Calendar No. 607

105TH CONGRESS

2D SESSION S. 2151

A BILL

To clarify Federal law to prohibit the dispensing or

ual.cide, euthanasia, or mercy killing of any individpose of causing, or assisting in causing, the suidistribution of a controlled substance for the purSEPTEMBER 24, 1998

Reported with an amendment and an amendment to the

title
II

Calendar No. 607

105TH CONGRESS

2D SESSION S. 2151

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,

euthanasia, or mercy killing of any individual.

IN THE SENATE OF THE UNITED STATES

JUNE 9, 1998

Mr. NICKLES (for himself, Mr. LOTT, Mr. COATS, Mr. INHOFE, Mr. HELMS,

Mr. MURKOWSKI, Mr. GRAMS, Mr. FAIRCLOTH, Mr. BOND, Mr. ENZI,

Mr. SESSIONS, Mr. HAGEL, Mr. COVERDELL, Mr. SMITH of New Hampshire, Mr. LIEBERMAN, Mr. BROWNBACK, Mr. CRAIG, Mr. ABRAHAM, Mr.

SANTORUM, Mr. ALLARD, Mr. GRASSLEY, Mr. DEWINE, Mr. KYL, and

Mr. HUTCHINSON) introduced the following bill; which was read twice

and referred to the Committee on the Judiciary

SEPTEMBER 24, 1998

Reported by Mr. HATCH, with an amendment and an amendment to the title

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL

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, euthanasia, or mercy

killing of any individual.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Lethal Drug Abuse

3 Prevention Act of 1998’’.

4 SEC. 2. FINDINGS; PURPOSES.

5 (a) FINDINGS.—Congress finds that—

6 (1) the use of certain narcotics and other dan7 gerous drugs is generally prohibited under the Con8 trolled Substances Act;

9 (2) under the Controlled Substances Act and

10 implementing regulations, an exception to this gen11 eral prohibition permits the dispensing and distribu12 tion of certain controlled substances by properly reg13 istered physicians for legitimate medical purposes;

14 (3) the dispensing or distribution of controlled

15 substances to assist suicide is not a legitimate medi16 cal purpose and should not be construed to be per17 missible under the Controlled Substances Act;

18 (4) the dispensing or distribution of certain

19 controlled substances for the purpose of relieving

20 pain and discomfort is a legitimate medical purpose

21 under the Controlled Substances Act and physicians

22 should not hesitate to dispense or distribute them

23 for that purpose when medically indicated; and

24 (5) for the reasons set forth in section 101 of

25 the Controlled Substances Act (21 U.S.C. 801), the

26 dispensing and distribution of controlled substances
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1 for any purpose, including that of assisting suicide,

2 affects interstate commerce.

3 (b) PURPOSES.—The purposes of this Act are—

4 (1) to provide explicitly that Federal law is not

5 intended to license the dispensing or distribution of

6 a controlled substance with a purpose of causing, or

7 assisting in causing, the suicide, euthanasia, or

8 mercy killing of any individual; and

9 (2) to encourage physicians to prescribe con10 trolled substances as medically appropriate in order

11 to relieve pain and discomfort, by reducing unwar12 ranted concerns that their registration to prescribe

13 controlled substances will thereby be put at risk, if

14 there is no intent to cause a patient’s death.

15 SEC. 3. LETHAL DRUG ABUSE PREVENTION.

16 (a) DENIAL OF REGISTRATION.—Section 303 of the

17 Controlled Substances Act (21 U.S.C. 823) is amended

18 by adding at the end the following:

19 ‘‘(i) DENIAL OF REGISTRATION.—The Attorney Gen20 eral shall determine that registration of an applicant

21 under this section is inconsistent with the public interest

22 if—

23 ‘‘(1) during the 5-year period immediately pre24 ceding the date on which the application is submit25 ted under this section, the registration of the appli-
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1 cant under this section was revoked under section

2 304(a)(4); or

3 ‘‘(2) the Attorney General determines, based on

4 clear and convincing evidence, that the applicant is

5 applying for the registration with the intention of

6 using the registration to take any action that would

7 constitute a violation of section 304(a)(4).’’.

8 (b) SUSPENSION OR REVOCATION OF REGISTRA9 TION.—

10 (1) IN GENERAL.—Section 304(a) of the Con11 trolled Substances Act (21 U.S.C. 824(a)) is amend12 ed—

13 (A) by redesignating paragraphs (4) and

14 (5) as paragraphs (5) and (6), respectively; and

15 (B) by inserting after paragraph (3) the

16 following:

17 ‘‘(4) has intentionally dispensed or distributed a

18 controlled substance with a purpose of causing, or

19 assisting in causing, the suicide, euthanasia, or

20 mercy killing of any individual, except that this

21 paragraph does not apply to the dispensing or dis22 tribution of a controlled substance for the purpose of

23 relieving pain or discomfort (even if the use of the

24 controlled substance may increase the risk of death),

25 so long as the controlled substance is not also dis-
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1 pensed or distributed for the purpose of causing, or

2 assisting in causing, the death of an individual for

3 any reason;’’.

4 (2) CONFORMING AMENDMENT.—Section

5 304(a)(5) of the Controlled Substances Act (21

6 U.S.C. 824(a)(5)) (as redesignated by paragraph (1)

7 of this subsection) is amended by inserting ‘‘other’’

8 after ‘‘such’’.

9 (c) PAIN RELIEF.—Section 304(c) of the Controlled

10 Substances Act (21 U.S.C. 824(c)) is amended—

11 (1) by striking ‘‘(c) Before’’ and inserting the

12 following:

13 ‘‘(c) PROCEDURES.—

14 ‘‘(1) ORDER TO SHOW CAUSE.—After any hear15 ing under paragraph (2), and before’’; and

16 (2) by adding at the end the following:

17 ‘‘(2) MEDICAL REVIEW BOARD ON PAIN RE18 LIEF.—

19 ‘‘(A) IN GENERAL.—The Attorney General

20 shall by regulation establish a board to be

21 known as the Medical Review Board on Pain

22 Relief (referred to in this subsection as the

23 ‘Board’).

24 ‘‘(B) MEMBERSHIP.—The Attorney Gen25 eral shall appoint the members of the Board—
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1 ‘‘(i) from among individuals who, by

2 reason of specialized education or substan3 tial relevant experience in pain manage4 ment, are clinical experts with knowledge

5 regarding standards, practices, and guide6 lines concerning pain relief; and

7 ‘‘(ii) after consultation with the Amer8 ican Medical Association, the American

9 Academy of Hospice and Palliative Medi10 cine, the National Hospice Organization,

11 the American Geriatrics Society, and such

12 other entities with relevant expertise con13 cerning pain relief, as the Attorney Gen14 eral determines to be appropriate.

15 ‘‘(C) DUTIES OF BOARD.—

16 ‘‘(i) HEARING.—If an applicant or

17 registrant claims that any action (or, in

18 the case of a proposed denial under section

19 303(i)(2), any potential action) that is a

20 basis of a proposed denial under section

21 303(i), or a proposed revocation or suspen22 sion under subsection (a)(4) of this sec23 tion, is an appropriate means to relieve

24 pain that does not constitute a violation of

25 subsection (a)(4) of this section, the appli-
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1 cant or registrant may seek a hearing be2 fore the Board on that issue.

3 ‘‘(ii) FINDINGS.—Based on a hearing

4 under clause (i), the Board shall make

5 findings regarding whether the action at

6 issue is an appropriate means to relieve

7 pain that does not constitute a violation of

8 subsection (a)(4). The findings of the

9 Board under this clause shall be admissible

10 in any hearing pursuant to an order to

11 show cause under paragraph (1).’’.

12 SEC. 4. CONSTRUCTION.

13 (a) IN GENERAL.—Nothing in this Act or the amend14 ments made by this Act shall be construed to imply that

15 the dispensing or distribution of a controlled substance be16 fore the date of enactment of this Act for the purpose of

17 causing, or assisting in causing, the suicide, euthanasia,

18 or mercy killing of any individual is not a violation of the

19 Controlled Substances Act (21 U.S.C. 801 et seq.).

20 (b) INCORPORATED DEFINITIONS.—In this section,

21 the terms ‘‘controlled substance’’, ‘‘dispense’’, and ‘‘dis22 tribute’’ have the meanings given those terms in section

23 102 of the Controlled Substances Act (21 U.S.C. 802).
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Lethal Drug Abuse Pre3 vention Act of 1998’’.

4 SEC. 2. FINDINGS; PURPOSES.

5 (a) FINDINGS.—Congress finds that—

6 (1) the use of certain narcotics and other drugs

7 or substances with a potential for abuse is strictly

8 regulated under the Controlled Substances Act;

9 (2) the dispensing and distribution of certain

10 controlled substances only by properly registered prac11 titioners only for legitimate medical purposes are per12 mitted under the Controlled Substances Act and im13 plementing regulations;

14 (3) the dispensing or distribution of controlled

15 substances to assist suicide or euthanasia are not le16 gitimate medical purposes and are not permissible

17 under the Controlled Substances Act;

18 (4) the dispensing or distribution of certain con19 trolled substances for the purpose of relieving pain

20 and discomfort are legitimate medical purposes and

21 are permissible under the Controlled Substances Act;

22 (5) inadequate treatment of pain, especially for

23 chronic diseases, irreversible diseases such as cancer,

24 and end-of-life care, is a serious public health problem

25 affecting hundreds of thousands of patients every

26 year; physicians should not hesitate to dispense or
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1 distribute controlled substances when medically indi2 cated for those conditions; and

3 (6) for the reasons set forth in section 101 of the

4 Controlled Substances Act (21 U.S.C. 801), the dis5 pensing and distribution of controlled substances for

6 any purpose, including that of assisting suicide or eu7 thanasia, affect interstate commerce.

8 (b) PURPOSES.—The purposes of this Act are—

9 (1) to provide explicitly that Federal law is not

10 intended to allow the dispensing or distribution of

11 any controlled substance with the purpose of causing,

12 or assisting in causing, the suicide or euthanasia, of

13 any individual; and

14 (2) to encourage practitioners to prescribe, dis15 pense, distribute, and administer controlled sub16 stances as medically appropriate in order to relieve

17 pain and discomfort, by reducing unwarranted con18 cerns that their registration to prescribe controlled

19 substances will thereby be put at risk, if there is no

20 intent to assist in causing a patient’s death.

21 SEC. 3. LETHAL DRUG ABUSE PREVENTION.

22 (a) ADDITIONAL GROUND FOR DENIAL OF REGISTRA23 TION.—Section 303 of the Controlled Substances Act (21

24 U.S.C. 823) is amended by adding at the end the following:
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1 ‘‘(i) The Attorney General shall determine that reg2 istration of an applicant under this section is inconsistent

3 with the public interest if—

4 ‘‘(1) during the 5-year period immediately pre5 ceding the date on which the application is submitted

6 under this section, the registration of the applicant

7 under this section was suspended or revoked under

8 section 304(a)(4); or

9 ‘‘(2) the Attorney General determines, based on

10 clear and convincing evidence, that the applicant is

11 applying for the registration with the intention of

12 using the registration to take any action that would

13 constitute a violation of section 304(a)(4).’’.

14 (b) SUSPENSION OR REVOCATION OF REGISTRA15 TION.—

16 (1) IN GENERAL.—Section 304(a) of the Con17 trolled Substances Act (21 U.S.C. 824(a)) is amend18 ed—

19 (A) by redesignating paragraphs (4) and

20 (5) as paragraphs (5) and (6), respectively; and

21 (B) by inserting after paragraph (3) the fol22 lowing:

23 ‘‘(4) has intentionally dispensed or distributed a

24 controlled substance with the purpose of causing, or

25 assisting in causing, the suicide or euthanasia of any
11

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1 individual, except that this paragraph does not apply

2 to the dispensing or distribution of a controlled sub3 stance—

4 ‘‘(A) for the purpose of alleviating pain or

5 discomfort (even if the use of the controlled sub6 stance may increase the risk of death), so long

7 as the controlled substance is not also dispensed

8 or distributed for the purpose of causing, or as9 sisting in causing, the death of an individual for

10 any reason; or

11 ‘‘(B) for the purpose of carrying out a sen12 tence of death under Federal or State law;’’.

13 (2) CONFORMING AMENDMENT.—Section

14 304(a)(5) of the Controlled Substances Act (21 U.S.C.

15 824(a)(5)) (as redesignated by paragraph (1) of this

16 subsection) is amended by inserting ‘‘other’’ after

17 ‘‘such’’ the first place the term appears.

18 (c) PAIN RELIEF.—Section 304(c) of the Controlled

19 Substances Act (21 U.S.C. 824(c)) is amended—

20 (1) by striking ‘‘(c) Before’’ and inserting the fol21 lowing:

22 ‘‘(c) PROCEDURES.—

23 ‘‘(1) ORDER TO SHOW CAUSE.—Before’’; and

24 (2) by adding at the end the following:

25 ‘‘(2) ASSISTED SUICIDE.—
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1 ‘‘(A) FINDINGS.—

2 ‘‘(i) IN GENERAL.—Prior to any pro3 ceeding under paragraph (1), where an

4 order to show cause may be based on sub5 section (a)(4) for denial, revocation, or sus6 pension of registration, the Attorney Gen7 eral shall make a finding that the applicant

8 or registrant—

9 ‘‘(I) has dispensed or distributed

10 a specific controlled substance that was

11 directly responsible for the death of an

12 individual; and

13 ‘‘(II) did not dispense or distrib14 ute the specific controlled substance as

15 medically indicated.

16 ‘‘(ii) CONSULTATION.—In making any

17 finding under clause (i)(II), the Attorney

18 General may consult with the Secretary of

19 Health and Human Services, as the Attor20 ney General, in consultation with the Sec21 retary, determines to be appropriate.

22 ‘‘(B) BURDEN OF PROOF.—At any proceed23 ing under paragraph (1), where the order to

24 show cause is based on subsection (a)(4) for de25 nial, revocation, or suspension of registration,
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1 the Attorney General shall have the burden of

2 proving, by clear and convincing evidence, that

3 the practitioner’s intent was to dispense or dis4 tribute a controlled substance with a purpose of

5 causing, or assisting in causing, the suicide or

6 euthanasia of any individual. In meeting such

7 burden, it shall not be sufficient to prove that the

8 registrant knew that the use of controlled sub9 stance may increase the risk of death.

10 ‘‘(C) REQUEST FOR REVIEW BY MEDICAL

11 ADVISORY BOARD ON PAIN RELIEF.—At any pro12 ceeding under paragraph (1), where the order to

13 show cause is based on subsection (a)(4) for de14 nial, revocation, or suspension of registration,

15 the practitioner may request, within 30 days

16 after the receipt of the order to show cause, that

17 the Medical Advisory Board on Pain Relief re18 view, in accordance with paragraph (3), the ad19 ministrative record of such proceeding as it re20 lates to subsection (a)(4).

21 ‘‘(3) MEDICAL ADVISORY BOARD ON PAIN RE22 LIEF.—

23 ‘‘(A) IN GENERAL.—The Secretary of

24 Health and Human Services, in consultation

25 with the Attorney General, shall by regulation
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1 establish a board to be known as the Medical Ad2 visory Board on Pain Relief (referred to in this

3 subsection as the ‘Board’).

4 ‘‘(B) MEMBERSHIP.—

5 ‘‘(i) IN GENERAL.—Subject to clause

6 (ii), the Secretary of Health and Human

7 Services, in consultation with the Attorney

8 General, shall appoint the members of the

9 Board—

10 ‘‘(I) from among individuals who

11 by reason of specialized education or

12 substantial relevant experience in pain

13 management, are clinical experts with

14 knowledge regarding standards, prac15 tices, and guidelines concerning pain

16 relief; and

17 ‘‘(II) after consultation with the

18 American Medical Association, the

19 American Academy of Pain Medicine,

20 the American Pain Society, the Amer21 ican Academy of Hospice and Pallia22 tive Medicine, the National Hospice

23 Organization, the American Geriatrics

24 Society, and such other entities with

25 relevant expertise concerning pain re-
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1 lief, as the Attorney General deter2 mines to be appropriate.

3 ‘‘(ii) PROHIBITION.—No member of the

4 Board may be an officer or employee of the

5 Federal Government.

6 ‘‘(C) DUTIES OF BOARD.—If, in accordance

7 with paragraph (2)(B), an applicant or reg8 istrant requests a review by the Board of the

9 record of a proceeding under paragraph (1), the

10 Board shall review the administrative record of

11 such proceeding as it relates to subsection (a)(4)

12 and issue to the Secretary of Health and Human

13 Services and the Attorney General an advisory

14 opinion as to whether the dispensing or distribu15 tion of the controlled substance at issue in the

16 proceeding was for the purpose of alleviating

17 pain or discomfort in a manner that does not

18 constitute a violation of subsection (a)(4). The

19 opinion of the Board under this subparagraph

20 shall be part of the administrative record and

21 shall be considered by the Attorney General in

22 determining whether to deny, revoke, or suspend

23 the registration involved.

24 ‘‘(D) COMPSENSATION OF MEMBERS.—Each

25 member of the Board shall be compensated at a
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1 rate equal to the daily equivalent of the annual

2 rate of basic pay prescribed for level IV of the

3 Executive Schedule under section 5315 of title 5,

4 United States Code, for each day (including

5 travel time) during which such member is en6 gaged in the performance of the duties of the

7 Board.

8 ‘‘(4) NO ADDITIONAL INVESTIGATIVE AUTHOR9 ITY.—Nothing in section 303(i), subsection (a)(4) of

10 this section, or this subsection may be construed to

11 provide the Attorney General with any additional in12 vestigative authority in any State, to the extent that

13 the law of the State prohibits assisted suicide or eu14 thanasia.’’.

15 SEC. 4. DESIGNATION OF LIAISON.

16 Not later than 30 days after the date of enactment of

17 this Act, the Secretary of Health and Human Services shall

18 designate an officer of the Department of Health and

19 Human Services to serve as a liaison between the Secretary

20 of Health and Human Services and the Attorney General

21 in carrying out this Act and the amendments made by this

22 Act.

23 SEC. 5. DIVERSION CONTROL FEE ACCOUNT.

24 Notwithstanding any other provision of law, for pur25 poses of section 111(b) of the Departments of Commerce,
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1 Justice, and State, the Judiciary, and Related Agencies Ap2 propriations, Act, 1993 (21 U.S.C. 886a), the operation of

3 the diversion control program of the Drug Enforcement Ad4 ministration shall be construed to include carrying out sec5 tion 303(i) of the Controlled Substances Act (21 U.S.C.

6 823(i)), as added by this Act, and subsections (a)(4), (c)(2),

7 and (c)(3) of section 304 of the Controlled Substances Act

8 (21 U.S.C. 824), as amended by this Act.

9 SEC. 6 APPLICABILITY; CONSTRUCTION.

10 (a) APPLICABILITY.—The amendments made by this

11 Act shall apply with respect to any controlled substance dis12 pensed or distributed on or after the date of enactment of

13 this Act.

14 (b) CONSTRUCTION.—Nothing in this Act or amend15 ments made by this Act shall be construed to imply that

16 the dispensing or distribution of a controlled substance be17 fore the date of enactment of this Act for the purpose of

18 causing, or assisting in causing, the suicide or euthanasia

19 of any individual is or is not a violation of the Controlled

20 Substances Act (21 U.S.C. 801 et seq.).

21 (c) INCORPORATED DEFINITIONS.—In this section, the

22 terms ‘‘controlled substance’’, ‘‘dispense’’, and ‘‘distribute’’

23 have the meanings given those terms in section 102 of the

24 Controlled Substances Act (21 U.S.C. 802).

Amend the title so as to read: ‘‘To clarify Federal

law to prohibit the dispensing or distribution of a con-
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trolled substance for the purpose of causing, or assisting

in causing, the suicide or euthanasia of any individual.’’.