,i #aafth ,,congress #b;d ,session ,h4 ,r4 #hfdd ,,in ,,the ,,house ,,of ,,representatives ,october #bj1 #bjbj,mr4 ,smith of ,missouri 7for himself and ,mr4 ,schneider7 introduced the following bill2 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 emergencies1 and for other purposes4 #a4 ,short title2 sense of ,congress ,this ,act may be cited as the ,secure ,america's ,medicine ,act of #bjbj4 #b4 ,ensuring the availability of critical medications in the event of public health emergencies 7a7 ,in general ,the ,public ,health ,service ,act is amended by inserting after section #cai;,f-#d of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 the following new section3 #cai;,f-#e4 ,ensuring the availability of critical medications in the event of public health emergencies 7a7 ,list of critical medications 7#a7 ,in general ,the ,secretary shall maintain a list of medications 7in this section referred to as critical medications7 with respect to which it is critical that the ,federal ,government ensure availability in the event of a public health emergency4 7#b7 ,collaboration ,the ,secretary shall carry out this subsection and subsection 7b7 in collaboration with the ,assistant ,secretary for ,preparedness and ,response1 the ,commissioner of ,food and ,drugs1 the ,director of the ,centers for ,disease ,control and ,prevention1 and the ,secretary of ,homeland ,security4 7#c7 ,timing of list2 reporting ,the ,secretary shall-- 7,a7 not later than #ahj days after the date of the enactment of the this section-- 7i7 establish the initial list required by paragraph 7#a72 7ii7 submit a report1 in a manner that does not compromise national security1 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 ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 setting forth-- 7,i7 the list in effect under paragraph 7#a72 7,,ii7 the reasons why each critical medication is included on the list2 7,,iii7 the reasons why other medications described in paragraph 7#d7 were not included2 and 7,,iv7 which critical medications are designated critical medications under subsection 7b7 and the reasons for each such designation2 and 7iii7 make publicly available the list in effect under paragraph 7#a7 and the most recent report under clause 7ii71 subject to any redactions or edits necessary to remove classified information or otherwise ensure that national security is not compromised2 and 7,b7 not later than ,march #ae of each year following the year in which the first list of critical medications is required by paragraph 7#a7-- 7i7 update the list required by paragraph 7#a72 7ii7 submit an updated report under subparagraph 7,a77ii72 and 7iii7 make publicly available such updated list and report in accordance with subparagraph 7,a77iii74 7#d7 ,required inclusion on list ,subject to paragraph 7#e71 the ,secretary shall include on the list under paragraph 7#a7 the following medications3 7,a7 ,commonly-used medications likely to be needed in order to prevent1 mitigate1 or treat the adverse health effects which frequently result from a public health emergency1 including medications routinely needed to effectively manage patients in hospital emergency rooms or intensive care units1 and medications needed during surgical procedures often required during a public health emergency4 7,b7 ,anti-infective medications1 including antibiotic1 antifungal1 and antiviral medications1 which are either commonly used to treat infectious diseases or have a significant likelihood of being needed to treat an infectious disease that1 if not so treated1 may result in a public health emergency4 7,c7 ,commonly-used medications which are life-supporting1 life-sustaining1 or intended for the use in the prevention or treatment of a debilitating disease or condition1 as such terms are defined in section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetics ,act and the regulations thereunder4 7#e7 ,limitations on inclusion on list ,the ,secretary-- 7,a7 shall not be required to include on the list under paragraph 7#a7 every medication meeting the criteria described in paragraph 7#d72 7,b7 shall prioritize the inclusion on the list under paragraph 7#a7 of #cjj to #djj medications meeting such criteria-- 7i7 that are most commonly used2 or 7ii7 for which a shortage would be most likely to have the greatest potential adverse health consequences2 7,c7 in applying subparagraph 7,b71 shall count as a single medication-- 7i7 all strengths1 dosage forms1 and package forms of a given medication2 7ii7 medications that are therapeutically equivalent 7under the ,food and ,drug ,administration's most recent publication of ,approved ,drug ,products with ,therapeutic ,equivalence ,evaluations72 and 7iii7 a biological product licensed under section #cea7;a7 and all biosimilar biological products that are licensed under section #cea7k7 using the biological product as the reference product2 and 7,d7 in applying subparagraph 7,b71 shall not prioritize the inclusion of any medication that is a qualified countermeasure 7as defined in section #cai;,f-#a7;a77#b771 a security countermeasure 7as defined in section #cai;,f-#b7;c77#a77;,b771 or a qualified pandemic and epidemic product 7as defined in section #cai;,f-#c7;i774 7#f7 ,public input and comment ,in developing and updating the list under paragraph 7#a71 the ,secretary shall solicit public input1 including by-- 7,a7 consulting 7through public meetings or other forms of engagement7 with relevant stakeholders1 including health care providers1 medical professional societies1 public health experts1 ,state and local public health departments1 patient groups1 and drug manufacturers and distributors2 7,b7 publishing in the ,federal ,register1 for public review and comment1 the ,secretary's proposed list of critical medications1 together with the ,secretary's reasons why each medication included on such proposed list was included and the reasons why other medications were not included2 7,c7 accepting public comment on such proposed list and reasons for a period of not less than #fj days2 7,d7 taking such comments into account in determining the final list under paragraph 7#a72 and 7,e7 addressing such comments in reporting under paragraph 7#c74 7#g7 ,additional considerations ,in developing and updating the list under paragraph 7#a71 the ,secretary shall consider-- 7,a7 the most recent annual threat-based review conducted by the ,secretary under section #cai;,f-#b7;a77#b71 the most recent report of the ,comptroller ,general of the ,united ,states under section #cai;,f-#b7;a77#e71 and the most recent recommendations of the ,public ,health ,emergency ,countermeasures ,enterprise established under section #bhaa-a2 7,b7 input from each member of the ,public ,health ,emergency ,countermeasures ,enterprise 7or a designee thereof72 and 7,c7 if available1 the report of the ,national ,academies of ,sciences1 ,engineering1 and ,medicine prepared pursuant to section #caja of the ,coronavirus ,aid1 ,relief1 and ,economic ,stability ,act 7,public ,law #aaf-acf74 7b7 ,designation of critical medications for which availability is at risk in the event of a public health emergency 7#a7 ,in general ,the ,secretary shall-- 7,a7 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 emergency1 on a timely basis1 within each portion of the ,united ,states where it is needed2 and 7,b7 designate each critical medication with respect to which the ,secretary determines there is not such an adequate assurance4 7#b7 ,factors to be taken into account ,in carrying out paragraph 7#a71 the ,secretary shall take into account factors including-- 7,a7 volume inventories of each critical medication that are normally available for use in the ,united ,states1 in the public and private sector1 in the absence of a public health emergency2 7,b7 current and expected production capacity1 in the ,united ,states and in foreign countries1 of each critical medication1 including the domestic and foreign capacity to surge production of each critical medication and the time required to do so1 taking into account1 among other things1 current marketplace trends and factors and the economic viability of creating and maintaining such surge capacity in the absence of nonemergency commercial demand2 7,c7 the potential demand and historic demand trends for each critical medication in the event of a public health emergency1 including demand in the ,united ,states and in foreign countries2 and 7,d7 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 emergency1 including constraints due to the unavailability or limited availability of such critical medication or any key ingredients thereof 7including active pharmaceutical ingredients7 from one or more foreign countries4 7#c7 ,conduct of evaluation ,in carrying out paragraph 7#a71 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 7including active pharmaceutical ingredients7 in the event of a public health emergency1 which may include-- 7,a7 whether and to what extent the existing sources of such supply for the ,united ,states are domestic or foreign1 the specific foreign countries from which any such foreign supply is obtained and in what quantities1 and the extent of the risk of a disruption in supply from each such foreign country in the event of a public health emergency2 7,b7 the location of each domestic and foreign establishment registered under section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act and identified in such registration as manufacturing1 preparing1 propagating1 or compounding such critical medication or a key ingredient thereof1 as well as1 for each such establishment1 the current and historical production thereof and the current production capacity thereof2 7,c7 the likelihood of continued or increased production from each domestic and foreign establishment referenced in subparagraph 7,b71 and the timeframe necessary for any increase in production1 taking into account regulatory1 logistical1 economic1 and other relevant factors2 and 7,d7 any economic1 regulatory1 or other impediments to domestic production thereof4 7#d7 ,timeframe for designation and reevaluation ,the ,secretary shall-- 7,a7 determine whether to designate a critical medication under paragraph 7#a7 not later than #ij days after the earlier of-- 7i7 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 7a77#d77;,b72 or 7ii7 the date that such medication became a critical medication pursuant to the final determination of the ,secretary in accordance with subsection 7a77#a77;,a72 or 7,b7 not later than ,march #ae each year1 reevaluate in accordance with paragraph 7#a77;,a7 each designation in effect under paragraph 7#a77;,b74 7#e7 ,public input and factors to be considered ,in carrying out paragraph 7#a71 the ,secretary shall-- 7,a7 consult with relevant stakeholders1 including those described in subsection 7a77#f77;,a72 7,b7 consider the annual threat-based review and reports referenced in and input received under subsection 7a77#g72 and 7,c7 consult with experts in medication production1 distribution1 and demand1 including economists or other analysts with expertise in the economic factors affecting domestic and foreign production and distribution of critical medications4 7#f7 ,incorporation of findings and determinations in submissions to ,congress ,with respect to each designated critical medication1 the ,assistant ,secretary for ,preparedness and ,response shall include in the annual coordinated #e-year budget plan required to be submitted under section #bhaa7;b77#g7 such amounts as are determined to be necessary or appropriate to fund the procurement or contracting required under subsection 7c7 for such designated critical medications4 7c7 ,procurement or contracting for designated critical medications ,to ensure availability in the event of a public health emergency ,subject to the availability of appropriations1 the ,secretary shall procure for the ,strategic ,national ,stockpile pursuant to section #cai;,f-#b7;a77#a77;,a77ii71 or otherwise enter into contracts under such section1 as necessary to ensure the availability of each designated critical medication1 in the quantities and at the times needed1 in the event of a public health emergency4 7d7 ,evaluating impediments to domestic production of critical medications1 and related recommendations 7#a7 ,report to ,congress ,not later than one year after the date of enactment of this section1 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 ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 a report containing-- 7,a7 findings on-- 7i7 the domestic and foreign production of critical medications and their key ingredients2 and 7ii7 impediments to the domestic production of critical medications and their key ingredients2 and 7,b7 recommendations for measures 7which may include legislative1 regulatory1 or other policy changes7 to remove such impediments or otherwise promote such domestic production 7which may include measures to ensure the economic viability of such domestic production or to address policies that competitively disadvantage such domestic production74 7#b7 ,coordination ,in preparing the report required by paragraph 7#a71 the ,secretary shall take into account any information provided to1 and any findings and recommendations of1 such ,commission4 7e7 ,definitions ,in this section3 7#a7 ,the term designated critical medication means a critical medication for which a designation is in effect under subsection 7b74 7#b7 ,the term medication means a drug 7as defined in section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 a biological product 7as defined in section #cea of this ,act71 or a combination product 7as described in section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 that is approved1 licensed1 or cleared1 as applicable1 under chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act4 7#c7 ,the term public health emergency means a disease or disorder1 including pandemics and other significant outbreaks of infectious diseases1 bioterrorist attacks1 the effects of chemical1 biological1 radiological1 or nuclear agents or toxins1 or the effects of extreme weather1 earthquakes1 or other natural disasters1 that the ,secretary has declared or may declare to be a public health emergency pursuant to section #cai4 7#d7 ,the term ,united ,states include the territories of the ,united ,states4 4 7b7 ,ensuring the availability of designated critical medications through the ,strategic ,national ,stockpile ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 by amending subsection 7a77#a7 to read as follows3 7#a7 ,in general 7,a7 ,maintaining stockpile or stockpiles ,the ,secretary1 in collaboration with the ,assistant ,secretary for ,preparedness and ,response1 the ,commissioner of ,food and ,drugs1 and the ,director of the ,centers for ,disease ,control and ,prevention1 and in coordination with the ,secretary of ,homeland ,security 7referred to in this section as the ,homeland ,security ,secretary71 shall-- 7i7 maintain a stockpile or stockpiles of drugs1 vaccines1 and other biological products1 medical devices1 and other supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 medical devices1 and diagnostic tests in the stockpile7 in such numbers1 types1 and amounts as are determined consistent with section #bhaa by the ,secretary to be appropriate and practicable1 taking into account other available sources1 to provide for and optimize the emergency health security of the ,united ,states1 including the emergency health security of children and other vulnerable populations1 in the event of a bioterrorist attack or other public health emergency and1 as informed by existing recommendations of1 or consultations with1 the ,public ,health ,emergency ,medical ,countermeasure ,enterprise established under section #bhaa-a1 make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph 7#b72 and 7ii7 enter into multiyear contracts 7each of which shall have a term of no less than #e years7 with private entities to ensure the availability1 in the event of a public health emergency1 of adequate domestic supplies of each designated critical medication1 as determined by the ,secretary under section #cai;,f-#e1 in lieu of or as a supplement to procuring and maintaining in such stockpile or stockpiles a physical accumulation of such designated critical medications1 through measures which may include-- 7,i7 one or more private entities' agreement to maintain specified inventory levels1 in specified domestic locations1 of one or more such designated critical medications1 or of one or more key ingredients thereof 7including active pharmaceutical ingredients71 under specified conditions 7including maintenance and inventory replacement prior to expiration71 and to make specified quantities of such designated critical medications or key ingredients thereof available when directed by the ,secretary1 on predetermined terms and conditions2 7,,ii7 one or more private entities' agreement to commence or maintain production of one or more such designated critical medications1 in specified locations1 or to build or maintain specified surge capacity for such production1 and to manufacture or otherwise make specified quantities of such designated critical medications available1 when directed1 on predetermined terms and conditions2 and 7,,iii7 compensation for maintenance of such inventory1 production1 or production capacity and associated overhead1 as necessary or appropriate4 7,b7 ,factors ,in entering into contracts under subparagraph 7,a77ii71 the ,secretary shall take into account as factors more significant than price-- 7i7 whether the designated critical medication would be produced in the ,united ,states2 7ii7 the track record and demonstrated ability of the given manufacturer to produce the designated critical medication in the required quantities when needed 7in domestic or foreign locations1 after consideration of whether supply from such foreign locations is at significant risk of disruption in the event of a public health emergency72 and 7iii7 the ,united ,states regulatory compliance history of the given manufacturer4 7,c7 ,preference ,in entering into contracts under subparagraph 7,a77ii71 the ,secretary may give preference to contracting with manufacturers of medications which are based in the ,united ,states4 7,d7 ,references ,references in this paragraph to the ,united ,states include any territory of the ,united ,states4 2 7#b7 in subsection 7a77#b77;,b7-- 7,a7 in the matter preceding clause 7i71 by inserting and each new or modified contract with a private entity under paragraph 7#a77;,a77ii7 after for each new or modified countermeasure procurement or replenishment2 7,b7 in clause 7i77,,iii71 by inserting or contracting for procurement after procurement2 7,c7 in clause 7i77,,iv71 by inserting or contracting for procurement after whether such procurement2 7,d7 in clause 7i77,v71 by inserting 7including through one or more contracts under paragraph 7#a77;,a77ii77 after stockpile2 and 7,e7 in clause 7ii71 by inserting or for which the ,secretary entered into a contract with a private entity under paragraph 7#a77;,a77ii71 after for each countermeasure procured or replenished under this subsection12 7#c7 in subsection 7a77#c77;,e7 by inserting the ,commissioner of ,food and ,drugs1 after ,assistant ,secretary for ,preparedness and ,response12 7#d7 in subsection 7a77#e77;,a7-- 7,a7 in the matter preceding clause 7i71 by inserting and any contracts entered into under paragraph 7#a77;,a77ii7 after any changes to the contents or management of the stockpile2 7,b7 in clause 7ii71 by striking or replenishment and inserting replenishment1 or contracting2 7,c7 in clause 7iv71 by striking an accounting of countermeasures procured1 modified1 or replenished under paragraph 7#a7 and inserting an accounting of countermeasures procured1 modified1 or replenished under paragraph 7#a77;,a77i7 or for which contracts with private entities were entered into under paragraph 7#a77;,a77ii72 7,d7 in clause 7v7-- 7i7 by inserting and contracts after decisions2 and 7ii7 by striking or replenished and inserting replenished or contracted2 and 7,e7 in clause 7vii71 by inserting and new or modified contracts with a private entity after replenishments2 7#e7 in subsection 7c77#g77;,b77ii71 by adding at the end the following subclause3 7,x7 ,nonapplicability to certain contracts ,none of the requirements set forth in this clause 7ii7 shall apply to contracts entered into under subsection 7a77#a77;,a77ii71 other than contracts for procurement of security countermeasures from the special reserve fund1 except that the ,secretary may1 at the ,secretary's discretion1 include any of the terms described in this clause1 or similar terms1 in any contract entered into under subsection 7a77#a77;,a77ii74 2 and 7#f7 by amending subsection 7e7 to read as follows3 7e7 ,definitions ,for the purposes of this section3 7#a7 ,the terms critical medication1 designated critical medication1 and medication have the meanings given to such terms in section #cai;,f-#e4 7#b7 ,the term stockpile includes-- 7,a7 a physical accumulation 7at one or more locations7 of the supplies described in subsection 7a7 7including any maintained in inventory under a contract with a private entity under subsection 7a77#a77;,a77ii7 under a contract with a private entity entered into under subsection 7a77#a77;,a77ii772 and 7,b7 any supplies described in subsection 7a77#a77;,a77i7 which a vendor or vendors agree to provide to the ,secretary under a contractual agreement between the ,secretary and such vendor or vendors1 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 7a77#a77;,a77ii74 4