,i #aaeth ,,congress #ast ,session ,h4 ,r4 #daaf ,,in ,,the ,,house ,,of ,,representatives ,october #be1 #bjag,mr4 ,doggett 7for himself1 ,mr4 ,cummings1 ,ms4 ,de,lauro1 ,mr4 ,ellison1 ,mr4 ,pocan1 ,mr4 ,grijalva1 ,mr4 ,cicilline1 ,mr4 ,cohen1 ,mr4 ,conyers1 ,mr4 ,higgins of ,new ,york1 ,ms4 ,kaptur1 ,mr4 ,nadler1 and ,mr4 ,raskin7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,public ,health ,service ,act to require reporting by drug manufacturers to increase transparency in drug pricing1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,transparent ,drug ,pricing ,act of #bjag4 #b4 ,drug manufacturer reporting ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#g4 ,drug manufacturer reporting 7a7 ,mandatory reporting ,a drug manufacturer shall submit to the ,secretary and to ,congress an annual report specifying with respect to the previous calendar year 7except as provided in subsection 7d77#b77-- 7#a7 the total expenditures of the manufacturer on-- 7,a7 domestic and foreign drug research and development1 including an itemized description of-- 7i7 basic and preclinical research2 7ii7 clinical research1 reported separately for each clinical trial2 7iii7 development of alternative dosage forms and strengths for the drug molecule or combinations1 including the molecule2 7iv7 other drug development activities1 such as nonclinical laboratory studies and record and report maintenance2 7v7 pursuing new or expanded indications for such drug through supplemental applications under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7vi7 carrying out postmarket requirements related to such drug1 including under section #eje7o77#c7 of such ,act2 7vii7 carrying out risk evaluation and mitigation strategies in accordance with section #eje-a of such ,act2 and 7viii7 marketing research2 7,b7 the acquisition of drug components and packaging1 in total and per unit sold1 broken out by source and cost and identifying specific costs that reflect internal transfers within the manufacturer's company2 7,c7 other acquisitions relating to drugs1 including for the purchase of patents and licensing or the acquisition of any corporate entity owning any rights to a drug during or after development of the drug2 and 7,d7 marketing1 advertising1 and educating for the promotion of a drug1 including a breakdown of amounts aimed at consumers1 prescribers1 managed care organizations1 and others1 irrespective of whether a particular drug is mentioned in the marketing1 advertising1 or educating2 7#b7 the gross revenue1 net revenue1 gross profit1 and net profit of the manufacturer with respect to drugs2 7#c7 the total number of units of each type of drug that were sold in interstate commerce2 7#d7 pricing information with respect to the sale of drugs1 including-- 7,a7 wholesale acquisition cost2 7,b7 net average price realized by prescription drug benefit managers for drugs provided to individuals in the ,united ,states1 after accounting for any rebates or other payments from the manufacturer to the pharmacy benefit manager and from the pharmacy benefit manager to the manufacturer2 and 7,c7 the net price of each drug1 after accounting for discounts1 rebates1 or other financial considerations1 charged to purchasers in each applicable country of the ,organisation for ,economic ,co-operation and ,development2 7#e7 any ,federal benefits received by the manufacturer with respect to a drug1 including the amounts and periods of impact for each such benefit1 including tax credits2 ,federal grants1 including from the ,national ,institutes of ,health1 the ,department of ,defense1 the ,department of ,energy1 the ,centers for ,disease ,control and ,prevention1 or other ,federal departments or agencies2 patent applications that benefitted from such grants2 patent extensions2 exclusivity periods2 and waivers of fees2 7#f7 the percentage of research and development expenditures described in clauses 7i7 through 7v7 of paragraph 7#a77;,a7 that were derived from ,federal funds2 7#g7 executive compensation for the chief executive officer1 chief financial officer1 and the #c other most highly compensated executive officers1 including bonuses1 paid by such manufacturer1 and stock options affiliated with the manufacturer that were offered to or accrued by such officers2 and 7#h7 any other information as the ,secretary may require4 7b7 ,voluntary supplemental reporting ,a drug manufacturer may supplement a report under subsection 7a7 with any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as-- 7#a7 total expenditures on drug research1 drug development1 and clinical trials on drugs that failed to receive approval by the ,food and ,drug ,administration2 and 7#b7 a list of drugs and drug prices of other manufacturers for purposes of comparison with the manufacturer's own drugs and drug prices4 7c7 ,special rule ,a drug manufacturer shall-- 7#a7 to the extent possible1 disaggregate the information required to be reported by this section by the particular drug involved2 and 7#b7 submit all information required to be reported by this section with respect to each applicable drug in a single annual report4 7d7 ,submission of reports 7#a7 ,in general 7,a7 ,submission by drug manufacturers ,drug manufacturers shall submit the annual reports required under this section to the ,secretary in a usable format1 as the ,secretary may require4 7,b7 ,collation by the ,secretary ,the ,secretary shall collate the reports received as described in subparagraph 7,a7 and submit such collated reports to ,congress1 together with an analysis of the reports by the ,secretary that includes-- 7i7 a summary of data from the reports2 7ii7 consideration of factors such as trends on research and development costs1 ,federal benefits1 and manufacturer patient assistance programs2 and 7iii7 the relationship between the factors described in clause 7ii7 and prescription drug prices4 7,c7 ,public availability ,the ,secretary shall make the reports submitted by manufacturers as described in subparagraph 7,a7 and the collated reports together with the analysis of the ,secretary described in subparagraph 7,b7 publicly available1 including by posting such reports to the internet website of the ,department of ,health and ,human ,services1 in a searchable format4 7#b7 ,initial report 7,a7 ,in general ,a drug manufacturer shall submit an initial report pursuant to this section not later than one year after the date of enactment of the ,transparent ,drug ,pricing ,act of #bjag 7except as provided in subparagraph 7,b774 7,b7 ,reporting period ,notwithstanding the requirement in subsection 7a7 that each report under such subsection be for the previous calendar year1 the initial report of a drug manufacturer under subsection 7a7 shall include1 for each drug marketed by the manufacturer1 the information described in paragraphs 7#a7 through 7#f7 of subsection 7a7 for the calendar year period beginning with the later of-- 7i7 the calendar year in which the drug was approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 was licensed under section #cea of this ,act1 or received an exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c7 of this ,act2 and 7ii7 the calendar year in which the manufacturer acquired the drug so approved1 licensed1 or exempted4 7,c7 ,small businesses ,in the case of a drug manufacturer that has fewer than #ejj employees1 the initial report required by in subparagraph 7,a7 shall be submitted by a date determined by the ,secretary1 which shall be-- 7i7 not earlier than the deadline described in subparagraph 7,a72 and 7ii7 not later than the date that is #c years after the date of enactment of the ,transparent ,drug ,pricing ,act of #bjag4 7e7 ,audit by third party ,the ,secretary shall select a percentage 7to be determined by the ,secretary7 of the reports submitted under subsection 7a7 for a fiscal year to be audited by an accredited third-party auditor 7to be selected by the ,secretary74 7f7 ,penalty for noncompliance ,the ,secretary shall report to the ,office of the ,inspector ,general any manufacturer's failure to submit a complete report as required under this section4 ,any manufacturer that fails to submit a complete report required under this section shall be subject to a civil penalty of up to #bjj1jjj for each day on which the violation continues4 ,the ,secretary shall collect the civil penalties under this subsection and1 without further appropriation1 shall use such funds to support research of the ,national ,institutes of ,health4 7g7 ,definition ,in this section1 the term drug manufacturer means the manufacturer of an approved drug 7including a drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and a biological product licensed under subsection 7a7 or 7k7 of section #cea of this ,act74 4