,,ii #aagth ,,congress #ast ,session ,s4 #bgdj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ad1 #bjba,mr4 ,brown 7for himself and ,mr4 ,cassidy7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines1 and to build a pipeline for domestic active pharmaceutical ingredient production4 #a4 ,short title ,this ,act may be cited as the ,promoting ,readiness and ,ensuring ,proper ,active pharmaceutical ingredient ,reserves of ,essential medicines ,act of #bjba or the ,,prepare ,act4 #b4 ,listing of essential generic medicines ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cai,m the following3 #cai,n4 ,listing of essential generic medicines 7a7 ,in general ,the ,secretary1 in consultation with the ,commissioner of ,food and ,drugs1 the ,assistant ,secretary for ,preparedness and ,response1 the ,secretary of ,defense1 ,secretary of ,homeland ,security1 and other heads of agencies1 as appropriate1 shall establish and make public a list of essential generic medicines determined1 in accordance with subsection 7b71 to be medically necessary to have available at all times4 7b7 ,requirements 7#a7 ,initial list ,the initial list of essential generic medicines under subsection 7a7 shall be the generic medicines included on the list of essential medicines1 medical countermeasures1 and critical inputs identified by the ,commissioner of ,food and ,drugs as published on ,october #cj1 #bjbj1 in accordance with section #c7;c7 of ,executive ,order #acidd4 7c7 ,updates 7#a7 ,annual review ,not less than once each year1 the ,secretary1 after consultation with the ,commissioner of ,food and ,drugs1 the ,assistant ,secretary for ,preparedness and ,response1 the ,secretary of ,defense1 ,secretary of ,homeland ,security1 and other heads of agencies1 as appropriate1 shall review and update the list of essential generic medicines required under subsection 7a74 7#b7 ,rationale ,in carrying out the annual review and update under paragraph 7#a71 the ,secretary shall provide a rationale for each essential generic medicine added to1 or removed from1 the list under subsection 7a74 7#c7 ,specific populations ,the ,secretary shall consider including on the list under subsection 7a71 and1 where appropriate1 include on such list1 essential generic medicines that are essential to specific subpopulations1 including pediatric populations1 in developing the list under such subsection4 7#d7 ,threat assessments 7,a7 ,in general ,the ,secretary1 after consultation with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a1 shall conduct regular threat assessments1 and take such assessments into consideration in updating the list in accordance with paragraph 7#a74 7,b7 ,threat assessments considerations ,each threat assessment under this paragraph shall include consideration of-- 7i7 the lack of existing domestic capacity of essential generic medicines2 7ii7 the concentration of current supply of the essential generic medicine or active pharmaceutical ingredients of the essential generic medicine in one geographical region2 7iii7 whether there are less than #b manufacturers of the essential generic medicine or active pharmaceutical ingredients of the essential generic medicine2 and 7iv7 the potential for increased demand in a public health emergency4 7#e7 ,director of the strategic active pharmaceutical ingredients reserve ,the ,secretary shall appoint a ,director of the ,strategic ,active ,pharmaceutical ,ingredients ,reserve who has experience in one or more of the following areas3 supply chain management1 disaster response1 pharmaceutical or active pharmaceutical ingredient development1 or logistics4 ,such ,director shall ensure a sufficient supply of the active pharmaceutical ingredients and critical components necessary to manufacture the essential generic medicines included on the list under subsection 7a7 in an amount adequate to serve the needs of patients living in the ,united ,states and in the appropriate dosage forms4 7d7 ,appeal process ,the ,secretary shall establish a process by which stakeholders may appeal a determination by the ,secretary not to include an essential generic medicine on the list under subsection 7a74 7e7 ,definitions ,in this section3 7#a7 ,drug ,the term drug has the meaning given such term in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and includes a biological product 7as defined in section #cea7;i7 of this ,act74 ,such term includes prescription and nonprescription drugs1 or active pharmaceutical ingredients of drugs4 7#b7 ,essential generic medicine ,the term essential generic medicine means a drug for which a generic is approved1 that is medically necessary to have available at all times because the drug is-- 7,a7 commonly used to prevent1 mitigate1 or treat a common disease or condition1 or used in a common procedure2 7,b7 an antibiotic or antifungal used to treat an infectious diseases2 7,c7 necessary to prevent or mitigate a public health emergency2 or 7,d7 life-supporting1 life-sustaining1 or intended for use in the prevention or treatment of a debilitating disease or condition4 4 #c4 ,establishment of the strategic active pharmaceutical ingredient reserve ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq471 as amended by section #b1 is further amended by inserting after section #cai,n the following3 #cai,n-#a4 ,strategic active pharmaceutical ingredient reserve 7a7 ,strategic ,active ,pharmaceutical ,ingredient ,reserve ,plan 7#a7 ,in general ,not later than #ij days after the date of enactment of the ,promoting ,readiness and ,ensuring ,proper ,active pharmaceutical ingredient ,reserves of ,essential medicines ,act of #bjba1 the ,secretary1 in consultation with the ,assistant ,secretary for ,preparedness and ,response1 the ,director of the ,centers for ,disease ,control and ,prevention1 the ,commissioner of ,food and ,drugs1 and the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 shall prepare and submit to ,congress a ,strategic ,active ,pharmaceutical ,ingredient ,reserve ,plan 7referred to in this section as the ,plan7 in accordance with subsection 7b71 which shall be used by the ,secretary in establishing and maintaining the ,strategic ,active ,pharmaceutical ,ingredient ,reserve described in subsection 7c74 7#b7 ,annual updates ,the ,secretary shall update the plan annually and1 by not later than ,june #a of each year1 submit the updated plan to the applicable committees of ,congress4 7#c7 ,national security considerations 7,a7 ,submissions ,the ,secretary shall ensure that any submission of the plan 7including any update to the plan7 to the applicable committees of ,congress is in a manner that does not compromise national security4 7,b7 ,exemption from disclosure ,information in the plan that1 in the judgment of the ,secretary1 would reveal public health vulnerabilities shall be exempt from disclosure under section #eeb7;b77#c7 of title #e1 ,united ,states ,code4 7b7 ,plan requirements 7#a7 ,in general ,the ,plan required under subsection 7a7 shall-- 7,a7 detail the design1 construction1 and filling of the storage and related facilities comprising the ,strategic ,active ,pharmaceutical ,ingredient ,reserve described in subsection 7c7 7referred to in this section as the ,reserve72 7,b7 detail the requirements for maintaining the ,reserve described in subsection 7c71 including-- 7i7 storage and testing requirements1 consistent with parts #baj and #baa of title #ba1 ,code of ,federal ,regulations1 or any successor regulation2 and 7ii7 any specific criteria agreed to by the ,secretary and the manufacturer of the essential generic medicine using the active pharmaceutical ingredient or key starting material2 7,c7 be designed to minimize the impact of any interruption or reduction in imports of-- 7i7 active pharmaceutical ingredients and other key starting materials that the ,secretary determines are1 or are likely to become1 dependent upon such imports for a substantial portion of finished essential generic medicines2 and 7ii7 finished dosage forms of essential generic medicines for which active pharmaceutical ingredients and other key starting materials are not imported2 7,d7 include provisions to strengthen domestic capacity for active pharmaceutical ingredient production1 storage1 and conversion2 and 7,e7 outline plans and processes for coordinating and consulting1 as appropriate1 with the ,assistant ,secretary for ,preparedness and ,response regarding relevant issues of interest pertaining to the maintenance and stocking of the strategic national stockpile4 7#b7 ,required components 7,a7 ,in general ,the ,plan shall include the following3 7i7 ,identification and prioritization of the essential generic medicines included on the most recent list under section #cai,n7a7-- 7,i7 that the ,secretary determines are essential for health care needs in the ,united ,states2 and 7,,ii7 for which the ,secretary determines that there is the greatest need to maintain a reserve of the active pharmaceutical ingredients and key starting materials for the essential generic medicines-- 7aa7 taking into account factors including the extent to which the ,united ,states is1 or is at risk of becoming1 dependent on foreign sources for a substantial portion of the domestic need2 and 7bb7 giving special consideration to the essential generic medicines at risk of supply interruption as a result of the factors described in section #cai,n7c77#d77;,b74 7ii7 ,an evaluation of the utilization levels of the essential generic medicines identified under clause 7i7 to inform how much of the active pharmaceutical ingredients of such medicines is required to cover the projected health care needs for one year of the ,united ,states population4 7iii7 ,a comprehensive assessment of the essential generic medicines identified under clause 7i71 including the existing manufacturing bases for each such medicine 7including identification and location of ownership of such facilities7 and whether the active pharmaceutical ingredients of such ingredients are manufactured domestically or abroad1 and whether finished dosage conversion steps for such essential generic medicines are performed domestically or abroad4 7iv7 ,the types of facilities1 equipment1 and technology required to appropriately store1 track1 test1 and convert all forms of active pharmaceutical ingredients that are critical inputs of drugs that are essential generic medicines1 preliminary proposed locations for such public and privately owned facilities in multiple locations in the ,united ,states1 the capacity required of the facilities used1 and the estimated cost of acquisition and storage of the active pharmaceutical ingredients and management and operation of the facilities4 7v7 ,an evaluation of the impact that the establishment and ongoing maintenance of the ,reserve may have1 including on availability and pricing of active pharmaceutical ingredients and finished drug dosages4 7vi7 ,a distribution plan for the active pharmaceutical ingredients held in the ,reserve1 which shall include-- 7,i7 protocols for the method of conversion of active pharmaceutical ingredients into finished drugs1 including conversion of key starting materials into active pharmaceutical ingredients and distribution from the ,reserve into the strategic national stockpile and other government and commercial pharmaceutical distribution networks2 and 7,,ii7 benchmarks for the ,secretary to initiate conversion of drug products that are essential generic medicines using the active pharmaceutical ingredients stored in the ,reserve for transfer to the strategic national stockpile or other government or commercial pharmaceutical distribution networks1 based on changes in the supply chain for the top essential generic medicines or a determination by the ,secretary regarding a threat to public health4 7vii7 ,a mechanism through which private sector manufacturers of active pharmaceutical ingredients or finished dosage forms may1 through contracts with existing ,reserve facilities1 store and withdraw such ingredients in the ,reserve to enhance resilience and reduce shortages and disruptions in the supply chain4 7viii7 ,a mechanism through which the ,federal ,government may purchase1 via manufacturing partners1 reserve capacity for finished drug manufacturing to convert active pharmaceutical ingredients into finished drugs for essential generic medicines4 7,b7 ,number of drugs 7i7 ,in general ,pursuant to subparagraph 7,a77i71 the ,secretary shall ensure that for the first year after the date of enactment of the ,promoting ,readiness and ,ensuring ,proper ,active pharmaceutical ingredient ,reserves of ,essential medicines ,act of #bjba1 the ,plan includes not less than #be essential generic medicines1 and that #be additional essential generic medicines are included in such ,plan for each year thereafter until the active pharmaceutical ingredients necessary to support the full list of essential generic medicines identified under section #cai,n7a7 are covered4 7ii7 ,prioritization ,the ,secretary shall prioritize essential generic medicines needed immediately in the event of an emergency4 7#c7 ,quantities of ,a,p,is and key starting materials 7,a7 ,in general ,to the maximum extent practicable1 the ,plan should include a plan to ensure that1 for each essential generic medicine included in the ,plan1 the active pharmaceutical ingredients used in the production of such medicine that are stored in the ,reserve are available in the minimum quantities as follows3 7i7 ,by the date that is #ah months after the date of enactment of the ,promoting ,readiness and ,ensuring ,proper ,active pharmaceutical ingredient ,reserves of ,essential medicines ,act of #bjba1 not less than #aj percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the ,united ,states4 7ii7 ,by the date that is #c years after such date of enactment1 not less than #be percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the ,united ,states4 7iii7 ,by the date that is #e years after such date of enactment1 not less than #ej percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the ,united ,states4 7iv7 ,by the date that is #aj years after such date of enactment1 not less than #ij percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the ,united ,states4 7,b7 ,calculation of quantity of ,,api ,in calculating the quantities of active pharmaceutical ingredients needed for purposes of subparagraph 7,a71 the ,secretary shall determine the quantity of each essential generic medicine required to cover the projected health care needs1 over a #a-year period1 of people living in the ,united ,states1 based on average annual demand during the #c-year period preceding the date of enactment of the ,promoting ,readiness and ,ensuring ,proper ,active pharmaceutical ingredient ,reserves of ,essential medicines ,act of #bjba4 7c7 ,administering the strategic active pharmaceutical ingredient reserve 7#a7 ,in general ,with respect to each active pharmaceutical ingredient and key starting material that is included in the ,plan1 the ,secretary shall place in storage1 transport1 track1 and exchange quantities of the substance that are-- 7,a7 produced in conformance with all quality requirements under this ,act and the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including the associated regulations of such ,acts2 7,b7 stored in compliance with-- 7i7 the requirements of parts #baj and #baa of title #ba1 ,code of ,federal ,regulations1 or any successor regulation2 and 7,c7 any specific criteria agreed to by the ,secretary and the manufacturer of the essential generic medicine using the active pharmaceutical ingredient or key starting material4 7#b7 ,requirements ,to the greatest extent practicable1 in carrying out paragraph 7#a71 the ,secretary shall acquire active pharmaceutical ingredients and key starting materials in a manner that minimizes cost1 minimizes vulnerability of the ,united ,states to severe shortages or disruptions for essential generic medicines1 minimizes the impact of acquisition of such ingredients and materials to the marketplace1 gives preference to domestic manufacturers1 and encourages competition in the marketplace4 7#c7 ,drawdown of the ,reserve 7,a7 ,in general ,the ,secretary may distribute active pharmaceutical ingredients and key starting materials in the ,reserve in order to initiate conversion of active pharmaceutical ingredients and finished dosage form1 in accordance with the ,plan developed under subsection 7b74 7,b7 ,deviations from plan ,in distributing active pharmaceutical ingredients and key starting materials under subparagraph 7,a71 the ,secretary1 in consultation with the ,commissioner of ,food and ,drugs and the ,assistant ,secretary for ,preparedness and ,response1 may deviate from the ,plan developed under subsection 7b7 only after certifying that the distribution from the ,reserve is required in response to a significant drug supply interruption4 7d7 ,consultation 7#a7 ,in general ,in carrying out this section1 the ,secretary shall consult with-- 7,a7 the ,commissioner of ,food and ,drugs1 with respect to identifying essential generic medicines2 7,b7 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 with respect to determining the volume of essential generic medicines needed domestically2 and 7,c7 the ,assistant ,secretary for ,preparedness and ,response1 and1 as appropriate1 the ,director of the ,centers for ,disease ,control and ,prevention1 regarding coordination with the strategic national stockpile4 7#b7 ,reporting by ,,fda ,the ,commissioner of ,food and ,drugs shall provide to the ,secretary the information collected under section #eaj7;j77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 for purposes of carrying out this section4 7e7 ,contracting 7#a7 ,in general ,in carrying out this section1 the ,secretary shall-- 7,a7 prioritize the purchase of active pharmaceutical ingredients and other key starting materials manufactured in the ,united ,states by domestic manufacturers to the maximum extent possible2 7,b7 contract with domestic entities for the-- 7i7 distribution of active pharmaceutical ingredients and finished drug products2 7ii7 storage1 withdrawal1 testing1 and conversion of active pharmaceutical ingredients and other key starting materials2 7iii7 tracking and coordinating the storage1 testing1 and sale of active pharmaceutical ingredients and other key starting materials2 7iv7 sale of active pharmaceutical ingredients in advance of their expiration dates2 and 7v7 manufacturing1 including continuous manufacturing as appropriate1 of an active pharmaceutical ingredient or other key starting material of an essential generic medicine that is anticipated to be in shortage1 as defined by the ,secretary for purposes of this section2 7,c7 give preference to domestic nonprofit and public-private partnerships1 as appropriate2 7,d7 ensure geographic diversity of the physical storage of active pharmaceutical ingredients and other key starting materials2 7,e7 support domestic manufacturers of active pharmaceuticals and other key starting materials and facilitate long-term domestic capacity for essential generic medicines in the ,united ,states2 and 7,f7 prioritize contracts that facilitate the conversation of active pharmaceutical ingredients and other key starting materials into finished dosage form4 7#b7 ,rule of construction ,nothing in this subsection shall be construed to limit the ,secretary's ability to enter into other types of contracts to facilitate the implementation of this section4 7f7 ,reports to ,congress ,the ,secretary shall report to the applicable committees of ,congress on supply chain resiliency with respect to active pharmaceutical ingredients for essential generic medicines1 the status of the ,reserve1 and other relevant information in a manner that does not compromise national security4 7g7 ,definitions ,in this section3 7#a7 ,applicable committees of ,congress ,the term applicable committees of ,congress means-- 7,a7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,intelligence of the ,senate2 and 7,b7 the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7#b7 ,essential generic medicine ,the term essential generic medicine means a drug included on the most current list under section #cai,n7a74 7#c7 ,key starting material ,the term key starting material means an active pharmaceutical ingredient or critical input used in the manufacturing of an essential generic medicine1 as well as ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such essential generic medicines1 including excipients and inactive ingredients4 7h7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section such sums as may be necessary4 4 #d4 ,waiver of certain ,,fda ,,anda requirements ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#ad7 ,notwithstanding any other provision of this section1 the holder of an approved application under this subsection that changes the source of an active pharmaceutical ingredient of the drug that is the subject of such application to a source available through the ,strategic ,active ,pharmaceutical ,ingredient ,reserve established under section #cai,n-#a of the ,public ,health ,service ,act-- 7,a7 shall not be required to update the approved application with respect to such change before changing the source2 and 7,b7 shall inform the ,secretary of the change1 through an update to the approved application or other manner determined appropriate by the ,secretary1 prior to commercial distribution of the drug4 4 #e4 ,,gao report ,by not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall prepare and submit a report to ,congress that includes-- 7#a7 an assessment of what is known about active pharmaceutical ingredient manufacturing1 including-- 7,a7 the time needed to develop and implement domestic manufacturing capabilities2 7,b7 projected costs of developing new manufacturing capabilities for active pharmaceutical ingredients not currently available domestically1 as of the date of the report2 and 7,c7 projected costs of expanding existing domestic capabilities and policies1 as of the date of the report1 that may help establish or strengthen domestic manufacturing capacity for active pharmaceutical ingredients1 excipients1 key starting materials1 components1 functional ingredients1 and finished dosage manufacturing facilities2 and 7#b7 an assessment of incentives already offered or being considered for the development or improvement of domestic capacity to manufacture active pharmaceutical ingredients1 their intermediates1 and their excipients1 including-- 7,a7 contractual arrangements for existing domestic storage and manufacturing of active pharmaceutical ingredients2 7,b7 guaranteed contracts for initial purchase and replenishment of essential generic medicines2 and 7,c7 other policies designed to help incentivize the relocation of manufacturing facilities to the ,united ,states or provide economic incentives for domestic production4