,i #aahth ,,congress #b;d ,session ,h4 ,r4 #fiib ,,in ,,the ,,house ,,of ,,representatives ,january #ab1 #bjbd,ms4 ,matsui 7for herself and ,mr4 ,bucshon7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to require the ,secretary of ,health and ,human ,services to establish a list of essential medicines1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,mapping ,america's ,pharmaceutical ,supply ,act or the ,,maps ,act4 #b4 ,essential medicines list update 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish and maintain a list of essential medicines4 7b7 ,criteria ,the list under subsection 7a7 shall consist of drugs and active pharmaceutical ingredients that-- 7#a7 are reasonably likely to be required to respond to a public health emergency or to a chemical1 biological1 radiological1 or nuclear threat2 or 7#b7 the shortage of which would pose a significant threat to the ,united ,states health care system or at-risk populations4 7c7 ,selection ,the ,secretary shall select drugs and active pharmaceutical ingredients for inclusion on the list under subsection 7a7-- 7#a7 based on the criteria specified in subsection 7b72 and 7#b7 from the list of essential medicines1 medical countermeasures1 and critical inputs developed by the ,food and ,drug ,administration in response to ,executive ,order #acidd 7#he ,fed4 ,reg4 #diibi7 and other relevant assessments or lists4 7d7 ,process 7#a7 ,in general ,before finalizing the list under subsection 7a7 or any update to such list1 the ,secretary shall-- 7,a7 publish a proposed list or update1 as applicable2 and 7,b7 provide an opportunity for public comment on the proposed list or update4 7#b7 ,initial list ,the ,secretary shall-- 7,a7 publish the proposed initial list under subsection 7a7 not later than #f months after the date of enactment of this ,act2 and 7,b7 publish the final initial list under subsection 7a7 not later than #a year after such date of enactment4 7#c7 ,regular review ,the ,secretary shall regularly review the list under subsection 7a7 to determine whether any updates should be made pursuant to paragraph 7#a74 7e7 ,relation to ,executive ,order ,the participation of the ,secretary in establishing1 maintaining1 and updating the list under subsection 7a7 shall be deemed to be full satisfaction of the requirements applicable to the ,secretary under section #c of ,executive ,order #acidd 7#he ,fed4 ,reg4 #diibi74 #c4 ,federal ,united ,states pharmaceutical supply chain mapping 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 in coordination with the heads of other relevant agencies1 shall support efforts1 including through public-private partnerships1 to map the entire ,united ,states pharmaceutical supply chain1 from inception to distribution1 and use data analytics to identify supply chain vulnerabilities and other national security threats4 ,such activities shall include1 at a minimum-- 7#a7 defining agency roles in monitoring the pharmaceutical supply chain and communicating supply chain vulnerabilities2 and 7#b7 with respect to drugs and active pharmaceutical ingredients on the list of essential medicines under section #b7;a71 establishing a database that shall include-- 7,a7 the location of establishments registered under subsection 7b71 7c71 or 7i7 of section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 involved in the production of-- 7i7 the finished dosage forms of the drugs on such list2 7ii7 the active pharmaceutical ingredients of such drugs2 or 7iii7 active pharmaceutical ingredients on such list2 7,b7 the amount of such finished dosage forms and active pharmaceutical ingredients produced at each such establishment2 7,c7 to the extent available-- 7i7 the location of establishments involved in the production of the key starting materials and excipients used to produce the finished dosage forms and active pharmaceutical ingredients referred to in subparagraph 7,a72 and 7ii7 the amount of such materials and excipients produced at each such establishment2 and 7,d7 any regulatory actions with respect to the establishments referred to in subparagraph 7,a7 or 7,c71 including with respect to-- 7i7 labeling requirements2 7ii7 registration and listing information required to be submitted under section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj72 7iii7 inspections and related regulatory activities conducted under section #gjd of such ,act 7#ba ,u4,s4,c4 #cgd72 7iv7 the seizure of such a drug or active pharmaceutical ingredient pursuant to section #cjd of such ,act 7#ba ,u4,s4,c4 #ccd72 7v7 any recalls of a drug or active pharmaceutical ingredient on the list of essential medicines under section #b7;a71 or a drug containing an active pharmaceutical ingredient on such list2 7vi7 inclusion of such a drug or active pharmaceutical ingredient on the drug shortage list under section #ejf;,e of such ,act 7#ba ,u4,s4,c4 #cef;e72 or 7vii7 prior reports of a discontinuance or interruption in the production of such a drug or active pharmaceutical ingredient under #ejf;,c of such ,act 7#ba ,u4,s4,c4 #cef;c74 7b7 ,report ,not later than #ah months after the date of enactment of this ,act1 and annually thereafter1 the ,secretary of ,health and ,human ,services1 in consultation with the heads of agencies with which such ,secretary coordinates under subsection 7a71 shall submit a report to ,congress on-- 7#a7 progress on implementing subsection 7a71 including any timelines for full implementation2 7#b7 gaps in data needed for full implementation of such subsection2 7#c7 how the database established pursuant to subsection 7a7 increases ,federal visibility into the pharmaceutical supply chain2 7#d7 how ,federal agencies are able to use data analytics to conduct predictive modeling of anticipated drug shortages or national security threats2 and 7#e7 the extent to which industry has cooperated in mapping the pharmaceutical supply chain4 7c7 ,confidential commercial information ,the exchange of information among the ,secretary of ,health and ,human ,services and the heads of other relevant agencies for purposes of carrying out this section shall not be a violation of section #aije of title #ah1 ,united ,states ,code4 7d7 ,clarification ,the information in the database established pursuant to subsection 7a7 shall not be publicly disclosed4 ,nothing in this subsection shall be construed to relieve the ,secretary of ,health and ,human ,services from the ,secretary's obligation to provide information to ,congress4