations, 
      especially when the practice is not reasonable and 
      necessary to the diagnosis and treatment of disease and 
      injury, legitimate health care, or compatible with the 
      physician's role as healer.
        As you know, this is an area of special interest to the 
      Congress. On March 20, the House Commerce Committee, by a 
      45-2 vote, approved legislation (H.R. 1003) to prohibit any 
      use of federal funds, programs or facilities to perform or 
      advocate assisted suicide. The bill was approved by the 
      full House of Representatives on April 10 by a vote of 398-
      to-16, by the Senate on April 16 by a vote of 99-to-0, and 
      signed by the President on April 30. Clearly Congress would 
      have a serious concern were any federal agency to construe 
      the intentional prescribing of lethal drugs for suicide as 
      a legitimate medical practice. Therefore, we would be 
      grateful for your prompt response.
        Sincerely,
                                              Orrin Hatch,
                                                    United States 
      Senator.
                                              Henry Hyde,
                                                    United States 
      Representative.
---------------------------------------------------------------------------
    \7\ Humphrey, Derek, ``Final Exit: The Practicalities of Self-
Deliverance and Assisted Suicide for the Dying,'' Hemlock Society, 
1991, pp. 117-120.
---------------------------------------------------------------------------
    A panoply of National and State medical associations have 
condemned the practice of assisted suicide, both in testimony 
to the Congress and in briefs accompanying the Vacco and 
Washington cases. Indeed, as noted in the Assisted Suicide 
Funding Restriction Act of 1997, while the Federal Government 
provides financial support for the provision and payment of 
healthcare services, assisted suicide, euthanasia, and mercy 
killing have been criminal offenses throughout the United 
States. That position is enjoined by the Federal Health Care 
Financing Administration, which has determined that physician-
assisted suicide is not ``reasonable and necessary'' to the 
diagnosis or treatment of disease and injury, and therefore is 
not reimbursable under Medicare.8
---------------------------------------------------------------------------
    \8\ Letter of May 1, 1996 from Debbie I. Chang, Director of the 
Office of Legislative and Intergovernmental Affairs, Health Care 
Financing Administration.
---------------------------------------------------------------------------
    In response to the letter of Chairmen Hyde and Hatch, the 
Drug Enforcement Administration undertook a serious review of 
case law, legal briefs, law review articles, and State laws 
related to assisted suicide. Citing that study, in a November 
5, 1997 response,9 DEA Administrator Constantine 
advised the Members of Congress that ``we are persuaded 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.' '' ``As a 
result,'' Mr. Constantine found, ``the activities you described 
in your letter to us would be, in our opinion, a violation of 
the CSA.''
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    \9\ U.S. Department of Justice,
    Drug Enforcement Adminstration,
    Washington, DC.

    Hon. Orrin G. Hatch,
    U.S. Senate,
    Washington, DC.

        Dear Senator Hatch: Thank you for your letter of July 29, 
      1997. In that letter, you requested the Drug Enforcement 
      Administration's (DEA) view as to ``whether delivering, 
      distributing, dispensing, prescribing, filling a 
      prescription, or administering a controlled substance with 
      the deliberate intent of assisting in a suicide would 
      violate the Controlled Substances Act (CSA), applicable 
      regulations, rulings, or other federal law subject to DEA 
      enforcement, notwithstanding the enactment of a state law 
      such as Oregon's Measure 16 which rescinds state penalties 
      against such prescriptions for patients with a life 
      expectancy of less than six months.''
        I apologize for the delay in responding to you. As you 
      know, the CSA authorizes DEA to revoke the registration of 
      physicians who dispense controlled substances without a 
      legitimate medical purpose. Historically, DEA's experience 
      with the phrase ``without a legitimate medical purpose'' 
      has focused on cases involving physicians who have provided 
      controlled substances to drug addicts and abusers. The 
      application of this phrase to cases involving physician-
      assisted suicide presented DEA with a new issue to review.
        Since receiving your inquiry, my staff has carefully 
      reviewed a number of cases, briefs, law review articles and 
      state laws relating to physician-assisted suicide, 
      including the documents referenced in your letter. In 
      addition, my staff has conducted a thorough review of prior 
      administrative cases in which physicians have dispensed 
      controlled substances for other than a ``legitimate medical 
      purpose.'' Based on that review, we are persuaded that 
      delivering, dispensing or prescribing a controlled 
      substance with the intent of assisting a suicide would not 
      be under any current definition of a ``legitimate medical 
      purpose.'' As a result, the activities that you described 
      in your letter to us would be, in our opinion, a violation 
      of the CSA.
        Because physician-assisted suicide would be a new and 
      different application of the CSA, a number of issues remain 
      unresolved. For example, suspicious or unnatural deaths 
      require a medico-legal investigation. The first priority in 
      such an investigation would be a comprehensive forensic 
      inquiry by a state or local law enforcement agency, which 
      is traditionally supported by the efforts of a medical 
      examiner, forensic pathologist, and/or coroner. At the 
      conclusion of this stage of the inquiry, the evidence often 
      is submitted to a grand jury or similar process for a 
      determination of potential criminal liability of the person 
      who assisted in the death.
        This initial determination as to the cause of death is 
      not DEA's responsibility. Rather, DEA would have to rely on 
      the evidence supplied to us by state and local law 
      enforcement agencies and prosecutors. If the information or 
      evidence presented to DEA indicates that a physician has 
      delivered, distributed, dispensed, prescribed or 
      administered a controlled substance with the deliberate 
      intent of assisting in a suicide, then DEA could initiate 
      revocation proceedings on the grounds that the physician 
      has acted ``without a legitimate medical purpose.''
        In addition to moving to revoke a physician's 
      registration for dispensing controlled substances ``without 
      a legitimate medical purpose,'' please also be aware that 
      the CSA provides a number of other grounds upon which DEA 
      might revoke the registration of a physician who assisted 
      in a suicide. For example, DEA will revoke the registration 
      of any physician whose state license to practice medicine 
      has been revoked for assisting suicide. Similarly, DEA has 
      authority to revoke the registration of any physician whose 
      acts in assisting a suicide result in a conviction under 
      state controlled substances laws.
        DEA must examine the facts on a case-by-case basis to 
      determine whether a physician's actions conflict with the 
      CSA. If the facts indicate that a physician has acted as 
      set forth in your letter, however, then DEA would have a 
      statutory basis to initiate revocation proceedings.
        I trust that this response addresses your inquiry. If you 
      have any further questions, please feel free to contact me.
        Sincerely,
                                                              
      Thomas A. Constantine,
                                                                  
        Administrator.
    Several months later, the two Chairmen received a letter 
10 from Attorney General Janet Reno which overturned 
the DEA position. Writing on June 5, 1998, General Reno said, 
``The Department has reviewed the issue thoroughly and has 
concluded that adverse action against a physician who has 
assisted in a suicide in full compliance with the Oregon Act 
would not be authorized by the CSA.''
---------------------------------------------------------------------------
    \10\ Office of the Attorney General,
    Washington, DC.

    Hon. Orrin G. Hatch,
    Chairman, Committee on the Judiciary,
    U.S. Senate, Washington, DC.

        Dear Mr. Chairman: This is in response to your request 
      concerning the question whether the Department of Justice, 
      through the Drug Enforcement Administration (``DEA''), may 
      invoke the Controlled Substances Act (``CSA''), 21 U.S.C. 
      Sec. Sec. 801-971, to take adverse action against 
      physicians who assist patients in ending their lives by 
      prescribing controlled substances. The issue has arisen in 
      the context of Oregon's ``Death with Dignity Act,'' Oreg. 
      Rev. Stat. Sec. Sec. 127.800-127.995, which permits 
      physicians to assist competent, terminally ill patients in 
      ending their lives in compliance with certain detailed 
      procedures. The Department has reviewed the issue 
      thoroughly and has concluded that adverse action against a 
      physician who has assisted in a suicide in full compliance 
      with the Oregon Act would not be authorized by the CSA.
        The Oregon Act was approved by Oregon voters on November 
      8, 1994, and went into effect on October 27, 1997. The Act 
      provides for a detailed procedure by which a mentally 
      competent, terminally ill patient may request to end his or 
      her life ``in a humane and dignified manner.'' O.R.S. 
      Sec. 127.805. The procedure requires, for example, that the 
      patient's competence and the voluntariness of the request 
      be documented in writing and confirmed by two witnesses, 
      see id. Sec. 127.801(1), that the patient's illness and 
      competence and the voluntariness of the request be 
      confirmed by a second physician, see id. Sec. 127.820, and 
      that the physician and patient observe certain waiting 
      periods, see id. Sec. Sec. 127.840, 127.850. Once a request 
      has been properly documented and the requisite waiting 
      periods have expired, the patient's attending physician may 
      prescribe, but not administer, medication to enable the 
      patient to take his or her own life. As a matter of state 
      law, physicians acting in accordance with the Oregon Act 
      are immune from liability as well as any adverse 
      disciplinary action for having rendered such assistance.
        Prior to the Oregon Act's taking effect last year, you 
      wrote to DEA Administrator Thomas Constantine seeking the 
      DEA's view as to whether delivering, distributing, 
      dispensing, prescribing, or administering a controlled 
      substance with the intent of assisting in a suicide would 
      violate the CSA notwithstanding a state law such as the 
      Oregon Act. In response, Administrator Constantine 
      explained that ``physician-assisted suicide would be a new 
      and differnet application of the CSA,'' and that the 
      determination whether to pursue adverse action under the 
      CSA would first require ``a medico-legal investigation'' 
      involving ``state and local law enforcement agencies and 
      prosecutors.'' He also stated, however, that ``the 
      activities that you described in your letter to us would 
      be, in our opinion, a violation of the CSA.'' Subsequently, 
      many other Members of Congress have sent letters urging 
      that I support the DEA's conclusions and enforce federal 
      laws and regulations accordingly. I have received other 
      correspondence supporting a contrary conclusion.
        The Department has conducted a thorough and careful 
      review of the issue of whether the CSA authorizes adverse 
      action against a physician who prescribes a controlled 
      substance to assist in a suicide in compliance with Oregon 
      law.
        The CSA is a complex regulatory scheme that controls the 
      authorized distribution of a scheduled drugs. Physicians, 
      for example, are authorized to prescribe and distribute 
      scheduled drugs only pursuant to their registration with 
      the DEA, and the unauthorized distribution of drugs is 
      generally subject to criminal and administrative action. 
      The relevant provisions of the CSA provide criminal 
      penalties for physicians who dispense controlled substances 
      beyond ``the course of professional practice,'' 21 U.S.C. 
      Sec. 802(21), see id. Sec. 841(b), and provide for 
      revocation of the DEA drug registrations of physicians who 
      have engaged either in such criminal conduct or in other 
      ``conduct which may threaten the public health and 
      safety,'' id. Sec. 823(f). Because these terms are not 
      further defined by the statute, we must look to the purpose 
      of the CSA to understand their scope.
        The CSA was intended to keep legally available controlled 
      substances within lawful channels of distribution and use. 
      See S. Rep. No. 91-613, at 3 (1969). It sought to prevent 
      both the trafficking in these substances for unauthorized 
      purposes and drug abuse. The particular drug abuse that 
      Congress intended to prevent was that deriving from the 
      drug's ``stimulant, depressant, or hallucinogenic effect on 
      the central nervous system,'' 21 U.S.C. Sec. 811(f).
        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 
      absence of a federal law prohibiting that practice. Indeed, 
      the CSA is essentially silent with regard to regulating the 
      practice of medicine that involves legally available drugs 
      (except for certain specific regulations dealing with the 
      treatment of addicts, see 42 U.S.C. Sec. 257a; 21 C.F.R. 
      Sec. 291.505).
        Even more fundamentally, there is no evidence that 
      Congress, in the CSA, intended to assign DEA the novel role 
      of resolving the ``earnest and profound debate about the 
      morality, legality, and practicality of physician-assisted 
      suicide,'' Washington v. Glucksberg, 117 S. Ct. 2258, 2275 
      (1997), simply because that procedure involves the use of 
      controlled substances. If Congress had assigned DEA this 
      role under the CSA, it would ultimately be DEA's task to 
      determine whether assistance in the commission of a 
      suicide, in compliance with a state law specifically 
      permitting and regulating such assistance, nevertheless 
      falls outside the legitimate practice of medicine and is 
      inconsistent with the public interest. These questions, 
      however, are not susceptible of scientific or factual 
      resolution, but rather are fundamental questions of 
      morality and public policy. Such a mission falls well 
      beyond the purpose of the CSA.
        The state of Oregon has reached the considered judgment 
      that physician-assisted suicide should be authorized under 
      narrow conditions and in compliance with certain detailed 
      procedures. Under these circumstances, we have concluded 
      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. We 
      emphasize that our conclusion is limited to these 
      particular circumstances. Adverse action under the CSA may 
      well be warranted in other circumstances: for example, 
      where a physician assists in a suicide in a state that has 
      not authorized the practice under any conditions, or where 
      a physician fails to comply with state procedures in doing 
      so. However, the federal government's pursuit of adverse 
      actions against Oregon physicians who fully comply with 
      that state's Death with Dignity Act would be beyond the 
      purpose of the CSA.
        Finally, notwithstanding our interpretation of the CSA as 
      it applies to the Oregon Act, it is important to underscore 
      that the President continues to maintain his longstanding 
      position against assisted suicide and any Federal support 
      for that procedure. This position was recently codified 
      when he signed the Assisted Suicide Funding Restriction Act 
      last year. While states ordinarily have primary 
      responsibility for regulating physicians, the President and 
      the Administration nonetheless remain open to working with 
      you and other interested members of Congress on this 
      complex but extremely important issue.
        Sincerely,
                                                              
      Janet Reno.
    General Reno's letter appeared to be, in part, a response 
to an October 8, 1997 action by the U.S. Supreme Court to deny 
certiorari in the case of Lee v. Oregon 11 which 
removed the final barrier to implementation of Oregon's Death 
With Dignity Act. The Death With Dignity Act allows terminally 
ill Oregon residents, those who are determined to have fewer 
than 6 months to live, to request from their attending 
physician a prescription for drugs to end their life. The 
Oregon Act requires a 15-day waiting period, three requests 
from the patient, one of which must be in writing, and a second 
physician's opinion. The Oregon measure does not permit lethal 
injection, mercy killing, or active euthanasia, but makes clear 
that actions taken in accordance with the law do not constitute 
suicide, mercy killing or homicide.12
---------------------------------------------------------------------------
    \11\ 107 F.3d 1382 (9th Cir. 1997) cert. denied, 66 U.S.L.W. 3282.
    \12\ Oreg. Rev. Stat. Sec. Sec. 127.800-127.995.
---------------------------------------------------------------------------
    In her letter, General Reno related that the Department had 
conducted a thorough and careful review of the issue of whether 
the CSA authorizes adverse action against a physician who 
prescribes a controlled substance to assist in a suicide in 
compliance with Oregon law, and concluded 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.'' In rendering that decision, 
General Reno noted that it applied to a narrow set of 
conditions and in compliance with certain detailed procedures 
(e.g. those in the Oregon law) and concluded that ``adverse 
action under the CSA may well be warranted in other 
circumstances: for example, where a physician assists in a 
suicide in a State that has not authorized the practice under 
any conditions, or where a physician fails to comply with State 
procedures in doing so.''
    Amplifying further on General Reno's views, Joseph N. Onek, 
Principal Deputy Associate Attorney General, testified before 
the Senate Committee on the Judiciary on July 31, 1998 that 
their lengthy legal analysis of existing law concluded that the 
DEA is not authorized to take action against physicians who are 
in compliance with the laws of their own States regarding 
physician-assisted suicide.
    Mr. Onek testified that the Department had based its 
conclusion on the legislative history of the Controlled 
Substances Act and the actual language of the Act which he said 
provided no evidence that the Congress intended to delegate to 
the DEA the right to decide whether State-approved physician-
assisted suicide constituted a legitimate medical purpose. He 
contrasted that decision with the instance of the use of 
marijuana for medical purposes, as authorized in at least two 
States. In that instance, according to Mr. Onek, Congress has 
specifically extended the national control of the CSA by acting 
to place marijuana specifically on the list of Schedule I 
controlled substances, which have no currently accepted medical 
use.
    Enactment of S. 2151 will resolve the divergence of opinion 
between the DEA and the DoJ and is intended to clarify that the 
Controlled Substance Act does apply on a national basis to 
cases of assisted suicide, State law notwithstanding. While 
some have expressed concern about any legislative effort which 
might appear to override State laws, it is important to note 
that the Federal Government has asserted for decades its 
appropriate role in regulating substances of abuse, including 
the Federal Controlled Substances Act which was enacted in 1970 
as a national statute to set uniform standards governing the 
use of drugs with a high potential for abuse. The Committee has 
approved S. 2151 consistent with the national nature of the 
Controlled Substances Act, which does not envision variances in 
law from State to State with respect to drugs with a high 
potential for abuse.

                    III. SECTION-BY-SECTION ANALYSIS

    Following is a section-by-section analysis of the 
Chairman's substitute as ordered reported by the Committee on 
September 24, 1998:

Section 1. Short title

    Entitles the Act the ``Lethal Drug Abuse Prevention Act of 
1998.''

Section 2. Findings; purposes

    Makes a series of findings about the regulation of drugs 
with a potential for abuse under the Controlled Substances Act, 
the use of such drugs by practitioners for legitimate medical 
purposes, the need for improved treatment of pain, and the fact 
that dispensing and distributing such drugs affects interstate 
commerce. Relates the purposes of the bill to: (1) provide 
explicitly that Federal law does not allow the dispensing or 
distribution of a controlled substance to cause or assist a 
suicide or euthanasia; and (2) encourage the use of such 
substances when medically appropriate to relieve pain and 
discomfort.

Section 3. Lethal drug abuse prevention

    Adds a new subsection (I) to section 303 of the Controlled 
Substances Act (``Registration Requirements'') to require the 
Attorney General to determine that registration of an applicant 
is inconsistent with the public interest in either of two 
cases: (1) when the registration has either been revoked or 
suspended in the past 5 years because the registrant 
intentionally dispensed or distributed a controlledsubstance to 
cause or assist in a suicide or euthanasia; or (2) when the Attorney 
General determines (based on a clear and convincing evidence standard) 
that the applicant intends to use the registration to cause or assist 
in a suicide.
    Amends section 304 (``Denial, Revocation or Suspension of 
Registration'') to add to the list of factors the Attorney 
General considers in suspending or revoking a registration a 
new consideration (304(a)(4)) of whether the registrant has 
intentionally dispensed or distributed a controlled substance 
with the purpose of causing or assisting in causing the suicide 
or euthanasia of any individual.
    Makes clear that prior to commencing any action under the 
new section 304(a), the Attorney General must find that the 
registrant dispensed or distributed a specific controlled 
substance which was directly responsible for the death of an 
individual, and that the registrant did not dispense or 
distribute the controlled substance as medically indicated. The 
term ``medically indicated'' refers to the use of a controlled 
substance where the use of such substance is reasonable and 
necessary for the treatment of a patient and is not consistent 
with intentionally causing the death of the patient. The 
Attorney General may consult with the Secretary of HHS as she 
deems appropriate in making such a finding. HHS is required to 
appoint an individual or office which will serve as the 
principal liaison in carrying out the Act.
    Clarifies that the new 304(a)(4) does not apply to 
dispensing and distributing controlled substances to alleviate 
pain or discomfort (even if it may increase the risk of death) 
or to carry out a death sentence. The burden rests with the 
Attorney General to prove by clear and convincing evidence that 
the practitioner's intent was to cause or assist in causing the 
suicide or euthanasia.
    The Secretary of Health and Human Services and the Attorney 
General will establish a ``Medical Advisory Board on Pain 
Relief,'' The membership is appointed after consultation with 
pain relief experts and will be drawn from individuals with 
experience in pain management and relief. A practitioner 
subject to investigation under 304(a)(4) may request that the 
Medical Advisory Board on Pain Relief review the administrative 
record of the proceeding and issue an opinion to the Attorney 
General on whether the dispensing or distribution of the 
controlled substance at issue was for the purpose of 
alleviating pain or discomfort consistent with 304(a)(4).
    Makes explicit that nothing in these amendments to the 
Controlled Substances Act shall be construed to grant the 
Attorney General additional investigative authority in any 
State to the extent that the law of the State prohibits 
assisted suicide or euthanasia.

Section 4. Designation of liaison

    Requires the Secretary of Health and Human Services to 
designate an officer to serve as liaison with the Attorney 
General.

Section 5. Diversion control fee account

    Clarifies that, because the activities under this 
legislation are consistent with the Drug Enforcement 
Administration's registration activities under current law, 
agency activities, including review board activities, pursuant 
to this bill are to be reimbursed under the diversion control 
fee account.

Section 6. Applicability; construction

    Explains that the changes in the bill apply with respect to 
any controlled substance dispensed or distributed after date or 
enactment. Clarifies that the Act does not change current law 
prior to enactment with respect to the use of a controlled 
substance in an assisted suicide or euthanasia.

             IV. LEGISLATIVE HISTORY AND VOTES IN COMMITTEE

    S. 2151, the ``Lethal Drug Abuse Prevention Act of 1998'' 
was introduced on June 9, 1998 by Senators Don Nickles, Trent 
Lott and 11 other Senators.13 On July 31, 1998, the 
Judiciary Committee held a hearing to examine issues associated 
with the legislation, including its effect on the provision of 
palliative care to terminally ill patients, its 
interrelationship with State law, and the role of the Drug 
Enforcement Administration in the regulation of controlled 
substances. The Committee heard testimony from three panels of 
witnesses, including Members of Congress, representatives of 
the Administration, and public advocates expert in end-of-life 
care issues.
---------------------------------------------------------------------------
    \13\ S. 2151 is currently sponsored by Senators: Nickles; Lott; 
Coats, Inhofe, Helms, Murkowski, Grams, Faircloth, Bond, Enzi, 
Sessions, Hazel, Coverdell, Smith (NH), Lieberman, Brownback, Craig, 
Abraham, Santorum, Allard, Grassley, DeWine, Kyl, and Hutchinson.
---------------------------------------------------------------------------
    In the first panel, Senator Nickles testified that the sole 
purpose of the legislation is to clarify that assisted suicide 
is not a ``legitimate medical purpose'' under the Controlled 
Substances Act and that, therefore, federally-controlled 
substances cannnot be prescribed or dispensed for that purpose. 
Enactment of the Lethal Drug Abuse Prevention Act of 1998 will 
ensure that Federal authorization to prescribe DEA-regulated 
drugs does not include the authority to prescribe such drugs to 
cause a patient's death, Senator Nickles explained.
    Also on panel one, Senator Ron Wyden strongly opposed S. 
2151. He testified that he believes the underlying message of 
S. 2151, with which he completely disagrees, is that Congress 
can better decide what is best for the people than the voters 
in Oregon. Senator Wyden expressed other concerns with the 
bill, including his belief that it would tie the hands of 
doctors who treat patients in severe pain, including the 
terminally ill. He argued that the bill could cause doctors to 
underprescribe medication and less aggressively comfort 
patients in intractable pain.
    As the final witness in the first panel, Senator Gordon 
Smith explained he believed assisted suicide is an issue of 
conscience, not a States' rights issue, but rather an issue of 
what the law should be with respect to life. He outlined his 
own experience with the law as an Oregon State Senator and a 
member of its Health Care and Bioethics Committee, as well 
ashis experiences as a lay bishop visiting the sick, elderly and the 
dying. Senator Smith argued that the bill should eliminate any 
retroactive prosecution of doctors in Oregon, and it should more fully 
define a high tolerance for aggressive palliative care.
    Testifying for the Administration on the second panel were 
Joseph N. Onek, Principal Deputy Associate Attorney General, 
U.S. Department of Justice, and Thomas A. Constantine, 
Administrator, Drug Enforcement Administration. Mr. Onek 
testified that, although the President is against physician-
assisted suicide and any Federal support of it, he believes S. 
2151 is flawed in many ways. He raised three principle 
objections to the legislation: First, that he believed it would 
compromise the DEA's core mission of preventing drug abuse and 
the diversion of controlled drugs; second, that the bill might 
inappropriately involve DEA in decisions about the use of pain 
medication and lessen the cooperation the agency receives from 
the medical community; and third, that the legislation could 
``intimidate'' physicians from providing adequate palliative 
care.
    DEA Administrator Constantine related the analysis used to 
develop his November 5, 1997 response to Congress, concluding 
that while he believed the DEA has authority with respect to 
the use of controlled substances in an assisted suicide, the 
agency would make any decision to initiate a revocation on a 
case-by-case basis after a careful review of the facts.
    The third panel of witnesses consisted of experts who deal 
with end-of-life issues and physician-assisted suicide. As the 
first witness in this panel, Dr. Ralph Meich, a professor of 
pharmacology at Brown University, and the founder of the Rhode 
Island Cancer Initiative, expressed his support of S. 2151 
stating that it clarifies important ethical and legal 
distinctions between appropriate medical use of therapeutic 
drugs for pain control in palliative care and lethal misuse of 
such drugs to accomplish assisted suicide. Dr. Meich also 
believes that the use of the controlled substances regulated by 
this legislation should be subject to DEA regulation.
    Dr. Joanne Lynn, president of the Americans for Better Care 
of the Dying, and representing the American Geriatrics Society, 
expressed her opposition to the bill. She testified that it is 
her belief that this bill will have a deleterious effect on 
pain management of the chronically ill. She fears this 
legislation will have the unintended consequence of increasing 
pain suffered by the terminally ill by deterring physicians 
from prescribing adequate doses of scheduled pain management 
drugs.
    The next witness, Dr. Walter Hunter, medical director of 
the South Oakland County Hospice of Michigan, testified in 
support of the legislation, stating that his bill will not 
interfere with his ability, as a hospice physician, to deliver 
palliative care. Dr. Hunter argued that increased scrutiny of 
treatment practices by the DEA will only improve the quality of 
care by his colleagues. Hospice care serves as an alternative 
to the need for physician-assisted suicide by providing proper 
palliative care to the terminally ill which Dr. Hunter believes 
will not survive if legalization of assisted suicide occurs.
    Dr. Harold S. Sox, Jr., president of the American College 
of Physicians (ACP)-American Society of Internal Medicine 
(ASIM), testified in opposition to the proposed legislation. 
Dr. Sox argued that the ACP-ASIM opposes S. 2151 primarily 
because they fear that physicians who aggressively prescribe 
pain medication could face disciplinary proceedings under the 
new act. Dr. Sox said this will result in a reluctance of 
physicians to effectively treat pain.
    Andrew Batavia is an Associate Professor of the Health 
Services Administration Program with the School of Policy and 
Management in the College of Urban and Public Affairs at 
Florida International University. He testified in opposition to 
S. 2151 because he believes such legislation violates basic 
Republican principles of federalism, sound legislation, 
regulatory restraint, and fairness. He argued that S. 2151 
supersedes the right of Oregon citizens who have had two 
elections deciding the policy of assisted suicide in their 
State, and as a result the Federal Government should not 
preempt this law.
    As the final witness, Gayle Hafner of Not Dead Yet (NDY), 
testified in support of S. 2151. Ms. Hafner argued that there 
have been years of medical discrimination against people with 
disabilities and therefore categorically opposes physician-
assisted suicide. NDY believes that quality of life in disabled 
people is underestimated by many doctors and that doctors often 
prey on the fears of newly disabled people and sway them into 
making a so-called choice for death decisions.
    The bill was considered by the full committee in an 
executive session on September 24, 1998, where the committee 
voted 11-6 to report the bill as amended to the Senate. Voting 
in favor were Senators Thurmond, Grassley, Specter, Thompson, 
Kyl, DeWine, Ashcroft, Abraham, Sessions, Biden and Hatch, and 
in opposition were Senators Leahy, Kennedy, Kohl, Feinstein, 
Feingold and Torrricelli.
    The House companion bill, H.R. 4006, was introduced on June 
5, 1998 by Judiciary Committee Chairman Henry Hyde and 
Representative James Oberstar. The Subcommittee on the 
Constitution approved the bill, as amended on July 22, 1998. 
The full committee ordered it reported on August 4, 1998.
    The Committee met to consider the bill on Thursday, 
September 24, 1998. Senator Hatch offered a substitute 
amendment which was agreed to by unanimous consent. The bill 
was ordered favorably reported, as amended, by a rollcall vote 
of 11 yeas to 6 nays, as follows:
        YEAS                          NAYS
Thurmond                            Leahy
Grassley (by proxy)                 Kennedy (by proxy)
Specter (by proxy)                  Kohl (by proxy)
Thompson                            Feinstein
Kyl (by proxy)                      Feingold (by proxy)
DeWine                              Torricelli
Ashcroft (by proxy)
Abraham
Sessions
Biden
Hatch

           V. EXPLANATION OF LEGISLATION AND COMMITTEE VIEWS

    The Lethal Drug Abuse Prevention Act of 1998 is intended to 
clarify Federal law with respect to the use of controlled 
substances in cases of assisted suicide and euthanasia, and at 
the same time highlight the concern of Congress that medical 
professionals be encouraged to provide appropriate palliative 
care for those in chronic pain. The Committee is aware that 
criticisms have been raised that this legislation will have 
unintended consequences which might inappropriately reduce the 
level of care that the terminally ill might receive. The 
Committee believes that many of these criticisms are based on 
erroneous information, an unfair reading of the provisions, or 
an analysis of the bill prior to adoption of the Chairman's 
substitute.

                          A. Scope of the Bill

    One key misconception about S. 2151 is that it is intended 
to eradicate all assisted suicide, a misunderstanding 
frequently cited by opponents of the bill. Indeed, the 
testimony of the Justice Department before this Committee was 
replete with such references. At that hearing, Mr. Onek 
testified that:

          The proposed revision of the Controlled Substances 
        Act through S. 2151 would not necessarily accomplish 
        the intended effect of banning all assisted suicides, 
        as there are several plausible means of assisted 
        suicide or euthanasia which do not involve the use of 
        controlled substances.14
---------------------------------------------------------------------------
    \14\ Testimony of Mr. Joseph N. Onek before the Senate Committee on 
the Judiciary, July 31, 1998.

    The Principal Deputy Associate Attorney General also told 
---------------------------------------------------------------------------
the Committee the legislation is:

          Likely to be ineffective in preventing physician-
        assisted suicide, because, in fact, physician-assisted 
        suicide does not require the use of controlled 
        substances. Furthermore, in the real world, most 
        terminally ill patients already have an ample supply of 
        such substances to use in conjunction with an assisted 
        suicide effort. In short, just as the DEA is, in our 
        view, the wrong agency to deal with this issue, the 
        Controlled Substances Act is the wrong 
        vehicle.15
---------------------------------------------------------------------------
    \15\ Testimony of Joseph N. Onek before the Committee on the 
Judiciary, July 31, 1998.

    The Committee is not so ignorant as to believe that this 
legislation will thwart all suicides or assisted suicides. Nor 
is the bill intended to do so. Indeed, no amount of regulation 
could accomplish that purpose. Instead, the purpose of S. 2151, 
as highlighted above, is to ratify the uniform, national nature 
of the Controlled Substances Act, to clarify that its 
provisions intended to regulate drugs with a potential for 
abuse apply equally in all states.

                             B. Federalism

    Another erroneous criticism of the bill is that it usurps 
the power of States to enact legislation, a power which is 
reserved under the 10th amendment to the Constitution. Related 
to that argument is the allegation that the bill is intended to 
overturn the Oregon Death with Dignity Act. Again, these 
allegations appear to be based more on fear than reality.
    The Controlled Substances Act (CSA) was enacted almost 30 
years ago as a measure to ensure strict, national regulation of 
drugs which have a serious potential for abuse. The CSA is 
achieving its purpose of imposing that nationwide system of 
controls to reduce the potentialfor drugs to be abused, while 
at the same time improving pain care. In 1970, when the Controlled 
Substances Act was enacted, 70 percent of the drug-related emergency 
room visits were caused by legitimate drugs. By 1990, that figure had 
fallen to 20 percent.
    While as a matter of general principle, the Federal 
Government should defer to the States wherever and whenever 
possible, there are a myriad of areas in which there is a need 
for over-arching Federal supremacy. For example, on numerous 
occasions, the Congress has affirmed and then reaffirmed the 
Federal Food, Drug and Cosmetic Act as the Nation's principal 
regulatory authority over one-quarter of the Nation's consumer 
goods. Similarly, given the devastating national problem of 
illicit drug use, the Controlled Substances Act itself finds, 
``The illegal importation, manufacture, distribution, and 
possession improper use of controlled substances have a 
substantial and detrimental effect on the health and general 
welfare of the American people.'' The Committee views enactment 
of S. 2151 as entirely consistent with that Federalism 
principle.
    It is difficult to see how a 50-state, crazy quilt approach 
to the regulation of controlled substances can adequately 
protect the health of the American public. Using controlled 
substances as agents not for bona fide medical purposes, but 
instead to extinguish life, flies in the face of Hippocrates' 
great teaching: ``First do no harm.''
    Under the CSA, the Drug Enforcement Administration has 
become the Nation's chief steward in the prevention of abuse of 
controlled substances. The Committee believes that this 
amendment to the CSA will unambiguously empower DEA, in close 
consultation with HHS and other medical experts, to take action 
against those who would flaunt the CSA and use controlled 
substances to effectuate the ultimate harm.

                           C. Palliative Care

    The Committee also wishes to take this opportunity to 
address the criticism that this legislative effort will thwart 
legitimate pain treatment, by encouraging a ``climate of fear'' 
in which practitioners will err on the side of safety by not 
dispensing or distributing adequate medication. This 
trepidation has been echoed by a number of organizations 
opposing the legislation.
    Representatives of the pain care community, in particular, 
expressed concern in two areas: That the bill would allow the 
Drug Enforcement Administration to undertake unwarranted 
investigations too easily; and that these investigations might 
be both time-consuming and costly, and result in unwarranted 
revocation of a license. In fact, mindful of this trepidation, 
the Committee undertook a serious effort to change the 
legislation and insert safeguards which are intended to provide 
practitioners with the peace of mind that legitimate medical 
practice will not be threatened. The Committee is extremely 
cognizant of those concerns, and took a number of steps to make 
certain that the bill which was reported created a favorable 
climate for palliative care.
    The Committee wishes to reassure medical practitioners that 
Congress encourages the use of palliative care, and 
particularly the legitimate use of Controlled Substances to 
treat painful, chronic diseases or terminal illnesses. The 
Chairman's substitute makes a number of needed corrections 
which it hopes will serve as that encouragement. For example, 
the bill clarifies that prior to commencing any investigation 
of suspected assisted suicide, the Attorney General must make 
two specific findings that the registrant: (1) dispensed or 
distributed a specific controlled substance which was directly 
responsible for the death of an individual; and (2) did not 
dispense or distribute the specific controlled substance as 
medically indicated as set forth in this Act. The Committee 
inserted these provisions as a filter, to prove to the medical 
community that the DEA would not undertake any investigations 
under this legislation unless there were good cause for such an 
investigation.
    The Committee was also mindful of the concern that any 
investigation, once undertaken, is a serious event which, if 
not handled appropriately, has the potential of harming patient 
care and damaging the careers of registrants. Accordingly, the 
Committee has also inserted another safeguard to make certain 
that practitioners operating within the bounds of legitimate 
medical practice need not fear government intervention. The 
Chairman's mark adopted by the Committee includes the House-
reported language (H.R. 4006) which places the burden on the 
Attorney General in actions to revoke, deny, or suspend a 
registration because of suspected suicide assistance to prove 
(by a clear and convincing evidence standard) that the 
registrant intended to assist a suicide.
    As a final safeguard, the bill includes language in section 
304(a)(4) making clear that its provisions do not apply in 
cases in which the distribution or dispensing of the controlled 
substance was for the purpose of alleviating pain or 
discomfort, even if the use of the controlled substance might 
increase the risk of death, so long as the drug was not used 
for the purpose of causing the death of an individual. In 
combination, these are extremely high hurdles which the 
Committee believes will serve to ensure that only those who 
intend to assist in a suicide are subject to the provisions of 
the legislation.

                 D. Role of the DEA in Pain Management

    The Committee has also inserted language to address the 
concerns raised by the Administration that, in the words of Mr. 
Onek, ``this legislation will embroil the DEA in decisions 
about the use of pain medication for terminally ill patients 
which it is poorly equipped to make. Indeed, the legislation's 
call for a rather anomalous new pain relief board underscores 
the DEA's relative lack of expertise in this area.''
    We wish to note that, under current law and regulation, the 
DEA is required to make regular judgments about whether 
registrants are using controlled substances for legitimate 
medical purposes. Indeed, in the words of the DEA 
Administrator, ``the CSA authorizes DEA to revoke the 
registration of physicians who dispense controlled substances 
without alegitimate medical purpose.'' 16 In fact, 
the DEA has provided the Committee with a statement of policy 
17 which notes that the agency relies on the medical 
community itself, through its state licensing authorities and 
recognized experts, for the definitions and standards of medical 
practice. In the words of DEA:
---------------------------------------------------------------------------
    \16\ Letter to Senator Hatch and Rep. Hyde from Mr. Thomas A. 
Constantine, November 5, 1997.
    \17\ ``Statement of Policy for the Use and Handling of Controlled 
Substances in the Treatment of Pain,'' Drug Enforcement Administration 
(undated).

          Medical experts are currently reevaluating some basic 
        but long held beliefs concerning the extended use of 
        narcotic substances for chronic pain. This has 
        generated a need to more effectively define and 
        standardize practice guidelines in this sensitive area 
        of pain management as well as a need to update 
        educational efforts for physicians concerning the 
        pharmacology of narcotic analgesics, pain management 
        and addiction, as well as diversion and patient scams.
          DEA encourages the development of pain management 
        practice guidelines and educational programs by medical 
        boards to better define acceptable medical practice for 
        the management of pain with controlled substances. 
        Practice guidelines which reflect currently acceptable 
        standards and treatment modalities will prove 
        invaluable in helping a physician form his medical 
        judgment in making pain management decisions, and in 
        allaying any fear of adverse consequences from 
        licensing boards or investigative agencies when none is 
        justified. Practice guidelines assist everyone 
        concerned in better defining the elements of legitimate 
        pain treatment, thereby providing the courts and 
        licensing boards a sound and definitive basis to judge 
        instances which clearly fall outside acceptable norms.
          It is clear that decisions concerning the adequacy or 
        appropriateness of a particular form of medical 
        treatment rest entirely with the medical experts. 
        Consequently, DEA believes that continued involvement 
        of its representatives in the ongoing dialog with the 
        medical community should continue.

    Indeed, those who aver that it is not the responsibility of 
the DEA to insert itself into either State licensing activities 
or private medical practice with respect to pain management may 
be surprised to learn that the DEA has a long record of active 
involvement with the medical community in this regard. As 
recent examples, this year, the DEA participated in a July 21, 
1998 workshop with the University of Wisconsin Pain Policy 
Studies Group, the American Pain Society, and the Alliance of 
States with Prescription Monitoring Programs. The workshop was 
designed to foster an exchange of ideas on pain management. The 
DEA has also participated in a March, 1998 Symposium on Pain 
Management with the Federation of State Medical Boards meeting, 
and a January, 1998 Conference on Pain Management.
    It is also noteworthy that the DEA has worked within the 
pain community to reinforce that the agency's mission envisions 
legitimate use of controlled substances for pain relief. In 
March, 1990, the DEA published guidelines which stated 
``Controlled substances have legitimate clinical usefulness and 
the prescriber should not hesitate to consider prescribing them 
when they are indicated for the comfort and well-being of 
patients.'' 18 Similarly, in 1990, the DEA also 
said:
---------------------------------------------------------------------------
    \18\ ``Guidelines for Prescribers of Controlled Substances: A Joint 
Statement of the Drug Enforcement Administration and the DEA/
Practitioners Working Committee,'' Physician's Manual, Drug Enforcement 
Administration, rev. March 1990, p. 24.

          Controlled substances and, in particular narcotic 
        analgesics, may be used in the treatment of pain 
        experienced by a patient with a terminal illness or 
        chronic disorder. These drugs have a legitimate 
        clinical use and the physician should not hesitate to 
        prescribe, dispense, or administer them when they are 
        indicated for a legitimate medical purpose. It is the 
        position of the Drug Enforcement Administration that 
        these controlled substances should be prescribed, 
        dispensed, or administered when there is a legitimate 
        medical need.19
---------------------------------------------------------------------------
    \19\ Ibid, p. 21.
---------------------------------------------------------------------------

         E. Role of the Department of Health and Human Services

    Despite this long record of the Drug Enforcement 
Administration, the Committee has inserted explicit language to 
address concerns raised about the agency's experience and 
expertise in determining legitimate medical uses of controlled 
substances by making the Department of Health and Human 
Services a more integral part of the medical advisory board 
process, allowing a practitioner under investigation to request 
examination of the case by the medical advisory board, and 
enhancing the membership of the committee to reflect 
consultation with such experts as the American Medical 
Association, the American Academy of Pain Medicine, the 
American Pain Society, the American Academy of Hospice and 
Palliative Medicine, the National Hospice Organization, the 
American Geriatrics Society, and other entities with relevant 
expertise on pain relief.
    During consideration of this legislation, the Department of 
Justice wrote to Senator Hatch 20 and suggested that 
a better way to avoid assisted suicides is to develop consensus 
guidelines on the appropriate use of controlled substances for 
terminally ill patients. In that letter, the Department of 
Justice suggested that a board be charged with developing those 
guidelines and with recommending how the guidelines should be 
enforced.
---------------------------------------------------------------------------
    \20\ Letter of September 16, 1998 from L. Anthony Sutin, Acting 
Assistant Attorney General to Senator Orrin G. Hatch.
---------------------------------------------------------------------------
    The Committee rejects this bureaucratic response, noting 
that formation of a committeewill not take any concrete steps 
toward the goal of stopping assisted suicides, a goal which the 
President has stated he shares. The problem with the Justice Department 
suggestion is that a mere study delays implementation of what we have 
already shown to be the correct policy: That the Federal Government 
should not be involved in any way in assisting suicides. Indeed, the 
Committee believes that the preferable approach is contained in S. 
2151, as amended. That is, the DEA will continue to enforce the 
Controlled Substances Act's provisions requiring legitimate medical use 
of controlled substances, while at the same time continuing to work 
within the medical community to further its understanding of pain 
management practices.
    The Committee notes that, in addition to the Advisory Board 
chaired by HHS, the Committee has included language which makes 
clear that the Department of Justice may consult with HHS 
before commencing any investigation under this Act so that HHS 
may provide any needed medical judgment to DEA. Having built in 
these safeguards, the Committee believes that S. 2151, as 
ordered reported, obviates many of the concerns raised by the 
pain community and by the Administration.

   F. Investigative Authority of the Drug Enforcement Administration

    A fact neglected to be mentioned in this debate is that 
under current law, the Drug Enforcement Administration has the 
authority to regulate physician prescribing patterns, and to 
the extent that is a deterrent to effective pain management, 
the bill would not exacerbate the situation. The Committee 
intends to monitor the situation closely to make certain that, 
whether under current law or the law as modified by S. 2151, 
Drug Enforcement Administration practices do not discourage the 
legitimate use of controlled substances for palliative care.
    Nevertheless, the Chairman's mark also included language in 
section 4(c)(4) providing that nothing in the amendments to the 
Controlled Substances Act contained therein may be construed to 
provide the Drug Enforcement Administration with any additional 
investigative authority in any State, to the extent that the 
law of the State prohibits assisted suicide or euthanasia. This 
rule of construction simply makes clear that the intent of 
these amendments is not to supplant State efforts to enforce 
existing State laws against assisted suicide or euthanasia. 
Many States already have laws against assisted suicide; medical 
practitioners in those States are likely to have participated 
in enactment of those laws and understand the procedures 
involved and the standards applied. Presumably, the DEA will 
take the efficacy of those State laws into account as it 
assigns its scarce enforcement resources.
    This rule of construction is intended in part to allay the 
fears of those health care practitioners, in States with 
existing prohibitions in State law, that DEA might interpret 
this bill as a new mandate to open up overzealous Federal 
investigations that could duplicate or interfere with State 
efforts in this area. Nothing in this rule of construction will 
diminish the authority of the DEA to investigate and take 
necessary enforcement actions in any State. Consistent with the 
efficient administration of justice, every practitioners in 
every state will be treated equally under this new Federal law.

                            G. Death Penalty

    Section 3(b)(1)(B) of the bill, as amended, makes clear 
that nothing in this legislation will interfere with the 
ability of states or the Federal Government to carry out the 
death penalty. The Committee added this provision because at 
least one of the drugs commonly used in lethal injection, 
sodium thiopental, is a controlled substance, and the Committee 
wished to make clear that the DEA should not refuse to grant a 
registration under this Act to an applicant who will carry out 
a sentence of death under Federal or State law.
    In that regard, the Committee cites the 1985 Supreme Court 
decision of Heckler v. Cheney in which some prisoners duly 
convicted of capital crimes in the States of Texas and Oklahoma 
sought to avoid the death penalty on grounds that the FDA had 
not approved any drugs as safe and effective for causing death. 
In upholding FDA's discretion not to intervene in this case--
which was decided without any dissenting opinions--then-Justice 
Rehnquist wrote:

          The fact that the drugs involved in this case are 
        ultimately to be used in imposing the death penalty 
        must not lead this Court or other courts to import 
        profound differences of opinion over the meaning of the 
        eighth amendment to the Constitution into the domain of 
        administrative law.

    In filing his concurrence, Justice Brennan noted:

          I adhere to my view that the death penalty is in all 
        circumstances cruel and unusual punishment under the 
        8th and 14th amendments * * *. My concurrence here 
        should not be misread as an expression of approval for 
        the use of lethal injections to effect capital 
        punishment as an independent matter. The Court is 
        correct, however, that ``profound differences of 
        opinion over the meaning of the 8th amendment'' should 
        not influence our consideration of a question purely of 
        statutory administrative law.

    The Committee notes that these Justices, while holding 
completely opposite views on capital punishment, nevertheless 
agreed that this Constitutional battle should not be fought out 
in administrative statutes and that is exactly what section 
3(b)(1)(B) of the bill makes clear.

                         H. Criminal Liability

    The Committee also wishes to acknowledge the concern 
expressed that health care providers may incur a new criminal 
liability under this bill. The Controlled Substances Act--like 
its cousin the Federal Food, Drug, and Cosmetic Act--contains 
in parallel a series potential criminal and civil sanctions. 
That is not changed in this bill.
    Both the DOJ and DEA have a degree of discretion and 
flexibility in relegating minor violations to civil penalties 
or even formal or informal warnings. For more serious 
violations involving knowing and intentional possession or 
distribution of controlled substances, the statute contemplates 
more severe penalties. In fact, section 401 of the Act 
specifies certain criminal penalties if certain amounts of 
certain types of drugs are involved.
    A major sanction in the bill against those facilitating 
suicides is revocation or denial of DEA registration. Although 
this sanction, no doubt a heavy tool, is civil in nature, it 
provides a strong incentive under the bill for health care 
personnel not to engage in the practice of assisting suicides. 
We are confident this formidable civil sanction of loss of a 
DEA registration number would act to limit the situations in 
which DEA and DOJ believed that these more rigorous, criminal 
penalties should be applied.

               I. Multiple Users of Single Registrations

    The Committee also wishes to address the concern raised by 
certain registrants, such as hospitals or pharmacies, that the 
action of one of their licensees (e.g., residents or 
pharmacists) could result in the revocation of the facility's 
registration. Currently, the Controlled Substances Act holds 
the registrant responsible for the action of its employees. 
That is, each pharmacist who might dispense, or each resident 
who might prescribe, is not registered by the DEA, only the 
pharmacy or hospital would be. The amendments to the Controlled 
Substances Act do not, and should not, change any 
accountability system that is working.
    We are aware that some have suggested exempting pharmacists 
or hospitals from this legislation. It is important to note 
that pharmacists and the hospital personnel who dispense and 
administer controlled substances are an important part of the 
healthcare team. Their extensive knowledge of drug actions and 
side effects adds another layer of patient protection from the 
potential catastrophic consequences of powerful prescribed 
medications. Arbitrarily reducing their responsibility by 
allowing them to look the other way, as some have suggested, 
could harm patients. Nevertheless, the Committee intends to 
monitor this situation closely and will take action should it 
find that the registration system hinders the ability of 
patients to receive adequate pain care from health care 
professionals.

                       J. Patient Confidentiality

    Finally, some physicians have suggested to the Committee 
that language be included to address confidentiality concerns 
with respect to any investigations DEA might undertake pursuant 
to this act. The Committee feels compelled to note that the 
Congress has already given the DEA investigative authority to 
enforce the Controlled Substances Act, and that authority 
already allows the agency to use colleague and patient 
interviews to investigate reported violations of the Controlled 
Substances Act. This bill authorizes no new actions which are 
intended to violate patient confidentiality.
    More importantly, the Committee has inserted a safeguard 
which should limit the number of cases in which confidentiality 
concerns could arise. The bill requires that before the DEA 
undertakes an investigation of a possible assisted suicide, the 
Attorney General must make a finding that the registrant 
prescribed, dispensed, or administered the specific controlled 
substance which was directly responsible for the death. This 
provision will assure that the DEA investigates legitimate 
concerns. Killing a person is a serious matter, and any deaths 
by other than natural causes must be taken seriously and 
investigated accordingly. Therefore, law enforcement personnel, 
including the DEA, must have the ability to conduct interviews 
as appropriate. Again, this bill does not change the agency's 
current authorities with respect to investigation of violations 
of the Controlled Substances Act.

                           VI. COST ESTIMATE

    In accordance with paragraph 11(a) of rule XXVI of the 
Standing Rules of the Senate and section 404 of the 
Congressional Budget Act of 1974, the committee provides the 
following cost estimate prepared by the Congressional Budget 
Office:

                                     U.S. Congress,
                               Congressional Budget Office,
                                   Washington, DC, October 2, 1998.
Hon. Orrin G. Hatch,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 2151, the Lethal 
Drug Abuse Prevention Act of 1998.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Mark 
Grabowicz (for Federal costs), Lisa Cash Driskill (for the 
state and local impact), and Matthew Eyles (for the private-
sector impact).
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

               congressional budget office cost estimate

S. 2151--Lethal Drug Abuse Prevention Act of 1998

    Summary: S. 2151 would make it a violation of the 
Controlled Substances Act of 1970 to distribute or dispense a 
controlled substance to assist in suicide or euthanasia. 
Persons who violate the bill's provisions could face revocation 
of their license to prescribe controlled substances. The 
legislation would direct the Secretary of Health and Human 
Services, in consultation with the Attorney General, to 
establish the Medical Advisory Board on Pain Relief to assist 
in resolving disputes over the dispensing of controlled 
substances in certain instances of assisted suicide or 
euthanasia.
    CBO estimates that implementing S. 2151 would not result in 
any significant cost to the federal government. Because 
enactment of S. 2151 could affect direct spending and receipts, 
pay-as-you-go procedures would apply to the bill; however, CBO 
estimates that the amounts involved would be less than $500,000 
a year.
    S. 2151 contains no intergovernmental mandates as defined 
in the Unfunded Mandates Reform Act (UMRA) and would have no 
impact on the budgets of State, local, or tribal governments. 
The bill would impose a new private-sector mandate as defined 
in UMRA, but the direct costs imposed by the mandate would fall 
well below the statutory threshold established in UMRA ($100 
million in 1996, adjusted annually for inflation).
    Estimated costs to the Federal Government: Enacting the 
bill would increase administrative costs of the Drug 
Enforcement Administration (DEA) and the Department of Health 
and Human Services in cases of assisted suicide or euthanasia 
that involve controlled substances. Under the bill's 
provisions, any such costs, including those relating to the 
Medical Advisory Board on Pain Relief, would be funded from 
user fees that are deposited into the diversion control fee 
account. Such outlays would constitute direct spending. CBO 
anticipates very few of these cases, however, so the amount of 
additional spending would be negligible.
    If an individual's license to dispense controlled 
substances is revoked, the DEA could seize any such substances 
in his or her possession. Thus, enacting S. 2151 could lead to 
the seizure of more assets and their forfeiture to the United 
States, but we estimate that any such increase would be less 
than $500,000 annually in value. Proceeds from the sale of any 
such assets would be deposited as revenues into the assets 
forfeiture fund of the Department of Justice and spent from 
that fund in the same year. Thus, the change in direct spending 
from the assets forfeiture fund would match any increase in 
revenues to that fund.
    Pay-as-you-go considerations: The Balanced Budget and 
Emergency Deficit Control Act sets up pay-as-you-go procedures 
for legislation affecting direct spending or receipts. Enacting 
S. 2151 could affect both direct spending and receipts, but CBO 
estimates that any such effects would be less than $500,000 a 
year.
    Estimated impact on State, local, and tribal governments: 
S. 2151 contains no intergovernmental mandates as defined in 
UMRA and would have no impact on the budgets of state, local, 
or tribal governments. Although Oregon citizens voted to 
legalize doctor-assisted suicide for terminally ill patients, 
S. 2151 would not preempt that law. It would, however, make it 
legal for doctors to assist in suicide or euthanasia using 
drugs governed by the federal Controlled Substances Act.
    Estimated impact on the private sector: S. 2151 would 
impose a new private-sector mandate, as defined in UMRA. The 
bill would prohibit medical practitioners from intentionally 
dispensing or prescribing controlled substances for the purpose 
of assisting the suicide or euthanasia of an individual.
    Under current law, medical practitioners who are licensed 
by state medical boards must also register with the Attorney 
General through the DEA if they intend to dispense or prescribe 
controlled substances. Practitioners may now lose their federal 
registration to dispense those substances if the Attorney 
General, after considering specific factors, determines that 
the registration would not be in the public interest. 
Intentionally dispensing or prescribing controlled substances 
to assist or facilitate a suicide or euthanasia is not included 
in that list of factors, but under the provisions of S. 2151, 
it would be grounds for suspending or revoking a practitioner's 
federal license. In addition, controlled substances possessed 
by practitioners whose licenses have been revoked or suspended 
based on the bill's provisions would be subject to government 
seizure.
    CBO estimates that the direct costs of the mandate on 
federally registered practitioners would fall well below the 
statutory threshold in UMRA. In all states except Oregon, 
medical practitioners may not legally assist in the suicide or 
euthanasia of an individual. Moreover, one recent study 
indicates that only a small percentage of physicians who 
provide care for dying patients--about 6 percent--have actively 
helped patients die. Thus, the number of medical practitioners 
potentially affected by the prohibition would be small.
    Estimate prepared by: Federal Costs: Mark Grabowicz; Impact 
on State, Local and Tribal Governments: Lisa Cash Driskill; 
Impact on the Private Sector: Matthew Eyles.
    Estimate approved by: Robert A. Sunshine, Deputy Assistant 
Director for Budget Analysis.

                    VII. REGULATORY IMPACT STATEMENT

    In compliance with paragraph 11(b)(1), rule XXVI of the 
Standing Rules of the Senate, the Committee, after due 
consideration, concludes that S. 1301 will not have significant 
regulatory impact.

                       VIII. ADMINISTRATION VIEWS

                        U.S. Department of Justice,
                             Office of Legislative Affairs,
                                     Washington, DC, July 30, 1998.
Hon. Orrin G. Hatch,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
    Dear Mr. Chairman: As the Committee prepares to consider S. 
2151, the ``Lethal Drug Abuse Prevention Act of 1998,'' we 
write to provide the views of the Department of Justice on the 
bill. We look forward to working with you on this legislation.
    The President is opposed to assisted suicide and any 
Federal support for it. As such, he is open to working with you 
and other interested Members of Congress on this complex but 
extremely important issue. Having said this, the Administration 
believes that S. 2151 represents a flawed approach to the 
sensitive area of Federal regulation of medicine. We are fully 
cognizant of the general authority of the Drug Enforcement 
Administration (DEA) to regulate physicians' activities that 
facilitate the abuse or diversion of controlled substances. 
However, we are concerned that the insertion of the DEA into 
the role of overseer of the practice of medicine in the unique 
circumstances of suffering, terminally ill patients would 
inevitably divert agency attention away from the core mission 
of strictly controlling Schedule I drugs and preventing the 
abuse, diversion of and trafficking in all scheduled drugs.
    Determination of whether a practitioner's conduct which 
results in a patient's death--either in a specific instance or 
in general--is ``an appropriate means to relieve pain'' is far 
afield from the DEA's role, as envisaged by Congress and as 
carried out by the agency, under the original legislative 
rubric of the Controlled Substances Act (CSA). The medical, 
scientific, ethical, and related aspects of the practice of 
medicine at the end of life would involve DEA in issues in 
which it has no particular expertise. The use of a peer review 
board of pain management experts would lend needed consultation 
on the merits of any case, but the very necessity for such a 
board is evidence of the poor fit between the task DEA is being 
asked to undertake and its central expertise. Moreover, as 
noted below, the board's insertion in the context of a 
contested administrative proceeding could well complicate 
rather than elucidate matters surroundingphysician-assisted 
suicide.
    In addition to the above-noted concerns, the proposed 
revision in the Controlled Substances Act through S. 2151 would 
not necessarily accomplish the intended effect of banning all 
assisted suicides, as there are several plausible means of 
assisted suicide or euthanasia that do not involve the use of 
controlled substances. Typically, a controlled substance is 
used as a sedative; a non-controlled substance is used to 
actually bring about death. Thus, the CSA offers at best only a 
partial fix. If amendments to the CSA force physicians to use 
non-controlled substances to assist a patient to hasten as 
desired death, a procedure that would not explicitly be banned 
by the CSA, it will not save lives, but merely will increase 
the amount of pain suffered by those taking their lives.
    The limitations of this proposed ban on assisted suicide 
are apparent by examining the plausible scenario of a patient 
who has legally obtained a controlled substance from a 
physician for palliative purposes without disclosing an intent 
to commit suicide. Once that patient has decided to end his or 
her own life, they would need only to employ the services of a 
second physician, who would agree to assist in the suicide so 
long as the patient agrees to self medicate. As long as the 
second physician does not ``dispense of distribute'' a 
controlled substance, it is difficult to imagine how they could 
be subject to a revocation action under the proposed changes to 
the CSA. Moreover if the bill were modified broadly to reach 
those who merely assist in a suicide, including by providing 
their patients with truthful information, it would likely 
invite serious constitutional challenges.
    In addition to the foregoing concerns, the proposed bill 
raises several technical concerns. First, Sec. 3(a) would amend 
21 U.S.C. Sec. 823 to require denial of registration, as 
inconsistent with the pubic interest, of any application for 
registration that had either been revoked within the preceding 
five years under Sec. 824(a)(4) or for which there is ``clear 
and convincing evidence'' that it is sought ``with the 
intention of using the registration'' to assist a suicide or 
commit euthanasia. This latter provision may be unworkable. We 
are concerned that it is not practical to determine in advance 
an applicant's ``intent'' as to how he/she will use a 
registration; much less can this be determined by clear and 
convincing evidence. Certainly, few if any applicants will seek 
the controlled registration with assisted suicide as a primary 
intended use; even fewer would admit as much on an application. 
For most physicians, whether they use controlled substances for 
this purpose will depend on the circumstances, which cannot be 
foreseen in advance.
    There is an apparent inconsistency between Sec. 3(a) 
stating a new basis for action against a practitioner's 
registration under Sec. 824(a)(4), and Sec. 3(c), setting forth 
the responsibility of the new ``Medical Review Board on Pain 
Relief'' to issue an option under new Sec. 824(c)(3)(C)(i). 
Under the latter, the Board would review, for appropriateness 
as a means to relieve pain, ``any potential action'' (as 
opposed to ``intended'' action) by an applicant. Review of 
``potential'' action to even more speculative than ``intended'' 
action. Moreover, this section does not mention the clear and 
convincing evidence standard; it is not clear whether a 
different level of proof is intended.
    The new Board would afford a peer review process to any 
practitioner aggrieved by a show cause order under 21 U.S.C. 
Sec. 824(c) proposing to take adverse action against a 
practitioner's registration in light of physician-assisted 
suicide. This provision would for the first time inject a 
regulatory peer review process into the quasi-judicial 
administrative discipline process. The Board's opinion would be 
``admissible'' in any show cause hearing, but would it be 
binding in effect? If the DEA went against the Board's 
decision, either in favor of or against the physician, what 
would be the likely result on appeal? We think this Board--
undoubtedly a well-intended innovation designed to give the 
physician a fair hearing--unnecessarily creates a myriad of 
different issues.
    Finally, in Sec. 4, the language includes a statement that 
the amendment does not imply that the dispensing of a 
controlled substance before the date of enactment was not a 
violation of the CSA. In light of the Attorney General's letter 
of June 5, 1998, to you, concluding that ``adverse action 
against a physician who has assisted in a suicide in full 
compliance with the Oregon Act would not be authorized by the 
CSA,'' we recommend a neutral construction regarding the effect 
of this amendment (e.g., ``Nothing in this Act or the 
amendments made by this Act shall be construed to express an 
opinion as to whether the dispensing or distribution of a 
controlled substance before the date of enactment of this Act * 
* *'').
    Thank you for this opportunity to provide our views on this 
important matter. The Office of Management and Budget has 
advised that there is not objection from the standpoint of the 
Administration's program to the presentation of this report.
            Sincerely,
                                          L. Anthony Sutin,
                                 Acting Assistant Attorney General.
                                ------                                

                        U.S. Department of Justice,
                             Office of Legislative Affairs,
                                Washington, DC, September 16, 1998.
Hon. Orrin G. Hatch,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
    Dear Mr. Chairman: We responding to your letter of 
September 9, 1998, to Mr. Joseph Onek, Principal Deputy 
Associate Attorney General, regarding S. 2151, the ``Lethal 
Drug Abuse Prevention Act of 1998.'' We regret the delay in 
responding.
    The President is committed to working with you, Senator 
Leahy, and Members on and off the Judiciary Committee to help 
develop approaches to curtail assisted suicide. As you know, 
this position is consistent with his longstanding opposition to 
assisted suicide and his support for the Assisted Suicide 
Funding Restriction Act last year. As such, he has requested 
that the Justice Department and the Department of Health and 
Human Services work collaboratively with you and other Members 
of Congress on this issue.
    The President, however, is concerned that S.2151 will have 
unintended adverse consequences, which cannot adequately be 
remedied in the limited time remaining in this Congress. The 
negative impact S.2151 could have on the provision of pain 
relief medications for our nation's terminally ill is of 
particular concern to the Administration, as it is to virtually 
every major medical organization in the nation. These 
organizations share the President's abhorrence and opposition 
to assisted suicide, but, with very few exceptions, oppose the 
Lethal Drug Abuse Prevention Act.
    There is broad consensus that the American medical system 
does a poor job of providing palliative care to terminally ill 
patients and, in particular, that it fails to provide effective 
pain management. As a result, many patients unnecessarily 
suffer excruciating pain and some patients--in pain or fearing 
future pain--seriously consider suicide (physician assisted or 
otherwise).
    Health care experts in this field strongly believe that S. 
2151 exacerbates this problem. The legislation authorizes the 
DEA to impose serious civil penalties against physicians who 
dispense controlled substances to assist a patient suicide. The 
legislation may also authorize the imposition of criminal 
penalties on such physicians. Virtually all potent pain 
medications are controlled substances. Thus, physicians who 
dispense these medications to ease the pain of terminally ill 
patients could well fear that they could be the subject of a 
DEA investigation whenever a patient's death can be linked to 
the use of a controlled substance.
    The Lethal Drug Abuse Prevention Act is designed to address 
physicians' fears by prohibiting sanctions as long as 
physicians do not dispense the controlled substance with the 
intent of causing death. However, the issue of intent would not 
necessarily be resolved simply by asking physicians about their 
intent. To establish intent, the DEA might also need to 
investigate the details of the physician's prescribing 
practices and of the physician's relationships with the patient 
and the patient's family.
    It is precisely the fear of a DEA investigation that 
creates the potential to inhibit physicians from providing 
adequate paid medication to terminally ill patients. In 
response, physicians may under-medicate patients, patients may 
suffer unnecessary pain and, as a result of increased incidence 
of great pain amongst the terminally ill, patient suicides--
physician assisted or not--may increase. Such an outcome would 
be far more than ironic; it would be tragic. Understanding 
this, the American Medical Association, the American Nurses 
Association, the National Hospice Organization and many other 
respected national health organizations strongly oppose S. 
2151.
    We believe that the better way to avoid assisted suicides 
is to develop consensus guidelines on the appropriate use of 
controlled substances for terminally ill patients. Such 
guidelines would be designed to be sufficiently clear that a 
physician who followed them would be free from any fear of 
sanctions. The board charged with developing these guidelines 
would have representatives of doctors, nurses, consumers, 
theologians, ethicists, and law enforcement officials and would 
report back to the Congress and the Administration in a 
specified period of time. The board also could provide 
recommendations on the most appropriate entity to enforce these 
guidelines, as well as the authority and responsibility such an 
entity should have.
    Clearly, any board charged with developing guidelines for 
this area should be carefully chosen. If we pursued this 
approach, we would want to determine a mutually acceptable 
appointment process. If you find this advisory board concept 
acceptable, which would be one way of coming closer to a 
consensus approach, we would be pleased to work with you to 
establish--through legislation or, if legal and appropriate, by 
Executive Action--any such entity.
    The Administration believes that working together we can 
develop an appropriate way to address this important issue. We 
look forward to working with you in the future. The Office of 
Management and Budget has advised that there is not objection 
from the standpoint of the Administration's program to the 
presentation of this report. If we may be of additional 
assistance, we trust that you will not hesitate to call upon 
us.
            Sincerely,
                                          L. Anthony Sutin,
                                 Acting Assistant Attorney General.

             IX. ADDITIONAL VIEWS OF SENATOR ORRIN G. HATCH

    I join with my colleagues in condemning the practice of 
assisted suicide. To me, assisted suicide is morally and 
ethically reprehensible, an abhorrent practice which our 
society can ill-afford to see as a viable alternative to 
compassionate care and treatment. Indeed, the Congress spoke 
out overwhelmingly on this issue last year, when we passed the 
Assisted Suicide Funding Restriction Act by a vote of 99-0. I 
see S. 2151 as a logical extension of that vote. It is a 
measure that is fully consistent with that great teaching of 
the Hippocratic Oath: ``First do no harm,'' which is a central 
tenet of Western medicine.
    I am keenly aware that some in the medical community have 
expressed opposition to this legislation because they believe 
that it will discourage practitioners from the legitimate use 
of pain medication. In considering this legislation, I have 
consulted with a number of health care experts from Utah, 
including Dr. Sharon M. Weinstein, the new Director of 
Palliative Care for the renowned Huntsman Cancer Center at the 
University of Utah, Dr. Joseph Simone, from the Huntsman 
Center, Dr. Michael Ashburn, Director of the University of 
Utah's Pain Management Clinic, and Dr. Allan Nelson, 
representing Intermountain Health Care in Salt Lake.
    These eminent experts in palliative care have voiced the 
concerns about the unintended negative effects of this 
legislation on treatment of patients, and I am very sympathetic 
to their arguments. Both as Chairman of this Committee, and as 
a representative from the State of Utah, I have worked 
diligently to accommodate those who expressed those concerns.
    We have changed the bill significantly to address those 
fears and strengthen the safeguards against unwarranted 
actions. First, we have clarified that prior to commencing any 
investigation of a suspected assisted suicide, the Attorney 
General must make a finding that the registrant dispensed or 
distributed a specific controlled substance which was directly 
responsible for the death of an individual. Second, before any 
investigation, the Attorney General must find that the 
registrant did not dispense or distribute the specific 
controlled substance as medically indicated consistent with 
this Act. Third, we have included the House-reported language 
which places the burden on the Attorney General in actions to 
revoke, deny or suspend a registration because of suspected 
suicide to prove (by a clear and convincing evidence standard) 
that the registrant intended to assist a suicide. Fourth, the 
bill, along with last year's Assisted Suicide Funding 
Restriction Act (which called upon the Department of Health and 
Human Services to make educational grants improving end-of-life 
care) will make clear the congressional intent to improve pain 
care while preventing assisted suicide. In addition, in 
response to concerns raised by the medical community and the 
Administration, we have added language bringing HHS more into 
the process.
    I am aware this language does not completely satisfy those 
who oppose this bill. As this bill moves to the floor, I pledge 
to continue to work with medical experts to address their fears 
about this legislation, if any of these medical groups choose 
to do so. In fact, as I have publicly stated, I will go one 
step further. As Chairman of this Committee, I pledge that when 
this bill is enacted, as I believe it will be, if the DEA takes 
any actions which threaten the use of pain medication for 
legitimate medical purposes, I will work with the medical 
community to remedy those problems, whatever they may be.
    While I do sympathize with those who genuinely fear an 
unintended consequence from this legislation, I am hopeful they 
will read the revised draft with an open mind, in full 
cognizance of Drug Enforcement Administration's abundant 
current-law authority to regulate controlled substances. My 
ultimate concern is twofold: that we not incrementally, state-
by-state, embark down a path to undercut the powerful tools of 
the Controlled Substances Act to prevent drug diversion; and 
that we continue to recognize at a Federal level that assisted 
suicide is wrong.
    In closing, it is important to note that there are many 
other steps to prevent practitioner-assisted suicide. The 
Secretary of Health and Human Services should expeditiously 
move forward with the suicide prevention provisions in the 
bipartisan Suicide Funding Restriction Act of 1997. That Act 
authorizes the Secretary to fund research projects and training 
programs intended to reduce the rate of suicide including 
assisted suicide. Furthermore, the same legislation authorizes 
the Secretary to fund demonstration projects to reduce 
restrictions to hospice care.
    As an additional measure, the Secretary should be 
authorized to require as a condition of participation in 
Medicare that facilities, physician groups and health 
maintenance organizations measure the quality of end-of-life 
palliative care and take steps to remedy problems which are 
found, including poor use of pain medications by practitioners. 
Finally, the Secretary in cooperation with the Attorney General 
should determine whether alleged reduction in hospice 
enrollment resulting from efforts to reduce fraud and abuse in 
Medicare has adversely affected end-of-life palliative care.
    I look forward to working with my colleagues--both those 
who have supported S. 2151, and those who have opposed it--to 
address the myriad pain care and end-of-life issues in a 
comprehensive manner. Those steps, however, do not negate the 
need to address the Controlled Substances Act clarification in 
separate legislation which should move forward expeditiously.

                                                    Orrin G. Hatch.

                           X. MINORITY VIEWS

                              introduction

    As noted by Andrew I. Batavia, Special Assistant to 
Attorney General Dick Thornburgh during the Bush 
Administration, at the Senate Judiciary Committee hearing on S. 
2151, ``[t]he Lethal Drug Abuse Prevention Act:''

          I am a Republican, because I believe the Republican 
        Party is the party of principles. It is because I 
        believe in the principles of the Republican Party that 
        I strongly oppose this legislation. The Lethal Drug 
        Abuse Prevention Act is legislation that, in my view, 
        violates basic Republican principles of federalism, 
        sound legislation, regulatory restraint and 
        fairness.\1\
---------------------------------------------------------------------------
    \1\ Andrew I. Batavia, Testimony Before the Senate Judiciary 
Committee, July 31, 1998, at 93, lines 10-16.

    We, along with more than 50 national health organizations 
(most of which strongly oppose physician-assisted suicide), 
share the view of Mr. Batavia. Although we, like the majority, 
are troubled by physician-assisted suicide, we see this bill as 
an unnecessary encroachment on State medical boards' 
traditional regulatory role which may ultimately cause 
thousands of terminally ill patients to suffer needlessly and 
could lead to an increase in the number of assisted suicides.
The States are effectively dealing with the issue of physician-assisted 
        suicide
    S. 2151 is a serious violation of the basic tenets of 
federalism. Medical practice has always been regulated by the 
States under their traditional police powers; physician-
assisted suicide is no different. Currently, physician-assisted 
suicide is illegal in 45 States (36 by statute; nine under 
common law).\2\ In one State, Oregon, the citizens approved by 
referendum ``[t]he Death with Dignity Act,'' which provides for 
physician-assisted suicide under very limited and highly 
regulated circumstances.\3\ Moreover, at least 20 States have 
established commissions or task forces to examine end-of-life 
care issues, including physician-assisted suicide.\4\ Clearly, 
the States have made a concerted effort to address this issue 
intelligently and thoroughly. This Federal bill will not 
enhance the regulation of physician-assisted suicide. On the 
contrary, S. 2151 is at best superfluous and at worst, 
extremely harmful to the States' ongoing efforts in this area.
---------------------------------------------------------------------------
    \2\ Merrit, Dick; Fox-Grage, Wendy; and Rothouse, Marla of the 
National Conference of State Legislatures, and Lynn, Joanne; Cohn, 
Felicia; and Forlini, Janet Heald of the Center to Improve the Care of 
the Dying, The George Washington University, ``State Initiatives in 
End-of-Life Care: Policy Guide for State Legislators, National 
Conference of State Legislatures,'' at 40 (1998) (the ``End-of-Life 
Care: Policy Guide''). The four States which do not have a criminal 
statute or common law banning physician-assisted suicide are North 
Carolina, Ohio, Utah and Wyoming.
    \3\ Or. Rev. Stat. Sec. Sec. 127.800-127.995.
    \4\ End-of-Life Care: Policy Guide at 3.
---------------------------------------------------------------------------
    Although the majority argues that this bill is designed to 
mend a ``50-state, crazy quilt approach to the regulation of 
controlled substances,'' \5\ it is readily apparent that S. 
2151 was drafted and is being moved forward not in an effort to 
deal with controlled substances, but rather in a direct attempt 
to starkly limit the scope of the Oregon referendum and 
physician-assisted suicide in that State. Indeed, the majority 
points to the Oregon referendum, two recent Supreme Court cases 
on assisted-suicide, Vacco v. Quill \6\ and Washington v. 
Glucksberg,\7\ and the Presidential signature of the ``Assisted 
Suicide Prevention Act'' \8\ as key events precipitating the 
introduction of this bill.\9\ In fact, these two Supreme Court 
rulings held that the States, not the Federal Government, 
should determine how best to address the issue of physician-
assisted suicide, and the Assisted Suicide Prevention Act did 
not address this issue in outlawing the use of Federal funds 
for the practice of physician-assisted suicide.
---------------------------------------------------------------------------
    \5\ Majority Views at 32.
    \6\ 117 S. Ct. 2293 (1997).
    \7\ 117 S. Ct. 2258 (1997).
    \8\ P.L. 105-12.
    \9\ Majority Views at 32.
---------------------------------------------------------------------------
    S. 2151's efforts to usurp the rights of Oregon's citizens' 
to deal with the issue of physician-assisted suicide on a State 
level is indefensible. It is certainly ironic that the 
majority, which promotes itself as the party of State's rights, 
would choose to overrule a State law when it contradicts 
national Republican policy.

S. 2151 will have a chilling effect on palliative care and may increase 
        the demand for physician-assisted suicide

    Unrelieved pain is a public health crisis in the United 
States. Fifty percent of patients experience moderate to severe 
pain at least half the time in their last days of life.\10\ A 
study of 13,625 elderly patients living in Medicare/Medicaid 
certified nursing homes found that 26 percent of residents with 
daily pain received no medication for pain.\11\ This study also 
found that pain is most prevalent among nursing home residents 
with cancer; that pain is often left untreated, especially in 
African-Americans and older patients.\12\
---------------------------------------------------------------------------
    \10\ ``The Study to Understand Prognoses and Preferences for 
Outcomes and Risks of Treatment,'' The Journal of the American Medical 
Association, Vol. 274, 1591-98 (1995).
    \11\ Bernabie, R. et al., ``Pain Management in Elderly Patients 
with Cancer,'' The Journal of the American Medical Association, Vol. 
279, 1877-1882 (1998).
    \12\ Id.
---------------------------------------------------------------------------
    This bill will result in a step backwards in the treatment 
of pain; physicians will be hesitant to prescribe and 
pharmacists will be hesitant to dispense sufficient and 
appropriate doses of controlled substances due to a fear of 
unjust and unwarranted investigations and possible revocations 
of their Federal registrations. Indeed, physicians will have 
good reason to be troubled, because under S. 2151, the 
investigations will not be conducted by the State medical 
review boards which, since the passage of the Controlled 
Substances Act, have managed the responsibility of overseeing 
appropriate pain management. Instead, the investigations will 
be carried out by the Drug Enforcement Administration (the 
``DEA'') which, as noted by Principal Deputy Attorney General 
Joseph N. Onek, would ``embroil the DEA in decisions about the 
use of pain medication for terminally ill patients which it is 
poorly equipped to make.'' \13\
---------------------------------------------------------------------------
    \13\ Joseph N. Onek, Testimony Before the Senate Judiciary 
Committee, July 31, 1998, at 28, lines 15-17.
---------------------------------------------------------------------------
    A nationwide study of cancer physicians demonstrated a 
``reluctance to prescribe'' opioids due to concern about 
``excessive regulations'' which were viewed as barriers to 
effective cancer pain management.\14\ In addition, 71 percent 
of physicians surveyed in New York State reported that they do 
not prescribe effective medication for cancer pain, if such 
prescriptions require them to use a special State monitored 
prescription form for controlled substances even when the 
medication is legal and medically indicated for the 
patient.\15\ And in California, 69 percent of physicians 
surveyed stated that the risk of disciplinary action made them 
more reluctant to use opioids in pain management with one-third 
reporting that their patients may be suffering from neglected, 
treatable pain.\16\ We do not believe that doctors' and 
pharmacists' ability to request a hearing with the proposed 
Medical Advisory Board on Pain Management would adequately 
resolve their concerns and counteract this potential chilling 
effect. This is especially true because these medical 
practitioners can only request a hearing with the Board, which 
merely issues an advisory opinion, after any such investigation 
has begun.
---------------------------------------------------------------------------
    \14\ Von Roenn, J; Cleeland, C.S., et al., ``Results of Physicians' 
Attitudes toward Cancer Pain Management Survey,'' Proceedings of the 
American Society of Clinical Oncology, Vol 10, 326 (1991).
    \15\ New York State Public Health Council, Report to the 
Commissioner of Health, Breaking Down the Barriers to Effective Pain 
Management: Recommendations to Improve the Assessment and Treatment of 
Pain in New York State, January, 1998.
    \16\ Skelly, F.J., ``Fear of Sanctions Limits Prescribing of Pain 
Drugs,'' American Medical News, 19 (August 15, 1994).
---------------------------------------------------------------------------
    In the end, S. 2151 will not stop physician-assisted 
suicide. A physician could easily circumvent this law and still 
assist a suicide by prescribing a non-controlled substance, an 
over-the-counter drug, or common chemicals such as carbon 
monoxide or potassium (which Jack Kevorkian uses). Rather, the 
bill may have the perverse effect of increasing the demand for 
assisted suicide. As S. 2151 reduces the number of physicians 
who are willing to prescribe the most effective pain relieving 
medications (controlled substances such as narcotics and opioid 
analgesics), the number of patients who are forced to suffer 
will increase. These same patients, unable to handle the 
severity of their pain, will more likely turn to assisted 
suicide; the ultimate consequence we all want to protect 
against.
    We recognize that the issue of physician-assisted suicide 
is a difficult moral, ethical, and legal question that our 
society must confront. We believe, however, that this matter is 
best left to the States which have demonstrated that they can 
effectively and comprehensively address this issue. When the 
Federal Government prematurely supplants its views for those of 
the States, as the majority attempts to do with S. 2151, there 
is a definite chance of unintended consequences. The unintended 
consequences in this case are that palliative care will be 
diminished and patients will suffer needlessly. In addition, 
the bill may even lead to an increase in assisted suicides. 
Moreover, S. 2151 is likely to be wholly ineffective in 
curtailing physician-assisted suicides. We see no reason to 
accept these negative repercussions when the bill will deliver 
little to no positive results.

The established medical community strongly opposes the Hatch substitute 
        to S. 2151

    Over 50 national and State-based organizations, most of 
which oppose the practice of physician-assisted suicide, oppose 
the revised S. 2151 because of concerns related to pain 
management and the negative effect it will have on palliative 
care. Other concerns raised by these groups include the bill's 
override of the role of State medical licensure boards and 
interference with the goals of hospice and comfort care; the 
DEA's expanded role in determining the necessary and reasonable 
use of drugs; and the potentially onerous DEA investigatory 
process. We ask that a complete list of these organizations be 
included in this report.

                  Coalition To Improve Pain Management


                             pain patients


    American Chronic Pain Association
    American Pain Foundation
    American Society for Action on Pain
    National Foundation for the Treatment of Pain
    Pain Relief 2000
    Reflex Sympathetic Dystrophy Syndrome Association of 
America
    Triumph Over Pain Foundation


                               physicians


    American Academy of Pain Medicine
    American Academy of Family Physicians
    American Association for Geriatric Psychiatry
    American College of Physicians-American Society of Internal 
Medicine
    American Geriatrics Society
    American Medical Association
    American Medical Directors Association
    American Society of Anesthesiologists
    American Association for the Study of Headache
    Society of Critical Care Medicine


                                 nurses


    American Nurses Association
    American Society of Pain Management Nurses
    Hospice and Palliative Nurses Association
    Oncology Nursing Society


                              pharmacists


    Academy of Managed Care Pharmacy
    American Association of Colleges of Pharmacy
    American College of Clinical Pharmacy
    American Pharmaceutical Association
    American Society of Consultant Pharmacists
    American Society of Health-System Pharmacists


                                 cancer


    American Alliance of Cancer Pain Initiatives
    American Cancer Society
    American Society of Clinical Oncology
    Cancer Care, Inc.
    Leukemia Society of America
    National Alliance of Breast Cancer Organizations
    National Coalition for Cancer Survivorship
    Susan G. Komen Breast Cancer Foundation
    US TOO Prostate Cancer Organization
    Y-ME National Breast Cancer Organization


                      hospice and end-of-life care


    American Academy of Hospice & Palliative Medicine
    Americans for Better Care of the Dying
    Choice in Dying
    Delaware Hospice and Palliative Care Organization
    National Hospice Organization
    New Jersey Hospice and Palliative Care Organization
    Oregon Hospice Association


                         related organizations


    AIDS Action
    American Academy of Pain Management
    American Pain Society
    Deleware Association for Home & Community Care
    Delaware Ecumenical Council on Children and Families
    Federation of State Medical Boards
    National Health Council
    National PACE Association
    Pain Care Coalition

    While the Coalition to Improve Pain Management appreciates 
the effort of Senate Judiciary Committee Chairman Orrin Hatch 
and staff to attempt to improve S. 2151, the ``Lethal Drug 
Abuse Preventive Act'', we cannot support the Substitute. This 
broad group of health care organizations is firmly opposed to 
the Hatch Substitute Amendment, which was passed by the Senate 
Judiciary Committee on September 24, because it would have a 
devastating impact on the legitimate treatment of pain and 
symptoms at the end of life.
    Despite changes to the original bill, the Substitute does 
not address the serious concerns raised by the more than 50 
groups representing millions of patients in severe intractable 
pain and virtually every aspect of the American health care 
system--physicians, pharmacists, hospices, nurses and pain 
specialists--that provides care for dying people and other pain 
sufferers.
    Specifically, while the Hatch Substitute made minor changes 
to the procedural aspects of the bill, it retained the major 
objectionable provisions of S. 2151. The Substitute Amendment 
does not address the underlying concerns about DEA 
investigations, the triggers for those investigations, and 
numerous other problems with the original bill. The Substitute 
Amendment would: (1) result in more Americans in pain because 
fear of DEA investigations mandated by this bill will deter 
physicians from prescribing and pharmacists from dispensing 
pain medicines, and (2) increase the demand for suicide by 
making access to adequate pain care more difficult--severe and 
chronic pain is a leading cause of suicide.
    End-of-life care, physician-assisted suicide and improved 
pain management are too complex to address in a bill written in 
the last days of a congressional session. Such a bill will have 
lasting and severe consequences.
    These Organizations oppose the Hatch Substitute Amendment 
to S. 2151. Please vote no!

               S. 2151 Is Being Rushed Through the Senate

    We are gravely concerned that this legislation, which will 
have a significant impact on medical practices and end-of-life 
care across the nation, is being rushed through the Senate. 
Senator Nickles introduced S. 2151, the ``Lethal Drug Abuse 
Prevention Act'' on June 9, 1998. A hearing was held on July 
31, 1998, the last day before the Senate began its August 
recess.
    At the executive mark up of S. 2151, on September 24, 1998, 
after significant debate, several Senators, including Senators 
Leahy, Biden, Torricelli and Thompson, asked the Chairman to 
delay a vote on the bill for at least one more week so they 
could have additional time to review the Chairman's substitute 
language which had been circulated the day before. Instead of 
delaying the vote on this bill, the Committee proceeded to pass 
the bill by an 11-6 vote. We are especially concerned that 
Senators have had very little time to discuss the ramifications 
of the revised S. 2151, including the fact that no hearings 
have yet been held on this version of the bill. We are also 
concerned that this revised legislation is still opposed by 
over 50 national and State-based medical and hospice 
organizations. These organizations include the American Medical 
Association, the American Nurses Association, American 
Association of Colleges of Pharmacy, American Cancer Society 
and the American Academy of Hospice and Palliative Care. We 
intend to ensure that Senators, both on and off the Committee, 
have adequate time to investigate fully the ramifications of 
this legislation before being asked to vote on it in the full 
Senate. As the Coalition to Improve Pain Management has noted: 
``End-of-life care, physician-assisted suicide and improved 
pain management are too complex to address in a bill written in 
the last days of a congressional session. Such a bill will have 
lasting and severe consequences.''

 correspondence between the judiciary committee and the administration

    In July 1997, and again in October 1997, Senator Hatch and 
Representative Hyde, writing on behalf of the Senate and House 
Judiciary Committees, asked the Administrator of the DEA, 
Thomas Constantine, whether the prescribing or dispensing of a 
controlled substance with the ``deliberate intent of assisting 
a suicide'' would violate the Controlled Substances Act (CSA).
    In a letter dated November 5, 1997, Mr. Constantine 
responded that the ``delivering, dispensing or prescribing [of] 
a controlled substance with the intent of assisting a suicide 
would not fall under any current definition a `legitimate 
medical purpose.' ''
    On June 5, 1998, Attorney General Reno issued a letter on 
the Oregon referendum. The statement rejected the DEA position, 
as expressed in its November 1997 letter, by concluding that a 
physician or pharmacist, who assisted with a suicide in full 
compliance with the Oregon referendum, was not in violation of 
the CSA. Attorney General Reno reasoned that Congress, in the 
CSA, did not intend 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 absence of a federal law prohibiting that 
practice.'' Attorney General Reno also reiterated that the 
President continues to oppose assisted suicide and Federal 
support for it.
    If enacted, this bill would override the Department of 
Justice's position on this issue, and for the first time, 
empower the DEA to regulate and investigate doctors and 
pharmacists directly regarding their use of controlled 
substances for the purposes of pain relief.

  this bill is a direct affront to states' well established power to 
                       regulate medical practices

    The majority claims that S. 2151 will not usurp the police 
power of the States to regulate medical practices, and that it 
is not designed to negate Oregon's Death With Dignity Act. It 
is clear, however, that these are precisely the two things the 
bill will accomplish.
    Although the DEA has the authority to regulate how doctors 
and pharmacists use and dispense controlled substances, this 
regulatory power does not appear to include the ability to 
directly investigate doctors and pharmacists who have allegedly 
engaged in physician-assisted suicide. In the Attorney 
General's letter of June 5, 1998, the Department of Justice 
clearly limited its views to the situation in Oregon. By 
indicating that the DEA could not investigate doctors in 
Oregon, where physician-assisted suicide is permissible under 
certain limited circumstances, we do not believe the Department 
meant to imply that the DEA could investigate in other States. 
In our opinion, this letter did not resolve this issue. The 
States have traditionally regulated medical practice and all 50 
States have their own medical review boards which are the 
proper forum to investigate such matters.
    This bill would add an unnecessary new layer of review of 
medical and pharmacy practice regarding pain management by 
providing the DEA with the power to investigate doctors and 
pharmacists independent from any State criminal or medical 
board proceedings. In our view, not only should the DEA not 
have an independent investigatory power into allegations of the 
misuse of pain management drugs, it is also a power the DEA 
cannot handle. When asked during a Committee hearing whether 
the DEA can discern between an appropriate dosage of drugs and 
one intended to kill, DEA Administrator Constantine testified 
that:

          [T]hose types of evidentiary bases that you would 
        have to use would have to come from somebody in the 
        medical community * * *. So you really would need an 
        expert medical opinion to be able to say that the 
        administration of that level and amount of drugs to 
        that individual caused the death.\17\
---------------------------------------------------------------------------
    \17\ Testimony of Mr. Thomas Constantine before the Senate 
Committee on the Judiciary, July 31, 1998 at p. 55, lines 5-13.

    Moreover, the Principal Deputy Associate Attorney General, 
---------------------------------------------------------------------------
Joseph N. Onek testified that:

          [T]his legislation will embroil the DEA in decisions 
        about the use of pain medication for terminally ill 
        patients which it is poorly equipped to make. Indeed, 
        the legislation's call for a rather anomalous new pain 
        relief board underscores the DEA's relative lack of 
        expertise in this area.\18\

    \18\ Testimony of Mr. Joseph Onek before the Senate Committee on 
the Judiciary, July 31, 1998 at p. 28, lines 14-19.

    The Supreme Court has also suggested that the issue of 
physician-assisted suicide should be left to the States. In two 
decisions cited by the majority, Vacco v. Quill \19\ and 
Washington v. Glucksberg,\20\ the Court upheld State laws on 
assisted suicide and declined to federalize the issue by 
recognizing a fundamental right to assisted suicide. Justice 
O'Connor, in her concurring opinion in Glucksberg, concluded:
---------------------------------------------------------------------------
    \19\ 117 S.Ct. 2293 (1997).
    \20\ 117 S.Ct. 2258 (1997).

          States are presently undertaking extensive and 
        serious evaluation of physician-assisted suicide and 
        other related issues * * *. In such circumstances, 
        ``the * * * challenging task of crafting appropriate 
        procedures for safeguarding * * * liberty interests is 
        entrusted to the `laboratory' of the States * * * in 
        the first instance.'' \21\
---------------------------------------------------------------------------
    \21\ Washington v. Glucksberg, 117 S.Ct. 2303 (1997) (citations 
omitted).

    The Supreme Court's denial of certiorari in a case that 
challenged the Oregon referendum--Lee v. Oregon \22\--further 
demonstrates the Court's belief that the issue of assisted 
suicide is best left to the States.
---------------------------------------------------------------------------
    \22\ 107 F.3d 1382 (9th Cir. 1997), cert. denied, 66 U.S.L.W. 3282.
---------------------------------------------------------------------------
    In addition, the American public overwhelmingly agrees that 
assisted suicide should be handled by the States. The results 
of a national opinion survey released in July 1998 show that:

          76 percent of the respondents agree that ``[i]t is 
        not appropriate for Congress to get involved in 
        regulating legal drugs prescribed by doctors for their 
        patients.'' \23\
---------------------------------------------------------------------------
    \23\ Survey by GLS Research of Los Angeles.
---------------------------------------------------------------------------
          72 percent of the respondents oppose federal 
        legislation prohibiting doctors from prescribing 
        medication that a terminally ill patient could take to 
        end his or her own life.\24\
---------------------------------------------------------------------------
    \24\ Id.

    Despite the majority's statements to the contrary, S. 2151 
appears, in large part, to have been drafted to override 
Oregon's Death With Dignity Act. It is worth noting that before 
there was a State law permitting assisted suicide, Congress 
declined to take any action ``clarifying'' the CSA and its 
stance towards the use of controlled substances for assisted 
suicide.

            the history of the oregon death with dignity act

    While most States have engaged in the debate over 
physician-assisted suicide and decided to prohibit its 
practice, Oregon is the only State to date to have passed a law 
permitting the practice.
    Following Oregon's long standing tradition of public 
referenda, the State held two public referenda votes on the 
issue of physician-assisted suicide. The Oregon Death with 
Dignity Act was first passed by public referendum on November 
8, 1994, with 51 percent of the vote. The State legislature 
then decided to return the law for an additional public 
referendum in which voters were asked if they wanted to 
maintain the law. On November 4, 1997, Oregon's voters voted to 
keep the law by 60 percent of the vote.
    The Act provides for a comprehensive and detailed procedure 
by which a patient determined to be mentally competent and 
terminally ill may request assistance to end his or her life 
``in a humane and dignified manner.'' Under the Oregon law, the 
physician is required to provide extensive documentation, 
including that the patient has requested assistance in ending 
his or her life three times. One of these requests must be in 
writing and witnessed by two individuals who are not family 
members. The process must also include documentation that this 
is a voluntary request. A second opinion must confirm the 
patient is a capable adult with a terminal illness and who has 
less than six months to live. The patient and physician must 
also enter into a discussion about alternatives to physician-
assisted suicide. Should the patient decide that they want to 
engage in physician-assisted suicide, the patient must self 
administer the lethal dose.
    Within days of the second successful referendum, the Drug 
Enforcement Administration issued an opinion in which it 
declared it had the authority under the Controlled Substances 
Act to prosecute physicians in Oregon, who in compliance with 
Oregon law, prescribe drugs at the request of a terminally ill 
patient. However, on June 5, 1998, in a letter narrowly written 
in the context of Oregon's law, the Attorney General determined 
that the DEA did not have such authority under the Controlled 
Substance Act. In that letter the Attorney General 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 absence of a federal law 
        prohibiting that practice.

The Attorney General also noted in this letter:

          Even more fundamentally, there is no evidence that 
        Congress, in the CSA, intended to assign DEA the novel 
        role of resolving the ``earnest and profound debate 
        about the morality, legality and practicality of 
        physician-assisted suicide,'' Washington v. Glucksberg 
        * * * simply because that procedure involved the use of 
        controlled substances.

    In September 1998, Oregon released information concerning 
the first 10 cases of assisted suicide. Two of these 
individuals died before taking the medication prescribed for 
them. Of the 10 individuals, five were men and five were women. 
In all but one case, cancer was the terminal diagnosis.

     we share the concerns of the medical community regarding this 
                              legislation

S. 2151 will discourage effective and necessary palliative care

    This bill will make physicians and pharmacists far less 
likely to prescribe and dispense the most effective pain 
management drugs, thus, needlessly causing patients to suffer 
from otherwise treatable pain. Opioids are the major class of 
analgesics used in the management of moderate to severe pain 
because of their effectiveness, ease of establishing an 
appropriate dose and favorable risk to benefit ratio.\25\ 
Opioids, however, are also classified as a controlled substance 
under the CSA. The DEA, therefore, will have the ability to 
interfere in the physician-patient and/or pharmacist-patient 
relationship to determine why they are prescribing or 
dispensing this medication. This will inevitably lead to 
physicians and pharmacists not prescribing or dispensing or 
perhaps under-prescribing opioids in an effort to escape 
unnecessary bureaucracy and potentially harmful investigations.
---------------------------------------------------------------------------
    \25\ The Cancer Pain Management Panel. Clinical Management of 
Cancer Pain. Practice Guideline No. 9 Agency for Health Care Policy and 
Research, U.S. Department of Health and Human Services, March, 1994 pp. 
49-60.
---------------------------------------------------------------------------
    Overly bureaucratic regulation of pain management drugs has 
already been demonstrated to discourage effective palliative 
care. The Institute of Medicine (IOM) published a report in 
1997 entitled ``Approaching Death: Improving Care At The End of 
Life,'' which stated ``studies have repeatedly indicated that a 
significant proportion of dying patients and patients with 
advanced disease experience serious pain, despite the 
availability of effective pharmacological and other options for 
relieving most pain.'' In addition, the IOM stated that 
controlled substance laws may obstruct good care, due to 
specific provisions or fear and misunderstanding surrounding 
legal requirements. ``Pain prescribing laws stand out in this 
regard and, in the view of the [End-of-Life] Committee, warrant 
revisions to minimize discouragement of effective pain 
management.''
    In addition, numerous studies have also demonstrated that 
government regulations are one of the barriers to effective 
pain treatment. For example:
          A 1998 survey completed by the New York Ad Hoc 
        Committee on Pain Management for the New York State 
        Health Commissioner found that physicians ``may be 
        concerned that aggressive pain management using 
        controlled substances could be misconstrued as 
        inappropriate prescribing and could lead to 
        (disciplinary) proceedings;''
          A 1990 Journal of Pain and Symptom Management article 
        stated that one-quarter of State medical licensing and 
        disciplinary board members surveyed were unaware that 
        prescribing opioids for an extended period for cancer 
        patients was both legal andacceptable medical practice; 
\26\
---------------------------------------------------------------------------
    \26\ Joranson, D.E. Federal and State Regulation of Opioids. 
Journal of Pain and Symptom Management 5 (1990) S12-23.-
---------------------------------------------------------------------------
          A study of 13,625 elderly cancer patients living in 
        Medicare/Medicaid certified nursing homes found 26 
        percent of residents with daily pain received no 
        medication for pain. Daily pain is prevalent among 
        nursing home residents with cancer; that pain is often 
        left untreated, especially in African American and 
        older patients; \27\ and
---------------------------------------------------------------------------
    \27\ Bernabei R., et al. Pain Management in Elderly Patients with 
Cancer. JAMA, June 17, 1998: 279: 1877-1882.-
---------------------------------------------------------------------------
          A nationwide study of cancer physicians showed 
        ``reluctance to prescribe'' opioids and concern about 
        ``excessive regulations'' as barriers to cancer pain 
        management. Doctors' concerns were greatest in States 
        with triplicate prescription programs.\28\
---------------------------------------------------------------------------
    \28\ Von Roenn J., Cleeland, CS, et al. Results of Physicians' 
attitudes toward cancer pain management survey. Proceedings of the 
American Society of Clinical Oncology 109 1991, 326.
---------------------------------------------------------------------------
    These studies point to the need for less regulation. S.2151 
would cause the opposite result.
    S. 2151 would provide a level of unprecedented federal 
intrusion into the practice of medicine, while not addressing 
the underlying need that may cause some patients to seek 
physician-assisted suicide. The literature and medical 
practitioners themselves repeatedly point to the need for 
better provider and patient education concerning pain 
management and a regulatory environment in which providers do 
not fear investigations that might ruin their professional 
reputations.
    In addition, any DEA investigation will be quite intrusive, 
because it will have the virtually impossible task of 
discerning ``why'' a physician prescribed the drug he or she 
did and ``why'' the particular amount of that drug was 
prescribed. As many health care providers have pointed out and 
as was discussed in the Department of Justice's testimony 
before the Committee, in the real world, most terminally ill 
patients already have an ample supply of such substances on 
hand to use in any suicide effort. The DEA, therefore, will not 
be able to make an objective determination based upon the drug 
and dosage the patient had on hand. Rather, the DEA will be 
forced to determine the intent of every prescription or 
combination of prescriptions. This cannot be done without an 
intrusive investigation that pries both into the practice of 
the physician and pharmacist involved and the lives of the 
family and friends of the deceased. As noted by the Justice 
Department:

          The Lethal Drug Abuse Prevention Act is designed to 
        address physicians' fears by prohibiting sanctions so 
        long as physicians do not dispense the controlled 
        substance with the intent of causing death. However, 
        the issue of intent would not necessarily be resolved 
        simply by asking physicians about their intent. To 
        establish intent, the DEA might also need to 
        investigate the details of the physician's prescribing 
        practices and of the physician's relationship with the 
        patient and the patient's family.\29\
---------------------------------------------------------------------------
    \29\ Letter of L. Anthony Sutin, Acting Assistant Attorney General, 
to Orrin G. Hatch, September 16, 1998.
---------------------------------------------------------------------------

S. 2151 may further expand the DEA's authority over the practice of 
        medicine

    This bill could be interpreted to expand the DEA's 
authority over the medical profession beyond its purported 
purpose. The DEA's current mission is to determine the 
``appropriate use'' of drugs only as part of an effort to 
prevent diversion and illegal drug trafficking. Yet, the 
majority states that the term ``medically indicated'' as used 
in this bill refers to the use of a controlled substance where 
the use of such substance is ``reasonable and necessary'' for 
the treatment of a patient and is not consistent with 
intentionally causing the death of the patient. If this 
statement is true, the DEA's authority could be interpreted to 
go beyond examining the intent of the provider and the 
appropriate use of the drug. The DEA could now also examine 
what is ``reasonable and necessary'' in the care of the patient 
which is a very different kind of determination than one of 
appropriate use. The CSA was never intended to be used by the 
DEA as a source of authority to make the medical determination 
of what is a reasonable and necessary use of drugs for patient 
care beyond the narrow scope of preventing the diversion of or 
illegal trafficking in drugs.

The medical advisory board on pain relief is not a sufficient safeguard 
        to protect against the potential harms of S. 2151

    Proponents of the bill believe the Medical Advisory Board 
on Pain Relief (the Board or Advisory Board) would provide an 
adequate shield for health care providers because these 
physicians and pharmacists could request that the Board review 
their case after they have been notified that they are subject 
to a DEA investigation. Unfortunately, the Board's review is 
likely to be too little, too late. The Board only issues 
advisory opinions and can only be brought into the process 
after an investigation has already begun. In addition, the 
organizations to be named to this Board oppose this legislation 
and were not consulted in the drafting of the bill. Finally, 
the pharmacists are alarmed because the Board does not include 
any representation by pharmacists.
    The majority also states that the Department of Health and 
Human Services (HHS) would serve as the chief medical advisor 
for the DEA in implementing this legislation. However, the 
actual legislation provides no specific responsibilities for 
the liaison and its input appears to be non-binding. The 
Chairman's additional language requiring such a liaison with 
HHS in itself is a determination that the DEA currently lacks 
the expertise necessary to determine the intent or the 
reasonable and necessary use of the drugs in question.

The Attorney General cannot make a finding without an investigation

    The majority argues that this revised bill provides another 
layer of protection to physicians and pharmacists by requiring 
the Attorney General to make a finding that a physician or 
pharmacist has dispensed or distributed a specific controlled 
substance which was directly responsible for the death of an 
individual before a DEA investigation can be commenced. It is 
unclear to us, however, how the Attorney General can make such 
findings without first conducting some sort of potentially 
intrusive investigation.

S. 2151 is not necessary to insure the uniform application of the 
        Controlled Substances Act

    The majority states that this legislation is necessary to 
avoid the creation of 50 different state policies regarding the 
Controlled Substances Act. The CSA classifies drugs as to their 
dependence and medical use and is directed to prevent diversion 
and illegal drug trafficking. No evidence has been brought 
forward to show that States are revising the schedules included 
in the CSA. If the proponents want uniform usage of drugs in 
the practice of medicine, then the federal government would 
have to preempt state medical and pharmacy laws. Such an effort 
would run counter to the long established way in which States, 
not the Federal government, have regulated medicine and 
pharmacy practices.

State medical boards are the proper forum for governing pain management 
        practices

    Since they were established in the late nineteenth century, 
State medical boards have evolved into sophisticated regulatory 
agencies dedicated to ensuring the public is protected from 
unacceptable practitioners. All States have medical licensing 
boards which oversee the practice of medicine, including 
physicians' prescribing patterns. The current system of State 
medical licensure has worked well in assuring that the public 
health is protected. This system is also the most appropriate 
and most effective forum for regulating pain management 
practices.
    S. 2151 would establish a new and burdensome oversight 
mechanism whereby the DEA would have prospective authority to 
deny DEA registration based on the DEA's interpretation of the 
provider's intent. This conflicts with the mission of State 
medical licensure boards, which, unlike the DEA, have long held 
the role of assuring appropriate delivery of medical care. If 
enacted, this legislation would replace the well-established 
system of peer review and regulation at the State level with an 
untested and superfluous federal enforcement mechanism.
    According to the Federation of State Medical Boards (FSMB), 
in cases where the inappropriate prescribing of controlled 
substances is determined, the State medical boards require a 
physician to surrender his or her DEA certificate as part of 
the disciplinary action taken and notify the DEA of such 
action. The surrendering of the DEA certificate may be only one 
of the conditions imposed upon the physician and if the 
physician fails to comply with all the terms of the 
disciplinary action, the board may then revoke the physician's 
medical license.
    Under the current system, all physicians are subject to 
peer review while licensed. Hospitals, other health care 
organizations and insurance companies are asked to provide 
licensing boards with any information about adverse actions 
they have taken against individual physicians. These reports 
are reviewed by the State boards and, if necessary, 
disciplinary action is taken. In addition, a majority of State 
boards require all licensees to continue their medical 
education in order to maintain licensure. These processes are 
designed to help identify those individuals who should no 
longer be engaged in the practice of medicine and to ensure 
that physicians maintain their level of medical knowledge and 
clinical abilities.
    In some States, State licensure boards are taking steps to 
educate physicians on the proper use of pain medication for 
patients nearing the end of life. Recently, the FSMB published 
``Proposed Model Guidelines for the Use of Controlled 
Substances'' in the treatment of pain. The federation is 
recommending all States adopt these model guidelines as a way 
to educate and reassure physicians that they can safely use 
controlled substances to treat pain.
    Clearly, the State boards have taken a comprehensive 
approach to the governing and advising of physicians and 
pharmacists on the practice of pain management. There is no 
reason to strip them of their responsibility or to pile on 
layers of unnecessary federal bureaucracy.

S. 2151 will interfere with the goals of hospice and comfort care

    In 1997, 3200 hospices cared for nearly a half-million 
terminally ill patients in the United States. Hospices provide 
comprehensive and compassionate care by addressing the 
physical, psychological, social and spiritual needs of dying 
patients and their families. One of the main goals of hospice 
care is to treat patients' pain aggressively through a variety 
of means, including the use of controlled substances. These 
include the use of morphine and other opioids so the patient 
can maintain the highest quality of life during their remaining 
days.
    In Oregon, as a result of the physician-assisted suicide 
debate and the State's law which requires physicians and their 
patients to discuss options other than physician-assisted 
suicide, use of hospice care has increased significantly. 
Oregon's rapidly increasing use of hospice care demonstrates 
the public's need for information concerning alternatives to 
physician-assisted suicide and the overall need for 
improvements in end-of-life care.
    S. 2151 neither addresses the public's need for information 
concerning alternatives to physician-assisted suicide nor 
promotes improvements in end-of-life care that might make a 
terminally ill individual seek other options. Palliative care 
and pain management are both evolving fields that should be 
left to medical professionals, not law enforcement, to provide 
care for the dying without excessive government intrusion. S. 
2151 does not address these serious concerns, and in the 
opinion of an overwhelming number of physicians, pharmacists, 
hospice providers, nurses and pain patients, will only 
exacerbate the problems of pain management and hinder the 
ongoing evolution of the fields of palliative care and pain 
management.

                               conclusion

    Physician assisted-suicide is a disturbing practice which 
we all seek to eliminate. We would prefer that no person ever 
be put in the situation where he or she is suffering so much 
pain, that he or she chooses self-inflicted death over the 
agony being endured. The reality, however, is that physician 
assisted-suicide does exist, and this bill, S. 2151, will do 
little to stop or even reduce the practice.
    Indeed, the majority, under the guise of amending the 
Controlled Substances Act, has attempted to substitute its 
judgment for those of the States, especially that of Oregon. 
The result of this misguided effort is a bill that will 
discourage appropriate, palliative care and may actually 
increase the demand for physician-assisted suicide.
    If the majority wishes to effectively reduce physician-
assisted suicide, it should address the root causes of the 
practice. Patients do not commit assisted-suicide because their 
physicians have the power to prescribe controlled substances 
for pain relief. On the contrary, patients largely commit 
suicide, because they are suffering from chronic pain and/or 
depression, because they fear being a burden on their loved 
ones, or because they do not have access to palliative or 
hospice care. This bill does nothing to address these far 
reaching and complex problems. In fact, S. 2151 will exacerbate 
these problems.
    We, therefore, cannot support this bill.

                                   Patrick Leahy.
                                   Russ Feingold.
                                   Herb Kohl.
                                   Ted Kennedy.
                                   Dianne Feinstein.

                      XI. Changes in Existing Law

    In compliance with paragraph 12 of rule XXVI of the 
Standing Rules of the Senate, changes in existing law made by 
S. 2151, as reported, are shown as follows (existing law which 
would be omitted is enclosed in bold brackets, new matter is 
printed in italic, and existing law in which no change is 
proposed is shown in roman type):

UNITED STATES CODE

           *       *       *       *       *       *       *


TITLE 21--FOOD AND DRUGS

           *       *       *       *       *       *       *


             CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL

                 Subchapter I--Control and Enforcement

Part A--Introductory Provisions

           *       *       *       *       *       *       *


Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances

           *       *       *       *       *       *       *


Sec. 823. Registration requirements

      manufacturers of controlled substances in schedules i and ii

    (a) The Attorney General * * *

           *       *       *       *       *       *       *


practitioners dispensing narcotic drugs for narcotic treatment; annual 
          registration; separate registration; qualifications

    (g) Practitioners * * *

           *       *       *       *       *       *       *


            applicants for distribution of list i chemicals

    (h) The Attorney General shall register an applicant to 
distribute a list I chemical unless the Attorney General 
determines that registration of the applicant is inconsistent 
with the public interest. Registration under this subsection 
shall not be required for the distribution of a drug product 
that is exempted under section 802(39)(A)(iv) of this title. In 
determining the public interest for the purpose of this 
subsection, the Attorney General shall consider--
          (1) maintenance by the applicant of effective 
        controls against diversion of listed chemicals into 
        other than legitimate channels;

           *       *       *       *       *       *       *

          (5) such other factors as are relevant to and 
        consistent with the public health and safety.
    (i) The Attorney General shall determine that registration 
of an applicant under this section is inconsistent with the 
public interest if--
          (1) during the 5-year period immediately preceding 
        the date on which the application is submitted under 
        this section, the registration of the applicant under 
        this section was suspended or revoked under section 
        304(a)(4); or
          (2) the Attorney General determines, based on clear 
        and convincing evidence, that the applicant is applying 
        for the registration with the intention of using the 
        registration to take any action that would constitute a 
        violation of section 304(a)(4).

Sec. 824. Denial, revocation, or suspension of registration

                                Grounds

    (a) A registration pursuant to section 823 of this title to 
manufacture, distribute, or dispense a controlled substance or 
a list I chemical may be suspended or revoked by the Attorney 
General upon a finding that the registrant--
          (1) has materially falsified any application filed 
        pursuant to or required by this subchapter or 
        subchapter II of this chapter;
          (2) has been convicted of a felony under this 
        subchapter or subchapter II of this chapter or any 
        other law of the United States, or of any State, 
        relating to any substance defined in this subchapter as 
        a controlled substance or a list I chemical;
          (3) has had his State license or registration 
        suspended, revoked, or denied by competent State 
        authority and is no longer authorized by State law to 
        engage in the manufacturing, distribution, or 
        dispensing of controlled substances or list I chemicals 
        or has had the suspension, revocation, or denial of his 
        registration recommended by competent State authority;
          (4) has intentionally dispensed or distributed a 
        controlled substance with the purpose of causing, or 
        assisting in causing, the suicide or euthanasia of any 
        individual, except that this paragraph does not apply 
        to the dispensing or distribution of a controlled 
        substance--
                  (A) for the purpose of alleviating pain or 
                discomfort (even if the use of the controlled 
                substance may increase the risk of death), so 
                long as the controlled substance is not also 
                dispensed or distributed for the purpose of 
                causing, or assisting in causing, the death of 
                an individual for any reason; or
                  (B) for the purpose of carrying out a 
                sentence of death under Federal or State law;
          [(4)] (5) has committed such acts as would render his 
        registration under section 823 of this title 
        inconsistent with the public interest as determined 
        under such other section; or
          [(5)] (6) has been excluded (or directed to be 
        excluded) from participation in a program pursuant to 
        section 1320a-7(a) of Title 42.
A registration pursuant to section 823(g) of this title to 
dispense a narcotic drug for maintenance treatment or 
detoxification treatment may be suspended or revoked by the 
Attorney General upon a finding that the registrant has failed 
to comply with any standard referred to in section 823(g) of 
this title.

                   Limits of revocation or suspension

    (b) the Attorney General may limit revocation or suspension 
of a registration to the particular controlled substance or 
list I chemical with respect to which grounds for revocation or 
suspension exist.

                service of show cause order; proceedings

    [(c) Before] (c) Procedures._
           (1) Order to show cause._Before taking action 
        pursuant to this section, or pursuant to a denial of 
        registration under section 823 of this title, the 
        Attorney General shall serve upon the applicant or 
        registrant an order to show cause why registration 
        should not be denied, revoked, or suspended. The order 
        to show cause shall contain a statement of the basis 
        thereof and shall call upon the applicant or registrant 
        to appear before the Attorney General at a time and 
        place stated in the order, but in no event less than 
        thirty days after the date of receipt of the order. 
        Proceedings to deny, revoke, or suspend shall be 
        conducted pursuant to this section in accordance with 
        subchapter II of chapter 5 of Title 5. Such proceedings 
        shall be independent of, and not in lieu of, criminal 
        prosecutions or other proceedings under this subchapter 
        or any other law of the United States.
          (2) Assisted suicide.--
                  (A) Findings.--
                          (i) In general.--Prior to any 
                        proceeding under paragraph (1), where 
                        an order to show cause may be based on 
                        subsection (a)(4) for denial, 
                        revocation, or suspension of 
                        registration, the Attorney General 
                        shall make a finding that the applicant 
                        or registrant--
                                  (I) has dispensed or 
                                distributed a specific 
                                controlled substance that was 
                                directly responsible for the 
                                death of an individual; and
                                  (II) did not dispense or 
                                distribute the specific 
                                controlled substance as 
                                medically indicated.
                          (ii) Consultation.--In making any 
                        finding under clause (i)(II), the 
                        Attorney General may consult with the 
                        Secretary of Health and Human Services, 
                        as the Attorney General, in 
                        consultation with the Secretary, 
                        determines to be appropriate.
                  (B) Burden of proof.--At any proceeding under 
                paragraph (1), where the order to show cause is 
                based on subsection (a)(4) for denial, 
                revocation, or suspension of registration, the 
                Attorney General shall have the burden of 
                proving, by clear and convincing evidence, that 
                the practitioner's intent was to dispense or 
                distribute a controlled substance with a 
                purpose of causing, or assisting in causing, 
                the suicide or euthanasia of any individual. In 
                meeting such burden, it shall not be sufficient 
                to prove that the registrant knew that the use 
                of the controlled substance may increase the 
                risk of death.
                  (C) Request for review by medical advisory 
                board on pain relief.--At any proceeding under 
                paragraph (1), where the order to show cause is 
                based on subsection (a)(4) for denial, 
                revocation, or suspension of registration, the 
                practitioner may request, within 30 days after 
                the receipt of the order to show cause, that 
                the Medical Advisory Board on Pain Relief 
                review, in accordance with paragraph (3), the 
                administrative record of such proceeding as it 
                relates to subsection (a)(4).
          (3) Medical Advisory board on pain relief.--
                  (A) In general.--The Secretary of Health and 
                Human Services, in consultation with the 
                Attorney General, shall by regulation establish 
                a board to be known as the Medical Advisory 
                Board on Pain Relief (referred to in this 
                subsection as the ``Board'').
                  (B) Membership.--
                          (i) In general.--Subject to clause 
                        (ii), the Secretary of Health and Human 
                        Services, in consultation with the 
                        Attorney General, shall appoint the 
                        members of the Board--
                                  (I) from among individuals 
                                who by reason of specialized 
                                education or substantial 
                                relevant experience in pain 
                                management, are clinical 
                                experts with knowledge 
                                regarding standards, practices, 
                                and guidelines concerning pain 
                                relief; and
                                  (II) after consultation with 
                                the American Medical 
                                Association, the American 
                                Academy of Pain Medicine, the 
                                American Pain Society, the 
                                American Academy of Hospice and 
                                Palliative Medicine, the 
                                National Hospice Organization, 
                                the American Geriatrics 
                                Society, and such other 
                                entities with relevant 
                                expertise concerning pain 
                                relief, as the Attorney General 
                                determines to be appropriate.
                          (ii) Prohibition.--No member of the 
                        board may be an officer or employee of 
                        the Federal Government.
                  (C) Duties of board.--If, in accordance with 
                paragraph (2)(B), an applicant or registrant 
                requests a review by the Board of the record of 
                a proceeding under paragraph (1), the Board 
                shall review the administrative record of such 
                proceeding as it relates to subsection (a)(4) 
                and issue to the Secretary of Health and Human 
                Services and the Attorney General an advisory 
                opinion as to whether the dispensing or 
                distribution of the controlled substance at 
                issue in the proceeding was for the purpose of 
                alleviating pain or discomfort in a manner that 
                does not constitute a violation of subsection 
                (a)(4). The opinion of the Board under this 
                subparagraph shall be part of the 
                administrative record and shall be considered 
                by the Attorney General in determining whether 
                to deny, revoke, or suspend the registration 
                involved.
                  (D) Compensation of members.--Each member of 
                the Board shall be compensated at a rate equal 
                to the daily equivalent of the annual rate of 
                basic pay prescribed for level IV of the 
                Executive Schedule under section 5315 of title 
                5, United States Code, for each day (including 
                travel time) during which such member is 
                engaged in the performance of the duties of the 
                Board.
          (4) No additional investigative authority.--Nothing 
        in section 303(i), subsection (a)(4) of this section, 
        or this subsection may be construed to provide the 
        Attorney General with any additional investigative 
        authority in any State, to the extent that the law of 
        the State prohibits assisted suicide or euthanasia.

                                
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