[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2932 Introduced in House (IH)]

  2d Session
                                H. R. 2932

    To amend the Federal Food, Drug, and Cosmetic Act to revise the 
 requirements of that Act relating to the dissemination of scientific 
                         information on drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 1, 1996

    Mr. Burr (for himself, Mr. Coburn, Mr. Stenholm, Mr. Upton, Mr. 
 Brewster, Mr. Bilbray, Mrs. Lincoln, and Mr. Heineman) introduced the 
    following bill; which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to revise the 
 requirements of that Act relating to the dissemination of scientific 
                         information on drugs.

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

SECTION 1. DISSEMINATION OF SCIENTIFIC INFORMATION.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(n)(1) The holder of an approved new drug application may 
distribute in any manner to a health professional (including a health 
provider or insurer) a reprint of an article in an independent peer-
reviewed medical textbook, journal, or medical compendium which 
includes information about the drug that is not in the package insert, 
if the reprint is accompanied by a copy of the package insert and a 
statement that the reprint includes information that has not been 
approved by the Food and Drug Administration. Reprints distributed 
under this subsection shall not be regulated as advertising or labeling 
and shall not be required to be submitted to the Secretary.
    ``(2) With respect to an approved indication for a new drug, and 
for any pharmacoeconomic information relating to a drug, the Secretary 
shall not take action to prevent the use of advertising or labeling 
(except the package insert) unless the Secretary determines in writing, 
after an informal hearing, that the advertising or labeling is likely 
to cause misuse of the drug in a way that is unsafe or ineffective.
    ``(3) For purposes of this subsection, the term `peer-reviewed 
journal' includes journals of medical societies associated with a 
certifying board of the American Board of Medical Specialties or an 
equivalent organization in health economics and such other journals as 
the Commissioner shall designate by regulation. This function may not 
be further delegated.''.

SEC. 2. EFFECTIVE DATE.

    The amendment made by section 1 shall take effect upon the date of 
enactment of this Act.
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