,i #aafth ,,congress #b;d ,session ,h4 ,r4 #gaac ,,in ,,the ,,house ,,of ,,representatives ,june #d1 #bjbj,ms4 ,schakowsky 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 ,emergency ,office of ,manufacturing for ,public ,health1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,covid-#ai ,emergency ,manufacturing ,act of #bjbj4 #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;,b4 ,manufacturing of drugs1 biological products1 devices1 and personal protective equipment 7a7 ,emergency office of manufacturing for public health 7#a7 ,establishment ,there is established within the ,department of ,health and ,human ,services an office to be known as the ,emergency ,office of ,manufacturing for ,public ,health 7referred to in this section as the ,office74 7#b7 ,purpose ,the purposes of the ,office are-- 7,a7 to ensure an adequate supply of1 and increase access to1 prescription drugs1 biological products1 devices1 and other supplies1 including personal protective equipment1 necessary to1 as appropriate1 diagnose1 mitigate1 prevent1 or treat ,,covid-#ai and to mitigate the harm the ,,covid-#ai pandemic might otherwise cause for the strategic national stockpile under section #cai;,f-#b1 ,federal1 ,state1 local1 and ,native health programs1 and the commercial market2 7,b7 to address shortages in the strategic national stockpile and commercial market of prescription drugs1 biological products1 devices1 and personal protective equipment used to treat conditions other than ,,covid-#ai2 and 7,c7 to provide prescription drugs1 biological products1 devices1 and personal protective equipment necessary to diagnose1 mitigate1 prevent1 and treat ,,covid-#ai and to mitigate the harm the ,,covid-#ai pandemic might otherwise cause1 to ,federal1 ,state1 local1 and ,native health programs1 at no cost1 and to consumers in the commercial market and other international entities at cost4 7#c7 ,personnel 7,a7 ,director 7i7 ,in general ,the ,office shall be headed by a ,director1 who shall be appointed by the ,president1 not later than #ae days after the date of enactment of the ,,covid-#ai ,emergency ,manufacturing ,act of #bjbj1 by and with the advice and consent of the ,senate4 7ii7 ,acting director ,the ,assistant ,secretary for ,preparedness and ,response1 if in compliance with subparagraph 7,c71 may serve as ,director of the ,office in an acting capacity until the later of ,senate confirmation of a ,director or #c months after date of enactment of the ,,covid-#ai ,emergency ,manufacturing ,act of #bjbj4 7iii7 ,compensation ,the ,director shall be compensated at the rate prescribed for level ,,iii of the ,executive ,schedule under section #ecad of title #e1 ,united ,states ,code4 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 manufacturer 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 or the agent terminates its status1 as applicable4 7ii7 ,senior executives of law-breaking companies ,no former senior executive of a covered entity-- 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 ,for purposes of clause 7ii71 the term covered entity means any entity that is-- 7,i7 a drug manufacturer2 and 7,,ii7 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 ,,covid-#ai products and other applicable drugs1 biological products1 and devices when authorized under this section2 7ii7 obtain rights to manufacture applicable ,,covid-#ai products and applicable drugs1 biological products1 and devices as authorized under this section2 7iii7 manufacture1 or enter into contracts with entities to manufacture1 applicable ,,covid-#ai products and other applicable drugs1 biological products1 and devices as authorized under this section2 7iv7 determine a fair price for each applicable drug1 biological product1 and device1 in accordance with subparagraph 7,b77ii72 7v7 sell manufactured applicable drugs1 biological products1 and devices at a fair price1 as authorized under this section2 7vi7 provide1 at no cost1 applicable ,,covid-#ai products to ,federal1 ,state1 local1 and ,native health programs1 and other domestic health care providers and suppliers1 as determined by the ,secretary2 7vii7 sell1 at-cost1 applicable ,,covid-#ai products to other commercial entities and international entities1 in accordance with subparagraph 7,b77i72 and 7viii7 manufacture1 or enter into contracts with entities to manufacture1 active pharmaceutical ingredients for use by the ,office or for sale to other entities4 7,b7 ,pricing determinations 7i7 ,at-cost price ,in determining an at-cost price for an applicable ,,covid-#ai product under subparagraph 7,a77vii7 the ,office shall consider-- 7,i7 the cost to the ,federal ,government of manufacturing the applicable ,,covid-#ai product2 7,,ii7 the administrative costs of operating the ,office2 and 7,,iii7 the cost to acquire or manufacture applicable ,,covid-#ai product under this section4 7ii7 ,fair price ,in determining a fair price for an applicable drug1 biological product1 or device under subparagraph 7,a77iv7 the ,office shall consider-- 7,i7 the impact of price on patient access to the applicable drug1 biological product1 or device2 7,,ii7 the cost of the applicable drug1 biological product1 or device to ,federal or ,state health care programs2 7,,iii7 the cost to the ,federal ,government of manufacturing the applicable drug1 biological product1 or device2 7,,iv7 the administrative costs of operating the ,office2 7,v7 the cost to acquire or manufacture the applicable drug1 biological product1 or device under this section2 and 7,,vi7 the impact of price on market competition for the applicable drug1 biological product1 or device4 7iii7 ,transparency ,all prices charged for applicable ,,covid-#ai products and applicable drugs1 biological products1 or devices shall be made publicly available by the ,office4 7,c7 ,obtaining rights to manufacture and market 7i7 ,in general ,when necessary to fulfill the ,office's duties under this section1 the ,office shall acquire the rights to manufacture and market applicable ,,covid-#ai products and applicable drugs1 biological products1 and devices as authorized under this section4 7ii7 ,licensing authority 7,i7 ,in general ,notwithstanding any other provision of law1 the ,secretary shall issue licenses1 as useful for fulfilling the duties under this ,act1 allowing the ,office to practice or have practiced 7which may include licensure of retroactive practice7 any invention in the ,united ,states or territories of the ,united ,states1 including making1 using1 offering to sell or selling1 importing1 or exporting such invention1 to reference or rely upon clinical trial data submitted to a regulatory authority or the grant of marketing approval1 and to access and use otherwise confidential information1 including know-how1 related to the manufacture of an applicable ,,covid-#ai product or applicable drug1 biological product1 or device4 7,,ii7 ,non-voluntary licensing ,for any license that involves a non-voluntary authorization to use patented inventions1 regulatory test data1 data1 know-how or other intellectual property rights1 the license shall provide for reasonable remuneration to rights holders such as a reasonable royalty on the sales of product1 a #a-time payment1 or some combination1 provided that the combined royalty payments to all rights holders shall not exceed the percentage of sales that is the average percent of all royalty payments reported to the ,internal ,revenue ,service by companies in the pharmaceutical and medicines sector1 ,north ,american ,industry ,classification ,system code #cbedaj1 provided that when products are distributed for free1 the royalty shall be based upon the cost of goods4 ,when there are multiple rights holders1 the allocation of the total royalty payments shall be determined by-- 7aa7 agreement among the rights holders2 7bb7 allocation by arbitration among the rights holders2 or 7cc7 if neither item 7aa7 nor 7bb7 applies1 by the ,office4 7iii7 ,transparency ,subject to clause 7iv71 the ,secretary shall post any contract agreement under subparagraph 7,a7 or license issued under clause 7ii7 on the public internet website of the ,department of ,health and ,human ,services1 on the date on which such agreement or license takes effect4 7iv7 ,protected information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 7,d7 ,active pharmaceutical ingredients 7i7 ,in general ,the ,office shall manufacture1 or enter into contracts with entities to manufacture1 an active pharmaceutical ingredient applicable to a drug or biological product that is either an applicable ,,covid-#ai product or an applicable drug or biological product if-- 7,i7 the ,office determines that such ingredient is not readily available from existing suppliers or the existing supply of such ingredient to the domestic market is vulnerable to disruption2 7,,ii7 the manufacture of such ingredient would improve the ability of other entities to enter the market for the manufacture of applicable ,,covid-#ai products or applicable drugs1 biological products1 or devices1 or otherwise expand the manufacture of applicable ,,covid-#ai products or applicable drugs1 biological products1 or devices2 or 7,,iii7 the manufacture of such ingredient is necessary for the ,office to carry out its duties under this section4 7ii7 ,price determinations ,in determining the price at which to sell an active pharmaceutical ingredient manufactured in accordance with 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,e7 ,priority ,in awarding contracts under this paragraph1 the ,office shall prioritize entities manufacturing applicable ,,covid-#ai products and applicable drugs1 biological products1 and devices using components originating and manufactured in the ,united ,states4 7,f7 ,contract requirements ,all contracts issued under this paragraph shall include a requirement that the contract recipients reasonably price products produced under the contract4 7b7 ,manufacturing of products 7#a7 ,in general ,as soon as practicable after the date of enactment of this section1 but no later than #a month after such date of enactment1 the ,office shall begin-- 7,a7 manufacturing1 or entering into contracts with entities for the manufacture of applicable ,,covid-#ai products and applicable drugs1 biological products1 and devices1 prioritizing drugs1 biological products1 devices or personal protective equipment the manufacture of which would provide the greatest public health impact2 and 7,b7 constructing1 or entering into contracts to construct1 manufacturing facilities1 including the construction of advanced manufacturing technology1 ,,rna vaccines1 ,,dna vaccines1 recombinant protein vaccines1 viral vector-based vaccines1 live attenuated vaccines1 inactivated vaccines1 or other therapeutics1 after clinical data relating to such products have demonstrated strong positive indications of safety and efficacy1 to ensure immediate production at-scale upon ,federal approval4 7#b7 ,submission of applications ,for each applicable ,,covid-#ai product1 and for each applicable drug1 biological product1 or device that the ,office determines should be manufactured1 as provided for under this section1 the ,secretary shall-- 7,a7 submit an application under subsection 7b7 or 7j7 of section #eje1 or under section #eae1 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or subsection 7a7 or 7k7 of section #cea 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 application or notification72 7,b7 request an emergency use authorization of the product under section #efd;,a 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 obtain 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 subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 or cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 rights to manufacture such applicable drug4 7#c7 ,manufacturing timelines 7,a7 ,personal protective equipment ,not later than #a month after the date of enactment of this section1 the ,secretary shall begin the public manufacturing of personal protective equipment1 including surgical masks1 surgical gowns1 face shields1 and ,n#ie masks1 meeting the definition of applicable ,,covid-#ai product and in accordance with this section4 7,b7 ,,covid-#ai diagnostic test materials ,not later than #a month after the date of enactment of this section1 the ,secretary shall begin the public manufacturing of materials necessary for the development of ,,covid-#ai diagnostic tests1 including chemical reagents1 test swabs1 and materials necessary to develop serological ,,covid-#ai tests1 meeting the definition of applicable ,,covid-#ai product and in accordance with this section4 7,c7 ,,covid-#ai treatment drugs ,as soon as practicable after the date of enactment of this section1 the ,secretary shall begin the public manufacturing of drugs and biological products in shortage1 and any devices used to administer such drugs and biological products1 that are used for treatment of severe ,,covid-#ai cases1 including albuterol1 drugs used to intubate patients1 antibiotics1 and antivirals1 meeting the definition of applicable ,,covid-#ai product and in accordance with this section4 7#d7 ,priority manufacturing ,the ,office shall prioritize the manufacturing of applicable ,,covid-#ai products and applicable drugs1 biological products1 and devices that would have the greatest impact on-- 7,a7 diagnosing1 mitigating1 preventing1 treating1 or curing ,,covid-#ai2 7,b7 limiting the harm the ,,covid-#ai pandemic might otherwise cause to public health and the economy2 7,c7 addressing shortages of drugs1 biological1 products1 and devices2 7,d7 reducing the cost of combating ,,covid-#ai to ,federal1 ,state1 local1 and ,native health programs2 and 7,e7 alleviating demographic disparities in ,,covid-#ai outcomes or access to diagnosis1 mitigation1 prevention1 and treatment4 7c7 ,provision of products 7#a7 ,provision of applicable ,,covid-#ai products ,the ,secretary shall provide applicable ,,covid-#ai products at no cost to ,federal1 ,state1 local1 and ,native health programs1 and other domestic health care providers and suppliers1 including domestic commercial health care providers1 as determined by the ,secretary1 and sell at cost applicable ,,covid-#ai products to other commercial entities and international entities4 ,amounts received from the sale of such drugs shall be used for the activities of the ,office4 7#b7 ,provision of applicable drugs1 biological products and devices ,the ,secretary shall sell applicable drugs1 biological products1 and devices produced under this section at a fair price to other entities4 ,amounts received from the sale of such drugs shall be used to replenish the national strategic stockpile under section #cai;,f-#b4 7d7 ,oversight of contracts ,in the case of applicable ,,covid-#ai products and applicable drugs1 biological products1 and devices manufactured via contracts1 the ,inspector ,general of the ,department of ,health and ,human ,services shall conduct a review of not fewer than #a of every #c contracts entered into under this section1 and of the entities entering into such contracts1 to ensure that the ,office is issuing contracts under fair and reasonable terms and conditions1 including facilitating the procurement by the ,federal ,government of applicable ,,covid-#ai products and applicable drugs1 biological products1 and medical devices at fair and reasonable prices4 ,the ,inspector ,general shall make each such review public and1 in cases where such a review identifies unreasonable prices1 submit recommendations to ,congress on how the ,office should improve its contracting systems to ensure reasonable pricing4 7e7 ,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 a monthly report during the public health emergency declared by the ,secretary under section #cai on ,january #ca1 #bjbj1 with respect to ,,covid-#ai1 and a final report #c months after the public health emergency has concluded1 that includes-- 7#a7 an assessment of the major supply chain challenges facing hospitals1 medical providers1 the ,federal ,government1 ,state1 local1 and tribal governments1 and the private sector in procuring drugs1 biological products1 devices1 and personal protective equipment to combat and prevent the spread of ,,covid-#ai2 and 7#b7 a description of the status of all drugs1 biological products1 devices1 active pharmaceutical ingredients1 and personal protective equipment for which manufacturing has been authorized under this section1 including drugs1 biological products1 devices1 active pharmaceutical ingredients1 and personal protective equipment being manufactured1 drugs1 biological products1 devices1 active pharmaceutical ingredients1 and personal protective equipment for which the ,office has submitted an application for approval or a notification for clearance or classification to the ,food and ,drug ,administration but has not yet received approval1 clearance1 or classification1 and drugs1 biological products1 devices1 active pharmaceutical ingredients1 and personal protective equipment for which the ,office has received approval1 clearance1 or classification from the ,food and ,drug ,administration but are not being manufactured4 7f7 ,definitions ,in this section3 7#a7 ,applicable drug1 biological product1 or device definition ,the term applicable drug1 biological product1 or device means a drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act71 combination product 7as described in section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 or device 7as defined in section #bja7;h7 of the ,federal ,food ,drug 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 is included in the drug shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,b7 is vulnerable to shortage4 7#b7 ,applicable ,,covid-#ai product definition 7,a7 ,in general ,the term applicable ,,covid-#ai product means a product that is included on a list that the ,secretary of ,health and ,human ,services1 in consultation with the ,commissioner of ,food and ,drugs1 the ,assistant ,secretary for ,preparedness and ,response1 and the ,director of the ,centers for ,disease ,control and ,prevention1 shall compile not later than #b weeks after the date of enactment of this section and shall review and update1 as necessary1 every #b weeks of -- 7i7 qualified pandemic or epidemic products1 as defined under section #cai;,f-#c1 that are-- 7,i7 7aa7 drugs1 biological products1 and devices that are manufactured1 used1 designed1 developed1 modified1 licensed or procured-- 7,,aa7 to diagnose1 mitigate1 prevent1 treat1 or cure ,,covid-#ai2 or 7,,bb7 to limit the harm the ,,covid-#ai pandemic might otherwise cause2 7bb7 drugs1 biological products1 and devices that are manufactured1 used1 designed1 developed1 modified1 licensed1 or procured to diagnose1 mitigate1 prevent1 treat1 or cure a serious or life-threatening disease or condition caused by a product described in item 7aa72 or 7cc7 drugs1 biological products1 devices or technologies intended to enhance the use or effect of a drug1 biological product1 or device described in item 7aa7 or 7bb72 and 7ii7 personal protective equipment1 including protective equipment for eyes1 face1 head1 and extremities1 protective clothing1 respiratory devices1 and protective shields and barriers1 used to protect people from ,,covid-#ai infection4 7,b7 ,consultation ,in developing the list described in subparagraph 7,a71 the ,secretary shall consult with the ,administrator of the ,federal ,emergency ,management ,administration and the ,secretary of ,defense to ensure that1 in instances where the ,president has enacted the ,defense ,production ,act to produce applicable ,,covid-#ai products1 the ,office does not replicate or overproduce products being developed under the ,act4 7#c7 ,native health program ,the term ,native health program shall include-- 7,a7 a program provided through the ,indian ,health ,service2 7,b7 any health program operated by-- 7i7 an ,indian tribe1 or ,tribal organization1 as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act2 7ii7 an inter-tribal consortium1 as defined in section #eja7;a7 of the ,indian ,self-,determination and ,education ,assistance ,act2 or 7iii7 an urban ,indian organization1 as defined in section #d of the ,indian ,health ,care ,improvement ,act2 and 7,c7 any health program provided through a ,native ,hawaiian health care system1 as defined in section #ab of the ,native ,hawaiian ,health ,care ,improvement ,act4 7#d7 ,domestic health care provider ,the term domestic health care provider shall include the direct support professional1 home health1 and personal care attendant workforce4 7g7 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary to carry out this section4 4