[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3938 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 3938

   To permit the approval and administration of drugs and devices to 
                    patients who are terminally ill.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 21, 1998

 Mr. Shaw (for himself, Mr. Christensen, Mr. Ramstad, Mrs. Johnson of 
Connecticut, Mr. Coburn, Mr. Romero-Barcelo, Mr. Hayworth, Mr. Neal of 
 Massachusetts, Mr. Bunning, Mr. Burton of Indiana, and Mr. Hilliard) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To permit the approval and administration of drugs and devices to 
                    patients who are terminally ill.

    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 ``Terminally Ill Access to Treatment 
Act of 1998''.

SEC. 2. DRUGS AND DEVICES FOR TERMINALLY ILL.

    (a) Approval.--The Secretary of Health and Human Services shall 
approve, for purposes of treating the terminally ill only, drugs and 
devices which have not received final approval from the Food and Drug 
Administration and which have not been shown to be unsafe.
    (b) Administration.--It is not illegal for a health care 
practitioner to administer a drug or device approved under subsection 
(a) to a terminally ill patient if the practitioner--
            (1) has given the patient sufficient notice that the drug 
        or device has not received final approval from the Food and 
        Drug Administration and should be considered experimental; and
            (2) has received from such patient or the patient's legal 
        representative written approval to administer such drug or 
        device.
    (c) Unsafe Drug or Device.--If a health care practitioner 
administers, in accordance with subsection (b), a drug or device 
approved under subsection (a) and determines the drug is unsafe and has 
caused acute harm to the practitioner's terminally ill patient, the 
practitioner shall cease the administration of the drug or device and 
shall report to the Secretary of Health and Human Services the 
practitioner's findings of acute harm.
    (d) Notice.--The Secretary of Health and Human Services shall give 
timely public notice of--
            (1) the benefits derived from a drug or device approved 
        under subsection (a); and
            (2) any harm caused by a drug or device approved under 
        subsection (a).
    (e) Definitions.--For purposes of this section--
            (1) the term ``terminally ill'' means an individual who has 
        been certified by a physician as having an illness or physical 
        condition which can reasonably be expected to result in death 
        in 24 months or less after the date of certification; and
            (2) the term ``physician'' has the same meaning as is given 
        that term by section 1861(r)(1) of the Social Security Act (42 
        U.S.C 1395x(r)(1)).
                                 <all>