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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6992 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 6992

 To require the Secretary of Health and Human Services to establish a 
          list of essential medicines, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            January 12, 2024

Ms. Matsui (for herself and Mr. Bucshon) 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 establish a 
          list of essential medicines, 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 ``Mapping America's Pharmaceutical 
Supply Act'' or the ``MAPS Act''.

SEC. 2. ESSENTIAL MEDICINES LIST UPDATE.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall establish and 
maintain a list of essential medicines.
    (b) Criteria.-- The list under subsection (a) shall consist of 
drugs and active pharmaceutical ingredients that--
            (1) are reasonably likely to be required to respond to a 
        public health emergency or to a chemical, biological, 
        radiological, or nuclear threat; or
            (2) the shortage of which would pose a significant threat 
        to the United States health care system or at-risk populations.
    (c) Selection.--The Secretary shall select drugs and active 
pharmaceutical ingredients for inclusion on the list under subsection 
(a)--
            (1) based on the criteria specified in subsection (b); and
            (2) from the list of essential medicines, medical 
        countermeasures, and critical inputs developed by the Food and 
        Drug Administration in response to Executive Order 13944 (85 
        Fed. Reg. 49929) and other relevant assessments or lists.
    (d) Process.--
            (1) In general.--Before finalizing the list under 
        subsection (a) or any update to such list, the Secretary 
        shall--
                    (A) publish a proposed list or update, as 
                applicable; and
                    (B) provide an opportunity for public comment on 
                the proposed list or update.
            (2) Initial list.--The Secretary shall--
                    (A) publish the proposed initial list under 
                subsection (a) not later than 6 months after the date 
                of enactment of this Act; and
                    (B) publish the final initial list under subsection 
                (a) not later than 1 year after such date of enactment.
            (3) Regular review.--The Secretary shall regularly review 
        the list under subsection (a) to determine whether any updates 
        should be made pursuant to paragraph (1).
    (e) Relation to Executive Order.--The participation of the 
Secretary in establishing, maintaining, and updating the list under 
subsection (a) shall be deemed to be full satisfaction of the 
requirements applicable to the Secretary under section 3 of Executive 
Order 13944 (85 Fed. Reg. 49929).

SEC. 3. FEDERAL UNITED STATES PHARMACEUTICAL SUPPLY CHAIN MAPPING.

    (a) In General.--The Secretary of Health and Human Services, in 
coordination with the heads of other relevant agencies, shall support 
efforts, including through public-private partnerships, to map the 
entire United States pharmaceutical supply chain, from inception to 
distribution, and use data analytics to identify supply chain 
vulnerabilities and other national security threats. Such activities 
shall include, at a minimum--
            (1) defining agency roles in monitoring the pharmaceutical 
        supply chain and communicating supply chain vulnerabilities; 
        and
            (2) with respect to drugs and active pharmaceutical 
        ingredients on the list of essential medicines under section 
        2(a), establishing a database that shall include--
                    (A) the location of establishments registered under 
                subsection (b), (c), or (i) of section 510 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) 
                involved in the production of--
                            (i) the finished dosage forms of the drugs 
                        on such list;
                            (ii) the active pharmaceutical ingredients 
                        of such drugs; or
                            (iii) active pharmaceutical ingredients on 
                        such list;
                    (B) the amount of such finished dosage forms and 
                active pharmaceutical ingredients produced at each such 
                establishment;
                    (C) to the extent available--
                            (i) the location of establishments involved 
                        in the production of the key starting materials 
                        and excipients used to produce the finished 
                        dosage forms and active pharmaceutical 
                        ingredients referred to in subparagraph (A); 
                        and
                            (ii) the amount of such materials and 
                        excipients produced at each such establishment; 
                        and
                    (D) any regulatory actions with respect to the 
                establishments referred to in subparagraph (A) or (C), 
                including with respect to--
                            (i) labeling requirements;
                            (ii) registration and listing information 
                        required to be submitted under section 510 of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360);
                            (iii) inspections and related regulatory 
                        activities conducted under section 704 of such 
                        Act (21 U.S.C. 374);
                            (iv) the seizure of such a drug or active 
                        pharmaceutical ingredient pursuant to section 
                        304 of such Act (21 U.S.C. 334);
                            (v) any recalls of a drug or active 
                        pharmaceutical ingredient on the list of 
                        essential medicines under section 2(a), or a 
                        drug containing an active pharmaceutical 
                        ingredient on such list;
                            (vi) inclusion of such a drug or active 
                        pharmaceutical ingredient on the drug shortage 
                        list under section 506E of such Act (21 U.S.C. 
                        356e); or
                            (vii) prior reports of a discontinuance or 
                        interruption in the production of such a drug 
                        or active pharmaceutical ingredient under 506C 
                        of such Act (21 U.S.C. 356c).
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, and annually thereafter, the Secretary of Health and Human 
Services, in consultation with the heads of agencies with which such 
Secretary coordinates under subsection (a), shall submit a report to 
Congress on--
            (1) progress on implementing subsection (a), including any 
        timelines for full implementation;
            (2) gaps in data needed for full implementation of such 
        subsection;
            (3) how the database established pursuant to subsection (a) 
        increases Federal visibility into the pharmaceutical supply 
        chain;
            (4) how Federal agencies are able to use data analytics to 
        conduct predictive modeling of anticipated drug shortages or 
        national security threats; and
            (5) the extent to which industry has cooperated in mapping 
        the pharmaceutical supply chain.
    (c) Confidential Commercial Information.--The exchange of 
information among the Secretary of Health and Human Services and the 
heads of other relevant agencies for purposes of carrying out this 
section shall not be a violation of section 1905 of title 18, United 
States Code.
    (d) Clarification.--The information in the database established 
pursuant to subsection (a) shall not be publicly disclosed. Nothing in 
this subsection shall be construed to relieve the Secretary of Health 
and Human Services from the Secretary's obligation to provide 
information to Congress.
                                 <all>
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