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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5806 Introduced in House (IH)]

<DOC>

115th CONGRESS
  2d Session
                                H. R. 5806

To require the Secretary of Health and Human Services to issue guidance 
with respect to the expedited approval of certain drugs, and for other 
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2018

Mr. Burgess (for himself, Mr. Bucshon, and Mr. Griffith) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL

 
To require the Secretary of Health and Human Services to issue guidance 
with respect to the expedited approval of certain drugs, and for other 
                               purposes.

    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 ``21st Century Tools for Pain and 
Addiction Treatment Act''.

SEC. 2. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN AND ADDICTION 
              THERAPIES.

    (a) Public Meetings.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall hold not less 
than one public meeting to address the challenges and barriers of 
developing non-addictive medical products intended to treat pain or 
addiction, which may include--
            (1) the application of novel clinical trial designs 
        (consistent with section 3021 of the 21st Century Cures Act 
        (Public Law 114-255)), use of real world evidence (consistent 
        with section 505F of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355g)), and use of patient experience data 
        (consistent with section 569C of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb-8c)) for the development of non-
        addictive medical products intended to treat pain or addiction; 
        and
            (2) the application of eligibility criteria under sections 
        506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 356, 360e-3) for non-addictive medical products intended 
        to treat pain or addiction.
    (b) Guidance.--Not later than one year after the public meetings 
are conducted under subsection (a) the Secretary shall issue one or 
more final guidance documents, or update existing guidance documents, 
to help address challenges to developing non-addictive medical products 
to treat pain or addiction. Such guidance documents shall include 
information regarding--
            (1) how the Food and Drug Administration may apply sections 
        506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 356, 360e-3) to non-addictive medical products intended 
        to treat pain or addiction, including the circumstances under 
        which the Secretary--
                    (A) may apply the eligibility criteria under such 
                sections 506 and 515B to non-opioid or non-addictive 
                medical products intended to treat pain or addiction;
                    (B) considers the risk of addiction of controlled 
                substances approved to treat pain when establishing 
                unmet medical need; and
                    (C) considers pain, pain control, or pain 
                management in assessing whether a disease or condition 
                is a serious or life-threatening disease or condition; 
                and
            (2) the methods by which sponsors may evaluate acute and 
        chronic pain, endpoints for non-addictive medical products 
        intended to treat pain, the manner in which endpoints and 
        evaluations of efficacy will be applied across and within 
        review divisions, taking into consideration the etiology of the 
        underlying disease, and the manner in which sponsors may use 
        surrogate endpoints, intermediate endpoints, and real world 
        evidence.
    (c) Medical Product Defined.--In this section, the term ``medical 
product'' means a drug (as defined in section 201(g)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product 
(as defined in section 351(i) of the Public Health Service Act (42 
U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))).
                                 <all>
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