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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5811 Engrossed in House (EH)]

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115th CONGRESS
  2d Session
                                H. R. 5811

_______________________________________________________________________

                                 AN ACT

 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
postapproval study requirements for certain controlled substances, 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. POSTAPPROVAL STUDY REQUIREMENTS.

    (a) Purposes of Study.--Section 505(o)(3)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is amended by adding at 
the end the following:
                            ``(iv) To assess a potential reduction in 
                        effectiveness of the drug for the conditions of 
                        use prescribed, recommended, or suggested in 
                        the labeling thereof if--
                                    ``(I) the drug involved--
                                            ``(aa) is or contains a 
                                        substance for which a listing 
                                        in any schedule is in effect 
                                        (on a temporary or permanent 
                                        basis) under section 201 of the 
                                        Controlled Substances Act; or
                                            ``(bb) is a drug that has 
                                        not been approved under this 
                                        section or licensed under 
                                        section 351 of the Public 
                                        Health Service Act, for which 
                                        an application for such 
                                        approval or licensure is 
                                        pending or anticipated, and for 
                                        which the Secretary provides 
                                        notice to the sponsor that the 
                                        Secretary intends to issue a 
                                        scientific and medical 
                                        evaluation and recommend 
                                        controls under the Controlled 
                                        Substances Act; and
                                    ``(II) the potential reduction in 
                                effectiveness could result in the 
                                benefits of the drug no longer 
                                outweighing the risks.''.
    (b) Establishment of Requirement.--Section 505(o)(3)(C) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(C)) is 
amended by striking ``such requirement'' and all that follows through 
``safety information.'' and inserting the following: ``such 
requirement--
                            ``(i) in the case of a purpose described in 
                        clause (i), (ii), or (iii) of subparagraph (B), 
                        only if the Secretary becomes aware of new 
                        safety information; and
                            ``(ii) in the case of a purpose described 
                        in clause (iv) of such subparagraph, if the 
                        Secretary determines that new effectiveness 
                        information exists.''.
    (c) Applicability.--Section 505(o)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by adding at the end 
the following new subparagraph:
                    ``(G) Applicability.--The conduct of a study or 
                clinical trial required pursuant to this paragraph for 
                the purpose specified in subparagraph (B)(iv) shall not 
                be considered a new clinical investigation for the 
                purpose of a period of exclusivity under clause (iii) 
                or (iv) of subsection (c)(3)(E) or clause (iii) or (iv) 
                of subsection (j)(5)(F).''.
    (d) New Effectiveness Information Defined.--Section 505(o)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(2)) is 
amended by adding at the end the following new subparagraph:
                    ``(D) New effectiveness information.--The term `new 
                effectiveness information', with respect to a drug that 
                is or contains a controlled substance for which a 
                listing in any schedule is in effect (on a temporary or 
                permanent basis) under section 201 of the Controlled 
                Substances Act, means new information about the 
                effectiveness of the drug, including a new analysis of 
                existing information, derived from--
                            ``(i) a clinical trial; an adverse event 
                        report; a postapproval study or clinical trial 
                        (including a study or clinical trial under 
                        paragraph (3));
                            ``(ii) peer-reviewed biomedical literature;
                            ``(iii) data derived from the postmarket 
                        risk identification and analysis system under 
                        subsection (k); or
                            ``(iv) other scientific data determined to 
                        be appropriate by the Secretary.''.
    (e) Conforming Amendments With Respect to Labeling Changes.--
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(o)(4)) is amended--
            (1) in subparagraph (A)--
                    (A) in the heading, by inserting ``or new 
                effectiveness'' after ``safety'';
                    (B) by striking ``safety information'' and 
                inserting ``new safety information or new effectiveness 
                information such''; and
                    (C) by striking ``believes should be'' and 
                inserting ``believes changes should be made to'';
            (2) in subparagraph (B)(i)--
                    (A) by striking ``new safety information'' and by 
                inserting ``new safety information or new effectiveness 
                information''; and
                    (B) by inserting ``indications,'' after ``boxed 
                warnings,'';
            (3) in subparagraph (C), by inserting ``or new 
        effectiveness information'' after ``safety information''; and
            (4) in subparagraph (E), by inserting ``or new 
        effectiveness information'' after ``safety information''.
    (f) Rule of Construction.--Nothing in the amendments made by this 
section shall be construed to alter, in any manner, the meaning or 
application of the provisions of paragraph (3) of section 505(o) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)) with respect to 
the authority of the Secretary of Health and Human Services to require 
a postapproval study or clinical trial for a purpose specified in 
clauses (i) through (iii) of subparagraph (B) of such paragraph (3) or 
paragraph (4) of such section 505(o) with respect to the Secretary's 
authority to require safety labeling changes. 

            Passed the House of Representatives June 19, 2018.

            Attest:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5811

_______________________________________________________________________

                                 AN ACT

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
postapproval study requirements for certain controlled substances, and 
                          for other purposes.
```