,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #fbid ,,in ,,the ,,house ,,of ,,representatives ,june #bh1 #bjah,mr4 ,shimkus 7for himself and ,mr4 ,crdenas7 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 encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,re-,valuing ,anti-,microbial ,products ,act of #bjah or the ,,revamp ,act4 #b4 ,exclusivity to encourage development of novel therapies targeting serious microbial infections ,subchapter ,b of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et seq47 is amended by inserting after section #ebi;,a the following3 #ecj4 ,exclusivity to encourage development of novel therapies targeting serious microbial infections 7a7 ,in general ,if the ,secretary approves an application pursuant to section #eje7;c7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for a drug that has been designated as a priority antimicrobial product under subsection 7k71 the ,secretary shall award to the holder of the application a #ab-month exclusivity extension period described in subsection 7c7 for the sole purpose of conveying such extension1 in whole or in portions1 to other sponsors or holders to be applied with respect to one or more other drugs-- 7#a7 for which an application is submitted under section #eje7;b77#a72 7#b7 for which at approval1 new chemical entity exclusivity is granted under subsection 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje2 and 7#c7 that is designated as a fast track product under section #ejf7;b74 7b7 ,notice to ,secretary ,upon making a conveyance under subsection 7a71 the holder of the approved application for the priority antimicrobial product involved shall submit a notice to the ,secretary including-- 7#a7 the name of the priority antimicrobial product2 7#b7 the name of the recipient drug2 and 7#c7 the duration of the conveyed exclusivity extension period4 7c7 ,effect of conveyance 7#a7 ,extension of other applicable exclusivity periods ,immediately upon the ,secretary's receipt of a notice under subsection 7b71 with respect to the recipient drug1 the following exclusivity periods 7as applicable7 are each extended by the conveyed exclusivity extension period3 7,a7 ,the #d-year1 #e-year1 #dh-month1 and #g-year periods described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje4 7,b7 ,the #c-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f7 of section #eje4 7,c7 ,the #g-year period described in section #ebg4 7#b7 ,drugs subject to listed patents ,immediately upon the ,secretary's receipt of a notice under subsection 7b71 the period during which an approval of an application may not be made effective by operation of subsection 7c77#c7 or 7j77#e77;,b7 of section #eje1 as applicable1 in the case of a recipient drug that is the subject of-- 7,a7 a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77ii7 or 7j77#b77;,a77vii77,,ii7 of section #eje2 7,b7 a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iii7 or 7j77#b77;,a77vii77,,iii7 of section #eje2 or 7,c7 a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iv7 or 7j77#b77;,a77vii77,,iv7 of section #eje if in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed1 shall be extended after the date the listed patent expires 7including any patent extensions7 for a period equal to the conveyed exclusivity extension period4 7d7 ,timing of conveyance and notice ,the conveyance of an exclusivity extension period pursuant to subsection 7a7 and the provision of notice under subsection 7b7 shall be made no later than-- 7#a7 in the case of a priority antimicrobial product that is a drug1 the last day of the ninth year of the #e-year period described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii71 as extended1 as applicable1 under section #eje;,e2 and 7#b7 in the case of a priority antimicrobial product that is a biological product1 the last day of the eleventh year of the exclusivity period described in section #cea7k77#g77;,a7 of the ,public ,health ,service ,act applicable with respect to such product4 7e7 ,permitted transactions ,except as provided in this section1 the holder of a conveyed exclusivity extension period may sell1 exchange1 convey1 or hold for use1 such period4 7f7 ,exception ,a period referred to in paragraph 7#a7 or 7#b7 of subsection 7c7 shall not be extended under such subsection if the conveyance of an exclusivity extension period pursuant to subsection 7a7 or the provision of notice under subsection 7b7 is made later than #d years prior to the expiration of such period4 7g7 ,limitations 7#a7 ,number of awards ,the ,secretary may make not more than #aj awards under subsection 7a74 7#b7 ,award for prior approved application ,a drug is not eligible for designation under this section as a priority antimicrobial product if an application for approval or licensure of such drug was approved under section #eje7;b7 or licensed under section #cea7;a7 of the ,public ,health ,service ,act before ,january #a1 #bjah4 7#c7 ,drugs intended for cosmetic purpose ,a drug is not eligible for designation under this section as a priority antimicrobial product if the drug is intended to promote hair growth or for any other cosmetic purpose4 7#d7 ,conveyance date ,the holder of an exclusivity extension period awarded under or conveyed pursuant to subsection 7a7 may not convey such period to be applied with respect to a drug unless such drug is or will be first approved under section #eje7;c7 on or after ,january #a1 #bjbc4 7h7 ,contribution upon conveyance ,as a condition on the award of an exclusivity extension period to the holder of a drug pursuant to subsection 7a71 the ,secretary shall require the holder1 upon any conveyance of the period pursuant to such subsection1 in whole or in portions1 to make a monetary contribution to the ,foundation for the ,national ,institutes of ,health that-- 7#a7 is in an amount that is equal to #e percent of the total value of the consideration received by the holder as a result of the conveyance2 and 7#b7 is designated to be used by the ,foundation to conduct or support early-stage research on the development of products to treat or prevent a disease attributable to a multi-drug resistant bacterial or fungal pathogen4 7i7 ,relation to pediatric exclusivity ,any extension of a period under subsection 7c7 shall be in addition to any extension of the period under section #eje;,a of this ,act1 and any reference to a period in subsection 7c7 is deemed to be a reference to the period as extended under such section #eje;,a1 if applicable4 7j7 ,critical need antimicrobial priorities 7#a7 ,committee on ,developing ,critical ,need ,antimicrobials ,not later than #fj days after the date of enactment of the ,re-,valuing ,anti-,microbial ,products ,act of #bjah1 the ,secretary shall establish a ,committee on ,developing ,critical ,need ,antimicrobials4 7#b7 ,membership ,the members of the ,committee shall include-- 7,a7 one representative of the ,food and ,drug ,administration2 7,b7 one representative of the ,centers for ,disease ,control and ,prevention2 7,c7 one representative of the ,biomedical ,advanced ,research and ,development ,authority2 and 7,d7 five representatives of the community of other stakeholders with research1 commercialization1 clinical1 public health1 and economic expertise in the field of antimicrobial resistance1 which representatives shall include at least one physician with experience treating infections caused by multidrug resistant organisms4 7#c7 ,duties ,the ,committee shall-- 7,a7 not later than #fj days after all of the initial members of the ,committee have been appointed1 develop and publish on the website of the ,office of the ,assistant ,secretary for ,preparedness and ,response a proposed list of critical need antimicrobial priorities consisting of specific multi-drug resistant bacterial or fungal pathogens1 which list shall be developed taking into consideration-- 7i7 specific prevention or treatment of bacterial or fungal infections for which there is an unmet medical need2 and 7ii7 susceptibility to specific microorganisms and treatment need for multi-drug resistant pathogens2 7,b7 perform other activities1 as determined necessary by the ,secretary1 to support the designation of priority antimicrobial products under subsection 7k7 and the review and disposition of applications for priority antimicrobial products under subsection 7a72 and 7,c7 develop recommendations to the ,secretary and the ,congress regarding other incentives needed to ensure a robust and renewable pipeline of antimicrobial drugs1 with priority given to antimicrobial drugs that are first in class1 possess a novel mechanism of action1 or treat a vulnerable population such as children4 7#d7 ,finalization and updating of list of critical need antimicrobials priorities ,upon receipt from the ,committee of the initial proposed list of critical need antimicrobial priorities or proposed updates to such list1 the ,secretary shall-- 7,a7 provide a period of public notice and comment on the proposal1 including by publishing the proposed list on the ,internet2 7,b7 hold public meetings to elicit input from stakeholders on the proposal2 and 7,c7 not later than #ahj days after the ,secretary's receipt of the proposal1 publish a final version of the list4 7#e7 ,subsequent updates ,the ,secretary1 in coordination with the ,committee1 shall revise1 and publish in accordance with paragraph 7#d71 the list of critical need antimicrobial priorities within #cj days of approval of a product designated under subsection 7k7 or if the ,secretary determines it is necessary1 but in any case no later than every #b years4 7#f7 ,restriction on removal from list ,no critical need antimicrobial priority may be removed from the list of critical need antimicrobial priorities until after submission of the report required by subsection 7n77#a74 7k7 ,designation of priority antimicrobial products 7#a7 ,request ,the manufacturer or sponsor of a drug may request that the ,secretary designate a drug as a priority antimicrobial product at any time before or after submission of an application for approval or licensure of such drug under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable4 7#b7 ,designation ,not later than #fj days after the submission of a request under paragraph 7#a71 the ,secretary1 in coordination with the ,committee1 shall-- 7,a7 7i7 approve the request if the drug subject to the request is intended to treat or prevent a disease attributable to a multi-drug resistant bacterial or fungal pathogen that is listed as a critical need antimicrobial priority pursuant to subsection 7j72 or 7ii7 disapprove the request if the drug subject to the request is not intended to treat or prevent such a disease2 and 7,b7 notify the requestor of such action and1 for any disapproval1 include in such notification an explanation of the reason for the disapproval4 7#c7 ,limitation ,a designation under paragraph 7#b7 shall not be withdrawn for any reason1 including modifications to the list of critical need antimicrobial priorities1 unless the ,secretary finds that the request for such designation contained an untrue statement of material fact4 7l7 ,antimicrobial susceptibility testing devices ,as a condition on designation of a priority antimicrobial product pursuant to subsection 7k71 the sponsor of such product shall-- 7#a7 make such product available to antimicrobial susceptibility test device manufacturers as early in the development process as possible2 and 7#b7 submit a plan for such availability to the ,secretary4 7m7 ,appropriate use ,as a condition on designation of a priority antimicrobial product pursuant to subsection 7k71 the sponsor of such product shall agree to-- 7#a7 identify1 track1 and make publicly available antimicrobial resistance occurrence data and trends for such product2 7#b7 develop1 through the sponsor's chief compliance officer1 the sponsor's chief medical officer1 or another appropriate designee1 written guidelines and procedures to ensure appropriate use of such product1 including appropriate-- 7,a7 promotional practices2 7,b7 education to encourage appropriate use2 7,c7 surveillance and monitoring2 and 7,d7 stewardship2 7#c7 develop education and communications strategies for educating health care professionals about such product and its appropriate use2 and 7#d7 submit to the ,food and ,drug ,administration1 beginning at #bd months after the date of approval pursuant to section #eje7;c7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act of an application for such product1 and every two years thereafter so long as such product is marketed in the ,united ,states1 an assessment of the sponsor's stewardship activities relating to such product4 7n7 ,studies 7#a7 ,joint study by ,,hhs and ,,gao 7,a7 ,in general ,beginning #e years after the date of enactment of the ,re-,valuing ,anti-,microbial ,products ,act of #bjah or on the date that the ,secretary awards the fifth exclusivity extension period under this section1 whichever is earlier1 the ,director of the ,centers for ,disease ,control and ,prevention and ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of the program under this section for the development of priority antimicrobial products4 7,b7 ,contents of the study ,in conducting the study under subparagraph 7,a71 the ,director of the ,centers for ,disease ,control and ,prevention and ,comptroller ,general shall examine-- 7i7 the indications and usage for each drug for which an exclusivity extension period was awarded under subsection 7a72 7ii7 the development of resistance to each drug for which an exclusivity extension period was awarded under subsection 7a72 7iii7 the private and societal value of each drug for which an exclusivity extension period was awarded under subsection 7a72 and 7iv7 the impact on patients and public and private markets of the recipient drug with respect to which a conveyed exclusivity extension period was used4 7,c7 ,report ,not later than #a year after the date by which the study under subparagraph 7,a7 is required to begin under subparagraph 7,a71 the ,director of the ,centers for ,disease ,control and ,prevention and ,comptroller ,general shall submit to the ,congress a report containing the results of the study4 7#b7 ,study by ,,gao ,not later than the date that is #e years after the date of the first award under subsection 7a71 the ,comptroller ,general of the ,united ,states shall-- 7,a7 complete a study on the actual and projected impacts of the program under this section on ,federal expenditures2 and 7,b7 submit a report on the results of such study to the ,congress4 7o7 ,report on reauthorization ,not later than #ahj days after the ,secretary awards the ninth exclusivity extension period under this section1 the ,committee shall submit a report to the ,secretary and the ,congress containing recommendations on the reauthorization of this section1 including recommendations on increasing the number of awards allowed by subsection 7g77#a74 7p7 ,definitions ,in this section3 7#a7 ,the term biological product has the meaning given to such term in section #cea7;i7 of the ,public ,health ,service ,act4 7#b7 ,the term ,committee means the ,committee on ,developing ,critical ,need ,antimicrobials established under subsection 7j74 7#c7 ,the term conveyed exclusivity extension period means an exclusivity extension period conveyed pursuant to subsection 7a74 7#d7 ,the term priority antimicrobial product means a product that is designated under subsection 7k74 7#e7 ,the term recipient drug means a drug approved under section #eje receiving a conveyed exclusivity extension period4 4