,,ii #aadth ,,congress #b;d ,session ,s4 #cjef ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #ad1 #bjaf ,mr4 ,leahy 7for himself1 ,mr4 ,grassley1 ,ms4 ,klobuchar1 and ,mr4 ,lee7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to provide for certain causes of action relating to delays of generic drugs and biosimilar biological products4 #a4 ,short title ,this ,act may be cited as the ,creating and ,restoring ,equal ,access to ,equivalent ,samples ,act of #bjaf or the ,,creates ,act of #bjaf4 #b4 ,findings ,congress finds the following3 7#a7 ,it is the policy of the ,united ,states to promote competition in the market for drugs and biological products by facilitating the timely entry of low-cost generic and biosimilar versions of those drugs and biological products4 7#b7 ,since their enactment in #aihd and #bjaj1 respectively1 the ,drug ,price ,competition and ,patent ,term ,restoration ,act of #aihd 7,public ,law #ih-dag2 #ih ,stat4 #aehe7 and the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,subtitle ,a of title ,,vii of ,public ,law #aaa-adh2 #abd ,stat4 #hjd71 have provided pathways for making lower-cost versions of previously approved drugs and previously licensed biological products available to the people of the ,united ,states in a timely manner1 thereby lowering overall prescription drug costs for patients and taxpayers by billions of dollars each year4 7#c7 ,in order for these pathways to function as intended1 developers of generic drugs and biosimilar biological products 7referred to in this section as generic product developers7 must be able to obtain quantities of the reference listed drug or biological product with which the generic drug or biosimilar biological product is intended to compete 7referred to in this section as a covered product7 for purposes of supporting an application for approval by the ,food and ,drug ,administration1 including for testing to show that-- 7,a7 a prospective generic drug is bioequivalent to the covered product in accordance with subsection 7j7 of section #eje of the ,federal1 ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or meets the requirements for approval of an application submitted under subsection 7b77#b7 of that section2 or 7,b7 a prospective biosimilar biological product is biosimilar to or interchangeable with its reference biological product under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k771 as applicable4 7#d7 ,for drugs and biological products that are subject to a risk evaluation and mitigation strategy1 another essential component in the creation of low-cost generic and biosimilar versions of covered products is the ability of generic product developers to join the manufacturer of the covered product 7referred to in this section as the license holder7 in a single1 shared system of elements to assure safe use and supporting agreements1 or secure a variance therefrom1 as required by section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74 7#e7 ,contrary to the policy of the ,united ,states 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 products1 certain license holders are preventing generic product developers from obtaining quantities of the covered product necessary for the generic product developer to support an application for approval by the ,food and ,drug ,administration1 including testing to show bioequivalence1 biosimilarity1 or interchangeability to the covered product1 in some instances based on the justification that the covered product is subject to a risk evaluation and mitigation strategy with elements to assure safe use under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74 7#f7 ,the ,director of the ,center for ,drug ,evaluation and ,research at the ,food and ,drug ,administration has testified that some manufacturers of covered products have used ,,rems and distribution restrictions adopted by the manufacturer on their own behalf as reasons to not sell quantities of a covered product to generic product developers1 causing barriers and delays in getting generic products on the market4 ,the ,food and ,drug ,administration has reported receiving significant numbers of inquiries from generic product developers who were unable to obtain samples of covered products to conduct necessary testing and otherwise meet requirements for approval of generic drugs4 7#g7 ,the ,chairwoman of the ,federal ,trade ,commission has testified that the ,federal ,trade ,commission continues to be very concerned about potential abuses by manufacturers of brand drugs of ,,rems or other closed distribution systems to impede generic competition4 7#h7 ,also contrary to the policy of the ,united ,states 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 products1 certain license holders are impeding the prompt negotiation and development on commercially reasonable terms of a single1 shared system of elements to assure safe use1 which may be necessary for the generic product developer to gain approval for its drug or licensing for its biological product4 7#i7 ,while the antitrust laws may address the refusal by some license holders to provide quantities of a covered product to a generic product developer1 a more tailored legal pathway would help ensure that generic product developers can obtain necessary quantities of a covered product in a timely way for purposes of developing a generic drug or biosimilar biological product1 facilitating competition in the marketplace for drugs and biological products4 7#aj7 ,while the antitrust laws may address actions by license holders who impede the prompt negotiation and development on commercially reasonable terms of a single1 shared system of elements to assure safe use1 a more tailored legal pathway would help ensure that license holders negotiate such agreements in good faith and in a timely manner1 facilitating competition in the marketplace for drugs and biological products4 #c4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7b7 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 demonstrate sameness1 biosimilarity1 or interchangeability for purposes of 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 any product1 including any device1 that is marketed or intended for use with such drug or biological product2 and 7,b7 does not include any drug or biological product that the ,secretary has determined to be currently in shortage and 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 the shortage will not be promptly resolved-- 7i7 as demonstrated by the fact that the drug or biological product has been in shortage for more than #f months2 or 7ii7 as otherwise determined by the ,secretary2 7#b7 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#c7 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#d7 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#e7 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#f7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#h7 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-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 and 7#i7 the term sufficient quantities means an amount of a covered product that allows the eligible product developer to-- 7,a7 conduct testing to support an application-- 7i7 for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 for licensing under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to such an application for approval or licensing4 7b7 ,civil actions 7#a7 ,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 paragraph 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 7i7 ,in general ,to prevail in a civil action brought under subparagraph 7,a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7,i7 that-- 7aa7 the covered product is not subject to a ,,rems with ,,etasu2 or 7bb7 if the covered product is subject to a ,,rems with ,,etasu-- 7,,aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with clause 7ii72 and 7,,bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7,,ii7 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 7,,iii7 that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder2 and 7,,iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7aa7 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 7bb7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7,,aa7 the date on which the license holder received the request for the covered product2 or 7,,bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with clause 7ii74 7ii7 ,authorization for covered product subject to a ,,rems with ,,etasu 7,i7 ,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 7,,ii7 ,authorization ,not later than #ij days after the date on which a request under subclause 7,i7 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-- 7aa7 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 7bb7 development and testing that involves human clinical trials1 if the eligible product developer has-- 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 provided4 7,,iii7 ,notice ,a covered product authorization issued under this clause 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 subparagraph 7,a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7i7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7,i7 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 7,,ii7 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 or 7ii7 that-- 7,i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7,,ii7 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 7,,iii7 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 holder4 7,d7 ,remedies 7i7 ,in general ,if an eligible product developer prevails in a civil action brought under subparagraph 7,a71 the court shall-- 7,i7 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 7,,ii7 award to the eligible product developer reasonable attorney fees and costs of the civil action2 and 7,,iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide other 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-- 7aa7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7bb7 that the license holder failed to comply with an order issued under subclause 7,i74 7ii7 ,maximum monetary amount ,a monetary amount awarded under clause 7i77,,iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7,i7 beginning on-- 7aa7 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 7bb7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7,,aa7 the date on which the license holder received the request2 or 7,,bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b77ii72 and 7,,ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7iii7 ,avoidance of delay ,the court may issue an order under clause 7i77,i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under subclause 7,,ii7 or 7,,iii7 of clause 7i71 or the amount of any such award4 7#b7 ,failure to reach agreement on shared system 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 paragraph in an appropriate district court of the ,united ,states alleging the license holder-- 7i7 failed to reach agreement with respect to a single1 shared system of elements to assure safe use with respect to the covered product2 or 7ii7 refused to allow the eligible product developer to join a previously approved system of elements to assure safe use with respect to that product4 7,b7 ,elements ,to prevail in a civil action brought under subparagraph 7,a71 an eligible product developer shall prove1 by a preponderance of the evidence1 that-- 7i7 the eligible product developer has sought approval of 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 has sought a license for a biological product under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 referencing a covered product subject to a ,,rems with ,,etasu2 7ii7 the covered product is subject to a ,,rems with ,,etasu that requires a single1 shared system of elements to assure safe use with respect to the covered product2 7iii7 at least #abj days have elapsed since the developer first initiated an attempt to reach an agreement with the license holder that would allow the product developer to participate in a single1 shared system of elements to assure safe use2 7iv7 the license holder and eligible product developer have not reached an agreement that would allow the eligible product developer to participate in a single1 shared system of elements to assure safe use on commercially reasonable terms2 and 7v7 the ,secretary has not waived the requirement for the covered product to be part of such a single1 shared system4 7,c7 ,remedies 7i7 ,in general ,if an eligible product developer prevails in a civil action brought under subparagraph 7,a71 the court shall-- 7,i7 order the license holder to-- 7aa7 with the approval of the ,secretary1 enter into a single1 shared system of elements to assure safe use with the eligible product developer on commercially reasonable terms2 7bb7 with the approval of the ,secretary1 allow the eligible product developer to join a previously approved system of elements to assure safe use with respect to the covered product on commercially reasonable terms2 or 7cc7 demonstrate that the ,secretary has waived the requirement for the covered product to be part of a single1 shared system of elements to assure safe use2 7,,ii7 award to the eligible product developer reasonable attorney fees and costs of the civil action2 and 7,,iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to reach agreements that would allow other eligible product developers to participate in a single1 shared system of elements to assure safe use on commercially reasonable terms if the court finds1 by a preponderance of the evidence-- 7aa7 that the license holder1 without a legitimate business justification1 delayed-- 7,,aa7 the entry of the eligible product developer into a single1 shared system of elements to assure safe use with respect to the covered product2 or 7,,bb7 the securing of a waiver of the requirement of a single1 shared system of elements to assure safe use with respect to the covered product2 or 7bb7 that the license holder failed to comply with an order issued under subclause 7,i74 7ii7 ,maximum monetary amount ,a monetary amount awarded under clause 7i77,,iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7,i7 beginning on the date that is #aba days after the date on which the product developer first initiated an attempt to reach an agreement with the license holder that would allow the product developer to participate in a single1 shared system of elements to assure safe use with respect to the covered product2 and 7,,ii7 ending on the date on which the eligible product developer and license holder reached an agreement that would allow the product developer to participate in a single1 shared system of elements to assure safe use with respect to the covered product4 7iii7 ,avoidance of delay ,the court may issue an order under clause 7i77,i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under subclause 7,,ii7 or 7,,iii7 of clause 7i71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder shall not be liable for any claim 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 ,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