[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5687 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 5687

 To amend the Federal Food, Drug, and Cosmetic Act to require improved 
 packaging and disposal methods with respect to certain drugs, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 7, 2018

Mr. Hudson (for himself, Mr. Butterfield, and Mr. Budd) 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 to require improved 
 packaging and disposal methods with respect to 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 ``Securing Opioids and Unused 
Narcotics with Deliberate Disposal and Packaging Act of 2018'' or the 
``SOUND Disposal and Packaging Act''.

SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH RESPECT TO 
              THE PACKAGING OR DISPOSAL OF CERTAIN DRUGS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 505-1 (21 U.S.C. 355-1) the 
following new section:

``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.

    ``(a) Orders.--
            ``(1) In general.--The Secretary may, after consultation 
        with relevant stakeholders, issue an order requiring the holder 
        of a covered application to implement or modify one or more 
        technologies, controls, or measures with respect to the 
        packaging or disposal of one or more drugs identified in the 
        covered application, if the Secretary determines such 
        technologies, controls, or measures to be appropriate to help 
        mitigate the risk of abuse or misuse of such drug or drugs, 
        including by reducing the availability of unused drugs.
            ``(2) Assuring access and minimizing burden.--Technologies, 
        controls, or measures required under paragraph (1) shall--
                    ``(A) be commensurate with the specific risk of 
                abuse or misuse of the drug listed in the covered 
                application;
                    ``(B) considering such risk, not be unduly 
                burdensome on patient access to the drug, considering 
                in particular the available evidence regarding the 
                expected or demonstrated public health impact of such 
                technologies, controls, or measures; and
                    ``(C) reduce the risk of abuse or misuse of such 
                drug.
            ``(3) Order contents.--An order issued under paragraph (1) 
        may--
                    ``(A) provide for a range of options for 
                implementing or modifying the technologies, controls, 
                or measures required to be implemented by such order; 
                and
                    ``(B) incorporate by reference standards regarding 
                packaging or disposal set forth in an official 
                compendium, established by a nationally or 
                internationally recognized standard development 
                organization, or described on the public Internet 
                website of the Food and Drug Administration, so long as 
                the order includes the rationale for incorporation of 
                such standard.
            ``(4) Orders applicable to drug class.--When a concern 
        about the risk of abuse or misuse of a drug relates to a 
        pharmacological class, the Secretary may, after consultation 
        with relevant stakeholders, issue an order under paragraph (1) 
        which applies to the pharmacological class.
    ``(b) Compliance.--The holder of a covered application shall--
            ``(1) submit a supplement containing proposed changes to 
        the covered application to comply with an order issued under 
        subsection (a) not later than--
                    ``(A) 180 calendar days after the date on which the 
                order is issued; or
                    ``(B)(i) such longer time period as specified by 
                the Secretary in such order; or
                    ``(ii) if a request for an alternative date is 
                submitted by the holder of such application not later 
                than 60 calendar days after the date on which such 
                order is issued--
                            ``(I) such requested alternative date if 
                        agreed to by the Secretary; or
                            ``(II) another date as specified by the 
                        Secretary; and
            ``(2) implement the changes approved pursuant to such 
        supplement not later than the later of--
                    ``(A) 90 calendar days after the date on which the 
                supplement is approved; or
                    ``(B) the end of such longer period as is--
                            ``(i) determined to be appropriate by the 
                        Secretary; or
                            ``(ii) approved by the Secretary pursuant 
                        to a request by the holder of the covered 
                        application that explains why such longer 
                        period is needed, including to satisfy any 
                        other applicable Federal statutory or 
                        regulatory requirements.
    ``(c) Alternative Measures.--The holder of the covered application 
may propose, and the Secretary shall approve, technologies, controls, 
or measures regarding packaging, storage, or disposal other than those 
specified in the applicable order issued under subsection (a), if such 
technologies, controls, or measures are supported by data and 
information demonstrating that such alternative technologies, controls, 
or measures can be expected to mitigate the risk of abuse or misuse of 
the drug or drugs involved, including by reducing the availability of 
unused drugs, to at least the same extent as the technologies, 
controls, or measures specified in such order.
    ``(d) Dispute Resolution.--If a dispute arises in connection with a 
supplement submitted under subsection (b), the holder of the covered 
application may appeal a determination made with respect to such 
supplement using applicable dispute resolution procedures specified by 
the Secretary in regulations or guidance.
    ``(e) Definitions.--In this section--
            ``(1) the term `covered application' means an application 
        submitted under subsection (b) or (j) of section 505 for 
        approval under such section or an application approved under 
        section 351 of Public Health Service Act, with respect to a 
        drug that is or contains an opioid for which a listing in 
        schedule II or III (on a temporary or permanent basis) is in 
        effect under section 202 of the Controlled Substances Act; and
            ``(2) the term `relevant stakeholders' may include 
        scientific experts within the drug manufacturing industry; 
        brand and generic drug manufacturers; standard development 
        organizations; wholesalers and distributors; payers; health 
        care providers; pharmacists; manufacturers; poison centers; and 
        representatives of the National Institute on Drug Abuse, the 
        National Institutes of Health, the Centers for Disease Control 
        and Prevention, the Centers for Medicare & Medicaid Services, 
        the Drug Enforcement Agency, the Consumer Product Safety 
        Commission, individuals who specialize in treating addiction, 
        and patient and caregiver groups.''.
    (b) Prohibited Acts.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph 
(j) the following:
    ``(k) If it is a drug approved under a covered application (as 
defined in section 505-2(e)), the holder of which does not meet the 
requirements of paragraphs (1) and (2) of subsection (b) of such 
section.''.
    (c) Required Content of an Abbreviated New Drug Application.--
Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(2)(A)) is amended--
            (1) in clause (vii)(IV), by striking ``and'' at the end;
            (2) in clause (viii), by striking the period at the end and 
        inserting ``; and''; and
            (3) by adding at the end the following:
                            ``(ix) if the drug is or contains an opioid 
                        for which a listing in schedule II or III (on a 
                        temporary or permanent basis) is in effect 
                        under section 202 of the Controlled Substances 
                        Act, information to show that the applicant has 
                        proposed technologies, controls, or measures 
                        related to the packaging or disposal of the 
                        drug that are comparably effective to those 
                        required for the applicable listed drug under 
                        section 505-2, if applicable.''.
    (d) Grounds for Refusing To Approve an Abbreviated New Drug 
Application.--Section 505(j)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(4)), is amended--
            (1) in subparagraph (J), by striking ``or'' at the end;
            (2) in subparagraph (K), by striking the period at the end 
        and inserting ``; or''; and
            (3) by adding at the end the following:
                    ``(L) if the drug is a drug described in paragraph 
                (2)(A)(ix) and the applicant has not proposed 
                technologies, controls, or measures related to the 
                packaging or disposal of such drug that the Secretary 
                determines are comparably effective to those required 
                for the applicable listed drug under section 505-2.''.
    (e) Rules of Construction.--
            (1) Any labeling describing technologies, controls, or 
        measures related to packaging, storage, or disposal intended to 
        mitigate the risk of abuse or misuse of a drug product that is 
        subject to an abbreviated new drug application, including 
        labeling describing differences from the reference listed drug 
        resulting from the application of section 505-2 of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (a), shall 
        not be construed--
                    (A) as changes to labeling not permissible under 
                clause (v) of section 505(j)(2)(A) of such Act (21 
                U.S.C. 355(j)(2)(A)), or a change in the conditions of 
                use prescribed, recommended, or suggested in the 
                labeling proposed for the new drug under clause (i) of 
                such section; or
                    (B) to prohibit approval of an abbreviated new drug 
                application under subparagraph (B) or (G) of section 
                505(j)(4) of such Act (21 U.S.C. 355(j)(4)).
            (2) For a covered application that is an application 
        submitted under subjection (j) of section 505 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355), subparagraph 
        (j)(2)(A) of such section 505 shall not be construed to limit 
        the type of data or information the Secretary of Health and 
        Human Services may request or consider in connection with 
        making any determination under section 505-2.
    (f) GAO Report.--Not later than 12 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall prepare and submit to the Congress a report containing--
            (1) a description of available evidence, if any, on the 
        effectiveness of site-of-use, in-home controlled substance 
        disposal products and packaging technologies;
            (2) identification of ways in which such disposal products 
        intended for use by patients, consumers, and other end users 
        that are not registrants under the Controlled Substances Act, 
        are made available to the public and barriers to the use of 
        such disposal products;
            (3) identification of ways in which packaging technologies 
        are made available to the public and barriers to the use of 
        such technologies;
            (4) a description of Federal oversight, if any, of site-of-
        use, in-home controlled substance disposal products, 
        including--
                    (A) identification of the Federal agencies that 
                oversee such products;
                    (B) identification of the methods of disposal of 
                controlled substances recommended by these agencies for 
                site-of-use, in-home disposal; and
                    (C) a description of the effectiveness of such 
                recommendations at preventing the diversion of legally 
                prescribed controlled substances;
            (5) a description of Federal oversight, if any, of 
        controlled substance packaging technologies, including--
                    (A) identification of the Federal agencies that 
                oversee such technologies;
                    (B) identification of the technologies recommended 
                by these agencies, including unit dose packaging, 
                packaging that provides a set duration, or other 
                packaging systems that may mitigate abuse or misuse; 
                and
                    (C) a description of the effectiveness of such 
                recommendations at preventing the diversion of legally 
                prescribed controlled substances; and
            (6) recommendations on--
                    (A) whether site-of-use, in-home controlled 
                substance disposal products and packaging technologies 
                require Federal oversight and, if so, which agencies 
                should be responsible for such oversight and, as 
                applicable, approval of such products or technologies; 
                and
                    (B) the potential role of the Federal Government in 
                evaluating such products to ensure product efficacy.
                                 <all>