Title: Secure America’s Medicine Act of 2020
Policy area: Health

Summary:
Secure America's Medicine Act of 2020
This bill requires the Department of Health and Human Services (HHS) to develop and annually update, in collaboration with the Department of Homeland Security and others, a list of critical medications that the federal government should ensure are available in the event of a public health emergency.
HHS must develop an initial list and report to Congress on its rationale for including or excluding certain medications. For annual updates, HHS must solicit public input on the contents of the list by consulting with relevant stakeholders and through the Federal Register. In addition, HHS must evaluate the factors that impact the supply of each medication on the list and identify any that may not be available in sufficient quantities in the event of a public health emergency.
For any medications with insufficient availability, HHS must take certain actions to include them in the Strategic National Stockpile, and the bill makes changes to the administration of the stockpile to allow HHS to enter into additional types of contracts to acquire these medicines. The bill also requires the Public Health Emergency Medical Countermeasures Enterprise (which coordinates federal preparedness efforts with respect to medical countermeasures) and the Government Accountability Office to address these contracts in their activities and reports related to the stockpile.
HHS must also report to Congress on barriers to, and make recommendations to promote, domestic production of critical medications.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8644 Introduced in House (IH)]

<DOC>






116th CONGRESS
  2d Session
                                H. R. 8644

  To ensure the availability of critical medications in the event of 
           public health emergencies, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 20, 2020

 Mr. Smith of Missouri (for himself and Mr. Schneider) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
  To ensure the availability of critical medications in the event of 
           public health emergencies, 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; SENSE OF CONGRESS.

    This Act may be cited as the ``Secure America's Medicine Act of 
2020''.

SEC. 2. ENSURING THE AVAILABILITY OF CRITICAL MEDICATIONS IN THE EVENT 
              OF PUBLIC HEALTH EMERGENCIES.

    (a) In General.--The Public Health Service Act is amended by 
inserting after section 319F-4 of such Act (42 U.S.C. 247d-6e) the 
following new section:

``SEC. 319F-5. ENSURING THE AVAILABILITY OF CRITICAL MEDICATIONS IN THE 
              EVENT OF PUBLIC HEALTH EMERGENCIES.

    ``(a) List of Critical Medications.--
            ``(1) In general.--The Secretary shall maintain a list of 
        medications (in this section referred to as `critical 
        medications') with respect to which it is critical that the 
        Federal Government ensure availability in the event of a public 
        health emergency.
            ``(2) Collaboration.--The Secretary shall carry out this 
        subsection and subsection (b) in collaboration with the 
        Assistant Secretary for Preparedness and Response, the 
        Commissioner of Food and Drugs, the Director of the Centers for 
        Disease Control and Prevention, and the Secretary of Homeland 
        Security.
            ``(3) Timing of list; reporting.--The Secretary shall--
                    ``(A) not later than 180 days after the date of the 
                enactment of the this section--
                            ``(i) establish the initial list required 
                        by paragraph (1);
                            ``(ii) submit a report, in a manner that 
                        does not compromise national security, to the 
                        Committee on Appropriations and the Committee 
                        on Energy and Commerce of the House of 
                        Representatives and the Committee on 
                        Appropriations and the Committee on Health, 
                        Education, Labor, and Pensions of the Senate, 
                        setting forth--
                                    ``(I) the list in effect under 
                                paragraph (1);
                                    ``(II) the reasons why each 
                                critical medication is included on the 
                                list;
                                    ``(III) the reasons why other 
                                medications described in paragraph (4) 
                                were not included; and
                                    ``(IV) which critical medications 
                                are designated critical medications 
                                under subsection (b) and the reasons 
                                for each such designation; and
                            ``(iii) make publicly available the list in 
                        effect under paragraph (1) and the most recent 
                        report under clause (ii), subject to any 
                        redactions or edits necessary to remove 
                        classified information or otherwise ensure that 
                        national security is not compromised; and
                    ``(B) not later than March 15 of each year 
                following the year in which the first list of critical 
                medications is required by paragraph (1)--
                            ``(i) update the list required by paragraph 
                        (1);
                            ``(ii) submit an updated report under 
                        subparagraph (A)(ii); and
                            ``(iii) make publicly available such 
                        updated list and report in accordance with 
                        subparagraph (A)(iii).
            ``(4) Required inclusion on list.--Subject to paragraph 
        (5), the Secretary shall include on the list under paragraph 
        (1) the following medications:
                    ``(A) Commonly-used medications likely to be needed 
                in order to prevent, mitigate, or treat the adverse 
                health effects which frequently result from a public 
                health emergency, including medications routinely 
                needed to effectively manage patients in hospital 
                emergency rooms or intensive care units, and 
                medications needed during surgical procedures often 
                required during a public health emergency.
                    ``(B) Anti-infective medications, including 
                antibiotic, antifungal, and antiviral medications, 
                which are either commonly used to treat infectious 
                diseases or have a significant likelihood of being 
                needed to treat an infectious disease that, if not so 
                treated, may result in a public health emergency.
                    ``(C) Commonly-used medications which are life-
                supporting, life-sustaining, or intended for the use in 
                the prevention or treatment of a debilitating disease 
                or condition, as such terms are defined in section 506C 
                of the Federal Food, Drug, and Cosmetics Act and the 
                regulations thereunder.
            ``(5) Limitations on inclusion on list.--The Secretary--
                    ``(A) shall not be required to include on the list 
                under paragraph (1) every medication meeting the 
                criteria described in paragraph (4);
                    ``(B) shall prioritize the inclusion on the list 
                under paragraph (1) of 300 to 400 medications meeting 
                such criteria--
                            ``(i) that are most commonly used; or
                            ``(ii) for which a shortage would be most 
                        likely to have the greatest potential adverse 
                        health consequences;
                    ``(C) in applying subparagraph (B), shall count as 
                a single medication--
                            ``(i) all strengths, dosage forms, and 
                        package forms of a given medication;
                            ``(ii) medications that are therapeutically 
                        equivalent (under the Food and Drug 
                        Administration's most recent publication of 
                        `Approved Drug Products with Therapeutic 
                        Equivalence Evaluations'); and
                            ``(iii) a biological product licensed under 
                        section 351(a) and all biosimilar biological 
                        products that are licensed under section 351(k) 
                        using the biological product as the reference 
                        product; and
                    ``(D) in applying subparagraph (B), shall not 
                prioritize the inclusion of any medication that is a 
                qualified countermeasure (as defined in section 319F-
                1(a)(2)), a security countermeasure (as defined in 
                section 319F-2(c)(1)(B)), or a qualified pandemic and 
                epidemic product (as defined in section 319F-3(i)).
            ``(6) Public input and comment.--In developing and updating 
        the list under paragraph (1), the Secretary shall solicit 
        public input, including by--
                    ``(A) consulting (through public meetings or other 
                forms of engagement) with relevant stakeholders, 
                including health care providers, medical professional 
                societies, public health experts, State and local 
                public health departments, patient groups, and drug 
                manufacturers and distributors;
                    ``(B) publishing in the Federal Register, for 
                public review and comment, the Secretary's proposed 
                list of critical medications, together with the 
                Secretary's reasons why each medication included on 
                such proposed list was included and the reasons why 
                other medications were not included;
                    ``(C) accepting public comment on such proposed 
                list and reasons for a period of not less than 60 days;
                    ``(D) taking such comments into account in 
                determining the final list under paragraph (1); and
                    ``(E) addressing such comments in reporting under 
                paragraph (3).
            ``(7) Additional considerations.--In developing and 
        updating the list under paragraph (1), the Secretary shall 
        consider--
                    ``(A) the most recent annual threat-based review 
                conducted by the Secretary under section 319F-2(a)(2), 
                the most recent report of the Comptroller General of 
                the United States under section 319F-2(a)(5), and the 
                most recent recommendations of the Public Health 
                Emergency Countermeasures Enterprise established under 
                section 2811-1;
                    ``(B) input from each member of the Public Health 
                Emergency Countermeasures Enterprise (or a designee 
                thereof); and
                    ``(C) if available, the report of the National 
                Academies of Sciences, Engineering, and Medicine 
                prepared pursuant to section 3101 of the Coronavirus 
                Aid, Relief, and Economic Stability Act (Public Law 
                116-136).
    ``(b) Designation of Critical Medications for Which Availability Is 
at Risk in the Event of a Public Health Emergency.--
            ``(1) In general.--The Secretary shall--
                    ``(A) evaluate each critical medication to 
                determine whether there is adequate assurance that it 
                will be available in sufficient quantities in the event 
                of a public health emergency, on a timely basis, within 
                each portion of the United States where it is needed; 
                and
                    ``(B) designate each critical medication with 
                respect to which the Secretary determines there is not 
                such an adequate assurance.
            ``(2) Factors to be taken into account.--In carrying out 
        paragraph (1), the Secretary shall take into account factors 
        including--
                    ``(A) volume inventories of each critical 
                medication that are normally available for use in the 
                United States, in the public and private sector, in the 
                absence of a public health emergency;
                    ``(B) current and expected production capacity, in 
                the United States and in foreign countries, of each 
                critical medication, including the domestic and foreign 
                capacity to surge production of each critical 
                medication and the time required to do so, taking into 
                account, among other things, current marketplace trends 
                and factors and the economic viability of creating and 
                maintaining such surge capacity in the absence of 
                nonemergency commercial demand;
                    ``(C) the potential demand and historic demand 
                trends for each critical medication in the event of a 
                public health emergency, including demand in the United 
                States and in foreign countries; and
                    ``(D) potential constraints on the timely 
                manufacture and distribution of each critical 
                medication in sufficient quantities for each portion of 
                the United States where it is needed in the event of 
                public health emergency, including constraints due to 
                the unavailability or limited availability of such 
                critical medication or any key ingredients thereof 
                (including active pharmaceutical ingredients) from one 
                or more foreign countries.
            ``(3) Conduct of evaluation.--In carrying out paragraph 
        (1), the Secretary may consider such other factors as the 
        Secretary considers relevant to determining the supply chain 
        vulnerability of each critical medication and each key 
        ingredient thereof (including active pharmaceutical 
        ingredients) in the event of a public health emergency, which 
        may include--
                    ``(A) whether and to what extent the existing 
                sources of such supply for the United States are 
                domestic or foreign, the specific foreign countries 
                from which any such foreign supply is obtained and in 
                what quantities, and the extent of the risk of a 
                disruption in supply from each such foreign country in 
                the event of a public health emergency;
                    ``(B) the location of each domestic and foreign 
                establishment registered under section 510 of the 
                Federal Food, Drug, and Cosmetic Act and identified in 
                such registration as manufacturing, preparing, 
                propagating, or compounding such critical medication or 
                a key ingredient thereof, as well as, for each such 
                establishment, the current and historical production 
                thereof and the current production capacity thereof;
                    ``(C) the likelihood of continued or increased 
                production from each domestic and foreign establishment 
                referenced in subparagraph (B), and the timeframe 
                necessary for any increase in production, taking into 
                account regulatory, logistical, economic, and other 
                relevant factors; and
                    ``(D) any economic, regulatory, or other 
                impediments to domestic production thereof.
            ``(4) Timeframe for designation and reevaluation.--The 
        Secretary shall--
                    ``(A) determine whether to designate a critical 
                medication under paragraph (1) not later than 90 days 
                after the earlier of--
                            ``(i) the date that such medication was 
                        first proposed by the Secretary to be a 
                        critical medication through publication in the 
                        Federal Register in accordance with subsection 
                        (a)(4)(B); or
                            ``(ii) the date that such medication became 
                        a critical medication pursuant to the final 
                        determination of the Secretary in accordance 
                        with subsection (a)(1)(A); or
                    ``(B) not later than March 15 each year, reevaluate 
                in accordance with paragraph (1)(A) each designation in 
                effect under paragraph (1)(B).
            ``(5) Public input and factors to be considered.--In 
        carrying out paragraph (1), the Secretary shall--
                    ``(A) consult with relevant stakeholders, including 
                those described in subsection (a)(6)(A);
                    ``(B) consider the annual threat-based review and 
                reports referenced in and input received under 
                subsection (a)(7); and
                    ``(C) consult with experts in medication 
                production, distribution, and demand, including 
                economists or other analysts with expertise in the 
                economic factors affecting domestic and foreign 
                production and distribution of critical medications.
            ``(6) Incorporation of findings and determinations in 
        submissions to congress.--With respect to each designated 
        critical medication, the Assistant Secretary for Preparedness 
        and Response shall include in the annual coordinated 5-year 
        budget plan required to be submitted under section 2811(b)(7) 
        such amounts as are determined to be necessary or appropriate 
        to fund the procurement or contracting required under 
        subsection (c) for such designated critical medications.
    ``(c) Procurement or Contracting for Designated Critical 
Medications To Ensure Availability in the Event of a Public Health 
Emergency.--Subject to the availability of appropriations, the 
Secretary shall procure for the Strategic National Stockpile pursuant 
to section 319F-2(a)(1)(A)(ii), or otherwise enter into contracts under 
such section, as necessary to ensure the availability of each 
designated critical medication, in the quantities and at the times 
needed, in the event of a public health emergency.
    ``(d) Evaluating Impediments to Domestic Production of Critical 
Medications, and Related Recommendations.--
            ``(1) Report to congress.--Not later than one year after 
        the date of enactment of this section, the Secretary shall make 
        available to the Committee on Appropriations and the Committee 
        on Energy and Commerce of the House of Representatives and the 
        Committee on Appropriations and the Committee on Health, 
        Education, Labor, and Pensions of the Senate, a report 
        containing--
                    ``(A) findings on--
                            ``(i) the domestic and foreign production 
                        of critical medications and their key 
                        ingredients; and
                            ``(ii) impediments to the domestic 
                        production of critical medications and their 
                        key ingredients; and
                    ``(B) recommendations for measures (which may 
                include legislative, regulatory, or other policy 
                changes) to remove such impediments or otherwise 
                promote such domestic production (which may include 
                measures to ensure the economic viability of such 
                domestic production or to address policies that 
                competitively disadvantage such domestic production).
            ``(2) Coordination.--In preparing the report required by 
        paragraph (1), the Secretary shall take into account any 
        information provided to, and any findings and recommendations 
        of, such Commission.
    ``(e) Definitions.--In this section:
            ``(1) The term `designated critical medication' means a 
        critical medication for which a designation is in effect under 
        subsection (b).
            ``(2) The term `medication' means a drug (as defined in 
        section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act), 
        a biological product (as defined in section 351 of this Act), 
        or a combination product (as described in section 503(g) of the 
        Federal Food, Drug, and Cosmetic Act) that is approved, 
        licensed, or cleared, as applicable, under chapter V of the 
        Federal Food, Drug, and Cosmetic Act or section 351 of this 
        Act.
            ``(3) The term `public health emergency' means a disease or 
        disorder, including pandemics and other significant outbreaks 
        of infectious diseases, bioterrorist attacks, the effects of 
        chemical, biological, radiological, or nuclear agents or 
        toxins, or the effects of extreme weather, earthquakes, or 
        other natural disasters, that the Secretary has declared or may 
        declare to be a public health emergency pursuant to section 
        319.
            ``(4) The term `United States' include the territories of 
        the United States.''.
    (b) Ensuring the Availability of Designated Critical Medications 
Through the Strategic National Stockpile.--Section 319F-2 of the Public 
Health Service Act (42 U.S.C. 247d-6b) is amended--
            (1) by amending subsection (a)(1) to read as follows:
            ``(1) In general.--
                    ``(A) Maintaining stockpile or stockpiles.--The 
                Secretary, in collaboration with the Assistant 
                Secretary for Preparedness and Response, the 
                Commissioner of Food and Drugs, and the Director of the 
                Centers for Disease Control and Prevention, and in 
                coordination with the Secretary of Homeland Security 
                (referred to in this section as the `Homeland Security 
                Secretary'), shall--
                            ``(i) maintain a stockpile or stockpiles of 
                        drugs, vaccines, and other biological products, 
                        medical devices, and other supplies (including 
                        personal protective equipment, ancillary 
                        medical supplies, and other applicable supplies 
                        required for the administration of drugs, 
                        vaccines and other biological products, medical 
                        devices, and diagnostic tests in the stockpile) 
                        in such numbers, types, and amounts as are 
                        determined consistent with section 2811 by the 
                        Secretary to be appropriate and practicable, 
                        taking into account other available sources, to 
                        provide for and optimize the emergency health 
                        security of the United States, including the 
                        emergency health security of children and other 
                        vulnerable populations, in the event of a 
                        bioterrorist attack or other public health 
                        emergency and, as informed by existing 
                        recommendations of, or consultations with, the 
                        Public Health Emergency Medical Countermeasure 
                        Enterprise established under section 2811-1, 
                        make necessary additions or modifications to 
                        the contents of such stockpile or stockpiles 
                        based on the review conducted under paragraph 
                        (2); and
                            ``(ii) enter into multiyear contracts (each 
                        of which shall have a term of no less than 5 
                        years) with private entities to ensure the 
                        availability, in the event of a public health 
                        emergency, of adequate domestic supplies of 
                        each designated critical medication, as 
                        determined by the Secretary under section 319F-
                        5, in lieu of or as a supplement to procuring 
                        and maintaining in such stockpile or stockpiles 
                        a physical accumulation of such designated 
                        critical medications, through measures which 
                        may include--
                                    ``(I) one or more private entities' 
                                agreement to maintain specified 
                                inventory levels, in specified domestic 
                                locations, of one or more such 
                                designated critical medications, or of 
                                one or more key ingredients thereof 
                                (including active pharmaceutical 
                                ingredients), under specified 
                                conditions (including maintenance and 
                                inventory replacement prior to 
                                expiration), and to make specified 
                                quantities of such designated critical 
                                medications or key ingredients thereof 
                                available when directed by the 
                                Secretary, on predetermined terms and 
                                conditions;
                                    ``(II) one or more private 
                                entities' agreement to commence or 
                                maintain production of one or more such 
                                designated critical medications, in 
                                specified locations, or to build or 
                                maintain specified surge capacity for 
                                such production, and to manufacture or 
                                otherwise make specified quantities of 
                                such designated critical medications 
                                available, when directed, on 
                                predetermined terms and conditions; and
                                    ``(III) compensation for 
                                maintenance of such inventory, 
                                production, or production capacity and 
                                associated overhead, as necessary or 
                                appropriate.
                    ``(B) Factors.--In entering into contracts under 
                subparagraph (A)(ii), the Secretary shall take into 
                account as factors more significant than price--
                            ``(i) whether the designated critical 
                        medication would be produced in the United 
                        States;
                            ``(ii) the track record and demonstrated 
                        ability of the given manufacturer to produce 
                        the designated critical medication in the 
                        required quantities when needed (in domestic or 
                        foreign locations, after consideration of 
                        whether supply from such foreign locations is 
                        at significant risk of disruption in the event 
                        of a public health emergency); and
                            ``(iii) the United States regulatory 
                        compliance history of the given manufacturer.
                    ``(C) Preference.--In entering into contracts under 
                subparagraph (A)(ii), the Secretary may give preference 
                to contracting with manufacturers of medications which 
                are based in the United States.
                    ``(D) References.--References in this paragraph to 
                the United States include any territory of the United 
                States.'';
            (2) in subsection (a)(2)(B)--
                    (A) in the matter preceding clause (i), by 
                inserting ``and each new or modified contract with a 
                private entity under paragraph (1)(A)(ii)'' after ``for 
                each new or modified countermeasure procurement or 
                replenishment'';
                    (B) in clause (i)(III), by inserting ``or 
                contracting for procurement'' after ``procurement'';
                    (C) in clause (i)(IV), by inserting ``or 
                contracting for procurement'' after ``whether such 
                procurement'';
                    (D) in clause (i)(V), by inserting ``(including 
                through one or more contracts under paragraph 
                (1)(A)(ii))'' after ``stockpile''; and
                    (E) in clause (ii), by inserting ``or for which the 
                Secretary entered into a contract with a private entity 
                under paragraph (1)(A)(ii),'' after ``for each 
                countermeasure procured or replenished under this 
                subsection,'';
            (3) in subsection (a)(3)(E) by inserting ``the Commissioner 
        of Food and Drugs,'' after ``Assistant Secretary for 
        Preparedness and Response,'';
            (4) in subsection (a)(5)(A)--
                    (A) in the matter preceding clause (i), by 
                inserting ``and any contracts entered into under 
                paragraph (1)(A)(ii)'' after ``any changes to the 
                contents or management of the stockpile'';
                    (B) in clause (ii), by striking ``or 
                replenishment'' and inserting ``replenishment, or 
                contracting'';
                    (C) in clause (iv), by striking ``an accounting of 
                countermeasures procured, modified, or replenished 
                under paragraph (1)'' and inserting ``an accounting of 
                countermeasures procured, modified, or replenished 
                under paragraph (1)(A)(i) or for which contracts with 
                private entities were entered into under paragraph 
                (1)(A)(ii)'';
                    (D) in clause (v)--
                            (i) by inserting ``and contracts'' after 
                        ``decisions''; and
                            (ii) by striking ``or replenished'' and 
                        inserting ``replenished or contracted''; and
                    (E) in clause (vii), by inserting ``and new or 
                modified contracts with a private entity'' after 
                ``replenishments'';
            (5) in subsection (c)(7)(B)(ii), by adding at the end the 
        following subclause:
                                    ``(X) Nonapplicability to certain 
                                contracts.--None of the requirements 
                                set forth in this clause (ii) shall 
                                apply to contracts entered into under 
                                subsection (a)(1)(A)(ii), other than 
                                contracts for procurement of security 
                                countermeasures from the special 
                                reserve fund, except that the Secretary 
                                may, at the Secretary's discretion, 
                                include any of the terms described in 
                                this clause, or similar terms, in any 
                                contract entered into under subsection 
                                (a)(1)(A)(ii).''; and
            (6) by amending subsection (e) to read as follows:
    ``(e) Definitions.--For the purposes of this section:
            ``(1) The terms `critical medication', `designated critical 
        medication', and `medication' have the meanings given to such 
        terms in section 319F-5.
            ``(2) The term `stockpile' includes--
                    ``(A) a physical accumulation (at one or more 
                locations) of the supplies described in subsection (a) 
                (including any maintained in inventory under a contract 
                with a private entity under subsection (a)(1)(A)(ii) 
                under a contract with a private entity entered into 
                under subsection (a)(1)(A)(ii)); and
                    ``(B) any supplies described in subsection 
                (a)(1)(A)(i) which a vendor or vendors agree to provide 
                to the Secretary under a contractual agreement between 
                the Secretary and such vendor or vendors, and any 
                designated critical medications which a private entity 
                is required to manufacture or otherwise supply under an 
                agreement between the Secretary and such private entity 
                entered into pursuant to subsection (a)(1)(A)(ii).''.
                                 <all>