,i #aafth ,,congress #b;d ,session ,h4 ,r4 #hihg ,,in ,,the ,,house ,,of ,,representatives ,december #af1 #bjbj,mr4 ,joyce of ,pennsylvania introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend the ,public ,health ,service ,act to incentivize the manufacture of certain medicines in the ,united ,states and to enhance the security of the ,united ,states pharmaceutical supply chain1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,enhancing the ,security of the ,u4,s4 ,pharmaceutical ,supply ,chain ,act of #bjbj4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,sec4 #c4 ,identification1 development1 and procurement of priority medicines4,sec4 #d4 ,priority medicine production credit4,sec4 #e4 ,improving regulatory efficiencies for transfer of drugs4 #c4 ,identification1 development1 and procurement of priority medicines 7a7 ,priority medicines ,title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh et seq47 is amended by adding at the end the following3 #bhjd4 ,identification of priority medicines 7a7 ,priority medicines ,the ,secretary shall designate as a priority medicine each covered product that-- 7#a7 7,a7 is necessary for use in a public health emergency declared under section #cai2 or 7,b7 is at high risk of becoming in short supply2 and 7#b7 has a vulnerable global supply chain4 7b7 ,global supply chain vulnerability ,in determining whether a covered product has a vulnerable global supply chain under subsection 7a77#b71 the ,secretary shall consider-- 7#a7 the findings of the ,national ,academies of ,sciences1 ,engineering1 and ,medicine in the report published pursuant to section #daaa of the ,,cares ,act 7,public ,law #aaf-acf72 7#b7 the number of manufacturers of each covered product2 7#c7 the manufacturing locations1 and amount produced1 of each covered product2 7#d7 the history of the importation of each priority medicine2 and 7#e7 the probability of the imposition of duties on the importation of each covered product4 7c7 ,consultation ,in carrying out subsection 7a71 the ,secretary shall consult with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a4 7d7 ,publication of list ,the ,secretary shall-- 7#a7 not later than #ahj days after the date of enactment of this section1 publish a preliminary list of priority medicines2 7#b7 provide an opportunity for public comment on such preliminary list2 7#c7 not later than #a year after such date of enactment1 publish a final list of priority medicines2 and 7#d7 on an annual basis1 review and1 as appropriate1 update such list4 7e7 ,definitions ,in this section3 7#a7 ,active pharmaceutical ingredient ,the term active pharmaceutical ingredient-- 7,a7 means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis1 cure1 mitigation1 treatment1 or prevention of a disease1 or to affect the structure or any function of the body of a human or animal2 and 7,b7 does not include-- 7i7 intermediates used in the synthesis of a drug product2 or 7ii7 components that may undergo chemical change in the manufacture of a drug product and be present in a drug product in a modified form that is intended to furnish such activity or effect4 7#b7 ,covered product ,the term covered product means a drug 7including a biological product7 or an active pharmaceutical ingredient4 7#c7 ,priority medicine ,the term priority medicine means a priority medicine for which a designation is in effect under subsection 7a74 4 7b7 ,national ,strategic ,health ,strategy ,section #bhjb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77 is amended by adding at the end the following3 7#aa7 ,priority medicines ,supporting the identification1 production1 and procurement of priority medicines designated under section #bhjd4 4 7c7 ,public ,health ,emergency ,medical ,countermeasures ,enterprise recommendations ,section #bhaa-a7;c77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7c77 is amended by adding at the end the following3 7,e7 ,provide recommendations to the ,secretary with respect to the priority medicines designated under section #bhjd4 4 7d7 ,strategic plan for countermeasure research1 development1 and procurement ,section #cai,l7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,b71 by striking and at the end2 7,b7 in subparagraph 7,c71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following3 7,d7 the development and procurement of priority medicines designated under section #bhjd4 2 and 7#b7 by adding at the end the following3 7#c7 ,priority medicines ,with respect to the development and procurement of priority medicines1 the ,secretary shall promote a diverse and sustainable supply chain1 including through grants and purchases4 4 7e7 ,critical drug consideration ,section #caja of the ,,cares ,act 7,public ,law #aaf-acf7 is amended-- 7#a7 by redesignating subsection 7d7 as subsection 7e72 and 7#b7 after executing the redesignation in paragraph 7#a71 by inserting after subsection 7c7 the following3 7d7 ,consideration ,with respect to any analysis of a critical drug under subsection 7b77#a71 the ,secretary shall consider the vulnerability of such drug with respect to the global supply chain1 including an analysis of-- 7#a7 the number of manufacturers of such drug2 7#b7 the manufacturing locations1 and amounts produced1 of such drug2 7#c7 the history of the importation of such drug2 and 7#d7 the probability of the imposition of duties on the importation of such drug4 4 #d4 ,priority medicine production credit 7a7 ,in general ,subpart ,d of part ,,iv of subchapter ,a of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #de,u4 ,priority medicine production credit 7a7 ,general ,rule ,for purposes of section #ch1 the priority medicine production credit determined under this section for the taxable year is an amount equal to #ej percent of the qualified priority medicine expenses for the taxable year4 7b7 ,qualified priority medicine expenses 7#a7 ,qualified priority medicine expenses ,the term qualified priority medicine expenses means direct and indirect costs paid or incurred by the taxpayer during the taxable year for the production of priority medicines4 7#b7 ,priority medicines ,for purposes of this section1 a priority medicine is a medicine that was included1 within the #e calendar years immediately preceding the taxable year1 on the list developed and published by the ,secretary of ,health and ,human ,services pursuant to section #bhjd7;d7 of the ,public ,health ,service ,act4 7#c7 ,coordination with section #bfc;,a 7,a7 ,coordination with section #bfc;,a ,in applying section #bfc;,a1 indirect costs shall be allocated between the production of priority medicines and the production of other medicines based on the ratio in which the number of doses of the priority medicines produced in the taxable year bears to the total number of doses of all medicines produced by the taxpayer in that taxable year to which the expense is attributable4 7,b7 ,regulations and guidance ,the ,secretary shall by regulation or other guidance prescribe rules for the proper allocation of indirect costs described in subparagraph 7,a74 4 7b7 ,credit allowed as business credit ,section #ch7;b7 of the ,internal ,revenue ,code of #aihf 7relating to current year business credit7 is amended by striking plus at the end of paragraph 7#cb71 by striking the period at the end of paragraph 7#cc7 and inserting 1 plus1 and adding at the end the following new paragraph3 7#cd7 the priority medicine production credit determined under section #de,u4 4 7c7 ,conforming amendments 7#a7 ,coordination with section #ei 7,a7 ,section #ei;,a7b77#a77;,b77ii7 is amended-- 7i7 in subclause 7,i71 by striking plus1 at the end2 7ii7 in subclause 7,,ii71 by striking the period at the end1 and inserting 1 plus2 and 7iii7 by adding at the end the following3 7,,iii7 the credit allowed under section #ch for the taxable year which is properly allocable to the priority medicine production credit determined under section #de,u4 4 7,b7 ,section #ei;,a7b77#b77;,b7 is amended to read as follows3 7,b7 by reducing 7but not below zero7 the regular tax liability 7as defined in section #bf7;b77 for purposes of subparagraph 7,b7 thereof by the excess 7if any7 of the aggregate amount of the credits allowed under this chapter against such regular tax liability over the credit allowed under section #ch for the taxable year which is properly allocable to the priority medicine production credit determined under section #de,u1 rather than the excess described in such paragraph4 4 7#b7 ,coordination with research credit ,section #da7;c77#d77;,a7 is amended by striking #ad and inserting #bj4 7d7 ,clerical amendment ,the table of sections for subpart ,d of part ,,iv of subchapter ,a of part ,,iv of subchapter ,a of chapter #a of the ,internal ,revenue ,code of #aihf is amended by inserting after the item relating to section #de,t the following new item3 ,sec4 #de,u4 ,priority medicine production credit4 7e7 ,effective date ,the amendments made by this section shall apply to qualified priority medicine expenses paid or incurred after ,december #ca1 #bjbj4 #e4 ,improving regulatory efficiencies for transfer of drugs ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended by inserting after section #eje-a of such ,act 7#ba ,u4,s4,c4 #cee-a7 the following3 #eje-b4 ,transfer of drugs to domestic establishments 7a7 ,in general ,beginning not later than #ij days after the date of the enactment of this section1 the ,secretary shall expedite the review and approval of a supplemental application to an abbreviated new drug application approved under section #eje7;j7 or a new drug application approved under section #eje7;c7 that seeks to transfer manufacturing of one or more finished dosage forms of a drug or one or more active pharmaceutical ingredients therein from one or more foreign establishments to one or more new or existing domestic establishments4 7b7 ,before supplemental application submission 7#a7 ,development and pre-submission ,after an applicant submits a meeting request with respect to expedited review and approval of a supplemental application pursuant to subsection 7a71 the ,secretary shall-- 7,a7 not later than #cj days after receiving such request1 conduct a meeting with the applicant to-- 7i7 discuss the information necessary to approve the supplemental application2 and 7ii7 if applicable1 schedule a pre-approval inspection2 and 7,b7 not later than #fj days after receiving such request1 conduct a meeting with the applicant to-- 7i7 provide advice to the applicant with respect to the supplemental application2 and 7ii7 if applicable1 select a first drug to be identified in accordance with subsection 7c74 7#b7 ,review and approval ,in carrying out subsection 7a71 the ,secretary shall-- 7,a7 review and take action with respect to a supplemental application not later than #f months after the date of submission or resubmission of such application2 and 7,b7 where the ,secretary recommends a change to a domestic establishment following an inspection of such establishment1 reinspect the establishment not later than #ij days after receiving a request from the applicant for reinspection4 7#c7 ,relation to fee performance goals ,the deadlines specified in paragraph 7#a7 supersede any conflicting performance goals identified in any statute reauthorizing the fee programs in parts #b and #g of subchapter ,c of title ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7c7 ,contents ,with respect to a supplemental application under subsection 7a7 for a transfer of the site of manufacture of multiple drugs that share a similar manufacturing process1 the ,secretary shall-- 7#a7 request a list of the drugs2 7#b7 from the list under paragraph 7#a71 identify a first drug to be transferred2 7#c7 determine the criteria necessary to receive approval of the supplemental application2 and 7#d7 require the applicant to demonstrate1 as part of such criteria1 that each foreign establishment from which the drugs are to be transferred has a satisfactory inspection history with respect to the drugs4 7d7 ,subsequent transfer of drugs that share a similar manufacturing process ,after the approval of a supplemental application under subsection 7a7 for the transfer of the manufacturing of a first drug identified by the ,secretary pursuant to subsection 7c77#b7 from one or more foreign establishments to one or more new or existing domestic establishments1 the ,secretary may allow the applicant to so transfer drugs that share a similar manufacturing process with such first drug pursuant to submission of a report under section #ejf;,a7d77#b7 rather than by requiring submission of a supplemental application4 7e7 ,working group 7#a7 ,establishment ,not later than #ij days after the date of enactment of this section1 the ,secretary shall establish an intra-agency working group to be known as the ,facility ,transfer ,working ,group4 7#b7 ,membership ,the ,secretary shall appoint members of the ,facility ,transfer ,working ,group from among officials and employees of the ,department of ,health and ,human ,services who-- 7,a7 represent a cross-section of the ,department of ,health and ,human ,services2 and 7,b7 have expertise on establishments used to manufacture drugs4 7#c7 ,duties ,the ,facility ,transfer ,working ,group shall-- 7,a7 assist the ,secretary in carrying out this section2 7,b7 upon request by an applicant1 conduct an informational site visit during the developmental phase to discuss requirements with the applicant with respect to facility design1 site status1 and validation2 7,c7 not later than #cj days after conducting an informational site visit under subparagraph 7,b71 provide advice and feedback to the applicant with respect to facility issues that may prevent approval of the supplemental application under subsection 7a71 including any issues with the facility transfer plans2 and 7,d7 participate in any pre-approval inspection required by the ,secretary for an establishment or provide feedback to the ,secretary with respect to a supplemental application described in subsection 7a74 7f7 ,additional informational visits ,upon request by the applicant1 the ,secretary may conduct informational site visits in addition to an informational site visit conducted by the ,facility ,transfer ,working ,group under subsection 7e74 7g7 ,guidance 7#a7 ,issuance ,not later than #a year after the date of enactment of this section1 the ,secretary shall issue guidance with respect to this section4 7#b7 ,content ,the guidance issued under this paragraph shall include-- 7,a7 the process by which an applicant may seek expedited review and approval of a supplemental application under subsection 7a72 and 7,b7 a description of the actions the ,secretary may take to expedite the submission and review of such supplemental application4 7h7 ,definitions ,in this section3 7#a7 ,satisfactory inspection history ,the term satisfactory inspection history means1 with respect to a drug1 a history consisting of one or more inspections in which the most recent manufacturing inspection was a satisfactory manufacturing inspection during which-- 7,a7 no objectionable conditions or practices were found2 or 7,b7 objectionable conditions were found and voluntary corrective action was left to the manufacturer4 7#b7 ,similar manufacturing process ,the term similar manufacturing process means processes used to manufacture drugs that share at least one unit operation having the same design principle4 4