,,ii #aafth ,,congress #b;d ,session ,s4 #cech ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ai1 #bjbj,mr4 ,rubio 7for himself1 ,ms4 ,warren1 ,mr4 ,cramer1 ,mr4 ,murphy1 and ,mr4 ,kaine7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to require the ,secretary of ,defense to submit to ,congress a report on the reliance by the ,department of ,defense on imports of certain pharmaceutical products made in part or in whole in certain countries1 to establish postmarket reporting requirements for pharmaceuticals1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,strengthening ,america's ,supply ,chain and ,national ,security ,act4 #b4 ,report on reliance by ,department of ,defense on pharmaceutical products from certain countries 7a7 ,in general ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,defense1 in coordination with the ,secretary of ,health and ,human ,services1 shall submit to the appropriate congressional committees a classified report on the reliance by the ,department of ,defense on imports of certain pharmaceutical products made in part or in whole in a covered country4 7b7 ,elements ,the report required by subsection 7a7 shall-- 7#a7 analyze the percent of pharmaceutical products used by the ,department of ,defense that are made in part or in whole in a covered country1 including-- 7,a7 drugs2 7,b7 active ingredients2 7,c7 raw pharmaceutical components2 7,d7 nonprescription drugs intended for human use2 and 7,e7 any other pharmaceutical product1 or its components1 as the ,secretary considers appropriate2 7#b7 assess the products identified under paragraph 7#a7 to determine-- 7,a7 whether the ,department of ,defense can procure the product from other sources2 7,b7 whether reliance by the ,department of ,defense on the product is likely1 or has significant potential1 to be used for a military1 geopolitical1 or economic advantage against the ,united ,states2 7,c7 whether reliance on the product creates a risk for the ,united ,states2 and 7,d7 what impact there would be if access to the product was terminated2 7#c7 set forth recommendations to ensure that by #bjbe no pharmaceutical products purchased for beneficiaries of health care from the ,department of ,defense or any associated program are made in part or in whole in a covered country2 7#d7 assess the resilience and capacity of the current supply chain and industrial base to support national defense if no pharmaceutical products purchased for beneficiaries of health care from the ,department of ,defense or any associated program are made in part or in whole in a covered country1 including with respect to-- 7,a7 the manufacturing capacity of the ,united ,states2 7,b7 gaps in domestic manufacturing capabilities1 including non-existent1 extinct1 threatened1 and single-point-of-failure capabilities2 and 7,c7 supply chains with single points of failure and limited resiliency2 7#e7 set forth recommendations-- 7,a7 to diversify supply of pharmaceutical products away from complete dependency on sources of supply in countries that are competitors of the ,united ,states or politically unstable that may cut off supply in the ,united ,states2 7,b7 to address critical bottlenecks in the supply of pharmaceutical products in the ,united ,states2 and 7,c7 to mitigate single points of failure and limited resilience of supply chains for pharmaceutical products in the ,united ,states2 and 7#f7 set forth recommendations for legislative and administrative action necessary to avoid1 or prepare for1 contingencies identified in the report4 7c7 ,publication of unclassified summary ,concurrent with the submittal of the report required by subsection 7a71 the ,secretary of ,defense shall publish on a publicly available internet website of the ,department of ,defense an unclassified summary of the report4 7d7 ,definitions ,in this section3 7#a7 ,appropriate congressional committees ,the term appropriate congressional committees means-- 7,a7 the ,committee on ,armed ,services1 the ,select ,committee on ,intelligence1 the ,committee on ,finance1 the ,committee on ,banking1 ,housing1 and ,urban ,affairs1 and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 and 7,b7 the ,committee on ,armed ,services1 the ,permanent ,select ,committee on ,intelligence1 the ,committee on ,ways and ,means1 the ,committee on ,financial ,services1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7#b7 ,covered country ,the term covered country means-- 7,a7 ,china2 and 7,b7 any other country as determined by the ,secretary of ,defense for national security purposes4 7#c7 ,drug ,the term drug means a product subject to regulation under section #eje or section #hjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee or #chb7 or under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,nonprescription drug ,the term nonprescription drug has the meaning given that term in section #gfj7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;aa7a77#b774 #c4 ,modification of rules of origin for pharmaceutical products 7a7 ,trade agreements ,section #cjh7d77;,b7 of the ,trade ,agreements ,act of #aigi 7#ai ,u4,s4,c4 #beah7d77;,b77 is amended-- 7#a7 in clause 7i71 by striking instrumentality1 or and inserting instrumentality12 7#b7 in clause 7ii7-- 7,a7 by inserting 1 other than an active pharmaceutical ingredient1 after part of materials2 and 7,b7 by striking the period at the end and inserting 1 or2 and 7#c7 by inserting before the period at the end the following3 7iii7 in the case of an article which consists of an active pharmaceutical ingredient1 the pharmaceutical ingredient is wholly the growth1 product1 or manufacture of that country or instrumentality4 7b7 ,federal ,acquisition ,regulation ,not later than #ahj days after the date of the enactment of this ,act1 the ,president shall prescribe regulations to update sections #eb4bbe-e and #be4jjc of title #dh1 ,code of ,federal ,regulations 7or successor regulations7 to be consistent with rules of origin determinations for active pharmaceutical ingredients made under section #cjh7d77;,b7 of the ,trade ,agreements ,act of #aigi 7#ai ,u4,s4,c4 #beah7d77;,b771 as amended by subsection 7a74 #d4 ,postmarket reporting requirements for pharmaceuticals 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall ensure that each holder of an approved application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 annually submit1 as part of the postmarket annual report required by the ,secretary under section #cad4ha7;b77#b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation71 the following information3 7#a7 ,the names and addresses of the sources of active and inactive ingredients of the drug4 7#b7 ,for each active and inactive ingredient of the drug1 the percentage of the aggregate amount of such ingredient used in the manufacture of the drug during the reporting period that is from each of the sources identified under paragraph 7#a74 7b7 ,disclosure of ,information ,the ,secretary of ,health and ,human ,services shall-- 7#a7 annually provide the information reported in paragraphs 7#a7 and 7#b7 of subsection 7a7 to the ,secretary of ,defense for purposes of understanding the dependency on foreign manufacturers of drugs used by members of the ,armed ,forces2 and 7#b7 publish the information reported under such paragraphs on a publicly available internet website of the ,federal ,government in a single1 aggregate form1 without disclosing proprietary information4