[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1294 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 1294

  To amend title 10, United States Code, to require the Secretary of 
   Defense to provide to members of the Armed Forces who receive an 
   investigational new drug relevant information regarding the drug, 
            including the possible side effects of the drug.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 10, 1997

 Mr. Kennedy of Rhode Island introduced the following bill; which was 
             referred to the Committee on National Security

_______________________________________________________________________

                                 A BILL


 
  To amend title 10, United States Code, to require the Secretary of 
   Defense to provide to members of the Armed Forces who receive an 
   investigational new drug relevant information regarding the drug, 
            including the possible side effects of the drug.

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

SECTION 1. NOTICE OF USE OF INVESTIGATIONAL NEW DRUGS.

    (a) Notice to Members Receiving Drugs.--(1) Chapter 55 of title 10, 
United States Code, is amended by adding at the end the following new 
section:
``Sec. 1107. Notice of use of investigational new drugs
    ``(a) Notice Required.--Whenever the Secretary of Defense requests 
or requires a member of the armed forces to receive an investigational 
new drug, the Secretary shall provide the member with notice containing 
the information specified in subsection (c). The notice shall be 
provided before the investigational new drug is first administered to 
the member, if practicable, but in no case later than 30 days after the 
investigational new drug is first administered to the member.
    ``(b) Form of Notice.--The notice required under subsection (a) 
shall be provided in writing unless the Secretary of Defense determines 
that the use of written notice is impractical because of the number of 
members receiving the investigational new drug, time constraints, or 
similar reasons. If the Secretary provides notice under subsection (a) 
in a form other than in writing, the Secretary shall submit to Congress 
a report describing the notification method used and the reasons for 
the use of the alternative method.
    ``(c) Content of Notice.--The notice required under subsection (a) 
shall include the following:
            ``(1) Clear notice that drug being administered is an 
        investigational new drug.
            ``(2) The reasons why the investigational new drug is being 
        administered.
            ``(3) Information regarding the possible side effects of 
        the investigational new drug, including any known side effects 
        possible as a result of the interaction of the investigational 
        new drug with other drugs or treatments being administered to 
        the members receiving the investigational new drug.
            ``(4) Such other information that, as a condition of 
        authorizing the use of the investigational new drug, the 
        Secretary of Health and Human Services may require to be 
        disclosed.
    ``(d) Definition.--In this section, the term `investigational new 
drug' means a drug covered by section 505(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(i)).''.
    (b) Clerical Amendment.--The table of sections at the beginning of 
such chapter is amended by adding at the end the following new item:

``1107. Notice of use of investigational new drugs.''.
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