,i #aaith ,,congress #ast ,session ,h4 ,r4 #daia ,,in ,,the ,,house ,,of ,,representatives ,june #bf1 #bjbe ,ms4 ,matsui 7for herself and ,mr4 ,crenshaw7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to improve coordination of ,federal efforts to identify and mitigate health and national security risks through maintaining a list of essential medicines1 conducting a risk assessment of essential medicine supply chains1 and creating a monitoring system to map essential medicine supply chains using data analytics4 #a4 ,short title ,this ,act may be cited as the ,mapping ,america's ,pharmaceutical ,supply ,act or the ,,maps ,act4 #b4 ,essential medicines list 7a7 ,in general ,the ,secretary1 in coordination with the heads of other relevant ,federal departments and agencies and in consultation with1 as appropriate1 stakeholders who have relevant expertise1 shall update and maintain a list of essential medicines 7referred to in this ,act as the ,essential ,medicines ,list71 initially developed in response to ,executive ,order #acidd 7#he ,fed4 ,reg4 #diibi71 to include active pharmaceutical ingredients and drugs-- 7#a7 that are directly related to responding to chemical1 biological1 radiological1 or nuclear threats and incidents covered by the ,national ,response ,framework2 7#b7 of greatest priority for providing health care and identified as being at high risk of shortage2 or 7#c7 the shortage of which would have an adverse health outcome on patients with chronic conditions4 7b7 ,updates to list ,the ,secretary shall review the ,essential ,medicines ,list regularly1 on a timeframe that the ,secretary determines necessary and appropriate1 and not less frequently than every #b years2 and shall update the ,essential ,medicines ,list as necessary based on the findings of such review4 7c7 ,compilation of initial list ,the ,secretary shall complete the first updates to the ,essential ,medicines ,list required pursuant to subsection 7a7 not later than #ahj days after the date of enactment of this ,act4 7d7 ,publication of list ,the ,secretary shall publish the ,essential ,medicines ,list promptly after each update pursuant to subsection 7b7 or 7c74 #c4 ,essential medicines risk assessment 7a7 ,in general ,the ,secretary1 in consultation with the heads of other relevant departments and agencies1 shall conduct a comprehensive risk assessment of the supply chains for active pharmaceutical ingredients and drugs included on the ,essential ,medicines ,list described in section #b4 7b7 ,contents of essential medicines risk assessment ,at a minimum1 the risk assessment under subsection 7a7 shall identify1 to the extent available-- 7#a7 key starting materials and excipients used in manufacturing the active pharmaceutical ingredients and drugs on the ,essential ,medicines ,list2 7#b7 the active pharmaceutical ingredients and drugs on the ,essential ,medicines ,list that rely on a foreign supplier for more than #ej percent of production2 7#c7 the active pharmaceutical ingredients and drugs on the ,essential ,medicines ,list that are sourced exclusively or primarily from a single supplier1 including drugs manufactured domestically from active pharmaceutical ingredients sourced exclusively or primarily from a single supplier2 7#d7 current domestic manufacturing capabilities for active pharmaceutical ingredients and drugs on the ,essential ,medicines ,list1 including the key starting materials and excipients of such ingredients and drugs1 and any cost-effective manufacturing technologies1 including advanced manufacturing2 7#e7 public health and national security risks1 including cybersecurity threats and critical infrastructure designations specific to the supply chains of active pharmaceutical ingredients and drugs included on the ,essential ,medicines ,list2 7#f7 any deficiencies1 lack of authorities1 or limitations in policy or process that reduce the ability of the ,federal ,government to address any identified public health or national security risks related to supply chains for active pharmaceutical ingredients and drugs included on the ,essential ,medicines ,list2 and 7#g7 how the ,federal ,government will mitigate such national security risks1 including through the use of authorities under the ,defense ,production ,act of #aiej 7#ej ,u4,s4,c4 #deja et seq474 7c7 ,report on assessment 7#a7 ,submission of report ,not later than #ahj days after the date of enactment of this ,act1 and annually thereafter1 the ,secretary1 in consultation with the heads of relevant ,federal departments and agencies consulted under subsection 7a71 shall submit a report with the findings under subsection 7b7 to the relevant ,committees of ,congress4 #d4 ,u4,s4 pharmaceutical supply chains mapping 7a7 ,pharmaceutical supply chain mapping ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in coordination with the heads of other relevant ,federal departments and agencies1 shall ensure coordination of efforts of the ,department of ,health and ,human ,services1 including through public-private partnerships1 to-- 7#a7 map1 or otherwise visualize1 the supply chains1 from manufacturing of key starting materials through manufacturing of finished dosage forms and distribution1 of drugs 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 included on the ,essential ,medicines ,list under section #b2 and 7#b7 use data analytics to identify supply chain vulnerabilities that pose a threat to public health or national security1 as determined by the ,secretary or the heads of other relevant ,federal departments and agencies4 7b7 ,requirements ,in carrying out subsection 7a71 the ,secretary shall-- 7#a7 describe the roles and responsibilities of agencies and offices within the ,department of ,health and ,human ,services related to monitoring such supply chains and assessing any related vulnerabilities2 and 7#b7 facilitate the exchange of information between ,federal departments1 agencies1 and offices1 as appropriate and necessary to enable such agencies and offices to carry out roles and responsibilities described in paragraph 7#a7 related to drugs described in subsection 7a77#a74 ,such information should include1 at a minimum-- 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 active pharmaceutical ingredients and finished dosage forms of drugs described in subsection 7a77#a71 and the amount of such ingredients and finished dosage forms produced at each such establishment2 7,b7 to the extent available and as appropriate1 the location of establishments so registered involved in the production of the key starting materials and excipients needed to produce the active pharmaceutical ingredients and finished dosage forms1 and the amount of such materials and excipients produced at each such establishment2 and 7,c7 any regulatory actions with respect to such drugs or the establishments manufacturing such drugs1 including with respect to inspections and related regulatory activities conducted under section #gjd of such ,act 7#ba ,u4,s4,c4 #cgd71 the seizure of such a drug pursuant to section #cjd of such ,act 7#ba ,u4,s4,c4 #ccd71 any recalls of such a drug2 inclusion of such a drug on the drug shortage list under section #ejf;,e of such ,act 7#ba ,u4,s4,c4 #cef;e71 or prior reports of a discontinuance or interruption in the production of such a drug under section #ejf;,c of such ,act 7#ba ,u4,s4,c4 #cef;c74 7c7 ,report ,not later than #ah months after the date of enactment of this ,act1 and annually thereafter1 the ,secretary1 in consultation with the heads of agencies with which the ,secretary coordinates under subsection 7a71 shall submit a report to the relevant committees of ,congress on-- 7#a7 the current status of efforts to map and analyze pharmaceutical supply chains1 as described in subsection 7a72 7#b7 activities of the ,secretary carried out under this section to coordinate efforts as described in subsection 7a71 including information sharing between relevant ,federal departments1 agencies1 and offices2 7#c7 the roles and responsibilities described in subsection 7b77#a71 including the identification of any gaps1 data limitations1 or areas of unnecessary duplication between such roles and responsibilities2 7#d7 the extent to which ,federal agencies use data analytics to conduct predictive modeling of anticipated drug shortages or risks associated with supply chain vulnerabilities that pose a threat to national security2 and 7#e7 the extent to which the ,secretary has engaged relevant industry in such mapping4 #e4 ,definitions ,in this ,act3 7#a7 ,advanced manufacturing ,the term advanced manufacturing has the meaning given the term advanced and continuous pharmaceutical manufacturing in section #cjaf7;h7 of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h7h774 7#b7 ,cybersecurity threat ,the term cybersecurity threat has the meaning given such term in section #bbjj of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #fej74 7#c7 ,drug ,the term drug has the meaning given such term in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g774 7#d7 ,secretary ,the term ,secretary1 except as otherwise specified1 means the ,secretary of ,health and ,human ,services4 #f4 ,additional provisions 7a7 ,clarification ,the participation of the ,secretary in developing and updating the list of essential medicines under section #b shall be deemed to be full satisfaction of the requirements applicable to such ,secretary under section #c of ,executive ,order #acidd 7#he ,fed4 ,reg4 #diibi74 7b7 ,confidential commercial information ,the exchange of information among the ,secretary and the heads of other relevant ,federal departments and agencies for purposes of carrying out sections #c and #d shall not be a violation of section #aije of title #ah1 ,united ,states ,code4 ,this section shall not be construed to affect the status1 if any1 of such information as trade secret or confidential commercial information for purposes of section #cja7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;j771 section #eeb of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7c7 ,cybersecurity measures ,the ,secretary shall ensure that robust cybersecurity measures are in place to prevent inappropriate access to1 or unauthorized disclosure of1 the information identified1 exchanged1 or disclosed under sections #c and #d4