[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1703 Introduced in House (IH)]

<DOC>






115th CONGRESS
  1st Session
                                H. R. 1703

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
           determining the intended use of drugs and devices.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 23, 2017

 Mr. Griffith 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 
           determining the intended use of drugs and devices.

    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 ``Medical Product Communications Act 
of 2017''.

SEC. 2. COMMUNICATIONS REGARDING INTENDED USES OF DRUGS AND DEVICES; 
              SCIENTIFIC EXCHANGE.

    The Federal Food, Drug, and Cosmetic Act is amended by inserting 
after section 201 of such Act (21 U.S.C. 321) the following:

``SEC. 201A. INTENDED USES OF DRUGS AND DEVICES.

    ``(a) Intended Use.--For purposes of this Act, including sections 
301(d), 502(f)(1), 505, 510, and 515 and for purposes of section 351 of 
the Public Health Service Act, the intended use of a drug, biological 
product, or device--
            ``(1) shall be determined by reference to the objective 
        intent of the manufacturer and sponsor of such drug, biological 
        product, or device, or persons acting on the manufacturer's or 
        sponsor's behalf, as demonstrated by statements contained in 
        labeling, advertising, or analogous oral statements; and
            ``(2) shall not be determined by reference to--
                    ``(A) actual or constructive knowledge of the 
                manufacturer or sponsor that such drug, biological 
                product, or device will be used in a manner that varies 
                from the use approved for marketing under section 505, 
                510, or 515 of this Act or section 351 of the Public 
                Health Service Act; or
                    ``(B) scientific exchange as described in 
                subsection (b).
    ``(b) Scientific Exchange.--
            ``(1) In general.--For purposes of this Act, including 
        sections 301(d), 502(f)(1), 505, 510(k), and 515 and for 
        purposes of section 351 of the Public Health Service Act, the 
        scientific exchange of information about a drug, biological 
        product, or device, as described in paragraph (2), shall not 
        constitute labeling, advertising, or evidence of a new intended 
        use.
            ``(2) Requirements for scientific exchange.--A 
        communication by a manufacturer or sponsor, or a person acting 
        on behalf of a manufacturer or sponsor, about the 
        manufacturer's or sponsor's drug, biological product, or 
        device, or use of such drug, biological product, or device, 
        that has not been approved for marketing under section 505, 
        510, or 515 of this Act or section 351 of the Public Health 
        Service Act, about a device or use of such device that has not 
        been approved or cleared for marketing under section 510 or 515 
        of this Act, or about information that is not included in the 
        drug, biological product, or device labeling, constitutes 
        scientific exchange when--
                    ``(A) the communication is supported by 
                scientifically appropriate and statistically sound 
                data, studies, or analyses;
                    ``(B) the communication includes a conspicuous and 
                prominent statement that the drug, biological product, 
                or device, or use of such drug, biological product, or 
                device, that is the subject of the communication, has 
                not been approved for marketing under section 505, 510, 
                or 515 of this Act or section 351 of the Public Health 
                Service Act, or that such communication includes 
                information that is not contained in the drug, 
                biological product, or device labeling, as applicable; 
                and
                    ``(C) for communications relating to a drug, 
                biological product, or device that has not been 
                approved for marketing under section 505, 510, or 515 
                of this Act or section 351 of the Public Health Service 
                Act, or relating to a use of a drug, biological 
                product, or device that has not been so approved, the 
                manufacturer and sponsor make no claims that such 
                product or use has been demonstrated to be safe or 
                effective.
            ``(3) Scientific exchange described.--The scientific 
        exchange of information under paragraph (2) may include--
                    ``(A) dissemination of scientific findings in 
                scientific or lay media;
                    ``(B) publication of results of scientific studies;
                    ``(C) letters to the editor in defense of public 
                challenges;
                    ``(D) communications at scientific or medical 
                conferences or meetings;
                    ``(E) dissemination of medical or scientific 
                publications, reference texts, or clinical practice 
                guidelines;
                    ``(F) communication, both proactive and reactive, 
                of information regarding a manufacturer's research and 
                development efforts;
                    ``(G) communication, both proactive and reactive, 
                of scientific, medical, or technical information or 
                findings, including communication of such information 
                by personnel in scientific, medical, or clinical 
                development departments of manufacturers; and
                    ``(H) communication, both proactive and reactive, 
                of health care economic and health outcomes 
                information, including communication of such 
                information delivered by or on behalf of the health 
                care economic or health outcomes departments of 
                manufacturers to an individual, group of individuals, 
                or entity responsible for contributing toward, 
                advising, or facilitating decisionmaking related to 
                health care resource or utilization management, 
                including decisions about the selection of drugs, 
                biological products, or devices for a population of 
                patients.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed--
                    ``(A) to authorize the Secretary to require that a 
                manufacturer or sponsor submit an application, 
                certification, or other such submission, or to seek the 
                Secretary's review or approval, before, during, or 
                subsequent to engaging in scientific exchange; or
                    ``(B) to limit the ability of manufacturers or 
                sponsors to engage in communications or activities that 
                properly constitute scientific exchange as that term is 
                described in paragraph (2) but that are not specified 
                in paragraph (3).''.
                                 <all>