,,ii #aafth ,,congress #ast ,session ,s4 #dgd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #ac1 #bjai,mr4 ,wyden 7for himself1 ,mr4 ,cardin1 ,mr4 ,carper1 ,mr4 ,coons1 ,ms4 ,duckworth1 ,ms4 ,klobuchar1 ,mr4 ,menendez1 ,ms4 ,stabenow1 and ,mr4 ,tester7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xi of the ,social ,security ,act to require drug manufacturers to publicly justify unnecessary price increases4 #a4 ,short title ,this ,act may be cited as the ,stopping the ,pharmaceutical ,industry from ,keeping drugs ,expensive 7,,spike7 ,act of #bjai4 #b4 ,drug manufacturer price transparency ,title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is amended by inserting after section #aabh,k the following new section3 #aabh,l4 ,drug manufacturer price transparency 7a7 ,in general ,effective beginning on ,july #a1 #bjai1 subject to subsection 7e71 the ,secretary shall require a manufacturer of an applicable drug to submit to the ,secretary the justification described in subsection 7c7 in accordance with the timing described in subsection 7d74 7b7 ,definitions ,in this section3 7#a7 ,applicable drug ,subject to paragraph 7#b71 the term applicable drug means a drug1 as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g771 that is subject to section #ejc7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cec7;b77#a771 and that the ,secretary determines is described in either of the following subparagraphs3 7,a7 ,the drug 7per dose7-- 7i7 has a wholesale acquisition cost of at least #aj dollars2 and 7ii7 had an increase in the wholesale acquisition cost of the drug1 with respect to determinations made-- 7,i7 during #bjbj1 of at least #ajj percent since the date of the enactment of this section2 7,,ii7 during #bjba1 of at least #ajj percent in the preceding #ab months or of at least #aej percent in the preceding #b years2 7,,iii7 during #bjbb1 of at least #ajj percent in the preceding #ab months or of at least #bjj percent in the preceding #c years2 7,,iv7 during #bjbc1 of at least #ajj percent in the preceding #ab months or of at least #bej percent in the preceding #d years2 or 7,v7 on or after ,january #a1 #bjbd1 of at least #ajj percent in the preceding #ab months or of at least #cjj percent in the preceding #e years4 7,b7 ,the drug 7per dose7-- 7i7 is in the top #ejth percentile of net spending under title ,,xviii or ,,xix in at least one of the preceding #e years2 and 7ii7 had an increase in the wholesale acquisition cost of the drug1 with respect to determinations made-- 7,i7 during #bjbj1 of at least #ae percent since the date of the enactment of this section2 7,,ii7 during #bjba1 of at least #ae percent in the preceding #ab months or of at least #bj percent in the preceding #b years2 7,,iii7 during #bjbb1 of at least #ae percent in the preceding #ab months or of at least #cj percent in the preceding #c years2 7,,iv7 during #bjbc1 of at least #ae percent in the preceding #ab months or of at least #dj percent in the preceding #d years2 or 7,v7 on or after ,january #a1 #bjbd1 of at least #ae percent in the preceding #ab months or of at least #ej percent in the preceding #e years4 7#b7 ,special rule ,for purposes of applying paragraph 7#a71 the ,secretary may substitute for each percentage described in subparagraph 7,a7 or 7,b7 of such paragraph 7other than the percentile described subparagraph 7,b77i7 of such paragraph7 a percentage within a de minimis range specified by the ,secretary below the percentage so described4 7#c7 ,manufacturer ,the term manufacturer has the meaning given that term in section #eha7aj7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;eee7#aj774 7#d7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b74 7c7 ,justification described ,the justification described in this subsection is all relevant information and supporting documentation necessary to justify the increase in the wholesale acquisition cost of the applicable drug of the manufacturer1 which may include the following3 7#a7 ,the individual factors that have contributed to the increase in the wholesale acquisition cost4 7#b7 ,an explanation of the role of each factor in contributing to such increase4 7#c7 ,total expenditures of the manufacturer on-- 7,a7 materials and manufacturing for such drug2 7,b7 acquiring patents and licensing for each drug of the manufacturer2 and 7,c7 costs to purchase or acquire the drug from another company1 if applicable4 7#d7 ,the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds4 7#e7 ,the total expenditures of the manufacturer on research and development for such drug4 7#f7 ,the total revenue and net profit generated from the applicable drug for each calendar year since drug approval4 7#g7 ,the total costs associated with marketing and advertising for the applicable drug4 7#h7 ,additional information specific to the manufacturer of the applicable drug1 such as-- 7,a7 the total revenue and net profit of the manufacturer for the period of such increase1 as determined by the ,secretary2 7,b7 metrics used to determine executive compensation2 7,c7 any additional information related to drug pricing decisions of the manufacturer1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials on drugs that failed to receive approval by the ,food and ,drug ,administration4 7d7 ,timing 7#a7 ,notification ,not later than #fj days after the date on which the ,secretary makes the determination that a drug is an applicable drug under subsection 7b71 the ,secretary shall notify the manufacturer of the applicable drug of such determination4 7#b7 ,submission of justification ,not later than #ahj days after the date on which a manufacturer receives a notification under paragraph 7#a71 the manufacturer shall submit to the ,secretary the justification required under subsection 7a74 7#c7 ,posting on internet website 7,a7 ,in general ,subject to subparagraph 7,b71 not later than #cj days after receiving the justification under paragraph 7#b71 the ,secretary shall post on the internet website of the ,centers for ,medicare ,medicaid ,services the justification1 together with a summary of such justification that is written and formatted using language that is easily understandable by beneficiaries under titles ,,xviii and ,,xix4 7,b7 ,exception ,the ,secretary shall establish a process under which a manufacturer of an applicable drug may submit a request to the ,secretary that certain proprietary information disclosed as part of justification in subsection 7c7 be excluded from the posting described in subparagraph 7,a7 if1 as determined by the ,secretary 7in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services71 the public disclosure of such information would directly lead to increased prices of prescription drugs4 ,if proprietary information is excluded from the posting pursuant to the preceding sentence1 to the extent feasible1 the summary of the information described in subparagraph 7,a7 shall include a summary of such proprietary information4 7e7 ,exception to requirement for submission ,the requirement to submit a justification under subsection 7a7 shall not apply in the case where the manufacturer1 after receiving the notification under subsection 7d77#a7 with respect to an applicable drug of the manufacturer1 reduces the wholesale acquisition cost of a drug so that it no longer meets the definition of an applicable drug under subsection 7b7 for at least a #f-month period1 as determined by the ,secretary4 7f7 ,penalties ,the provisions of subsection 7b77#c77;,c7 of section #aibg shall apply to a manufacturer that fails to submit the justification required under subsection 7a7 on a timely basis or that knowingly provides false information in the same manner as such provisions apply to a manufacturer with an agreement under that section4 4