[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3460 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 3460

  To amend title 10, United States Code, to require the consent of a 
  member of the Armed Forces before administering the member with an 
    investigational new drug or drug unapproved for its applied use.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 18, 1999

Mr. Bachus (for himself and Mr. Jones of North Carolina) introduced the 
 following bill; which was referred to the Committee on Armed Services

_______________________________________________________________________

                                 A BILL


 
  To amend title 10, United States Code, to require the consent of a 
  member of the Armed Forces before administering the member with an 
    investigational new drug or drug unapproved for its applied use.

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

SECTION 1. FINDINGS.

    The Congress finds the following:
            (1) Under current law, the Department of Defense may 
        administer drugs that have not obtained approval by the Food 
        and Drug Administration to members of the Armed Forces without 
        informing the members of the drug they are receiving or 
        obtaining consent of the members.
            (2) In a time when military recruiting is at historic lows, 
        and evidence of failure of the Department of Defense to 
        properly inform military personnel of the true nature of 
        medical treatment performed on members of the Armed Forces in 
        past conflicts, it is the duty of Congress to ensure that no 
        member of the Armed Forces will be administered an unapproved 
        drug without the informed consent of the member.
            (3) While there may be situations in which an unapproved 
        drug is the best protection for members of the Armed Forces 
        facing the threat of biological warfare, such members should 
        have the same constitutional protections as every other United 
        States citizen and therefore have the right to know about any 
        drug being administered to them.
            (4) Every member of the Armed Forces should be informed of 
        the nature and Food and Drug Administration approval status of 
        all drugs that the Department of Defense seeks to administer.

SEC. 2. CONSENT REQUIRED FOR ADMINISTRATION OF INVESTIGATIONAL NEW DRUG 
              OR DRUG UNAPPROVED FOR ITS APPLIED USE.

    (a) In General.--Section 1107 of title 10, United States Code, is 
amended--
            (1) by amending the heading to read as follows:
``Sec. 1107. Notice and consent required for use of an investigational 
              new drug or drug unapproved for its applied use'';
            (2) in subsection (a)--
                    (A) by inserting ``and Consent'' after ``Notice''; 
                and
                    (B) in paragraph (1)--
                            (i) by striking ``or requires''; and
                            (ii) by adding at the end the following new 
                        sentence: ``The Secretary may not administer an 
                        investigational new drug or drug unapproved for 
                        its applied use to a member without obtaining 
                        the consent of the member.''; and
            (3) by striking subsection (f); and
            (4) by redesignating subsection (g) as subsection (f).
    (b) Clerical Amendment.--The table of sections at the beginning of 
such chapter is amended to read as follows:

``1107. Notice and consent required for use of an investigational new 
                            drug or drug unapproved for its applied 
                            use.''.
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