,,ii #aahth ,,congress #ast ,session ,s4 #behf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bg1 #bjbc,mr4 ,cardin 7for himself1 ,ms4 ,smith1 and ,mr4 ,blumenthal7 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 expiration dates for life-saving drugs 7a7 ,in general ,a manufacturer of a life-saving drug shall-- 7#a7 submit to the ,secretary data and information as required by subsection 7b77#a72 7#b7 conduct and submit the results1 data1 and information 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 life-saving 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 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 a life-saving drug to1 by a specified date1 make any labeling change regarding the expiration date that the ,secretary determines to be appropriate based on the data and information required to be submitted under this section in accordance with labeling requirements under subparts ,f and ,g of part #baa of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 or any other data and information available to the ,secretary4 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 7e7 ,definition ,in this section1 the term life-saving drug means a drug described in section #ejf;,c7a74 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 7,a7 ,if a manufacturer fails to submit data and information as required under section #ejf;,c-#b7;b77#a71 fails to conduct or submit the results1 data1 and information generated by 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 7,b7 ,if a violation described in subparagraph 7,a7 is not corrected within the #cj-;day period following notification by the ,secretary of a violation described in subparagraph 7,a71 the manufacturer shall1 in addition to any penalty under subparagraph 7,a71 be subject to a civil monetary penalty of not more than #aj1jjj for each day of the violation after such period until the violation is corrected4 4 #c4 ,reporting on increases in demand for a drug 7a7 ,in general ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in the section heading1 by inserting or increase in demand for after production of2 7#b7 in subsection 7a71 in the matter following paragraph 7#b71 by striking drug1 and the reasons for such discontinuance or interruption and inserting drug1 or increase in the demand for such drug that is likely to lead to a shortage of the drug1 and the reasons for such discontinuance1 interruption1 or increase in demand2 7#c7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking 2 or and inserting a semicolon2 7,b7 by redesignating paragraph 7#b7 as paragraph 7#c72 7,c7 by inserting after paragraph 7#a7 the following3 7#b7 in the case of an increase in the demand for a drug1 not later than #cj days after the manufacture has knowledge of such increase2 or 2 and 7,d7 in paragraph 7#c71 as so redesignated1 by striking paragraph 7#a7 and inserting paragraph 7#a7 or 7#b72 and 7#d7 in subsection 7c71 by inserting 1 or increase in demand for1 after the manufacture of4 7b7 ,prohibited act 7#a7 ,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 7jjj7 ,the failure to notify the ,secretary as required under section #ejf;,c7a74 4 7#b7 ,enforcement ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;c77 is amended-- 7,a7 in paragraph 7c71 by adding before the period at the end the following3 2 or 7#g7 for having violated section #cja7;jjj7 if such person acted in good faith and had a reasonable basis for not notifying as required under section #ejf;,c2 and 7,b7 by adding at the end the following3 7h7 ,notwithstanding subsection 7a71 any manufacturer who violates section #cja7;jjj7 shall be subject to a civil penalty in an amount not to exceed #ej1jjj per violation4 4 #d4 ,supporting continuous manufacturing to prevent shortages for susceptible drugs 7a7 ,in general ,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 ,services 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 for grants from institutions of higher education or 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 shortage1 including as determined through notifications submitted to the ,secretary under section #ejf;,c4 7c7 ,grant selection ,as a condition for accepting a grant under this section1 an institution of higher education and nonprofit entity shall agree to develop and carrying out a robust plan focused on sustainability of the continuous manufacturing or other advanced manufacturing capabilities supported by the grant4 7d7 ,authorization of appropriations ,to carry out this section1 in additional to amounts otherwise made available for such purposes1 there is authorized to be appropriated #a1jjj1jjj1jjj for the period of fiscal years #bjbd through #bjbi4 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 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 that is intended for injection for intravenous use of infusion and whose manufacturing1 distribution1 and administration processes require sterile conditions4 4 7b7 ,,gao study on quality management purchasing ,the ,comptroller ,general of the ,united ,states shall conduct a study on including quality management maturity as a factor in prescription drug purchasing by ,federal health care programs 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f7771 and not later than #b years after the date of enactment of this ,act1 shall submit a report on such study to ,congress4 #e4 ,authority to use alternative payment under the ,medicare program for drugs and biologicals to prevent potential drug shortages 7a7 ,payment under part ,b ,section #ahdg;,a7e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7e77 is amended-- 7#a7 by striking ,payment in ,response to ,public ,health ,emergency4--,in the case and inserting 8,payments4-- 7#a7 ,in response to public health emergency ,in the case 2 and 7#b7 by adding at the end the following new paragraph3 7#b7 ,preventing potential drug shortages 7,a7 ,in general ,in the case of a drug or biological described in subparagraph 7,b71 the ,secretary may use the wholesale acquisition cost 7or other reasonable measure of a drug or biological price7 instead of the manufacturer's average sales price for quarters beginning on or after the date on which the ,secretary determines the drug or biological is described in such subparagraph and for subsequent quarters until the end of the quarter in which such drug or biological is removed from the drug shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 or in the case of a drug or biological described in subparagraph 7,b77ii77,,ii71 the date on which the ,secretary determines the manufacturing capacity or the number of manufacturers of such drug or biological is sufficient to prevent a potential shortage of the drug or biological4 7,b7 ,drug or biological described ,for purposes of subparagraph 7,a71 a drug or biological described in this subparagraph is a drug or biological-- 7i7 that is life-supporting1 life-sustaining1 or intended for use in the prevention or treatment of a debilitating disease or condition 7as those terms are defined for purposes of section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act and is subject to the reporting requirements under section #ejf;,c7b7 of such ,act71 including any such drug or biological that is used in emergency medical care or during surgery2 and 7ii7 7,i7 that is listed on the drug and biological shortage list maintained by the ,food and ,drug ,administration pursuant to section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and for which the manufacturer of such drug or biological notifies the ,secretary of a permanent discontinuance or an interruption that is likely to lead to a meaningful disruption in the manufacturer's supply of that drug or biological pursuant to section #ejf;,c7b77#a7 of such ,act2 or 7,,ii7 that was listed on such drug and biological shortage list within the preceding #e years and for which the manufacturing capacity of manufacturers with an approved application for such drug or biological1 or the number of manufacturers with an approved application for such drug or biological1 declines during a #f-month period1 as determined by the ,secretary4 7,c7 ,provision of additional information ,for each quarter in which the amount of payment for a drug or biological described in subparagraph 7,b7 pursuant to subparagraph 7,a7 exceeds the amount of payment for the drug or biological otherwise applicable under this section1 the manufacturer of such drug or biological shall provide to the ,secretary information related to the potential cause or causes of the shortage and the expected length of the shortage with respect to such drug4 4 7b7 ,additional payment under ,,ipps ,section #ahhf7;d77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77 is amended by adding at the end the following new subparagraph3 7,n7 ,the ,secretary shall establish a modifier or other mechanism for purposes of tracking utilization of drugs on the shortage list pursuant to section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and update the modifier to reflect the drugs on such list each calendar year4 4 7c7 ,,gao study on drug shortages ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 conduct a study on-- 7,a7 drugs and biologicals for which payment is made under the inpatient prospective payment system 7,,ipps7 under section #ahhf of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 and the hospital outpatient prospective payment system 7,,opps7 under section #ahcc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 that have been on the shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7c77#b77 in the last #e years2 and 7,b7 whether any changes to payment under such payment systems would decrease-- 7i7 the number of drugs and biologicals on such shortage list2 or 7ii7 the frequency with which the drugs and biologicals appear on such shortage list2 and 7#b7 submit to ,congress recommendations for legislation and administrative actions with respect to the matters described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a74