,,ii #aafth ,,congress #ast ,session ,s4 #ajb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #aj1 #bjai,mr4 ,sanders 7for himself1 ,mr4 ,booker1 ,mr4 ,blumenthal1 ,mrs4 ,gillibrand1 ,ms4 ,harris1 and ,ms4 ,warren7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to significantly lower prescription drug prices for patients in the ,united ,states by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries4 #a4 ,short title ,this ,act may be cited as the ,prescription ,drug ,price ,relief ,act of #bjai4 #b4 ,identification of excessively priced drugs 7a7 ,in general ,the ,secretary1 not later than #a year after the date of enactment of this ,act1 shall establish a process to conduct a review of all brand name drugs1 not less frequently than once per calendar year1 under which the ,secretary determines under subsection 7b7 whether the price of each such drug is excessive4 7b7 ,excessive price determinations 7#a7 ,international reference price 7,a7 ,in general ,the ,secretary shall determine that any brand name drug for which the domestic average manufacturing price exceeds the median price charged for such drug in the #e reference countries to have an excessive price4 ,in assessing the extent to which the price is excessive1 the ,secretary shall consider the factors described in paragraph 7#b74 7,b7 ,reference ,countries ,in this ,act1 the term reference countries means ,canada1 the ,united ,kingdom1 ,germany1 ,france1 and ,japan4 7,c7 ,requirement with respect to drugs for which certain reference country information is not available ,the ,secretary shall make a determination under paragraph 7#a7 for every brand name drug for which pricing information is available for at least #c of the #e reference countries4 7#b7 ,determinations based on other factors ,with respect to any brand name drug that is not determined to have an excessive price by operation of paragraph 7#a7 7including any drug for which there is insufficient data to make such a determination under such paragraph71 the ,secretary shall determine that such drug has an excessive price if the price of the drug is higher than reasonable taking into account the following factors3 7,a7 ,the size of the affected patient population4 7,b7 ,the value of the drug to patients1 including the impact of the price on access to the drug and the relationship of the price of the drug to its therapeutic health benefits4 7,c7 ,the risk adjusted value of ,federal ,government subsidies and investments related to the drug4 7,d7 ,the costs associated with development of the drug4 7,e7 ,whether the drug provided a significant improvement in health outcomes1 compared to other therapies available at the time of its approval4 7,f7 ,the cumulative global revenues generated by the drug4 7,g7 ,whether the domestic average manufacturer price of the drug increased during any annual quarter by a percentage that is more than the percentage increase in the consumer price index for all urban consumers for the respective annual quarter4 7,h7 ,other factors the ,secretary determines appropriate4 7c7 ,petition for determination 7#a7 ,in general ,any person may petition the ,secretary1 in accordance with section #eec7;e7 of title #e1 ,united ,states ,code1 to make an excessive drug price determination for an applicable drug under subsection 7b77#b74 ,not later than #ij days after the date of receipt of such a petition1 subject to paragraph 7#b71 the ,secretary shall-- 7,a7 make a determination under subsection 7b77#b7 regarding such drug2 or 7,b7 7i7 decline to make such a determination2 and 7ii7 make public the reasons why the ,secretary has declined to make such a determination4 7#b7 ,exception ,the ,secretary shall not make a determination under subsection 7b77#b7 for a drug in response to a petition under this section more frequently than once per calendar year4 7#c7 ,public availability ,the ,secretary shall make any petitions submitted under this subsection1 together with any documentation related to the petitions and the ,secretary's determinations on such petitions and rationale for such determinations1 publicly available1 including by posting such information on the database under section #e4 #c4 ,ending government-granted monopolies for excessively priced drugs 7a7 ,excessive drug price authority ,with respect to any brand name drug1 if the ,secretary determines under section #b that the price of the drug is excessive1 the ,secretary-- 7#a7 shall waive or void any government-granted exclusivities with respect to such drug1 effective on the date that the excessive price determination under section #b is made for such drug2 and 7#b7 shall grant open1 non-exclusive licenses allowing any person to make1 use1 offer to sell or sell1 or import into the ,united ,states such drug1 and to rely upon the regulatory test data of such drug1 in accordance with section #d4 7b7 ,expedited review ,the ,secretary shall prioritize the review of1 and act within #h months of the date of the submission of a generic drug application or a biosimilar biological product application if such application references a drug licensed under subsection 7a77#b74 7c7 ,civil actions ,if the ,secretary determines that the manufacturer of an excessively priced drug 7as determined under section #b7;a77 has increased the price of such drug during the period beginning on the date on which such price determination is made and ending on the date on which an entity begins manufacturing the drug under an open1 non-exclusive license under subsection 7a77#b71 the ,secretary may file a civil action in the ,united ,states district court for the district in which the manufacturer is located1 or in the ,united ,states district court for the ,district of ,columbia1 to recover damages in an amount equal to not less than the total amount of revenue derived by the manufacturer as a result of any such price increase during such period4 ,in actions brought under this subsection1 the district courts shall have jurisdiction to grant all appropriate relief including1 but not limited to1 injunctive relief and compensatory damages4 #d4 ,excessive drug price license 7a7 ,reasonable royalty 7#a7 ,in general ,an entity accepting an open1 non-exclusive license under section #c7;a77#b7 shall pay a reasonable royalty to the holder of a patent that claims the drug or that claims a use of the drug or to the holder of an application approved under subsection #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of the ,public ,health ,service ,act for which any government-granted exclusivity with respect to the drug was terminated under section #e7;a77#a74 7#b7 ,royalty rate ,such royalty rate shall be-- 7,a7 a percentage of sales1 where the percentage rate is no higher than the average royalty rate estimated from the data provided by the ,internal ,revenue ,service for pharmaceutical manufacturer ,federal income tax returns2 or 7,b7 an amount as determined by the ,secretary1 taking into account-- 7i7 the value of the drug to patients2 7ii7 the size of the affected patient population2 7iii7 the risk adjusted value of the ,federal ,government subsidies and investments related to the drug2 7iv7 whether the drug provided a significant improvement in health outcomes1 compared to other therapies available at the time of the approval2 7v7 the extent to which the brand name drug manufacturer has recovered risk adjusted investments related to the drug1 including the investments related to the invention1 regulatory test data and any other relevant research and development costs2 and 7vi7 any other information the ,secretary determines appropriate4 7b7 ,requirements 7#a7 ,in general ,a royalty rate under subsection 7a7 shall be consistent with making drugs available to purchasers1 including ,federal1 ,state1 local1 and nongovernmental purchasers and individuals1 at prices that are affordable and reasonable4 ,under no condition shall a royalty be set at a rate that would cause a product for which an open1 non-exclusive license was issued under section #c to be sold at an excessive price1 as determined under section #b4 7#b7 ,multiple affected parties ,in the case that there is one or more holders or investors in the patented inventions related to the drug in addition to the brand name manufacturer1 the royalty rate shall be divided among the holders or investors 7including such manufacturer7 in a manner agreed upon by the manufacturer and other holders or investors1 or1 in the absence of such an agreement1 in a manner the ,secretary determines to be appropriate4 7#c7 ,price ,an entity accepting an open1 non-exclusive license under section #c7;a77#b7 shall sell the drug at a price not higher than the excessive price determined for that drug under section #b7;b74 #e4 ,public excessive drug price database 7a7 ,excessive drug price database 7#a7 ,in general ,the ,secretary shall establish and maintain a comprehensive1 up-to-date database of brand name drugs and the excessive price determinations for such drugs under section #b4 7#b7 ,contents ,the database shall include1 at a minimum1 for each brand name drug1 for the applicable calendar year-- 7,a7 the name of the drug2 7,b7 the manufacturer2 7,c7 whether the drug was determined under section #b7;b7 to have an excessive price2 7,d7 the number of petitions the ,secretary received under section #b7;c7 to make an excessive price determination for the drug1 together with the information described in section #b7;c77#c72 7,e7 the number of open1 non-exclusive licenses the ,secretary has granted under section #c7;a77#b7 for generic drug or biosimilar biological product versions of the drug2 and 7,f7 the number of applications under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or under section #cea7k7 of the ,public ,health ,service ,act submitted to the ,secretary1 pursuant to such a license granted under section #c7;a77#b71 and the number of such applications that have been approved4 7#c7 ,certain determinations ,with respect to a determination made under section #b7;b77#a71 the ,secretary shall publish on the database such determination in accordance with paragraph 7#a7 within #cj days of receiving domestic and international pricing information from manufacturers under section #f4 7b7 ,annual reports to ,congress ,not later than #fj days after the first excessive price review under section #b is complete1 and annually thereafter1 the ,secretary shall submit to ,congress a report describing the excessive drug price review for the preceding year4 ,the report shall contain summary data regarding-- 7#a7 the total number of drugs that were reviewed2 7#b7 the total number of drugs determined to be excessively priced under each of paragraphs 7#a7 and 7#b7 of section #b7;b71 and the name and manufacturer of each such drug2 7#c7 the total number of drugs determined to be excessively priced1 listed by manufacturer2 7#d7 the extent to which the prices of the drugs identified under section #b were higher than reasonable1 on average2 7#e7 the total number of drugs for which an open-non-exclusive license has been granted under section #c7;a77#b72 7#f7 the total number of generic drug or biosimilar biological product applications received and approved that reference a drug so licensed2 7#g7 the median approval time for generic drug or biosimilar biological product applications that reference a drug so licensed2 7#h7 the total number of petitions the ,secretary received under section #b7;c7 to make excessive price determinations for drugs2 7#i7 a list of any manufacturers who failed to report information as required under section #f2 and 7#aj7 other appropriate information1 as the ,secretary determines or as ,congress requests4 7c7 ,public availability ,the ,secretary shall make the information in the database described in subsection 7a7 and the report in subsection 7b7 publicly available1 including on the internet website of the ,food and ,drug ,administration1 in a manner that is easy to find and understand4 #f4 ,drug manufacturer reporting 7a7 ,in general ,each manufacturer shall submit to the ,secretary1 in such format as the ,secretary may require1 an annual report that includes the following information for each brand name drug of the manufacturer1 with respect to the previous calendar year3 7#a7 ,the average manufacturer price of the drug in the ,united ,states and in the reference countries1 for the entire year1 and broken down for each quarter of the year4 7#b7 ,the wholesale acquisition cost of the drug in the ,united ,states and in the reference countries1 for the entire year1 and broken down for each quarter of the year4 7#c7 ,cumulative global revenues generated by the drug4 7#d7 ,annual net sales revenue generated by the drug in the ,united ,states and in the reference countries1 for the entire year1 and broken down for each quarter of the year4 7#e7 ,total expenditures on domestic and foreign drug research and development related to the drug1 itemized by-- 7,a7 basic and preclinical research2 7,b7 clinical research1 reported separately for each clinical trial2 7,c7 development of alternative dosage forms and strengths for the drug molecule or combinations1 including the molecule2 7,d7 other drug development activities1 such as nonclinical laboratory studies and record and report maintenance2 7,e7 pursuing new or expanded indications for such drug through supplemental applications under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,f7 carrying out postmarket requirements related to such drug1 including under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#f7 ,total expenditures on domestic and foreign marketing and advertising related to the drug4 7#g7 ,investments in human clinical trials related to the drug1 by each trial and each year1 including grants1 research contracts1 tax credits or deductions1 and reimbursements from public or private health plans or insurance1 and any other public sector subsidies or incentives1 such as the fair market value or priority review vouchers or other considerations4 7#h7 ,the estimated size of the affected patient population4 7#i7 ,additional information the manufacturer chooses to provide related to drug pricing decisions1 such as information related to the methodology used to set the price of the drug4 7#aj7 ,additional information as the ,secretary determines necessary to carry out this ,act1 including information for previous years4 7b7 ,report due date ,applicable manufacturers shall submit the reports described in subsection 7a7 not later than ,january #ae of the year following the date of enactment of this ,act1 and of each year thereafter4 7c7 ,penalty for noncompliance 7#a7 ,in general ,any manufacturer that fails to submit information for a drug as required by this section on a timely basis or that knowingly provides false information shall be liable for a civil monetary penalty1 as determined by the ,secretary under paragraph 7#b71 in addition to any other penalty under other applicable provisions of law4 7#b7 ,amount of penalty ,the amount of a civil penalty under paragraph 7#a7 shall be equal to the product of-- 7,a7 an amount1 as determined appropriate by the ,secretary1 which is-- 7i7 not less than #j4e percent of the gross revenues from sales for the previous calendar year of the drug for which the information was not submitted2 and 7ii7 not greater than #a percent of the gross revenues from sales for the previous calendar year of such drug2 and 7,b7 the number of days in the period between-- 7i7 the report due date under subsection 7b72 and 7ii7 the date on which the ,secretary receives the information required to be reported by the manufacturer under this section4 7#c7 ,use of civil penalty ,the ,secretary shall collect the civil penalties under this subsection and shall use such funds to support competitive research grant programs of the ,national ,institutes of ,health4 #g4 ,prohibition of anticompetitive behavior ,no manufacturer may engage in anticompetitive behavior violating section #e7;a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77 with another manufacturer that may interfere with the issuance and implementation of open1 non-exclusive licenses under this ,act or otherwise run contrary to the public interest in the availability of affordable prescription drugs4 #h4 ,definitions ,for the purposes of this ,act3 7#a7 ,average manufacturer price 7,a7 ,in general ,the term average manufacturer price1 with respect to a drug1 subject to subparagraph 7,b71 has the meaning given such term in section #aibg7k77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a772 or with respect to a drug for which there is no average manufacturer price as so defined1 such term shall mean the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b77 of the drug4 7,b7 ,application to reference countries ,with respect to reference countries1 the term average manufacturer price1 as defined in subparagraph 7,a71 shall be determined based on the price of the drug in the applicable reference country4 7#b7 ,biosimilar biological product ,the term biosimilar biological product means a biological product licensed pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 7#c7 ,brand name drug ,the term brand name drug means a drug that is-- 7,a7 approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or a biological product licensed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 7,b7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 and 7,c7 claimed in a patent or the use of which is claimed in a patent4 7#d7 ,generic drug ,the term generic drug means a drug approved pursuant to an application under section 7b77#b7 or 7j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7#e7 ,government-granted exclusivity ,the term government-granted exclusivity means prohibitions on the submission or approval of drug applications granted under any of the following3 7,a7 ,clauses 7ii7 through 7v7 of section #eje7;c77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e774 7,b7 ,section #eje7;j77#e77;,b77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 or clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f7 of such ,act4 7,c7 ,section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a74 7,d7 ,section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f74 7,e7 ,section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc74 7,f7 ,section #cea7k77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g774 7,g7 ,any other provision of law that provides for exclusivity 7or extension of exclusivity7 with respect to a drug4 7#f7 ,manufacturer ,the term manufacturer means the holder of an application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or of a license issued under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#g7 ,open1 non-exclusive license ,the term open1 non-exclusive license means a license that authorizes any person to use a patent held by a manufacturer that claims a brand name drug or a use of a brand name drug or rely upon regulatory test data for such drug1 including patents held in common by the manufacturer and other entities1 needed to produce1 manufacture1 import1 export1 distribute1 offer in liquidation1 sell1 buy1 or use such brand name drug4 7#h7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4