,i #aafth ,,congress #ast ,session ,h4 ,r4 #bbif ,,in ,,the ,,house ,,of ,,representatives ,april #ab1 #bjai ,ms4 ,schakowsky 7for herself and ,mr4 ,rooney of ,florida7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to require reporting regarding certain drug price increases1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,fair ,accountability and ,innovative ,research ,drug ,pricing ,act of #bjai or the ,,fair ,drug ,pricing ,act of #bjai4 #b4 ,reporting on justification for drug price increases ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,drug ,price ,reporting2 ,drug ,value ,fund #cii,,oo4 ,reporting on justification for drug price increases 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the license issued under section #cea of the ,public ,health ,service ,act2 or 7,b7 who is responsible for setting the price for the drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of this ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more per month supply or per a course of treatment that lasts less than a month and is-- 7i7 7,i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,,ii7 commonly administered by hospitals 7as determined by the ,secretary72 7ii7 not designated as a drug for a rare disease or condition under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7iii7 not designated by the ,secretary as a vaccine2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales were for individuals enrolled under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or under a ,state ,medicaid plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report required ,the manufacturer of a qualifying drug shall submit a report to the ,secretary for each price increase of a qualifying drug that will result in an increase in the wholesale acquisition cost of that drug that is equal to-- 7,a7 #aj percent or more over a #ab-month period2 or 7,b7 #be percent or more over a #cf-month period4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary not later than #cj days prior to the planned effective date of such price increase4 7c7 ,contents ,a report under subsection 7b7 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug on the planned effective date of such price increase2 7,b7 a justification for1 and description of1 each manufacturer's price increase that will occur during the #ab-month period described in subsection 7b77#a77;,a7 or the #cf-month period described in subsection 7b77#a77;,b71 as applicable2 7,c7 the identity of the initial developer of the drug2 7,d7 a description of the history of the manufacturer's price increases for the drug since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 7,e7 the current list price of the drug2 7,f7 the total expenditures of the manufacturer on-- 7i7 materials and manufacturing for such drug2 and 7ii7 acquiring patents and licensing for such drug2 7,g7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,h7 the total expenditures of the manufacturer on research and development for such drug that is used for-- 7i7 basic and preclinical research2 7ii7 clinical research2 7iii7 new drug development2 7iv7 pursuing new or expanded indications for such drug through supplemental applications under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of the ,public ,health ,service ,act2 and 7v7 carrying out postmarket requirements related to such drug1 including those under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,i7 the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 and 7,j7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer for each of the #ab- and #cf-month periods preceding the submission of the report2 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation for each of the #ab- and #cf-month periods preceding the submission of the report2 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 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 ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate4 7d7 ,civil penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section shall be subject to a civil penalty of #ajj1jjj for each day on which the violation continues4 7e7 ,public posting 7#a7 ,in general ,subject to paragraph 7#c71 not later than #cj days after the submission of a report under subsection 7b71 the ,secretary shall post the report on the public website of the ,department of ,health and ,human ,services4 7#b7 ,format ,in developing the format of such report for public posting1 the ,secretary shall consult stakeholders1 including beneficiary groups1 and shall seek feedback on the content and format from consumer advocates and readability experts to ensure such public reports are user-friendly to the public and are written in plain language that consumers can readily understand4 7#c7 ,trade secrets and confidential information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 #cii,,oo-#a4 ,use of civil penalty amounts ,the ,secretary shall1 without further appropriation1 collect civil penalties under section #cii,,oo and use the funds derived from such civil penalties1 in addition to any other amounts available to the ,secretary1 to carry out activities described in this part and to improve consumer and provider information about drug value and drug price transparency4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,in ,general ,subject to subsection 7b71 the ,secretary shall submit to ,congress1 and post on the public website of the ,department of ,health and ,human ,services in a way that is easy to use and understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #cii,,oo2 and 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to such section4 7b7 ,trade secrets and confidential information ,in carrying out this section1 the ,secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets4 4