,,ib ,union ,calendar ,no4 #cc #aafth ,,congress #ast ,session ,h4 ,r4 #ife ,report ,no4 #aaf-ee1 ,parts ,i and ,,ii ,,in ,,the ,,house ,,of ,,representatives ,february #e1 #bjai ,mr4 ,cicilline 7for himself1 ,mr4 ,sensenbrenner1 ,mr4 ,nadler1 ,mr4 ,collins of ,georgia1 ,mr4 ,welch1 and ,mr4 ,mc,kinley7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,may #aj1 #bjai ,additional sponsors3 ,mr4 ,meadows1 ,ms4 ,finkenauer1 ,mr4 ,doggett1 ,mr4 ,cole1 ,mr4 ,gallagher1 ,mr4 ,lipinski1 ,mr4 ,rush1 ,ms4 ,mc,collum1 ,mr4 ,pallone1 ,mr4 ,perry1 ,mr4 ,ruiz1 ,mrs4 ,dingell1 ,ms4 ,eshoo1 ,ms4 ,matsui1 ,mrs4 ,craig1 ,mr4 ,tonko1 ,mr4 ,gohmert1 ,mr4 ,van ,drew1 ,ms4 ,clarke of ,new ,york1 ,mr4 ,courtney1 ,mr4 ,allred1 ,ms4 ,schakowsky1 ,mr4 ,crow1 ,mr4 ,gonzalez of ,ohio1 ,mr4 ,larson of ,connecticut1 ,mr4 ,mc,adams1 ,mr4 ,schrader1 ,mr4 ,rodney ,davis of ,illinois1 ,mr4 ,pappas1 ,mr4 ,kennedy1 ,ms4 ,davids of ,kansas1 ,mr4 ,norcross1 ,ms4 ,spanberger1 ,mr4 ,quigley1 ,mr4 ,deutch1 ,mr4 ,langevin1 ,mr4 ,cooper1 ,mrs4 ,mc,bath1 ,mr4 ,raskin1 ,ms4 ,mucarsel-,powell1 ,mr4 ,stanton1 ,mr4 ,jordan1 ,ms4 ,wild1 ,mr4 ,cohen1 ,mr4 ,kim1 ,ms4 ,schrier1 ,mr4 ,joyce of ,ohio1 ,mr4 ,case1 ,mr4 ,khanna1 ,mr4 ,david ,scott of ,georgia1 ,ms4 ,houlahan1 ,mr4 ,casten of ,illinois1 ,mr4 ,norman1 ,ms4 ,pingree1 ,mr4 ,carbajal1 ,mr4 ,smith of ,washington1 ,ms4 ,wexton1 ,mr4 ,cisneros1 ,mr4 ,connolly1 ,ms4 ,underwood1 ,ms4 ,garcia of ,texas1 ,ms4 ,meng1 and ,mrs4 ,bustos ,may #aj1 #bjai ,reported from the ,committee on ,energy and ,commerce with an amendment ,strike out all after the enacting clause and insert the part printed in italic ,may #aj1 #bjai ,reported from the ,committee on the ,judiciary2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed ,for text of introduced bill1 see copy of bill as introduced on ,february #e1 #bjai ,a ,,bill ,to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products4 #a4 ,short title ,this ,act may be cited as the ,creating and ,restoring ,equal ,access to ,equivalent ,samples ,act of #bjai or the ,,creates ,act of #bjai4 #b4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term commercially reasonable1 market-based terms means-- 7,a7 a nondiscriminatory price for the sale of the covered product at or below1 but not greater than1 the most recent wholesale acquisition cost for the drug1 as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection 7b77#b77;,a77iv72 and 7,c7 no additional conditions are imposed on the sale of the covered product2 7#b7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to support approval of an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 or otherwise meet the requirements for approval under either such section1 any product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 does not include any drug or biological product that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 the drug or biological product has been on the drug shortage list in effect under such section #ejf;,e continuously for more than #f months2 or 7ii7 the ,secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage4 7#c7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 the term license holder means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#f7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#i7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 and 7#aj7 the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to-- 7,a7 conduct testing to support an application under-- 7i7 subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to approval of such an application4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a ,,rems with ,,etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #abj days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 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 product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder2 or 7,c7 that the license holder made an offer to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- 7i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ad days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #g days after the date on which the eligible product developer received such offer from the license holder2 or 7ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by the date that is #bj days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #aj days after the date on which the eligible product developer received such offer from the license holder4 7#d7 ,methods for transmission of requests for covered products ,a written request for a covered product1 offer to sell a covered product1 or acceptance of such an offer between the eligible product developer and the license holder 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 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney's fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,no violation of ,,rems ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended by adding at the end the following new subsection3 7l7 ,provision of samples not a violation of strategy ,the provision of samples of a covered product to an eligible product developer 7as those terms are defined in section #b7;a7 of the ,creating and ,restoring ,equal ,access to ,equivalent ,samples ,act of #bjai7 shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug4 4 7e7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 #c4 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 as amended by section #b1 is further amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different1 comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section #eje7;j71 and the applicable listed drug4 2 7#b7 in subsection 7i77#a71 by striking subparagraph 7,c7 and inserting the following3 7,c7 7i7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug1 which1 subject to clause 7ii71 for a drug that is the subject of an application under section #eje7;j7 may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an application under section #eje7;j7 and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 2 7#c7 in subsection 7i71 by adding at the end the following3 7#c7 ,shared ,,rems ,if the ,secretary approves1 in accordance with paragraph 7#a77;,c77i77,,ii71 a different1 comparable aspect of the elements to assure safe use under subsection 7f7 for a drug that is the subject of an abbreviated new drug application under section #eje7;j71 the ,secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section #eje7;j7 or #eje7;b7 that references the same listed drug4 2 and 7#d7 by adding at the end the following3 7m7 ,separate ,,rems ,when used in this section1 the terms different1 comparable aspect of the elements to assure safe use or different1 comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section #eje7;j7 that uses different methods or operational means than the strategy required under subsection 7a7 for the applicable listed drug1 or other application under section #eje7;j7 with the same such listed drug1 but achieves the same level of safety as such strategy4 4 #d4 ,rule of construction 7a7 ,in general ,nothing in this ,act1 the amendments made by this ,act1 or in section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 shall be construed as-- 7#a7 prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this ,act2 or 7#b7 in any way negating the applicability of a ,,rems with ,,etasu1 as otherwise required under such section #eje-a1 with respect to such covered product4 7b7 ,definitions ,in this section1 the terms covered product1 eligible product developer1 license holder1 and ,,rems with ,,etasu have the meanings given such terms in section #c7;a74 ,may #aj1 #bjai ,reported from the ,committee on ,energy and ,commerce with an amendment ,may #aj1 #bjai ,reported from the ,committee on the ,judiciary2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed