,i #aafth ,,congress #b;d ,session ,h4 ,r4 #eihb ,,in ,,the ,,house ,,of ,,representatives ,february #bf1 #bjbj,mr4 ,posey 7for himself and ,mr4 ,ryan7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to direct the ,secretary of ,health and ,human ,services to study ,american dependence on ,chinese pharmaceuticals and to empower the ,food and ,drug ,administration to issue boxed warnings in the case of critical contamination4 #a4 ,short title ,this ,act may be cited as the ,safe ,medicine ,act4 #b4 ,findings 7a7 ,findings ,congress finds the following3 7#a7 ,following the enactment of the ,drug ,price ,competition and ,patent ,term ,restoration ,act of #aihd 7,public ,law #ih-dag71 the ,people's ,republic of ,china was able to corner the market on generic drugs1 pharmaceutical ingredients1 and related materials through its steady supply of readily exploitable labor and threadbare safety regulations4 ,ninety percent of the medications taken by individuals in the ,united ,states are generic1 rendering them especially dependent on supplies originating in the ,people's ,republic of ,china4 7#b7 ,the number of drugs produced outside of the ,united ,states doubled between #bjja and #bjjh4 ,at present1 #hj percent of the active pharmaceutical ingredients used in drugs taken by individuals in the ,united ,states come from overseas1 mainly the ,people's ,republic of ,china and the ,republic of ,india4 ,the ,united ,states no longer produces penicillin1 with the last fermentation plant phasing out of production in #bjjd4 7#c7 ,in #bjjh1 the counterfeiting of ,heparin precursor chemicals by a ,chinese-based pharmaceutical plant led to the deaths of #ha individuals in the ,united ,states1 with #ghe more being severely injured4 ,the counterfeit product cost one-hundredth of the price of the real product1 indicating a clear economic motive for distributing contaminated materials4 7#d7 ,in #bjah1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 issued recalls of valsartan1 losartan1 and irbesartan1 common blood pressure drugs4 ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 determined that versions of such drugs have been contaminated1 as a result of ,chinese and ,indian manufacturing practices and that one ,chinese company1 ,zhejaiang ,huahai ,pharmaceuticals had systemic problems of supervision1 with the potent carcinogens ,n-,nitroso-,n-methyl-#d-;aminobutyric acid 7,,nmba71 ,n-,nitrosodimethylamine 7,,ndma71 and ,n-,nitrosodiethylamine 7,,ndea71 for a period of #d years before being detected4 7#e7 ,domestic pharmaceutical facilities are inspected every #b years1 whereas foreign pharmaceutical facilities are inspected only every #i years4 ,further1 inspections of foreign facilities by the ,food and ,drug ,administration have declined in the past #b years4 ,in the ,people's ,republic of ,china1 these inspections have fallen by more than #aj percent4 7#f7 ,in #bjaj1 the ,people's ,republic of ,china embargoed the shipment of rare earth metals to ,japan as political leverage in its negotiations over a boating incident that took place between the two countries in the ,east ,china ,sea4 ,national security experts warn that if such an incident were to take place between the ,united ,states and ,china1 and ,china were to embargo medicine and pharmaceutical ingredients1 the ,united ,states would be helpless4 ,united ,states dependence on ,chinese medicine and pharmaceutical ingredients poses a national security risk4 7b7 ,purposes ,the purposes of this ,act are-- 7#a7 to direct the ,secretary of ,health and ,human ,services to study the dependence of the ,united ,states on ,chinese drugs2 and 7#b7 to authorize the ,food and ,drug ,administration to order a temporary boxed warning on potentially contaminated drugs4 #c4 ,study of dependence of ,united ,states on ,chinese drugs ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the heads of other appropriate ,federal departments and agencies1 shall submit to ,congress a report on vulnerabilities to the ,united ,states medicine supply chain4 ,such report shall include-- 7#a7 an identification of any finished drugs and their essential components including raw materials1 chemical components1 and active ingredients necessary for the manufacture of medicines whose supply is at risk of disruption due to dependence on a single or limited number of providing countries2 7#b7 an identification of the defense and geopolitical contingencies that are sufficiently likely to arise that may disrupt1 strain1 compromise1 or eliminate supply chains of medicines and their essential components and recommendations for reasonable preparation for the occurrence of such contingencies2 7#c7 an assessment of the resilience and capacity of the current supply chain and industrial base to support the population of the ,united ,states upon the occurrence of the contingencies identified pursuant to paragraph 7#b71 including with respect to-- 7,a7 the manufacturing capacity of the ,united ,states2 7,b7 gaps in domestic manufacturing capabilities 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#d7 legislative1 regulatory1 and policy changes necessary to avoid1 or prepare for1 contingencies identified pursuant to paragraph 7#b72 7#e7 recommendations to diversify supply away from predominant dependency on sources of supply in competitor countries and politically unstable countries that may cut off ,united ,states supply1 and address critical bottlenecks and mitigate single points of failure and limited resilience2 and 7#f7 an assessment of the potential impact on domestic drug prices if the ,people's ,republic of ,china were to embargo the export of drugs and pharmaceutical ingredients to the ,united ,states4 #d4 ,authorizing temporary boxed warnings on potentially contaminated drugs ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 may issue a temporary order deeming certain drugs to be misbranded within the meaning of section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb71 if-- 7#a7 such drugs1 or the active pharmaceutical ingredients thereof1 are manufactured in a country that the ,secretary determines may be producing contaminated drugs 7or active pharmaceutical ingredients7 because of systemic problems of supervision in the manufacture of such drugs or active pharmaceutical ingredients2 and 7#b7 the labeling of such drugs does not bear a boxed warning of the potential for contamination4