[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2026 Introduced in House (IH)]

<DOC>






115th CONGRESS
  1st Session
                                H. R. 2026

     To improve patient access to emerging medication therapies by 
 clarifying the scope of permitted health care economic and scientific 
information communications between biopharmaceutical manufacturers and 
                   population health decision makers.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 6, 2017

 Mr. Guthrie introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
     To improve patient access to emerging medication therapies by 
 clarifying the scope of permitted health care economic and scientific 
information communications between biopharmaceutical manufacturers and 
                   population health decision makers.

    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 Information Exchange 
Act''.

SEC. 2. FACILITATING EXCHANGE OF INFORMATION PRIOR TO APPROVAL.

    Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(a)) is amended--
            (1) by redesignating subparagraph (2) as subparagraph (3);
            (2) by inserting after subparagraph (1) the following:
    ``(2) Health care economic information or scientific information 
provided to a payor, formulary committee, or other similar entity with 
knowledge and expertise in the area of health care economic analysis 
carrying out its responsibilities for the selection of drugs for 
coverage, reimbursement, or other population-based health care 
management, shall not be considered false or misleading or any other 
form of misbranding under this paragraph, or a violation of section 505 
of this Act or section 351 of the Public Health Service Act, or 
otherwise prohibited pre-approval promotion of a drug, if it is based 
on competent and reliable scientific evidence and relates to an 
investigational new drug or an investigational use of an approved drug. 
In order for information relating to an investigational use of an 
approved drug to be provided pursuant to this subparagraph, there must 
have been submitted to the Secretary a supplemental application for 
approval of such use, or the study or studies needed to support the 
submission of a supplemental application for such use must have been 
completed with the intention that a supplemental application will be 
submitted to the Secretary for approval of the use. For purposes of 
this subparagraph, scientific information includes clinical and pre-
clinical data and results relating to an unapproved drug therapy, or 
drug indication, or other condition of use being investigated or 
developed.''; and
            (3) in subparagraph (3), as redesignated--
                    (A) by striking ``(A)''; and
                    (B) by striking clause (B).
                                 <all>