II

104TH CONGRESS

1ST SESSION S. 78

To establish a temporary program under which parenteral diacetylmorphine

will be made available through qualified pharmacies for the relief of

intractable pain due to cancer, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JANUARY 4, 1995

Mr. INOUYE introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

To establish a temporary program under which parenteral

diacetylmorphine will be made available through qualified

pharmacies for the relief of intractable pain due to cancer, and for other purposes.

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Compassionate Pain

5 Relief Act’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—
2

•S 78 IS

1 (1) cancer is a progressive, degenerative, and

2 often painful disease that afflicts one out of every

3 four persons in the United States and is the second

4 leading cause of death;

5 (2) in the progression of terminal cancer, a sig6 nificant number of patients experience levels of in7 tense and intractable pain that cannot be effectively

8 treated by presently available medication;

9 (3) the effect of such pain often leads to a se10 vere deterioration in the quality of life of the patient

11 and heartbreak for the family of the patient;

12 (4) the therapeutic use of parenteral

13 diacetylmorphine is not permitted in the United

14 States but extensive clinical research has dem15 onstrated that the drug is a potent, highly soluble

16 painkilling drug when properly formulated and ad17 ministered under the supervision of a physician;

18 (5) it is in the public interest to make paren19 teral diacetylmorphine available to patients through

20 controlled channels as a drug for the relief of intrac21 table pain due to terminal cancer;

22 (6) diacetylmorphine is successfully used in

23 Great Britain and other countries for relief of pain

24 due to cancer;
3

•S 78 IS

1 (7) the availability of parenteral

2 diacetylmorphine for the limited purposes of control3 ling intractable pain due to terminal cancer will not

4 adversely affect the abuse of illicit drugs or increase

5 the incidence of pharmacy thefts;

6 (8) the availability of parenteral

7 diacetylmorphine will enhance the ability of physi8 cians to effectively treat and control intractable pain

9 due to terminal cancer; and

10 (9) it is appropriate for the Federal Govern11 ment to establish a temporary program to permit

12 the use of pharmaceutical dosage forms of paren13 teral diacetylmorphine for the control of intractable

14 pain due to terminal cancer.

15 SEC. 3. PARENTERAL DIACETYLMORPHINE PROGRAM.

16 Title III of the Public Health Service Act (42 U.S.C.

17 241 et seq.) is amended by adding at the end the following

18 new part:

19 ‘‘PART O—COMPASSIONATE PAIN RELIEF

20 ‘‘SEC. 399G. PARENTERAL DIACETYLMORPHINE.

21 ‘‘(a) REGULATIONS.—

22 ‘‘(1) IN GENERAL.—Not later than three

23 months after the date of the enactment of this part,

24 the Secretary shall issue regulations establishing a

25 program (referred to in this section as the ‘pro-
4

•S 78 IS

1 gram’) under which parenteral diacetylmorphine

2 may be dispensed from pharmacies for the relief of

3 intractable pain due to terminal cancer.

4 ‘‘(2) TERMINAL CANCER.—For purposes of this

5 section, an individual shall be considered to have ter6 minal cancer if there is histologic evidence of a ma7 lignancy in the individual and the cancer of the indi8 vidual is generally recognized as a cancer with a

9 high and predictable mortality.

10 ‘‘(b) MANUFACTURING.—Regulations established

11 under this section shall provide that manufacturers of par12 enteral diacetylmorphine for dispensing under the pro13 gram shall use adequate methods of, and adequate facili14 ties and controls for, the manufacturing, processing, and

15 packing of such drug to preserve the identity, strength,

16 quality, and purity of the drug.

17 ‘‘(c) AVAILABILITY TO PHARMACIES.—

18 ‘‘(1) REQUIREMENTS.—Regulations established

19 under this section shall require that parenteral

20 diacetylmorphine be made available only to phar21 macies that—

22 ‘‘(A) are hospital pharmacies or such other

23 pharmacies as the regulations specify;

24 ‘‘(B) are registered under section 302 of

25 the Controlled Substances Act (21 U.S.C. 822);
5

•S 78 IS

1 ‘‘(C) meet such qualifications as the regu2 lations specify; and

3 ‘‘(D) submit an application in accordance

4 with paragraph (2).

5 ‘‘(2) APPLICATION.—An application for paren6 teral diacetylmorphine shall—

7 ‘‘(A) be in such form and submitted in

8 such manner as the Secretary may prescribe;

9 and

10 ‘‘(B) contain assurances satisfactory to the

11 Secretary that—

12 ‘‘(i) the applicant will comply with

13 such special requirements as the Secretary

14 may prescribe respecting the storage and

15 dispensing of parenteral diacetylmorphine;

16 and

17 ‘‘(ii) parenteral diacetylmorphine pro18 vided under the application will be dis19 pensed through the applicant upon the

20 written prescription of a physician reg21 istered under section 302 of the Controlled

22 Substances Act (21 U.S.C. 822) to dis23 pense controlled substances in schedule II

24 of such Act (21 U.S.C. 812(2)).
6

•S 78 IS

1 ‘‘(3) INTENT OF CONGRESS.—It is the intent of

2 Congress that—

3 ‘‘(A) the Secretary shall primarily utilize

4 hospital pharmacies for the dispensing of paren5 teral diacetylmorphine under the program; and

6 ‘‘(B) the Secretary may distribute paren7 teral diacetylmorphine through pharmacies

8 other than hospital pharmacies in cases in

9 which humanitarian concerns necessitate the

10 provision of parenteral diacetylmorphine, a sig11 nificant need is shown for such provision, and

12 adequate protection is available against the di13 version of parenteral diacetylmorphine.

14 ‘‘(d) ILLICIT DIVERSION.—Regulations established

15 by the Secretary under this section shall be designed to

16 protect against the diversion into illicit channels of paren17 teral diacetylmorphine distributed under the program.

18 ‘‘(e) PRESCRIPTION BY PHYSICIANS.—Regulations

19 established under this section shall—

20 ‘‘(1) require that parenteral diacetylmorphine

21 be dispensed only to an individual in accordance

22 with the written prescription of a physician;

23 ‘‘(2) provide that a physician registered under

24 section 302 of the Controlled Substances Act (21

25 U.S.C. 822) may prescribe parenteral
7

•S 78 IS

1 diacetylmorphine for individuals for the relief of in2 tractable pain due to terminal cancer;

3 ‘‘(3) provide that any such prescription shall be

4 in writing; and

5 ‘‘(4) specify such other criteria for the prescrip6 tion as the Secretary may determine to be appro7 priate.

8 ‘‘(f) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—

9 The Federal Food, Drug, and Cosmetic Act (21 U.S.C.

10 301 et seq.) and titles II and III of the Comprehensive

11 Drug Abuse Prevention and Control Act of 1970 (21

12 U.S.C. 801 et seq. and 951 et seq.) shall not apply with

13 respect to—

14 ‘‘(1) the importing of opium;

15 ‘‘(2) the manufacture of parenteral

16 diacetylmorphine; and

17 ‘‘(3) the distribution and dispensing of paren18 teral diacetylmorphine,

19 in accordance with the program.

20 ‘‘(g) REPORTS.—

21 ‘‘(1) BY THE SECRETARY.—

22 ‘‘(A) IMPLEMENTATION AND ACTIVITIES.—

23 ‘‘(i) IMPLEMENTATION.—Not later

24 than 2 months after the date of the enact25 ment of this part and every third month
8

•S 78 IS

1 thereafter until the program is established

2 under subsection (a), the Secretary shall

3 prepare and submit to the Committee on

4 Energy and Commerce of the House of

5 Representatives and the Committee on

6 Labor and Human Resources of the Senate

7 a report containing information on the ac8 tivities undertaken to implement the pro9 gram.

10 ‘‘(ii) ACTIVITIES.—Not later than 1

11 year after the date the program is estab12 lished under subsection (a) and annually

13 thereafter until the program is terminated

14 under subsection (h), the Secretary shall

15 prepare and submit to the committees de16 scribed in clause (i) a report containing in17 formation on the activities under the pro18 gram during the period for which the re19 port is submitted.

20 ‘‘(B) PAIN MANAGEMENT.—Not later than

21 6 months after the date of the enactment of

22 this part, the Secretary shall prepare and sub23 mit to the Committee on Energy and Commerce

24 of the House of Representatives and the Com-
9

•S 78 IS

1 mittee on Labor and Human Resources of the

2 Senate a report that—

3 ‘‘(i) describes the extent of research

4 activities on the management of pain that

5 have received funds through the National

6 Institutes of Health;

7 ‘‘(ii) describes the ways in which the

8 Federal Government supports the training

9 of health personnel in pain management;

10 and

11 ‘‘(iii) contains recommendations for

12 expanding and improving the training of

13 health personnel in pain management.

14 ‘‘(2) BY THE COMPTROLLER GENERAL.—Not

15 later than 56 months after the date on which the

16 program is established under subsection (a), the

17 Comptroller General of the United States shall pre18 pare and submit to the committees referred to in

19 paragraph (1)(A)(i) a report containing information

20 on the activities conducted under the program dur21 ing such 56-month period.

22 ‘‘(h) TERMINATION AND MODIFICATION.—

23 ‘‘(1) IN GENERAL.—The Secretary may at any

24 time later than 6 months after the date on which the

25 program is established under subsection (a), modify
10

•S 78 IS

1 the regulations required by subsection (a) or termi2 nate the program if in the judgment of the Secretary

3 the program is no longer needed or if modifications

4 or termination are needed to prevent substantial di5 version of the diacetylmorphine.

6 ‘‘(2) FINAL TERMINATION.—The program shall

7 terminate 60 months after the date the program is

8 established under subsection (a).’’.

Æ