[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 78 Introduced in Senate (IS)]

  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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Compassionate Pain Relief Act''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) cancer is a progressive, degenerative, and often 
        painful disease that afflicts one out of every four persons in 
        the United States and is the second leading cause of death;
            (2) in the progression of terminal cancer, a significant 
        number of patients experience levels of intense and intractable 
        pain that cannot be effectively treated by presently available 
        medication;
            (3) the effect of such pain often leads to a severe 
        deterioration in the quality of life of the patient and 
        heartbreak for the family of the patient;
            (4) the therapeutic use of parenteral diacetylmorphine is 
        not permitted in the United States but extensive clinical 
        research has demonstrated that the drug is a potent, highly 
        soluble painkilling drug when properly formulated and 
        administered under the supervision of a physician;
            (5) it is in the public interest to make parenteral 
        diacetylmorphine available to patients through controlled 
        channels as a drug for the relief of intractable pain due to 
        terminal cancer;
            (6) diacetylmorphine is successfully used in Great Britain 
        and other countries for relief of pain due to cancer;
            (7) the availability of parenteral diacetylmorphine for the 
        limited purposes of controlling intractable pain due to 
        terminal cancer will not adversely affect the abuse of illicit 
        drugs or increase the incidence of pharmacy thefts;
            (8) the availability of parenteral diacetylmorphine will 
        enhance the ability of physicians to effectively treat and 
        control intractable pain due to terminal cancer; and
            (9) it is appropriate for the Federal Government to 
        establish a temporary program to permit the use of 
        pharmaceutical dosage forms of parenteral diacetylmorphine for 
        the control of intractable pain due to terminal cancer.

SEC. 3. PARENTERAL DIACETYLMORPHINE PROGRAM.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following new part:

                  ``Part O--Compassionate Pain Relief

``SEC. 399G. PARENTERAL DIACETYLMORPHINE.

    ``(a) Regulations.--
            ``(1) In general.--Not later than three months after the 
        date of the enactment of this part, the Secretary shall issue 
        regulations establishing a program (referred to in this section 
        as the `program') under which parenteral diacetylmorphine may 
        be dispensed from pharmacies for the relief of intractable pain 
        due to terminal cancer.
            ``(2) Terminal cancer.--For purposes of this section, an 
        individual shall be considered to have terminal cancer if there 
        is histologic evidence of a malignancy in the individual and 
        the cancer of the individual is generally recognized as a 
        cancer with a high and predictable mortality.
    ``(b) Manufacturing.--Regulations established under this section 
shall provide that manufacturers of parenteral diacetylmorphine for 
dispensing under the program shall use adequate methods of, and 
adequate facilities and controls for, the manufacturing, processing, 
and packing of such drug to preserve the identity, strength, quality, 
and purity of the drug.
    ``(c) Availability to Pharmacies.--
            ``(1) Requirements.--Regulations established under this 
        section shall require that parenteral diacetylmorphine be made 
        available only to pharmacies that--
                    ``(A) are hospital pharmacies or such other 
                pharmacies as the regulations specify;
                    ``(B) are registered under section 302 of the 
                Controlled Substances Act (21 U.S.C. 822);
                    ``(C) meet such qualifications as the regulations 
                specify; and
                    ``(D) submit an application in accordance with 
                paragraph (2).
            ``(2) Application.--An application for parenteral 
        diacetylmorphine shall--
                    ``(A) be in such form and submitted in such manner 
                as the Secretary may prescribe; and
                    ``(B) contain assurances satisfactory to the 
                Secretary that--
                            ``(i) the applicant will comply with such 
                        special requirements as the Secretary may 
                        prescribe respecting the storage and dispensing 
                        of parenteral diacetylmorphine; and
                            ``(ii) parenteral diacetylmorphine provided 
                        under the application will be dispensed through 
                        the applicant upon the written prescription of 
                        a physician registered under section 302 of the 
                        Controlled Substances Act (21 U.S.C. 822) to 
                        dispense controlled substances in schedule II 
                        of such Act (21 U.S.C. 812(2)).
            ``(3) Intent of congress.--It is the intent of Congress 
        that--
                    ``(A) the Secretary shall primarily utilize 
                hospital pharmacies for the dispensing of parenteral 
                diacetylmorphine under the program; and
                    ``(B) the Secretary may distribute parenteral 
                diacetylmorphine through pharmacies other than hospital 
                pharmacies in cases in which humanitarian concerns 
                necessitate the provision of parenteral 
                diacetylmorphine, a significant need is shown for such 
                provision, and adequate protection is available against 
                the diversion of parenteral diacetylmorphine.
    ``(d) Illicit Diversion.--Regulations established by the Secretary 
under this section shall be designed to protect against the diversion 
into illicit channels of parenteral diacetylmorphine distributed under 
the program.
    ``(e) Prescription by Physicians.--Regulations established under 
this section shall--
            ``(1) require that parenteral diacetylmorphine be dispensed 
        only to an individual in accordance with the written 
        prescription of a physician;
            ``(2) provide that a physician registered under section 302 
        of the Controlled Substances Act (21 U.S.C. 822) may prescribe 
        parenteral diacetylmorphine for individuals for the relief of 
        intractable pain due to terminal cancer;
            ``(3) provide that any such prescription shall be in 
        writing; and
            ``(4) specify such other criteria for the prescription as 
        the Secretary may determine to be appropriate.
    ``(f) Federal Food, Drug, and Cosmetic Act.--The Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and titles II and III of 
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 
U.S.C. 801 et seq. and 951 et seq.) shall not apply with respect to--
            ``(1) the importing of opium;
            ``(2) the manufacture of parenteral diacetylmorphine; and
            ``(3) the distribution and dispensing of parenteral 
        diacetylmorphine,
in accordance with the program.
    ``(g) Reports.--
            ``(1) By the secretary.--
                    ``(A) Implementation and activities.--
                            ``(i) Implementation.--Not later than 2 
                        months after the date of the enactment of this 
                        part and every third month thereafter until the 
                        program is established under subsection (a), 
                        the Secretary shall prepare and submit to the 
                        Committee on Energy and Commerce of the House 
                        of Representatives and the Committee on Labor 
                        and Human Resources of the Senate a report 
                        containing information on the activities 
                        undertaken to implement the program.
                            ``(ii) Activities.--Not later than 1 year 
                        after the date the program is established under 
                        subsection (a) and annually thereafter until 
                        the program is terminated under subsection (h), 
                        the Secretary shall prepare and submit to the 
                        committees described in clause (i) a report 
                        containing information on the activities under 
                        the program during the period for which the 
                        report is submitted.
                    ``(B) Pain management.--Not later than 6 months 
                after the date of the enactment of this part, the 
                Secretary shall prepare and submit to the Committee on 
                Energy and Commerce of the House of Representatives and 
                the Committee on Labor and Human Resources of the 
                Senate a report that--
                            ``(i) describes the extent of research 
                        activities on the management of pain that have 
                        received funds through the National Institutes 
                        of Health;
                            ``(ii) describes the ways in which the 
                        Federal Government supports the training of 
                        health personnel in pain management; and
                            ``(iii) contains recommendations for 
                        expanding and improving the training of health 
                        personnel in pain management.
            ``(2) By the comptroller general.--Not later than 56 months 
        after the date on which the program is established under 
        subsection (a), the Comptroller General of the United States 
        shall prepare and submit to the committees referred to in 
        paragraph (1)(A)(i) a report containing information on the 
        activities conducted under the program during such 56-month 
        period.
    ``(h) Termination and Modification.--
            ``(1) In general.--The Secretary may at any time later than 
        6 months after the date on which the program is established 
        under subsection (a), modify the regulations required by 
        subsection (a) or terminate the program if in the judgment of 
        the Secretary the program is no longer needed or if 
        modifications or termination are needed to prevent substantial 
        diversion of the diacetylmorphine.
            ``(2) Final termination.--The program shall terminate 60 
        months after the date the program is established under 
        subsection (a).''.
                                 <all>