,,ii #aagth ,,congress #b;d ,session ,s4 #djec ,,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 ,federal ,food1 ,drug1 and ,cosmetic ,act to grant eligible researchers access to eligible products at a discounted price for qualified research1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,discounted ,drugs for ,clinical ,trials ,act4 #b4 ,discounted sales of eligible products for qualified research purposes 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eje-b of such ,act 7#ba ,u4,s4,c4 #cee-a7 the following new section3 #eje-c4 ,discounted sales of eligible products for qualified research purposes 7a7 ,application by researcher ,to obtain an eligible product for qualified research at the discounted price1 an individual or entity shall submit to the ,secretary an application certifying and demonstrating that-- 7#a7 the individual or entity is an eligible researcher2 7#b7 the product being sought is an eligible product2 7#c7 the researcher seeks to use the eligible product for qualified research2 and 7#d7 the amount of the eligible product sought is reasonable for completing the qualified research4 7b7 ,duties of ,secretary ,the ,secretary shall-- 7#a7 review each application submitted under paragraph 7#a7 in a timely manner2 7#b7 provide to the applicant1 within a reasonable time of such submission-- 7,a7 a written order specifying the sufficient quantity of the eligible product approved to be purchased by the eligible researcher at the discounted price2 or 7,b7 a written denial of the application2 7#c7 require manufacturers and license holders to report to the ,secretary any additional information determined by the ,secretary to be necessary to carry out this section2 and 7#d7 annually publish information on the number and types of applications granted and denied under this section4 7c7 ,acquisition of discounted drug ,upon receipt from an eligible researcher of an order obtained under subsection 7b77#b77;,a7 for the acquisition of an eligible product for qualified research1 the manufacturer or license holder of the eligible product shall sell to the eligible researcher the quantity specified in the order at the discounted price4 7d7 ,civil action for failure ,to provide sufficient quantity of an eligible product 7#a7 ,in general ,an eligible researcher may bring a civil action against the manufacturer or license holder of an eligible product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the manufacturer or license holder has declined to provide the quantity of the eligible product specified in a written order from the ,secretary to the eligible researcher for the discounted price4 7#b7 ,elements ,to prevail in a civil action brought under paragraph 7#a71 an eligible researcher shall prove1 by a preponderance of the evidence1 that-- 7,a7 the eligible researcher has-- 7i7 obtained a written order for the specified quantity of the eligible product from the ,secretary in accordance with subsection 7b77#b77;,a72 and 7ii7 provided a copy of the order to the manufacturer or license holder2 and 7,b7 as of the date on which the civil action is filed1 the eligible researcher has not obtained the specified quantity of the eligible product at the discounted price by #ca days after the date on which the manufacturer or license holder received the eligible researcher's request for the eligible product1 including a copy of the written order4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible researcher requested to purchase the specified quantity of the eligible product from the manufacturer or license holder-- 7i7 neither the manufacturer1 license holder1 nor any of their agents1 wholesalers1 or distributors1 was engaged in the manufacturing or commercial marketing of the eligible product2 and 7ii7 neither the manufacturer1 license holder1 nor any of their agents1 wholesalers1 or distributors1 otherwise had access to inventory of the eligible product to supply the specified quantity to the eligible researcher at the discounted price2 7,b7 that-- 7i7 the manufacturer or license holder sells the eligible product through agents1 distributors1 or wholesalers2 7ii7 the manufacturer has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers on selling the eligible product to eligible researchers2 and 7iii7 the eligible product can be purchased by the eligible researcher in the specified quantity at the discounted price or a lower price from the agents1 distributors1 or wholesalers of the manufacturer or license holder2 or 7,c7 that the manufacturer or license holder made an offer to sell the specified quantity of the eligible product to the eligible researcher for the discounted price and the eligible researcher did not accept such offer by the date that is #ad days after the date on which the eligible product researcher received such offer4 7#d7 ,methods for transmission of requests for eligible products ,a written request for an eligible product1 offer to sell an eligible product1 or acceptance of such an offer between the eligible researcher and the manufacturer or license holder of the eligible product shall be made by-- 7,a7 certified or registered mail with return receipt requested2 7,b7 personal delivery2 or 7,c7 electronic means4 7#e7 ,remedies ,if an eligible researcher prevails in a civil action brought under paragraph 7#a71 the court shall-- 7,a7 order the manufacturer or license holder to provide to the eligible researcher without delay the specified quantity of the eligible product at the discounted price2 7,b7 award to the eligible researcher reasonable attorney's fees and costs of the civil action2 and 7,c7 award to the eligible researcher a monetary amount sufficient to deter the manufacturer or license holder from failing to provide eligible researchers with a sufficient quantity of an eligible product at the discounted price1 if the court finds1 by a preponderance of the evidence1 that the manufacturer or license holder1 without a legitimate business justification-- 7i7 delayed providing the specified quantity to the eligible researcher2 or 7ii7 failed to comply with a written order under subsection 7b77#b77;,a74 7#f7 ,maximum monetary amount ,a monetary amount awarded under paragraph 7#e7 shall not be greater than the revenue that the manufacturer or license holder earned on the eligible product beginning on the date that is #ca days after the date on which the manufacturer or license holder received the request and ending on the date on which the eligible researcher received the specified quantity of the eligible product4 7#g7 ,avoidance of delay ,the court may issue an order under paragraph 7#e77;,a7 before conducting further proceedings that may be necessary to determine-- 7,a7 whether the eligible researcher is entitled to an award under subparagraph 7,b7 or 7,c7 of paragraph 7#e72 or 7,b7 the amount of any such award4 7e7 ,limitation of liability ,a manufacturer or license holder of an eligible product obtained by an eligible researcher pursuant to this section shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of the eligible researcher to follow adequate safeguards to assure safe use of the eligible product1 including with respect to transportation1 handling1 use1 or disposal4 7f7 ,rule of construction ,this section shall not be construed to-- 7#a7 undermine or abrogate any requirement imposed pursuant to a risk evaluation and mitigation strategy under section #eje-a2 or 7#b7 interfere with the private right of action afforded under section #faj of division ,n of the ,further ,consolidated ,appropriations ,act1 #bjbj 7,public ,law #aaf-id7 7#ba ,u4,s4,c4 #cee-b note2 commonly referred to as the ,,creates ,act74 7g7 ,definitions ,in this section3 7#a7 ,commissioner ,the term ,commissioner means the ,commissioner of ,food and ,drugs4 7#b7 ,combination product ,the term combination product means a combination product described in section #ejc7;g74 7#c7 ,discounted price ,the term discounted price means the direct costs to the manufacturer or license holder of producing the eligible product4 7#d7 ,eligible product ,the term eligible product means-- 7,a7 any-- 7i7 drug approved under section #eje7;c7 of this ,act or biological product licensed under section #cea7;a7 of the ,public ,health ,service ,act2 7ii7 combination product including such a drug or biological product2 or 7iii7 product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 any product that is-- 7i7 a covered part ,d drug 7as defined in section #ahfj;,d-#b7;e7 of the ,social ,security ,act7 eligible for placement on1 with respect to a plan year1 a specialty tier 7as defined in section #dbc4efj of title #db1 ,code of ,federal ,regulations7 of a formulary for such plan year of a prescription drug plan under part ,d of title ,,xviii of such ,act or an ,,ma-,,pd plan under part ,c of such title2 or 7ii7 a drug 7including any biological product71 or combination product1 whose cost is determined by the ,commissioner to be prohibitive to the advancement of qualified research4 7#e7 ,eligible researcher ,the term eligible researcher means any individual seeking to obtain an eligible product for qualified research4 7#f7 ,license holder ,the term license holder means the holder of an application approved under section subsection 7c7 or 7j7 of section #eje of this ,act1 or a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 for an eligible product4 7#g7 ,qualified research ,the term qualified research means-- 7,a7 research in furtherance of an application under section #eje7;b7 or 7j7 of this ,act2 7,b7 research in furtherance of an application for a license under section #cea7;a7 or 7k7 of the ,public ,health ,service ,act2 7,c7 research for which an exemption for investigational use is granted pursuant to section #eje7;i7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act2 or 7,d7 research using an approved drug for an approved indication with the purpose of evaluating and comparing the clinical effectiveness1 risks1 or benefits of #b or more of any of the following3 7i7 ,health care interventions1 protocols for treatment1 care management1 delivery procedures1 diagnostic tools1 or integrative practices4 7ii7 ,drugs 7including biological products71 devices1 or combination products4 7iii7 ,any other treatments1 services1 practices1 or items being used in the treatment1 management1 or diagnosis of1 or prevention of1 illness or injury in individuals4 7#h7 ,sufficient quantity ,the term sufficient quantity means an amount of an eligible product no greater than the eligible researcher determines to be necessary to accomplish the qualified research and fulfill any related regulatory requirements4 4 7b7 ,regulations ,not later than #ahj days of the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate final regulations to carry out section #eje-c of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 including regulations to appropriately calculate the discounted price applicable with respect to an eligible product 7as such terms are defined in such section #eje-c74