[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2694 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 2694

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
    Service Act to require special testing for drugs and biological 
                        products used by women.


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                    IN THE HOUSE OF REPRESENTATIVES

                             July 21, 1993

  Mrs. Schroeder (for herself and Ms. Snowe) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
    Service Act to require special testing for drugs and biological 
                        products used by women.

    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 ``Pharmaceutical Interactions Safety 
Act''.

SEC. 2. CLINICAL INVESTIGATIONS.

    Section 505(b) of the Federal Food, Drug, and Cosmetic Act is 
amended by adding at the end the following:
    ``(4) Clinical investigations to be submitted as part of an 
application in accordance with paragraph (1)(A) shall include 
investigations of the possible interaction of the drug with relevant 
female or male hormones or related substances unless there is 
substantial evidence that there are no significant interactions between 
the drug under investigation and such substances or the inclusion of 
such investigations is otherwise inappropriate under guidelines 
established by the Secretary by rule.''.

SEC. 3. BIOLOGICAL PRODUCTS CLINICAL INVESTIGATIONS.  

    Section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) 
is amended by adding at the end the following:
    ``(3) Clinical investigations submitted as part of an application 
for a biological product in accordance with paragraph (1) shall include 
investigations of the possible interaction of the biological product 
with relevant female or male hormones or related substances unless 
there is substantial evidence that there are no significant 
interactions between the biological product under investigation and 
such substances or the inclusion of such investigations is otherwise 
inappropriate under guidelines established by the Secretary by rule.''.

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