,i #aafth ,,congress #ast ,session ,h4 ,r4 #ihe ,,in ,,the ,,house ,,of ,,representatives ,february #e1 #bjai ,mr4 ,welch 7for himself1 ,mr4 ,mc,kinley1 and ,mr4 ,cicilline7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products1 so as to enable eligible product developers to develop and test new products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,fair ,access for ,safe and ,timely ,generics ,act of #bjai or the ,,fast ,generics ,act of #bjai4 #b4 ,findings ,the ,congress finds the following3 7#a7 ,reference product license or approval holders are restricting competitive access to reference products by sponsors seeking to develop drugs1 generic drugs1 and biosimilars under section #eje7;b77#b7 or #eje7;j7 of the ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b7 and #cee7;j77 and under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 ,these restrictions are deterring and delaying development of drugs1 generic drugs1 and biosimilars by extending lawful patent-based monopolies beyond their lawful patent life4 7#b7 ,the enforcement provisions set forth in section #eje-a7;f77#h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f77#h77 have not been sufficient to prevent anti-competitive practices that interfere with access to reference products which is necessary for the timely development of affordable drugs1 generic drugs1 and biosimilars4 7#c7 ,there is not a regulatory structure in place that is sufficient to deter or remedy the anti-competitive harm that results when-- 7,a7 access to reference products is restricted to sponsors developing drugs1 generic drugs1 or biosimilars in accordance with section #eje7;b77#b7 or #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b7 or #cee7;j771 and section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k771 respectively2 or 7,b7 license holders impede the prompt negotiation and development of a single1 shared system of elements to assure safe use and supporting agreements under section #eje-a7;i77#a77;,b7 of such ,act 7#ba ,u4,s4,c4 #cee-a7;i77#a77;,b771 on commercially reasonable terms4 7#d7 ,requiring license holders to comply with requirements for competitive access to their products1 and for the negotiation and development of single1 shared systems of elements to assure safe use under section #eje-a7;i77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;i77#a77;,b771 and subjecting license holders to liability for failing to do so1 will not impose obligations on the courts that they cannot adequately and reasonably adjudicate4 #c4 ,competitive access to covered products for development 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-a of such ,act 7#ba ,u4,s4,c4 #cee-a7 the following new section3 #eje-b4 ,competitive access to covered products for development purposes 7a7 ,definitions ,in this section3 7#a7 ,covered product ,the term covered product-- 7,a7 means-- 7i7 any drug approved under section #eje or biological product licensed under section #cea of the ,public ,health ,service ,act2 7ii7 any combination thereof2 or 7iii7 when reasonably necessary to demonstrate sameness1 biosimilarity1 or interchangeability for purposes of this section1 section #eje1 or section #cea of the ,public ,health ,service ,act 7as applicable71 any product1 including any device1 that is marketed or intended for use with such drug or biological product2 and 7,b7 excludes any drug or biological product which the ,secretary has determined to be currently in shortage and that appears on the drug shortage list in effect under section #ejf;,e1 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 ,secretary4 7#b7 ,eligible product developer ,the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application under section #eje7;b77#b7 or #eje7;j7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act4 7#c7 ,license holder ,the term license holder means the holder of an application approved under section #eje7;b7 or section #eje7;j7 of this ,act or under section #cea of the ,public ,health ,service ,act for a covered product 7including the holder's agents1 wholesalers1 distributors1 assigns1 corporate affiliates1 and contractors74 7#d7 ,,rems ,the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a4 7#e7 ,,rems product ,the term ,,rems product means a covered product that-- 7,a7 is subject to a risk evaluation and mitigation strategy under section #eje-a2 or 7,b7 is deemed under section #iji7;b7 of the ,food and ,drug ,administration ,amendments ,act of #bjjg to have in effect an approved risk evaluation and mitigation strategy under section #eje-a4 7#f7 ,,rems impacting product distribution ,the term ,,rems impacting product distribution means a ,,rems that contains elements to assure safe use that impact the distribution of the product subject to the ,,rems4 7b7 ,competitive access to covered products as a condition on approval or licensing ,as a condition of approval or licensure1 or continuation or renewal of approval or licensure1 of a covered product under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 respectively1 the ,secretary shall require that the covered product's license holder not construe or apply any condition or restriction relating to the sale1 resale1 or distribution of the covered product1 including any condition or restriction adopted1 imposed1 or enforced as an aspect of a risk evaluation and mitigation strategy1 in a way that restricts or has the effect of restricting the supply of such covered product to an eligible product developer for development or testing purposes4 7c7 ,competitive access for development purposes to products with ,,rems impacting product distribution ,with respect to a product subject to a ,,rems impacting product distribution1 no aspect of such a ,,rems shall be construed or applied by the ,,rems product's license holder in a way that prohibits or restricts the supply1 at commercially reasonable1 market-based prices1 of such ,,rems product from the ,,rems product's license holder to an eligible product developer with an applicable individual covered product authorization obtained pursuant to subsection 7e7 for development and testing purposes4 7d7 ,single1 shared system of elements ,to assure safe use ,where an eligible product developer seeks approval of an application under #eje7;j7 referencing a ,,rems product whose ,,rems includes elements to assure safe use-- 7#a7 no license holder shall take any step that impedes-- 7,a7 the prompt development on commercially reasonable terms of a single1 shared system of elements to assure safe use under section #eje-a2 or 7,b7 the prompt entry on commercially reasonable terms of an eligible product developer into a previously approved system of elements to assure safe use2 and 7#b7 license holders shall negotiate in good faith towards the prompt development of 7or entry into7 a single1 shared system of elements to assure safe use under section #eje-a7;i7 on commercially reasonable terms4 7e7 ,procedures for obtaining access to covered products 7#a7 ,competitive access to products not subject to ,,rems impacting product distribution ,notwithstanding any other provision of law1 a license holder that receives a request from an eligible product developer or its agent for sufficient supplies of a covered product 7that is not subject to a ,,rems impacting product distribution7 to conduct testing necessary to support an application under section #eje7;b77#b7 or #eje7;j7 or under section #cea7k7 of the ,public ,health ,service ,act 7or otherwise meet the requirements for approval of such an application7 shall provide to the eligible product developer or its agent the quantity requested within #cj days of receipt of the request at a nondiscriminatory1 commercially reasonable1 market-based price for which such covered product has been previously sold by the license holder to third parties in the open market4 7#b7 ,competitive access to products subject to ,,rems impacting product distribution3 individual covered product authorization ,any eligible product developer may seek an authorization to obtain an individual covered product subject to a ,,rems impacting product distribution for development and testing purposes by making a written request to the ,secretary4 ,within #abj days of receiving such a request1 the ,secretary shall1 by written notice1 issue such authorization for purposes of-- 7,a7 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,b7 development and testing that involves human clinical trials if the eligible product developer has-- 7i7 submitted a protocol for testing that includes protections that will provide an assurance of safety comparable to the assurance of safety provided by any distribution restrictions governing the approval or licensure of the covered product2 or 7ii7 otherwise satisfied the ,secretary that such protections will be provided4 7#c7 7,a7 ,process for obtaining product pursuant to an authorization 7i7 ,an eligible product developer shall be entitled to obtain1 from the license holder of a covered product subject to a ,,rems impacting distribution1 sufficient quantities of the covered product for purposes of development and testing necessary to support an application under section #eje7;b77#b7 or #eje7;j7 or under section #cea7k7 of the ,public ,health ,service ,act1 or otherwise meet the requirements for approval of such application1 if the eligible product developer has obtained an applicable authorization under paragraph 7#b74 7ii7 ,each license holder shall publicly designate at least one wholesaler or specialty distributor to receive and fulfill requests for covered products submitted pursuant to paragraph 7#a7 or clause 7i7 of this paragraph4 7iii7 ,an eligible product developer shall initiate its acquisition of a covered product under clause 7i7 by providing or having its agent provide a written request for specific quantities of such covered product to the license holder4 7,b7 ,request contents and response ,a request under subparagraph 7,a77iii7 shall include a statement regarding the quantity of covered product sought for development or testing purposes1 and state that the eligible product developer has an authorization under paragraph 7#b7 to obtain the specific covered product4 ,within #cj days of receiving such a request1 the wholesaler or specialty distributor shall provide the requested quantity of the covered product at a nondiscriminatory1 commercially reasonable1 market-based price for which such covered product has been previously sold by the license holder to third parties in the open market4 7,c7 ,disclosure of information by wholesalers and specialty distributors ,in the event that a request is made to a wholesaler or specialty distributor under this paragraph1 the wholesaler or specialty distributor shall not disclose to the license holder of the covered product involved the identity of the eligible product developer1 but may disclose to such license holder-- 7i7 the fact that a request has been made2 7ii7 the dates on which the request was made and fulfilled2 7iii7 the commercial terms on which the request was fulfilled2 and 7iv7 the quantity of the covered product furnished by the wholesaler or specialty distributor in compliance with the request4 7,d7 ,imminent hazard ,at any time1 the ,secretary may prohibit1 limit1 or otherwise suspend a transfer of a covered product to an eligible product developer if the ,secretary determines that the transfer of such product to the eligible product developer would present an imminent hazard to the public health4 ,in such cases1 the ,secretary shall specify the basis for the determination1 including the specific information available to the ,secretary which served as the basis for such determination1 and confirm such determination in writing4 7f7 ,enforcement 7#a7 ,remedies ,an eligible product developer that is aggrieved by a violation of subsection 7b71 7c71 7d71 7e77#a7 or 7e77#c7 by a license holder may sue such license holder in a court of competent jurisdiction for injunctive relief and treble damages 7including costs and interest of the kind described in section #d7;a7 of the ,clayton ,act 7#ae ,u4,s4,c4 #ae7;a7774 7#b7 ,rule of construction 7,a7 ,preservation of antitrust laws ,nothing in this ,act1 or the amendments made by this ,act1 shall be construed to modify1 supersede1 or impair the operation of the antitrust laws4 7,b7 ,definition ,for purposes of paragraph 7#a71 the term antitrust laws shall have the meaning given such term in subsection 7a7 of the #ast section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab71 except that such term shall include section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such subsection applies to unfair methods of competition4 7g7 ,limitation of liability ,the holder of an approved application or license for a covered product shall not be liable for any claim arising out of an eligible product developer's failure to follow adequate safeguards to assure safe use of the covered product during development or testing activities conducted under this section4 4 7b7 ,waiver of single1 shared system requirement ,section #eje-a7;i77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;i77#a77;,c77 is amended-- 7#a7 in clause 7i71 by striking or at the end2 7#b7 in clause 7ii71 by striking the period at the end and inserting 2 or2 and 7#c7 by inserting after clause 7ii7 the following3 7iii7 the applicant for an abbreviated new drug application certifies that it attempted in good faith to create or negotiate entry into a single1 shared system1 but was unable to finalize commercially reasonable terms with the holder of the listed drug within #abj days1 and such certification includes a description of the efforts made by the applicant for the abbreviated new drug application to create or negotiate entry into a single1 shared system4 4 7c7 ,effective date ,this section and the amendments made by this section shall take effect upon enactment1 and shall apply to all approved applications or licenses for a covered product 7as defined in section #eje-b7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this section7 regardless of whether those applications or licenses were approved before1 on1 or after the date of enactment of this ,act4