,,ii #aagth ,,congress #b;d ,session ,s4 #djcg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #g1 #bjbb,ms4 ,stabenow 7for herself 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 amend the ,public ,health ,service ,act to increase the transparency of pharmaceutical research costs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,pharmaceutical ,research ,transparency ,act of #bjbb4 #b4 ,expansion of registry and results data bank to include costs of drug clinical trials 7a7 ,in general ,section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77 is amended-- 7#a7 by redesignating paragraph 7#g7 as paragraph 7#h72 and 7#b7 by inserting after paragraph 7#f7 the following new paragraph3 7#g7 ,creation of clinical trial cost data repository 7,a7 ,generally ,the ,secretary1 acting through the ,director of ,,nih1 shall create a publicly available ,federal website to serve as a repository of cost data for all applicable drug clinical trials 7in this paragraph referred to as the cost data repository74 ,such repository shall be searchable by the following criteria3 7i7 ,the responsible party or sponsor of the applicable drug clinical trial1 or any entity funding the applicable drug clinical trial4 7ii7 ,the name of the intervention1 including any drug being studied in the applicable drug clinical trial4 7iii7 ,the study phase of the applicable drug clinical trial4 7iv7 ,the start date and completion date of the applicable drug clinical trial4 7v7 ,such other criteria as the ,secretary deems appropriate4 7,b7 ,cost data defined ,for purposes of this paragraph1 the term cost data includes the following information3 7i7 ,the total cost of the applicable drug clinical trial4 7ii7 ,the cost of the trial per patient4 7iii7 ,expenditures for each of the following categories3 7,i7 ,personnel4 7,,ii7 ,any intervention or treatment that is administered in one or more arms of the applicable drug clinical trial4 7,,iii7 ,materials and supplies4 7,,iv7 ,health care services provided to subjects4 7,v7 ,site management4 7,,vi7 ,laboratory4 7,,vii7 ,equipment4 7,,viii7 ,the allocable portion of any facilities costs1 administrative costs1 or other costs that are not solely attributable to the applicable drug clinical trial4 7,,ix7 ,such other categories as the ,secretary may identify by regulation4 7,c7 ,posting of clinical trial cost data 7i7 ,in general ,except as provided in clause 7iii71 each responsible party of an applicable drug clinical trial shall post cost data for that trial to the cost data repository no later than #a year after the completion date of the trial4 7ii7 ,format and methodology of posting ,a cost data posting under clause 7i7 shall-- 7,i7 include individual data points for the information required under subparagraphs 7,b77i7 and 7,b77ii71 separated by year2 7,,ii7 include individual data points for each category listed under subparagraph 7,b77iii71 separated by year2 7,,iii7 limit the cost of the intervention or treatment under subparagraph 7,b77iii77,,ii7 to manufacturing costs unless the responsible party of the trial was required to purchase the intervention or treatment from an unaffiliated third party2 7,,iv7 include detailed documentation and methodology for the calculation of costs identified under subparagraph 7,b77iii77,,viii72 and 7,v7 include a signed certification that the posted data is complete and accurate4 7iii7 ,delayed posting of cost data and extensions 7,i7 ,seeking initial approval of drug1 or approval of a new use ,if the responsible party for an applicable drug clinical trial submits a certification that paragraph 7#c77;,e77iv7 or paragraph 7#c77;,e77v7 applies to such trial1 the responsible party shall post cost data under clause 7i7 at the time that clinical trial information is required to be submitted under the applicable paragraph4 7,,ii7 ,extension for good cause ,the ,director of ,,nih may provide an extension of the deadline for posting of cost data under clause 7i7 if the responsible party for the trial submits to the ,director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be posted4 ,the ,director of ,,nih may grant more than one such extension for a clinical trial1 but under no circumstances shall an extension under this subclause extend beyond the date that is #ah months after the completion date of the trial4 7,,iii7 ,extension to establish necessary infrastructure ,if necessary to establish the necessary infrastructure to accept1 organize1 and post cost data submitted under clause 7i71 the ,director of ,,nih may extend the deadline for the posting of cost data under clause 7i7 to not later than #b years after the date of enactment of the ,pharmaceutical ,research ,transparency ,act of #bjbb4 7,,iv7 ,rule of construction ,this clause shall not be construed to have any effect on reporting obligations of the responsible party under provisions other than this paragraph4 7,d7 ,linking to cost data repository 7i7 ,creation of field ,the ,director of ,,nih shall create a field within the registry and results data bank to include an electronic link to the relevant cost data posting under subparagraph 7,c77i74 7ii7 ,posting ,the responsible party for an applicable drug clinical trial shall post in the field created under clause 7i7 a link to the relevant cost data posting no later than #e days after initial posting of the cost data under subparagraph 7,c77i74 7,e7 ,rulemaking 7i7 ,in general ,the ,secretary shall promulgate regulations to carry out this paragraph that include-- 7,i7 definitions for each category of information identified in subparagraph 7,b72 7,,ii7 standards for allocating fixed expenditures across multiple years of an applicable drug clinical trial2 7,,iii7 a standard format for the submission and posting of cost data under this paragraph2 7,,iv7 procedures1 standards1 and requirements for the reporting documentation and methodology required under subparagraph 7,c77ii77,,iv72 and 7,v7 any other procedures1 standards1 or requirements necessary to ensure public transparency of cost data as required by this paragraph4 7ii7 ,initial regulations ,the ,secretary shall-- 7,i7 not later than one year after the date of enactment of the ,pharmaceutical ,research ,transparency ,act of #bjbb1 propose initial regulations under clause 7i72 and 7,,ii7 not later than #b years after such date of enactment1 finalize such regulations4 7,f7 ,applicability ,the requirements of this paragraph apply only to applicable drug clinical trials with a start date on or after the date of enactment of the ,pharmaceutical ,research ,transparency ,act of #bjbb4 4 7b7 ,conforming changes ,section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j771 as amended by subsection 7a71 is further amended-- 7#a7 in paragraph 7#a77;,a77iv71 by striking paragraph 7#b7 or under paragraph 7#c7 and inserting paragraph 7#b71 7#c71 or 7#g72 7#b7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a71 by striking paragraph 7#b7 or paragraph 7#c7 and inserting paragraph 7#b71 7#c71 or 7#g72 and 7,b7 in subparagraph 7,b77i71 by striking paragraphs 7#b7 and 7#c7 each place it appears and inserting paragraphs 7#b71 7#c71 and 7#g72 and 7#c7 in paragraph 7#e7-- 7,a7 in subparagraph 7,a71 by striking paragraphs 7#b7 and 7#c7 each place it appears and inserting paragraphs 7#b71 7#c71 and 7#g72 and 7,b7 in subparagraph 7,e77i71 by striking paragraphs 7#b7 or 7#c7 and inserting paragraph 7#b71 7#c71 or 7#g74 #c4 ,disclosure of research and development expenditures by drug manufacturers ,section #ac of the ,securities ,exchange ,act of #aicd 7#ae ,u4,s4,c4 #ghm7 is amended by adding at the end the following3 7s7 ,disclosure of research and development expenditures by drug manufacturers 7#a7 ,definitions ,in this subsection3 7,a7 ,drug ,the term drug means any product for which one or more components have been the subject of any of the following applications filed with the ,food and ,drug ,administration3 7i7 ,a new drug application 7or supplemental new drug application7 filed under subsection 7b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7ii7 ,a biologic product application 7or supplemental application7 filed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,drug manufacturer issuer ,the term drug manufacturer issuer means an issuer that-- 7i7 is required to file an annual report with the ,commission under subsection 7a72 and 7ii7 engages in the development1 manufacture1 or marketing of any drug4 7#b7 ,disclosure 7,a7 ,in general ,subject to the other provisions of this paragraph1 the ,commission shall issue rules that require each drug manufacturer issuer's annual report under subsection 7a7 to include information regarding the drug manufacturer issuer's research and development expenditures with respect to-- 7i7 a drug2 and 7ii7 any preliminary research or development of a drug product or drug substance1 as those terms are defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 for which the drug manufacturer issuer has not submitted an application described in clause 7i7 or 7ii7 of paragraph 7#a77;,a74 7,b7 ,initial rules ,the ,commission shall-- 7i7 not later than #a year after the date of enactment of the ,pharmaceutical ,research ,transparency ,act of #bjbb1 propose initial rules under subparagraph 7,a72 and 7ii7 not later than #b years after the date of enactment described in clause 7i71 finalize the rules required under subparagraph 7,a74 7,c7 ,required information ,the information required under subparagraph 7,a7 shall include total expenditures1 which shall be disaggregated to each stage of drug research and development1 including-- 7i7 basic research2 7ii7 pre-clinical research2 7iii7 phase ,i of a clinical investigation of a new drug1 as described in section #cab4ba7;a7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation2 7iv7 phase ,,ii of a clinical investigation of a new drug1 as described in section #cab4ba7;b7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation2 7v7 phase ,,iii of a clinical investigation of a new drug1 as described in section #cab4ba7;c7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation2 and 7vi7 post-market studies or clinical trials required under section #eje7o7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o774 7,d7 ,limitations calculation ,the calculation of expenditure information disclosed under subparagraph 7,a7 shall not include the following information1 although such information may be disclosed separately3 7i7 ,costs incurred in connection with licensing agreements or acquiring intellectual property4 7ii7 ,the cost of mergers or acquisitions4 7iii7 ,any intangible costs1 including estimates1 adjustments1 and assumptions related to the risk of failure1 or the risk associated with seeking regulatory approval by the ,food and ,drug ,administration or another agency4 7iv7 ,the estimated cost of capital4 7#c7 ,consultation in rulemaking ,in issuing rules under this subsection1 the ,commission-- 7,a7 shall consult with the ,commissioner of ,food and ,drugs and the ,director of the ,national ,institutes of ,health2 and 7,b7 may consult with the head of any other ,federal agency or entity that the ,commission determines is relevant4 4 #d4 ,severability ,if any provision of this ,act1 an amendment made by this ,act1 or the application of any such provision or amendment to any person or circumstance is held to be unconstitutional1 the remainder of the provisions of this ,act1 the amendments made by this ,act1 and the application of such provisions and amendments to any person or circumstance shall not be affected thereby4