,i #aahth ,,congress #ast ,session ,h4 ,r4 #ffjg ,,in ,,the ,,house ,,of ,,representatives ,december #e1 #bjbc,ms4 ,schakowsky 7for herself1 ,ms4 ,lee of ,california1 ,mr4 ,jackson of ,illinois1 ,ms4 ,norton1 ,ms4 ,jayapal1 ,mrs4 ,cherfilus-,mc,cormick1 ,mr4 ,davis of ,illinois1 ,mr4 ,garca of ,illinois1 and ,mr4 ,grijalva7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,public ,health ,service ,act to establish an ,office of ,drug ,manufacturing4 #a4 ,short title ,this ,act may be cited as the ,affordable ,drug ,manufacturing ,act of #bjbc4 #b4 ,public manufacturing of pharmaceuticals ,part ,a of 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 #caj;,c4 ,manufacturing of drugs 7a7 ,establishment of ,office of ,drug ,manufacturing 7#a7 ,in general ,there is established within the ,department of ,health and ,human ,services an office to be known as the ,office of ,drug ,manufacturing 7referred to in this section as the ,office74 7#b7 ,purpose ,the purpose of the ,office is-- 7,a7 to increase competition1 lower prices1 and address shortages in the market for prescription drugs1 including insulin1 asthma and chronic obstructive pulmonary disease 7,,copd7 inhalers1 naloxone1 epinephrine auto-injectors1 and antibiotics2 7,b7 to reduce the cost of prescription drugs to ,federal and ,state health programs1 taxpayers1 and consumers2 and 7,c7 to increase patient access to affordable drugs and associated devices4 7#c7 ,personnel 7,a7 ,director 7i7 ,in general ,the ,office shall be headed by a ,director1 who shall be appointed by the ,president4 7ii7 ,compensation ,the ,director shall be compensated at the rate prescribed for level ,,iii of the ,executive ,schedule4 7,b7 ,employees ,the ,director of the ,office1 in consultation with the ,secretary1 may fix the number of1 and appoint and direct1 all employees of the ,office4 7,c7 ,banned individuals 7i7 ,drug company lobbyists ,no former registered drug industry lobbyist-- 7,i7 may be appointed to the position of ,director of the ,office2 or 7,,ii7 may be employed by the ,office during the #f-year period beginning on the date on which the registered lobbyist terminates its registration in accordance with section #d7;d7 of the ,lobbying ,disclosure ,act of #aiie 7#b ,u4,s4,c4 #afjc7;d77 or the agent terminates its status1 as applicable4 7ii7 ,senior executives of law-breaking companies ,no former senior executive of a covered entity 7as defined in clause 7iii77 who was employed by such entity on any date on which wrongful conduct is the subject of a settlement1 decree or enforcement action described in clause 7iii77,,iii7 occurred-- 7,i7 may be appointed to the position of ,director of the ,office2 or 7,,ii7 may be employed by the ,office during the #f-year period beginning on the later of-- 7aa7 the date of the settlement2 and 7bb7 the date on which the enforcement action has concluded4 7iii7 ,covered entity ,the term covered entity means any entity that is currently-- 7,i7 a drug manufacturer2 7,,ii7 a wholesaler2 and 7,,iii7 7aa7 operating under ,federal settlement1 including a ,federal consent decree2 or 7bb7 the subject of an enforcement action in a court of the ,united ,states or by an agency4 7#d7 ,duties 7,a7 ,in general ,the ,office shall-- 7i7 prepare and submit applications for approval to the ,food and ,drug ,administration1 or enter into contracts for such submission1 for the manufacture of applicable drugs when authorized under this section1 and in accordance with subparagraph 7,g72 7ii7 acquire rights to manufacture applicable drugs as authorized under this section2 7iii7 manufacture1 or enter into contracts with entities1 with preference for nonprofit entities and public partners1 to manufacture1 applicable drugs as authorized under this section2 7iv7 determine a fair price for each applicable drug1 in accordance with subparagraph 7,b72 7v7 sell manufactured applicable drugs at a fair price as authorized under this section2 and 7vi7 manufacture1 or enter into contracts with entities1 with preference for nonprofit entities and public partners1 to manufacture active pharmaceutical ingredients for use by the ,office or for sale to other entities4 7,b7 ,transparency ,all prices paid and charged for applicable drugs and their inputs shall be made publicly available by the ,office4 7,c7 ,fair price ,in determining a fair price 7the price at which the ,office sells an applicable drug to a wholesaler or direct purchaser7 for an applicable drug under subparagraph 7,a77iv7 the ,office shall consider-- 7i7 the impact of price on patient access to the applicable drug2 7ii7 the cost of the applicable drug to ,federal or ,state health care programs2 7iii7 the cost to the ,federal ,government of manufacturing the applicable drug2 7iv7 the administrative costs of operating the ,office2 7v7 the cost to acquire or manufacture applicable drugs under this section2 7vi7 the impact of price on market competition for the applicable drug2 7vii7 the impact of formulary design on patient access to the applicable drug2 and 7viii7 the cost to acquire the applicable drug at the ,national ,average ,drug ,acquisition ,cost4 7,d7 ,acquiring right to manufacture and market ,the ,office may acquire the rights to manufacture and market applicable drugs as authorized under this section4 7,e7 ,active pharmaceutical ingredients 7i7 ,in general ,the ,office shall manufacture1 or enter into contracts with entities to manufacture1 an active pharmaceutical ingredient if-- 7,i7 the ,office determines that such ingredient is not readily available from existing suppliers2 7,,ii7 such ingredient is supplied by a single manufacturing facility2 7,,iii7 such ingredient is necessary for the manufacture of medical countermeasures or medicines deemed essential from a public health perspective2 7,,iv7 the manufacture of such ingredient would improve the ability of other entities to enter the market for the manufacture of applicable drugs or otherwise expand the manufacture of applicable drugs2 or 7,v7 the manufacture of such ingredient is necessary for1 or would improve the ability of1 the ,office to carry out its duties under this section4 7ii7 ,price determinations ,in determining what price at which to sell an active pharmaceutical ingredient under clause 7i71 the ,office shall consider the cost to manufacture the ingredient1 the administrative costs of the ,office with respect to the ingredient1 and the impact of such price on market competition for the ingredient4 7,f7 ,purchase requirements ,notwithstanding applicable laws relating to the procurement of prescription drugs1 the ,office shall establish minimum purchase requirements for the ,department of ,veterans ,affairs1 the ,department of ,defense1 the ,public ,health ,service1 and the ,coast ,guard to purchase drugs manufactured by or as a result of the ,office4 7,g7 ,limitation on undue influence ,the ,food and ,drug ,administration shall consider an application submitted by the ,office under subparagraph 7,a77i7 in the same manner in which the ,administration considers applications submitted by other manufacturers4 ,nothing in this paragraph shall be construed to require the ,food and ,drug ,administration to give special deference to any determination made1 or application submitted1 by the ,office4 7#e7 ,priority manufacturing ,the ,office shall prioritize the manufacturing of those applicable drugs that would have the greatest impact on-- 7,a7 lowering drug costs to patients2 7,b7 increasing competition and addressing drug shortages in the pharmaceutical market2 7,c7 improving public health2 7,d7 addressing health disparities2 7,e7 reducing the cost of prescription drugs to ,federal and ,state health programs2 or 7,f7 addressing public health emergencies as defined in this ,act1 the ,national ,emergencies ,act1 and the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act1 in coordination with the ,biomedical ,advanced ,research and ,development ,authority1 the ,administration for ,strategic ,preparedness and ,response1 the ,centers for ,disease ,control and ,prevention1 and any other ,federal agency that the ,office determines necessary1 to enable efficient procurement1 including contracting1 for the ,federal emergency response4 7#f7 ,manufacturing levels ,not later than #a year after the date of enactment of this section1 the ,office shall manufacture1 or enter into contracts with entities for the manufacture of1 not less than #ae applicable drugs4 ,not later than #c years after such date of enactment1 the ,office shall manufacture1 or enter into contracts with entities for the manufacture of1 not less than #be applicable drugs4 7#g7 ,reports to congress ,the ,director shall prepare and submit to the ,president1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 an annual report that includes-- 7,a7 an assessment of the major problems faced by patients in accessing affordable applicable drugs2 7,b7 a description of the status of all medications for which manufacturing has been authorized under this section1 including medications being manufactured1 medications for which the ,office has submitted an application to the ,food and ,drug ,administration but has not yet received approval1 and medications for which the ,office has received approval from the ,food and ,drug ,administration but are not being manufactured2 7,c7 in the case of antibiotics manufactured under this section1 an assessment from the ,centers for ,disease ,control and ,prevention and the ,food and ,drug ,administration on the impact of the manufacturing of antibiotics on antimicrobial resistance2 7,d7 an accounting of funds received from the sale of all medications for which manufacturing has been authorized under this section and the use of such funds2 7,e7 an analysis of how the public manufacture of drugs meeting the conditions described in paragraph 7#e7 would impact1 or has already impacted1 competition1 access to such drugs1 the costs of such drugs1 the costs of prescription drugs to ,federal and ,state health programs1 and public health2 and 7,f7 a description of the challenges faced by the ,office in carrying out its duties under paragraph 7#d74 7b7 ,submission of applications ,for each applicable drug that the ,office determines should be manufactured1 as provided for under this section1 the ,office shall-- 7#a7 submit an application under section #eje7;b77#b71 #eje7;j71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 or #cea7k7 of this ,act or submit a notification under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7or enter into a contract with another entity to submit such an application72 7#b7 request an emergency use authorization of the product1 as appropriate1 under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7or enter into a contract with another entity to submit an application for such use72 or 7#c7 acquire from the holder of an application approved under subsection 7c7 or 7j7 of section #eje or section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act1 or cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 rights to manufacture such applicable drug4 7c7 ,use 7#a7 ,in general ,the ,office shall sell a drug produced under this section at a fair price to other entities4 ,amounts received by the ,office from the sale of such drugs shall be used for the activities of the ,office4 7#b7 ,sale of approved application 7,a7 ,availability 7i7 ,in general ,for any applicable drug that the ,office is manufacturing1 the ,office shall1 beginning #c years after the date on which the ,office first undertakes manufacturing of such drug and annually thereafter1 make available for sale1 to any person who commits to manufacturing and marketing the applicable drug1 the approved application for the drug4 7ii7 ,continued compliance with ,,fda requirements ,the ,office shall ensure that any application purchased under clause 7i7 is consistent with existing standards applied by the ,food and ,drug ,administration related to the transfer of ownership rights for an approved application1 including any additional filing requirements that the purchaser would need to be in compliance with due to material changes in information provided in the approved application4 7,b7 ,failure to use ,if the ,office makes a determination that a person purchasing an approved application under subparagraph 7,a7-- 7i7 fails to market the applicable drug within #f months of the date of such purchase2 or 7ii7 increases the average manufacturer price for the applicable drug above the fair price 7increased by the consumer price index for all urban consumers 7as published by the ,bureau of ,labor ,statistics7 for that year71 the ,office shall revoke the purchaser's approved application and resume production of the applicable drug4 ,the ,office may waive the application of this subparagraph in the case of a ,national ,emergency or in any other case determined appropriate by the ,office4 7d7 ,ensuring patient access 7#a7 ,in general ,the ,office shall carry out appropriate activities to ensure the distribution and coverage of all applicable drugs that the ,office is manufacturing or has entered into a contract to manufacture under this section4 7#b7 ,advisory council ,the ,office shall establish an advisory council to inform the ,office on the identification of applicable drugs1 market landscape1 and supply chain considerations to ensure delivery of applicable drugs to consumers4 ,the advisory committee shall include representatives from community and retail pharmacies1 pharmacy benefit managers1 drug wholesalers1 hospitals1 health plans1 independent patient groups1 clinicians1 and consumer advocacy organizations4 7e7 ,insulin ,not later than #a year after the date of enactment of this section1 the ,office shall begin the public manufacturing of at least #a insulin product of each dosage form 7such as vial1 pump1 or pen dosage forms7 and of each different type of insulin 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 ultra-long acting1 and premixed71 meeting the definition of applicable drug and in accordance with this section4 7f7 ,asthma and ,,copd inhalers ,not later than #a year after the date of enactment of this section1 the ,office shall begin the public manufacturing of at least #a inhaler1 meeting the definition of applicable drug and in accordance with this section4 7g7 ,epinephrine auto-,injector ,not later than #a year after the date of enactment of this section1 the ,office shall begin the public manufacturing of an epinephrine auto-injector1 meeting the definition of applicable drug and in accordance with this section4 7h7 ,naloxone ,not later than #a year after the date of enactment of this section1 the ,office shall begin the public manufacturing of naloxone1 including naloxone indicated for community use1 meeting the definition of applicable drug and in accordance with this section4 7i7 ,antibiotics ,not later than #a year after the date of enactment of this section1 and in consultation with the ,centers for ,disease ,control and ,prevention and the ,food and ,drug ,administration to ensure the appropriate use of manufactured antibiotics1 the ,office shall begin the public manufacturing of no fewer than three discrete antibiotics meeting the definition of applicable drug in accordance with this section4 7j7 ,applicable drug ,in this section1 the term applicable drug means a drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 biological product 7as defined in section #cea of the ,public ,health ,service ,act71 or combination product 7as described in section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 for which an approved application under section #eje or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of the ,public ,health ,service ,act1 or clearance under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 is in effect1 and-- 7#a7 7,a7 for which1 with respect to a drug included in the list described in section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 each patent included with respect to such drug in such list has expired1 or each patent that claims a biological product has expired2 7,b7 any period of regulatory exclusivity granted under-- 7i7 clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 section #eje7;j77#e77;,b77iv7 of such ,act1 clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f7 of such ,act1 section #ebg of such ,act1 and any extension of such a period granted under section #eje;,a or #eje;,e of such ,act1 has expired2 or 7ii7 paragraph 7#f7 or 7#g7 of section #cea7k7 of the ,public ,health ,service ,act1 and any extension of such a period granted under paragraph 7#b7 or 7#c7 of section #cea7m7 of such ,act1 has expired2 and 7,c7 7i7 that is not being marketed in the ,united ,states2 or 7ii7 that is being marketed in the ,united ,states by #c or fewer manufacturers with an approved abbreviated new drug application or biosimilar 7not including manufacturers of authorized generics under a new drug application or biosimilar71 and that-- 7,i7 in the previous #e-year period1 has experienced an increase in the wholesale acquisition cost by at least #a of its manufacturers that is greater than the consumer price index for all urban consumers 7as published by the ,bureau of ,labor ,statistics7 for #a of the years in that the same period2 7,,ii7 is included in the drug shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,,iii7 7aa7 has an average wholesale acquisition cost that the ,office determines to be a barrier to patient access2 and 7bb7 is listed by the ,world ,health ,organization as an essential medicine2 or 7#b7 for which there is in effect a license1 or patent use is authorized1 under-- 7,a7 section #adih of title #bh1 ,united ,states ,code2 7,b7 section #bjb of title #ce1 ,united ,states ,code2 7,c7 section #bjc of title #ce1 ,united ,states ,code 7march-in rights72 7,d7 section #bji of title #ce1 ,united ,states ,code2 or 7,e7 any other licensing authority of the ,federal ,government4 7k7 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary to carry out this section4 4