,,ii #aaith ,,congress #b;d ,session ,s4 #dhge ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bc1 #bjbf,mr4 ,bennet 7for himself1 ,mr4 ,young1 ,mrs4 ,gillibrand1 ,mr4 ,rounds1 and ,mr4 ,hickenlooper7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to establish a program to develop innovative antimicrobial drugs targeting the most challenging pathogens and most threatening infections1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,pioneering ,antimicrobial ,subscriptions ,to ,end ,upsurging ,resistance ,act of #bjbf or the ,,pasteur ,act of #bjbf4 #b4 ,purpose ,the purpose of this ,act is to ensure the availability of antimicrobials to-- 7#a7 stimulate a new age of research1 development1 and market access to lifesaving medicines2 7#b7 ensure the appropriate use of lifesaving medicines2 7#c7 maintain the highest medical care standards for ,american patients2 7#d7 promote national health system preparedness2 and 7#e7 defend the ,united ,states and its military4 #c4 ,developing antimicrobial innovations ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,x ,u4,s4 ,,novel ,,antimicrobial ,,supply ,,contracts #cii,,pp4 ,contract application1 award1 and implementation 7a7 ,in general ,the ,secretary may enter into contracts with sponsors of eligible antimicrobials for the purpose of ensuring the availability of such eligible antimicrobials4 7b7 ,eligible antimicrobial ,to be eligible for a contract under this section1 an antimicrobial drug shall-- 7#a7 treat a pathogen-- 7,a7 included as an urgent or serious threat in the most recent ,antibiotic ,resistance ,threats in the ,united ,states report published by the ,centers for ,disease ,control and ,prevention2 or 7,b7 that the ,secretary has determined appropriate in consultation with the ,advisory ,group established under section #cii,,pp-#a2 and 7#b7 address an unmet medical need4 7c7 ,applications 7#a7 ,submission ,to be eligible to enter into a contract under this section1 a sponsor of an eligible antimicrobial shall submit to the ,secretary an application not later than #b years after the date on which the eligible antimicrobial is-- 7,a7 approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7including in accordance with section #ejf7;h7 of such ,act72 or 7,b7 licensed under section #cea7;a7 of this ,act4 7#b7 ,contents ,an application submitted under paragraph 7#a7 with respect to an eligible antimicrobial-- 7,a7 shall include-- 7i7 appropriate information to determine the score of the eligible antimicrobial in accordance with the methodology established under subsection 7d72 and 7ii7 such other information as the ,secretary determines appropriate2 and 7,b7 is not required to include information relating to pricing or research and development costs of the eligible antimicrobial4 7#c7 ,review ,not later than #ij days after the date on which the ,secretary receives an application under this subsection with respect to an eligible antimicrobial 7including a revised application under paragraph 7#d771 the ,secretary shall-- 7,a7 review the application2 7,b7 if the eligible antimicrobial's score is below the minimum scoring threshold described in subsection 7d77#a77;,b71 deny the application2 and 7,c7 if the eligible antimicrobial's score meets or exceeds such minimum scoring threshold1 approve the application and calculate annual payments for the contract under subsection 7f74 7#d7 ,revised applications ,beginning #a year after the denial of an application with respect to an eligible antimicrobial under paragraph 7#c71 and not more frequently than once every #b years thereafter1 the sponsor of the eligible antimicrobial may submit to the ,secretary a revised application for the eligible antimicrobial with additional information that may materially affect the eligible antimicrobial's score under subsection 7d74 7d7 ,scoring 7#a7 ,in general ,not later than #bgj days after the date of enactment of this part1 the ,secretary1 in consultation with the ,advisory ,group established under section #cii,,pp-#a1 the ,assistant ,secretary for ,preparedness and ,response1 the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 and the ,commissioner of ,food and ,drugs1 shall promulgate regulations1 after the consideration of comments received in response to a public request for information and a public hearing1 establishing-- 7,a7 a quantitative scoring methodology for eligible antimicrobials for which applications are submitted under this section2 and 7,b7 a minimum scoring threshold that the score of an eligible antimicrobial under paragraph 7#b7 must meet or exceed in order for the sponsor of such eligible antimicrobial to enter into a contract under this section4 7#b7 ,methodology ,an eligible antimicrobial shall receive a score1 calculated by points awarded based on criteria developed in consultation with the ,advisory ,group established under section #cii,,pp-#a within the following three categories1 with a weighting assigned to each criterion established under such categories and a greater number of points resulting in a higher score3 7,a7 ,category i ,the eligible antimicrobial's major contributions to patient care1 including-- 7i7 improving clinical outcomes for patients with multi-drug-resistant infections2 7ii7 improved dose frequency2 7iii7 reduced toxicity2 7iv7 reductions in adverse events2 and 7v7 benefits from the eligible antimicrobial's route of administration1 especially through oral administration or more than one administration method4 7,b7 ,category ii ,the innovative characteristics of the eligible antimicrobial1 including-- 7i7 being a first-approved antimicrobial drug that has the potential to address1 or has the evidence of addressing1 unmet medical needs for the treatment of a serious or life-threatening infection1 or1 to a lesser extent1 second and third drugs that treat such infection2 7ii7 containing no active moiety 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that has been approved in any other application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and containing no active ingredient licensed in any other biological product license application under section #cea7;a7 of this ,act2 7iii7 being a member of a new class of drugs with a novel target or novel mode of action that are distinctly different from the target or mode of any antimicrobial drug approved under such section #eje7;b7 or licensed under such section #cea7;a72 and 7iv7 addressing a multi-drug resistant infection through a novel chemical scaffold or mode of action4 7,c7 ,category iii ,the benefit of the eligible antimicrobial to health systems and public health1 including-- 7i7 not being affected by cross-resistance to one or more antimicrobials approved under such section #eje7;b7 or licensed under such section #cea7;a72 7ii7 manufacturing capabilities within the ,united ,states2 7iii7 improved product stability and storage2 7iv7 increased activity against resistance mechanisms2 and 7v7 reduction of the economic or population burden of antimicrobial resistance in the ,united ,states4 7e7 ,contract requirements ,as a condition of entering into a contract under this section with respect to an eligible antimicrobial1 the sponsor of the eligible antimicrobial shall-- 7#a7 beginning on the date that is #cj days after the sponsor receives its first payment under the contract and for the remainder of the contract term1 ensure-- 7,a7 the commercial availability of the eligible antimicrobial in the ,united ,states2 and 7,b7 sufficient supply of the eligible antimicrobial for antimicrobial susceptibility test device manufacturers2 7#b7 identify1 track1 and publicly report drug resistance data and trends using available data related to the eligible antimicrobial1 including the use of data collected by the ,secretary under section #cii,,pp-#b7;c72 7#c7 develop and implement education and communications strategies for health care professionals and patients concerning the appropriate use of the eligible antimicrobial1 such as-- 7,a7 information from labeling approved by the ,food and ,drug ,administration2 and 7,b7 communications for individuals with limited ,english proficiency and individuals with disabilities2 7#d7 submit to the ,secretary a plan regarding the appropriate use of the eligible antimicrobial1 including best practices for antimicrobial stewardship and a general description of how the product will be marketed4 ,the appropriate use plan may include a plan to collect data on the impact of diagnostics1 antimicrobial stewardship programs1 and other appropriate use efforts on patient outcomes and health-care costs2 7#e7 upon the request of the ,secretary1 submit to the ,secretary a plan for registering the eligible antimicrobial in countries other than the ,united ,states where an unmet medical need exists2 7#f7 undertake efforts to ensure a reliable drug supply chain1 including1 in the event of the ,food and ,drug ,administration determining that a shortage exists for the eligible antimicrobial1 not later than #cj days after such determination submitting to the ,secretary a plan to address such shortage2 7#g7 beginning on the date that is #cj days after the sponsor receives its first payment under the contract and for the remainder of the contract term1 manufacture the eligible antimicrobial drug at a volume that reasonably ensures the availability of sufficient quantities of the drug to meet the needs of individuals with the disease or condition for which the eligible antimicrobial is approved in the ,united ,states2 7#h7 abide by manufacturing and environmental best practices for the control of discharge of antimicrobial active pharmaceutical ingredients and other antimicrobial agents or products1 including the antibiotic manufacturing standard developed by the ,,amr ,industry ,alliance 7as described in the report titled ,minimizing risk of developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotics published in ,may #bjbe7 or seeking a sustainability certification from ,,bsi ,standards ,limited2 and 7#i7 abide by such other terms as the ,secretary may require under the contract4 7f7 ,annual payments 7#a7 ,in general ,pursuant to a contract entered into under this section1 the ,secretary shall make annual payments to the sponsor of an eligible antimicrobial for the duration of the contract term4 ,such payments shall begin not later than #ahj days after the date on which the ,secretary approves the contract4 7#b7 ,calculation system ,the ,secretary1 in consultation with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall promulgate regulations establishing a system for the calculation of the annual payments described in paragraph 7#a74 ,such system shall adhere to the following3 7,a7 ,minimum and maximum amount ,an annual payment may not be less than #ge1jjj1jjj or more than #cjj1jjj1jjj1 adjusted on an annual basis in accordance with the consumer price index for all urban consumers 7all items2 ,united ,states city average74 7,b7 ,adjustment for net revenue ,the annual payment shall be adjusted downward by the amount of net revenue from sales in the ,united ,states of the eligible antimicrobial during the previous #ab-month period1 including any legally mandated or voluntary discounts and rebates provided by the sponsor of the eligible antimicrobial1 such as volume discounts1 prompt pay discounts1 cash discounts1 free goods that are contingent on any purchase requirement1 chargebacks1 and rebates4 7#c7 ,disclosure of information ,the ,secretary may require the sponsor of an eligible antimicrobial to disclose to the ,secretary such information as the ,secretary requires to calculate an annual payment under this subsection4 ,notwithstanding any other provision of law1 such information shall be kept confidential and may not be-- 7,a7 disclosed by the ,secretary to any entity1 including other governmental or private parties1 in a form that reveals the identity of a specific manufacturer or the prices charged for drugs by such manufacturer2 or 7,b7 used by the ,secretary for any purpose other than calculating the annual payments under this subsection4 7#d7 ,termination of payments ,the ,secretary may cease annual payments pursuant to a contract entered into under this section if the ,secretary determines that the sponsor of the eligible antimicrobial subject to such contract-- 7,a7 permanently withdraws the eligible antimicrobial from the market in the ,united ,states2 7,b7 materially fails to meet one or more of the requirements described in subsection 7e7 after notice by the ,secretary and an opportunity to correct2 or 7,c7 does not conduct with due diligence a postmarket study required to be completed by the ,food and ,drug ,administration during the term of the contract4 7#e7 ,rule of construction ,nothing in this subsection shall be construed as authorizing the ,secretary-- 7,a7 to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code2 or 7,b7 to use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly1 disabled1 or terminally ill individual as of lower value than extending the life of an individual who is younger1 nondisabled1 or not terminally ill for the purposes of calculating annual payments under this subsection1 including in such a way that would limit patient access4 7g7 ,contract term 7#a7 ,length of term ,the term of a contract entered into under this section shall end on the earlier of-- 7,a7 the date that is #aj years after the date on which the contract is approved2 and 7,b7 the date on which the ,secretary determines at least one drug or biological product is-- 7i7 approved or licensed 7as applicable7-- 7,i7 under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 using the contract antimicrobial as the listed drug2 or 7,,ii7 under section #cea7k7 of the ,public ,health ,service ,act1 using the contract antimicrobial as the reference product2 and 7ii7 marketed pursuant to such approval or licensure4 7#b7 ,effect ,a contract shall remain in effect for the term described in paragraph 7#a7 even if the pathogen treated by the eligible antimicrobial is later removed from the ,antibiotic ,resistance ,threats in the ,united ,states report described in subsection 7b77#a77;,a74 7h7 ,other government participation ,the ,secretary shall make efforts to increase the participation of other governmental bodies in offering financial incentives to create commercial access to new and novel antimicrobials that are similar to the contracts under this section4 7i7 ,authority vested in the secretary ,the authority vested in the ,secretary by this section to enter into contracts may be performed without regard to such provisions of law or regulations relating to the making1 performance1 amendment1 or modification of contracts of the ,united ,states1 as the ,secretary may determine to be inconsistent with the furtherance of the purposes of this part4 #cii,,pp-#a4 ,critical need antimicrobial advisory group 7a7 ,in general ,not later than #fj days after the date of enactment of this part1 the ,secretary shall establish a ,critical ,need ,antimicrobial ,advisory ,group 7referred to in this part as the ,advisory ,group7 and appoint its members4 7b7 ,members ,the ,advisory ,group shall be composed of #ae members1 to be appointed by the ,secretary as follows3 7#a7 #d individuals who are physicians board-certified in infectious diseases4 7#b7 #d individuals who are experts with demonstrated expertise in antimicrobial resistance1 health economics1 or research and development or commercialization of antimicrobial drugs4 7#c7 #d individuals to serve as patient advocates1 who are well versed in antimicrobial treatment or resistance1 either as patients themselves or as caretakers4 7#d7 #c additional individuals who meet the qualifications specified in paragraph 7#a71 7#b71 or 7#c74 7c7 ,chair ,in addition to the members appointed under subsection 7b71 the ,secretary shall appoint #a individual to serve as a non-voting ,chair of the ,advisory ,group4 ,such individual shall meet the qualifications specified in paragraph 7#a71 7#b71 or 7#c7 of subsection 7b74 7d7 ,conflicts of interest ,in appointing members under subsection 7b7 and a ,chair under subsection 7c71 the ,secretary shall ensure that no member 7including the ,chair7 receives during the individual's term of service with the ,advisory ,group compensation in any manner from a commercial or for-profit entity that develops or intends to develop antimicrobial drugs4 ,in implementing the requirements of this part1 the ,secretary shall prohibit ,advisory ,group members 7including the ,chair7 from participating in any particular ,advisory ,group matter that will have a direct and predictable effect on their financial interests4 7e7 ,applicability of ,,faca 7#a7 ,in general ,except as otherwise provided in this section1 chapter #aj of title #e1 ,united ,states ,code 7commonly referred to as the ,federal ,advisory ,committee ,act7 shall apply to the ,advisory ,group4 7#b7 ,termination ,section #ajac of such title 7relating to the termination of advisory committees7 shall not apply to the ,advisory ,group4 #cii,,pp-#b4 ,encouraging appropriate use of antimicrobials and combating resistance 7a7 ,health facility grant program 7#a7 ,in general ,not later than #a year after the date of enactment of this part1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention 7in this subsection referred to as the ,secretary71 shall establish a grant program to support hospital1 skilled nursing facility1 and other health care facility efforts-- 7,a7 to judiciously use antimicrobial drugs1 such as by establishing or implementing appropriate use programs1 including infectious disease telehealth programs1 using appropriate diagnostic tools1 partnering with academic hospitals1 increasing health care-associated infection reporting and prevention efforts1 and monitoring antimicrobial resistance2 and 7,b7 to participate in the ,national ,healthcare ,safety ,network ,antimicrobial ,use and ,resistance ,module or the ,emerging ,infections ,program ,healthcare-,associated ,infections ,community ,interface activity of the ,centers for ,disease ,control and ,prevention1 as specified by the ,secretary1 relating to antimicrobial drugs4 7#b7 ,prioritization ,in awarding grants under paragraph 7#a71 the ,secretary shall prioritize health care facilities without an existing program to judiciously use antimicrobial drugs1 subsection 7d7 hospitals 7as defined in section #ahhf7;d77#a77;,b7 of the ,social ,security ,act7 that are located in rural areas 7as defined in section #ahhf7;d77#b77;,d7 of such ,act71 critical access hospitals 7as defined in section #ahfa7mm77#a7 of such ,act71 hospitals serving ,tribal populations1 and safety-net hospitals4 7#c7 ,standards for use of grant funds ,in implementing or expanding an antibiotic stewardship program1 an entity receiving a grant under paragraph 7#a7 shall adhere to nationally recognized guidelines and best practices1 including adequate staffing1 for improving antibiotic use4 7b7 ,antimicrobial stewardship pilot program for outpatient facilities 7#a7 ,antimicrobial stewardship pilot program for outpatient facilities ,not later than #b years after the date of enactment of this part1 the ,secretary1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention and the ,administrator of the ,centers for ,medicare ,medicaid ,services 7in this subsection referred to as the ,secretary71 shall establish a pilot program to make grants to entities to implement or expand antibiotic stewardship programs in outpatient facilities4 7#b7 ,implementation ,in developing the pilot program1 the ,secretary shall consult with professional societies with expertise in antibiotic stewardship4 7#c7 ,eligible entities ,to be eligible to receive a grant under paragraph 7#a71 an entity shall be-- 7,a7 a physician2 7,b7 a hospital outpatient department2 7,c7 an urgent care setting described in paragraph 7#e77;,a72 or 7,d7 a retail clinic described in paragraph 7#e77;,b74 7#d7 ,standards for use of grant funds ,in implementing or expanding an antibiotic stewardship program through a grant under this subsection1 an entity shall adhere to nationally recognized guidelines and best practices1 including adequate staffing1 for improving antibiotic use4 7#e7 ,prioritization ,in awarding grants under paragraph 7#a71 the ,secretary shall prioritize-- 7,a7 urgent care settings1 such as facilities that use ,place of ,service ,code #bj for urgent care developed by the ,centers for ,medicare ,medicaid ,services 7or any successor code72 and 7,b7 retail clinics1 meaning facilities that are co-located with a pharmacy or other retail commercial establishment1 such as those that use ,place of ,service ,code #ag for walk-in retail health clinics developed by the ,centers for ,medicare ,medicaid ,services 7or any successor code74 7#f7 ,report ,not later than #e years after the date of enactment of this part1 the ,secretary shall submit to ,congress a report on the impacts of the pilot program1 including recommendations for expanding antimicrobial stewardship to additional outpatient settings4 7c7 ,surveillance and reporting of antimicrobial use and resistance 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall use the ,national ,healthcare ,safety ,network and other appropriate surveillance systems to collect data and assess trends in antimicrobial resistance and antibiotic and antifungal use1 such as-- 7,a7 appropriate conditions and measures causally related to antimicrobial resistance1 including types of infections1 the source or body sites of infections1 the demographic information of patients with infections1 infection onset in a community or hospital setting1 increased lengths of hospital stay1 increased costs1 and rates of mortality2 and 7,b7 changes in bacterial and fungal resistance to antimicrobial drugs1 including changes in percent resistance1 prevalence of antimicrobial-resistant infections1 rates of mortality1 and other such changes4 7#b7 ,antimicrobial use data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall obtain reliable and comparable human antibiotic and antifungal drug consumption data 7including1 as available and appropriate1 volume antimicrobial distribution data and antibiotic and antifungal use data1 including prescription data7 by ,state or metropolitan areas4 ,to accomplish this1 the ,secretary may work with1 as appropriate1 ,federal departments and agencies 7including the ,department of ,veterans ,affairs1 the ,department of ,defense1 the ,department of ,homeland ,security1 the ,bureau of ,prisons1 the ,indian ,health ,service1 and the ,centers for ,medicare ,medicaid ,services71 private vendors1 health care organizations1 pharmacy benefit managers1 and other entities4 7#c7 ,antimicrobial resistance trend data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall intensify and expand efforts to collect antimicrobial resistance data and encourage adoption of the ,antimicrobial ,use and ,resistance ,module or other appropriate module within the ,national ,healthcare ,safety ,network and other appropriate surveillance systems among all health care facilities across the continuum of care1 including1 as appropriate1 acute care hospitals1 dialysis facilities1 nursing homes1 ambulatory surgical centers1 and other ambulatory health care settings in which antimicrobial drugs are routinely prescribed4 ,the ,secretary shall seek to collect such data from electronic medication administration reports and laboratory systems to produce the reports described in paragraph 7#e74 7#d7 ,diagnostics data ,the ,secretary shall collect data on tests used to diagnose and inform the appropriate treatment of infections in health care settings4 ,this includes data on the implementation of diagnostic stewardship to ensure the appropriate use of a diagnostic test before a treatment is prescribed1 and the use of diagnostics in monitoring and tracking infectious diseases4 ,the ,secretary shall collect data on the use of diagnostic tests through the ,national ,healthcare ,safety ,network 7in this paragraph referred to as the ,,nhsn7 ,antimicrobial ,use and ,resistance ,module or other appropriate ,,nhsn module4 ,these efforts shall be implemented in collaboration with external stakeholders1 including infectious disease professional societies1 patient advocacy organizations1 health care systems and professionals1 and the diagnostics industry4 7#e7 ,public availability of data ,beginning on the date that is #b years after the date of enactment of this part1 the ,secretary shall1 for the purposes of improving the monitoring of important trends in antimicrobial use and resistance1 and1 as appropriate1 patient outcomes in relation to antimicrobial resistance-- 7,a7 make the data described in paragraphs 7#a7 through 7#d7 publicly available through reports and web updates issued on a regular basis that is not less than annually2 and 7,b7 examine opportunities to make such data available in near real time4 #cii,,pp-#c4 ,definitions ,in this part3 7#a7 ,antimicrobial drug ,the term antimicrobial drug-- 7,a7 means-- 7i7 a drug that directly inhibits replication of or kills bacteria or fungi1 or acts on the substances produced by such bacteria or fungi1 relevant to the proposed indication at concentrations likely to be attainable in humans to achieve the intended therapeutic effect2 and 7ii7 a biological product that acts directly on bacteria or fungi or on the substances produced by such bacteria or fungi2 and 7,b7 does not include-- 7i7 a drug that achieves the effect described in subparagraph 7,a77i7 only at a concentration that cannot reasonably be studied in humans because of its anticipated toxicity2 or 7ii7 a vaccine4 7#b7 ,contract ,the term contract means a transaction other than a procurement contract1 grant1 or a cooperative agreement4 7#c7 ,contract antimicrobial ,the term contract antimicrobial means an antimicrobial drug or biological product for which a contract under this part is in effect4 7#d7 ,eligible antimicrobial ,the term eligible antimicrobial means an antimicrobial drug or biological product that satisfies the eligibility criteria described in section #cii,,pp7b74 #cii,,pp-#d4 ,appropriations 7a7 ,in general ,to carry out this part1 there is authorized to be appropriated1 and appropriated1 to the ,secretary1 out of amounts in the ,treasury not otherwise appropriated1 #f1jjj1jjj1jjj for fiscal year #bjbf1 to remain available until expended4 7b7 ,allocation ,the ,secretary may use not more than #f4e percent of the amounts appropriated under subsection 7a7 to carry out section #cii,,pp-#b4 7c7 ,emergency designation 7#a7 ,in general ,the amounts provided by this section are designated as an emergency requirement pursuant to section #d7;g7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj4 7#b7 ,designation in senate ,in the ,senate1 this section is designated as an emergency requirement pursuant to section #daab7;a7 of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress71 the concurrent resolution on the budget for fiscal year #bjah4 4