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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2452 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2452

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
    facilitating dissemination of health care economic information.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

 Mr. Long (for himself, Mr. Schrader, and Mr. Burgess) 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 with respect to 
    facilitating dissemination of health care economic information.

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

SECTION 1. FACILITATING DISSEMINATION OF HEALTH CARE ECONOMIC 
              INFORMATION.

    Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(a)) is amended--
            (1) by striking ``(a) If its'' and inserting ``(a)(1) If 
        its'';
            (2) by striking ``a formulary committee, or other similar 
        entity, in the course of the committee or the entity carrying 
        out its responsibilities for the selection of drugs for managed 
        care or other similar organizations'' and inserting ``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 or reimbursement'';
            (3) by striking ``directly relates'' and inserting 
        ``relates'';
            (4) by striking ``and is based on competent and reliable 
        scientific evidence. The requirements set forth in section 
        505(a) or in section 351(a) of the Public Health Service Act 
        shall not apply to health care economic information provided to 
        such a committee or entity in accordance with this paragraph'' 
        and inserting ``, is based on competent and reliable scientific 
        evidence, and includes, where applicable, a conspicuous and 
        prominent statement describing any material differences between 
        the health care economic information and the labeling approved 
        for the drug under section 505 or under section 351 of the 
        Public Health Service Act. The requirements set forth in 
        section 505(a) or in subsections (a) and (k) of section 351 of 
        the Public Health Service Act shall not apply to health care 
        economic information provided to such a payor, committee, or 
        entity in accordance with this paragraph''; and
            (5) by striking ``In this paragraph, the term'' and all 
        that follows and inserting the following:
    ``(2)(A) For purposes of this paragraph, the term `health care 
economic information' means any analysis (including the clinical data, 
inputs, clinical or other assumptions, methods, results, and other 
components underlying or comprising the analysis) that identifies, 
measures, or describes the economic consequences, which may be based on 
the separate or aggregated clinical consequences of the represented 
health outcomes, of the use of a drug. Such analyses may be comparative 
to the use of another drug, to another health care intervention, or to 
no intervention.
    ``(B) Such term does not include any analysis that relates only to 
an indication that is not approved under section 505 or under section 
351 of the Public Health Service Act for such drug.''.
                                 <all>
```