,i #aacth ,,congress #b;d ,session ,h4 ,r4 #efeg ,,in ,,the ,,house ,,of ,,representatives ,september #ah1 #bjad ,mr4 ,stivers 7for himself and ,mr4 ,welch7 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 #bjad or the ,,fast ,generics ,act of #bjad4 #b4 ,findings ,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;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 #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 ,these restrictions are deterring and delaying development of generic drugs 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 generic drugs and biosimilars4 7#c7 ,the opinion in ,verizon ,communications ,inc4 v4 ,law ,offices of ,curtis ,v4 ,trinko1 ,,llp1 #edj ,u4,s4 #cih 7#bjjd7 should not be construed to impair or bar the application of the antitrust laws consistent with the provisions of this ,act4 7#d7 ,there is not a regulatory structure in place that is sufficient to deter or remedy the anti-competitive harm that results when access to reference brand products is restricted to sponsors developing drugs1 generic drugs1 and biosimilars in accordance with section #eje7;b7 or #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b7 and #cee7;j771 and section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 respectively4 7#e7 ,requiring license holders to comply with requirements for competitive access to their products1 and subjecting license holders to antitrust 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 ,food ,drug 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 means any drug approved under section #eje or any biological product that is licensed under section #cea of the ,public ,health ,service ,act1 including-- 7,a7 any combination thereof2 and 7,b7 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 product4 7#b7 ,eligible product developer ,the term eligible product developer means a person that seeks to develop an application for the approval of a drug under section #eje7;b7 or #eje7;j7 or the licensing of a biological product under section #cea 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 or a license under section #cea of the ,public ,health ,service ,act for a covered product 7including the holder's agents1 wholesalers1 distributors1 assigns1 and corporate affiliates74 7#d7 ,,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 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 adopt1 impose1 or enforce any condition relating to the sale1 resale1 or distribution of the covered product1 including any condition adopted1 imposed1 or enforced as an aspect of a risk evaluation and mitigation strategy approved by the ,secretary1 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 to covered products other than ,,rems products for development purposes ,no license holder shall adopt1 impose1 or enforce any condition relating to the sale1 resale1 or distribution of a covered product that interferes with or restricts access to reasonable quantities of a covered product by an eligible product developer for development and testing purposes1 at commercially reasonable1 market-based prices1 from the license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product unless the license holder generally adopts1 imposes1 or enforces lawful conditions relating to the sale1 resale1 or distribution of a covered product1 with respect to other buyers of the covered product4 7d7 ,competitive access to ,,rems products for development purposes 7#a7 ,prohibited use of ,,rems to restrict access ,with respect to a ,,rems product1 no aspect of a risk evaluation and mitigation strategy under section #eje-a shall prohibit or restrict1 or be construed or applied to prohibit or restrict1 the supply of such ,,rems product to an eligible product developer for development and testing purposes1 at commercially reasonable1 market-based prices1 from the ,,rems product's license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the ,,rems product4 7#b7 ,single1 shared system of elements to assure safe use ,with respect to a ,,rems product1 no license holder shall take any step that impedes-- 7,a7 the prompt development of a single1 shared system of elements to assure safe use under section #eje-a2 or 7,b7 the entry on commercially reasonable terms of an eligible product developer into a previously approved system of elements to assure safe use4 7e7 ,procedures for obtaining access to covered products 7#a7 ,competitive access ,notwithstanding any other provision of law1 in the case of an eligible product developer that has an authorization to obtain a covered product in effect under paragraph 7#b7 or 7#c71 no license holder shall adopt1 impose1 or enforce any other condition relating to the sale1 resale1 or distribution of such covered product that interferes with or restricts access to reasonable quantities of the covered product by the eligible product developer for development and testing purposes1 at commercially reasonable1 market-based prices1 from the license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product1 unless the license holder generally adopts1 imposes1 or enforces lawful conditions relating to the sale1 resale1 or distribution of a covered product1 with respect to other buyers of the covered product4 7#b7 ,general covered products authorization ,any eligible product developer may seek a general covered products authorization1 authorizing the eligible product developer to obtain any covered product for the purposes of development and testing1 by making a written request to the ,secretary4 ,within #fj days after receiving such a request1 the ,secretary shall1 by written notice1 issue such authorization if-- 7,a7 the eligible product developer holds one or more approved applications or licenses for a covered product or1 in the absence of such approvals or licensures1 otherwise establishes that the eligible product developer can comply with the requirements of this ,act and other applicable law for the development and testing of covered products2 and 7,b7 the ,secretary does not find that the eligible product developer has materially failed to comply with the requirements of this ,act or other applicable law for the development and testing of covered products4 7#c7 ,individual covered product authorization ,any eligible product developer may seek an authorization to obtain an individual covered product for development and testing purposes by making a written request to the ,secretary4 ,within #fj 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 testing that involves human clinical trials if the eligible product developer has 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 product or the license holder's distribution of the covered product4 7#d7 ,failure by ,secretary to take final action ,if the #fj-;day period referred to in paragraph 7#b7 or 7#c7 expires without the ,secretary having taken final action on the request for authorization1 the ,secretary shall be deemed to have issued1 by written notice1 the requested authorization4 7#e7 7,a7 ,process for obtaining product pursuant to an authorization ,if an eligible product developer is unable1 for purposes of development and testing1 to obtain reasonable quantities of a covered product commercially1 either from the license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product1 any eligible product developer that has obtained authorization to do so1 in accordance with paragraph 7#b7 or 7#c71 shall be entitled to obtain such reasonable quantities of such covered product at the same commercially reasonable1 market based price on which such reasonable quantities of such covered product have been previously sold by the license holder to third parties in the open market4 ,such eligible product developer shall initiate its acquisition of such covered product by providing a written request for specific quantities of such covered product either-- 7i7 to any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product2 or 7ii7 in the event no such wholesaler or specialty distributor has been designated for such purpose by the license holder1 to the ,secretary4 7,b7 ,request contents ,such request shall include a statement regarding the quantity of covered product sought for development or testing purposes1 and state that either-- 7i7 the eligible product developer has1 or is deemed to have1 a general covered products authorization under paragraph 7#b72 or 7ii7 the eligible product developer has1 or is deemed to have1 an authorization under paragraph 7#c7 to obtain the specific covered product4 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 holder1 only if required to do so by the 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 ,disclosure pursuant to means specified by ,secretary ,in the event that a request is made to the ,secretary under this subsection1 then the ,secretary shall1 within #e business days of receipt of the request1 notify the license holder that a request for such covered product has been made1 and the quantity of the covered product requested1 and such license holder shall1 within #cj days after receiving notice from the ,secretary1 provide the quantity of the requested covered product1 through means specified by the ,secretary1 at a non-discriminatory1 commercially reasonable1 market-based price for which such covered product has been previously sold by the license holder 7or any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product7 to third parties in the open market4 ,the means established by the ,secretary under this clause shall not disclose to the license holder the identity of the eligible product developer that has requested quantities of the covered product for development and testing purposes4 7,e7 ,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 ,public and private enforcement 7#a7 ,application of certain provisions ,for purposes of this ,act and the ,public ,health ,service ,act1 a violation of a requirement or prohibition in subsection 7b71 7c71 7d77#a71 7d77#b71 or 7e77#a7 shall be treated in the case of a ,,rems product1 as a violation of the product's risk evaluation and mitigation strategy4 7#b7 ,remedies ,an eligible product developer that has authorization for access to a covered product from the ,secretary under subsection 7e7 and that is aggrieved by a violation of subsection 7b71 7c71 7d77#a71 7d77#b71 or 7e77#a7 by a license holder or any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product may sue such license holder 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 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 development or testing activities conducted under this section1 including a claim arising out of a failure of the eligible drug developer to follow adequate safeguards to assure safe use of the covered product4 7h7 ,reports 7#a7 ,report by ,,fda ,not later than #ahj days after the enactment of the ,fair ,access for ,safe and ,timely ,generics ,act of #bjad1 and annually thereafter1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall submit to ,congress a report that-- 7,a7 identifies each instance of noncompliance by any license holder with a requirement or prohibition in subsection 7b71 7c71 7d77#a71 7d77#b71 or 7e77#a72 and 7,b7 describes the actions taken by the ,secretary to remedy such noncompliance and to enforce such requirements and prohibitions1 whether by assessment of a penalty or otherwise4 7#b7 ,report by ,,ftc ,not later than #bgj days after the enactment of the ,fair ,access for ,safe and ,timely ,generics ,act of #bjad1 and annually thereafter1 the ,federal ,trade ,commission shall submit to ,congress a report that-- 7,a7 describes the complaints received by the ,commission pertaining to the withholding of competitive access to covered products1 the actions taken by the ,commission with respect to each such complaint1 and the result of each such ,commission action2 and 7,b7 examines the impact on the market entry of competing drug products1 and the pricing and availability of such products1 in the ,united ,states resulting from noncompliance by license holders with a requirement or prohibition in subsection 7b71 7c71 7d77#a71 7d77#b71 or 7e77#a74 4 7b7 ,prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7ddd7 ,any violation by the license holder of a covered product 7as such terms are defined in section #eje-b7;a7 7including its contractors1 assigns1 or corporate affiliates77 of a requirement or prohibition in subsection 7b71 7c71 7d77#a71 7d77#b71 or 7e77#a7 of section #eje-b 7relative to competitive access to covered products for development purposes74 4 7c7 ,waiver of single1 shared system requirement ,section #eje-a7;i77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;i77#a77;,b77 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 adding at the end 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 7d7 ,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