,,ii #aagth ,,congress #ast ,session ,s4 #beie ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #d1 #bjba,mr4 ,cardin 7for himself and ,ms4 ,smith7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to address prescription drug shortages and improve the quality of prescription drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,drug ,shortages ,prevention and ,quality ,improvement ,act4 #b4 ,lengthen expiration dates to mitigate critical drug shortages 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ejf;,c-#a 7#ba ,u4,s4,c4 #cef;c-#a7 the following3 #ejf;,c-#b4 ,extended shelf life dates for essential drugs 7a7 ,in general ,a manufacturer of a drug subject to notification requirements under section #ejf;,c7a7 7referred to in this section as an essential drug7 shall-- 7#a7 submit to the ,secretary data and information as required by subsection 7b77#a72 7#b7 conduct and submit the results of any studies required under subsection 7b77#b72 and 7#c7 make any labeling change described in subsection 7c7 by the date specified by the ,secretary pursuant to such subsection4 7b7 ,notification 7#a7 ,in general ,the ,secretary may issue an order requiring the manufacturer of any essential drug to submit1 in such manner as the ,secretary may prescribe1 data and information from any stage of development of the drug that are adequate to assess the shelf life stability of the drug to determine the longest supported expiration date4 7#b7 ,unavailable or insufficient data and information ,if the data and information required pursuant to an order issued under paragraph 7#a7 are not available or are insufficient1 the ,secretary may require the manufacturer of the drug to-- 7,a7 conduct studies adequate to provide the data and information in accordance with section #baa4aff of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 and 7,b7 submit to the ,secretary the results1 data1 and information generated by such studies when available4 7c7 ,labeling ,the ,secretary may issue an order requiring the manufacturer of an essential drug to1 by a specified date1 make any labeling change regarding the expiration period that the ,secretary determines to be appropriate based on the data and information required to be submitted under this section or any other data and information available to the ,secretary in accordance with labeling requirements under subpart ,g of part #baa of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7d7 ,confidentiality ,nothing in this section shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7b7 ,civil monetary penalty ,section #cjc7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;b77 is amended by adding at the end the following3 7#i7 ,if a drug manufacturer fails to submit data and information as required under section #ejf;,c-#b7;b77#a71 fails to conduct or submit the results of studies as required under section #ejf;,c-#b7;b77#c71 or fails to make a labeling change as required under section #ejf;,c-#b7;c71 such manufacturer shall be liable to the ,united ,states for a civil penalty in an amount not to exceed #aj1jjj for each such violation4 4 7c7 ,,gao ,study of shelf life data ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study examining the process by which prescription drug manufacturers submit data on shelf life to the ,food and ,drug ,administration4 ,in carrying out this study1 the ,comptroller ,general shall consider whether manufacturers adequately test the shelf life stability of their drug products subject to section #baa4aff of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7d7 ,shelf life stability guidance ,not later than #f months after the date of enactment of this ,act1 the ,secretary shall publish for notice and comment in the ,federal ,register updates to stability testing under section #baa4aff of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 #c4 ,quality ,management ,maturity ,sterile ,injectable ,drug ,pilot ,program 7a7 ,quality ,management ,maturity ,sterile ,injectable ,drug ,pilot ,program 7#a7 ,in general ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 shall commence the ,quality ,management ,maturity 7,,qmm7 ,sterile ,injectable ,drug ,pilot ,program 7referred to in this section as the pilot program7 under this section4 ,under such program1 the ,secretary shall-- 7,a7 select eligible drug manufacturers to participate in the program in accordance with paragraph 7#b72 and 7,b7 contract with a third-party contractor to develop a ,,qmm assessment tool and conduct assessments1 in cooperation with staff of the ,food and ,drug ,administration1 of each participant's quality management system4 7#b7 ,eligibility ,to be eligible to participate in the pilot program under this section1 a manufacturer shall-- 7,a7 be a for-profit or nonprofit entity2 7,b7 manufacture a prescription drug that is a sterile injectable drug2 7,c7 manufacture a drug that is deemed an essential medicine under ,executive ,order #acidd 7#he ,fed4 ,reg4 #diibi72 7,d7 have received a final classification of ,no ,action ,indicated or ,voluntary ,action ,indicated with respect to all inspections of all manufacturing facilities of the entity conducted by the ,food and ,drug ,administration within the #e-year period immediately preceding the date of enactment of this ,act2 7,e7 be a person who has registered one or more establishments under subsection 7b77#a7 or 7i77#a7 of section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 with respect to the manufacture of a prescription drug described in subparagraph 7,b72 and 7,f7 agree to-- 7i7 permit a third-party contractor to conduct regular assessments under the ,,qmm pilot program1 as described in paragraph 7#c71 either on-site or remotely2 7ii7 collect and submit metrics data to the ,food and ,drug ,administration and the contractor by an agreed upon date1 prior to each assessment described in clause 7i72 and 7iii7 be available for consultations with the third-party contractor and the ,food and ,drug ,administration prior to and after each assessment described in clause 7i71 including discussions regarding the participant's established ,,qmm-related activities and the contractor's post-assessment recommendations regarding these activities4 7#c7 ,assessments ,assessments that are conducted jointly by a third-party contractor1 in cooperation with staff of the ,food and ,drug ,administration1 will regularly conduct manufacturer facility assessments to determine the manufacturer's quality management maturity progress or status4 ,pilot program assessments will cover multiple topics and shall include-- 7,a7 supply chain management2 7,b7 manufacturing strategy and operations2 7,c7 safety1 environmental1 and regulatory compliance2 7,d7 inventory management2 7,e7 performance management and continual improvement2 7,f7 risk management2 7,g7 management review and responsibility2 7,h7 planning2 7,i7 workforce management2 7,j7 quality culture2 and 7,k7 customer experience4 7#d7 ,program duration ,not later than #f months after the date of enactment of this ,act1 the ,secretary shall publish instructions for applicants in the ,federal ,register4 ,such instructions shall include a timeline for the application period for such program1 and a #a-year timeline for the pilot program following such application period4 7b7 ,report to ,congress ,not later than #f months after the completion of the pilot program1 the ,secretary shall submit a report to ,congress on such pilot program4 ,such report shall include-- 7#a7 a summary of third-party assessments of each participating manufacturer's quality management system2 7#b7 recommendations on next steps towards developing a publicly available ,food and ,drug ,administration rating system for quality management maturity systems of sterile injectable drug manufacturing facilities1 including specific drugs manufactured at each facility2 7#c7 considerations the ,food and ,drug ,administration may take in updating guidance of current good manufacturing practice of sterile injectable drug products2 and 7#d7 recommendations on incorporating pilot programs 7or related work7 described in the guidances entitled1 ,quality ,management ,maturity for ,finished ,dosage ,forms ,pilot ,program for ,domestic ,drug ,product ,manufacturers2 ,program ,announcement1 issued by the ,food and ,drug ,administration on ,october #af1 #bjbj 7#he ,fed4 ,reg4 #fehbd71 and ,quality ,management ,maturity for ,active ,pharmaceutical ,ingredients ,pilot ,program for ,foreign ,facilities2 ,program ,announcement1 issued by the ,food and ,drug ,administration on ,october #af1 #bjbj 7#he ,fed4 ,reg4 #fehbh71 into publicly available ,food and ,drug ,administration rating systems for overall quality management maturity systems4 7c7 ,definition ,in this section1 the term sterile injectable drug means a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 a biological product licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 or a combination product 7as described in section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 whose primary mode of action is that of a drug or biological product1 whose manufacturing1 distribution1 and administration processes require sterile conditions4 #d4 ,improved data sharing3 ensuring timely and informative notification 7a7 ,in general ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7fff7 ,failure ,to provide timely and informative notification ,any manufacturer who violates a requirement of this ,act that relates to critical drugs by failing to provide timely1 adequate information related to drug shortages pursuant to section #ejf;,c7a7 shall be subject to a civil penalty in an amount not to exceed #ej1jjj per violation4 4 7b7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall promulgate final regulations to carry out section #cja7;fff7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 #e4 ,supporting continuous manufacturing to prevent shortages for susceptible drugs ,subtitle ,b of title ,,iii of the #bast ,century ,cures ,act is amended by inserting after section #cjaf 7#ba ,u4,s4,c4 #cii;h7 the following3 #cjag4 ,grants for continuous manufacturing to prevent drug shortages 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall solicit and1 beginning not later than one year after the date of enactment of the ,drug ,shortages ,prevention and ,quality ,improvement ,act1 receive1 requests from institutions of higher education and nonprofit entities engaged in the manufacture of sterile injectable drugs for the purpose of upgrading drug establishment to continuous manufacturing or other advanced manufacturing capabilities4 7b7 ,grant criteria ,an institution of higher education or a nonprofit entity shall be eligible for a grant under this section if such institution or entity manufactures a drug that-- 7#a7 is categorized as an essential medicine under ,executive ,order #acidd2 7#b7 is a sterile injectable drug2 and 7#c7 is vulnerable to shortage4 7c7 ,grant selection ,as a condition for accepting a grant under this section1 an institution of higher education and nonprofit entity shall agree to participate in the ,quality ,management ,maturity ,sterile ,injectable ,drug ,pilot ,program established under section #c of the ,drug ,shortages ,prevention and ,quality ,improvement ,act4 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #a1jjj1jjj1jjj for the period of fiscal years #bjbb through #bjbg4 7e7 ,definitions ,in this section3 7#a7 ,advanced manufacturing ,the term advanced manufacturing means an approach for the manufacturing of drugs that incorporates novel technology1 or uses an established technique or technology in a new or innovative way 7such as continuous manufacturing where the input materials are continuously transformed within the process by #b or more unit operations7 that enhances drug quality or improves the manufacturing process4 7#b7 ,continuous manufacturing ,the term continuous manufacturing-- 7,a7 means a process where the input materials are continuously fed into and transformed within the process1 and the processed output materials are continuously removed from the system2 and 7,b7 consists of an integrated process that consists of a series of #b or more unit operations4 7#c7 ,sterile injectable drug ,the term sterile injectable drug means a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 a biological product licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 or a combination product 7as described in section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 whose primary mode of action is that of a drug or biological product1 whose manufacturing1 distribution1 and administration processes require sterile conditions4 4