,i #aaith ,,congress #b;d ,session ,h4 ,r4 #giec ,,in ,,the ,,house ,,of ,,representatives ,march #ag1 #bjbf,mr4 ,sessions 7for himself and ,mr4 ,peters7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing a reciprocal approval mechanism with trusted international regulatory authorities4 #a4 ,short title ,this ,act may be cited as the ,fast-tracking ,approval for ,innovative ,rare disease therapies ,act or the ,,fair ,,act4 #b4 ,findings ,congress finds the following3 7#a7 ,patients in the ,united ,states often face significant delays in accessing innovative medicines compared to patients in other trusted nations4 7#b7 ,the lengthy regulatory process at the ,food and ,drug ,administration contributes to the movement of clinical trials abroad1 leading to fewer opportunities for ,united ,states patients to participate in cutting-edge research4 7#c7 ,china and other nations are rapidly expanding their clinical trial and biopharmaceutical development capacity1 threatening ,united ,states leadership in biomedical innovation4 7#d7 ,a reciprocal approval mechanism with trusted international regulatory authorities will accelerate access for ,united ,states patients to life-saving therapies and preserve the ,united ,states competitive position in biomedical research and innovation4 #c4 ,reciprocal marketing approval for certain drugs ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ebd;,b of such ,act 7#ba ,u4,s4,c4 #cfjn-#b7 the following3 #ebd;,c4 ,reciprocal marketing approval for certain drugs 7a7 ,in general ,a covered product with reciprocal marketing approval in effect under this section is deemed to be subject to an application or premarket notification for which an approval is in effect under section #eje7;c7 or #eaj7k7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable4 7b7 ,eligibility ,the ,secretary shall1 with respect to a covered product1 grant reciprocal marketing approval if-- 7#a7 the sponsor of the covered product submits a request for reciprocal marketing approval2 and 7#b7 the request demonstrates to the ,secretary's satisfaction that-- 7,a7 the covered product is lawfully marketed in a foreign country pursuant to an authorization from a trusted international regulatory authority of that country2 7,b7 absent reciprocal marketing approval1 the covered product is not approved for marketing1 as described in subsection 7a72 7,c7 the ,secretary has not1 because of any concern relating to the safety or effectiveness of the covered product1 rescinded or withdrawn any such approval2 7,d7 the authorization to market the covered product in a foreign country pursuant to an authorization from a trusted international regulatory authority of that country has not1 because of any concern relating to the safety or effectiveness of the covered product1 been rescinded or withdrawn2 and 7,e7 the covered product is intended for use in the diagnosis1 treatment1 or mitigation of an immediately life-threatening disease or condition4 7c7 ,request ,a request for reciprocal marketing approval shall-- 7#a7 be in such form1 be submitted in such manner1 and contain such information as the ,secretary determines necessary to determine whether the criteria listed in subsection 7b77#b7 are met2 and 7#b7 include1 with respect to each trusted international regulatory authority that authorized a covered product to be lawfully marketed in the foreign country involved1 as described in subsection 7b77#b77;,a71 an ,english translation 7if necessary7 of the dossier issued by such regulatory authority to authorize such marketing4 7d7 ,timing ,the ,secretary shall issue an order granting1 or declining to grant1 reciprocal marketing approval with respect to a covered product not later than #cj days after the ,secretary's receipt of a request under subsection 7b77#a7 for the product4 7e7 ,labeling2 post-,market requirements ,during the #cj-;day period described in subsection 7d71 the ,secretary shall finalize-- 7#a7 the form and content of the labeling for a covered product for which reciprocal marketing approval is to be granted2 and 7#b7 any postmarket studies the ,secretary determines necessary to ensure the safety and effectiveness of such product4 7f7 ,applicability of relevant provisions ,the provisions of this ,act shall apply with respect to a covered product for which reciprocal marketing approval is in effect to the same extent and in the same manner as such provisions apply with respect to a product for which approval of an application or premarket notification under section #eje7;c7 or #eaj7k7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable1 is in effect4 7g7 ,withdrawal of reciprocal marketing approval 7#a7 ,in general ,the ,secretary may1 at any time1 withdraw or suspend reciprocal marketing approval with respect to a covered product granted under this section if-- 7,a7 new clinical or real-world evidence demonstrates that the product presents an unreasonable risk of serious adverse events or mortality2 or 7,b7 the trusted international regulatory authority that originally authorized the covered product has rescinded or suspended its approval in the applicable foreign country4 7#b7 ,effect of withdrawal or suspension ,if the withdrawal or suspension under paragraph 7#a7 is based on adverse event reports occurring within the first #cj days after reciprocal marketing approval1 the ,secretary shall provide public notice and may require immediate cessation of marketing and distribution4 7#c7 ,phase-out option ,the ,secretary may implement a phase-out plan for withdrawal under paragraph 7#a71 including patient transition measures1 to protect public health while minimizing disruption to ongoing treatment4 7h7 ,fees for request ,for purposes of imposing fees under chapter ,,vii1 a request for reciprocal marketing approval under this section shall be treated as an application or premarket notification for approval under section #eje7;c7 or #eaj7k7 or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable4 7i7 ,report ,not later than #e years after the date of enactment of this section1 the ,secretary shall submit to the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a comprehensive report on-- 7#a7 the effectiveness of the reciprocal marketing approval program under this section in accelerating access to innovative medicines in the ,united ,states2 7#b7 the number of reciprocal marketing approvals of covered products granted or denied under this section2 7#c7 the impact of the reciprocal marketing approval program under this section on patient safety and adverse event reporting2 and 7#d7 recommendations for the continuation1 modification1 or termination of the reciprocal marketing approval program under this section4 7j7 ,definitions ,in this section3 7#a7 ,covered product ,the term covered product means a drug1 including a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7774 7#b7 ,immediately life-threatening disease or condition ,the term immediately life-threatening disease or condition has the meaning given such term in section #cab4cjj7;b77#a7 of title #ba1 ,code of ,federal ,regulations 7or successor regulations74 7#c7 ,trusted international regulatory authority ,the term trusted international regulatory authority means-- 7,a7 the ,european ,medicines ,agency2 7,b7 the ,medicines and ,healthcare ,products ,regulatory ,agency of the ,united ,kingdom2 7,c7 ,health ,canada2 and 7,d7 any other international regulatory authority designated by the ,secretary of ,health and ,human ,services4 4 #d4 ,reciprocal allowance of clinical investigations authorized by trusted international regulatory authorities ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #efi;,b 7#ba ,u4,s4,c4 #cfj;bbb-#h;b7 the following3 #efi;,b-#a4 ,reciprocal allowance of clinical investigations authorized by trusted international regulatory authorities 7a7 ,in general ,a manufacturer may seek reciprocal allowance to conduct a clinical trial under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act with respect to a qualified product by submitting an application for such allowance to the ,secretary4 7b7 ,application ,a manufacturer seeking reciprocal allowance under subsection 7a7 to conduct a clinical investigation as described in subsection 7a7 shall submit to the ,secretary an application containing-- 7#a7 the authorization by a trusted international regulatory authority to conduct the same clinical investigation with respect to a qualified product in the applicable foreign country2 and 7#b7 any supporting documentation for such authorization4 7c7 ,treatment ,the ,secretary shall1 for purposes of applying section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act-- 7#a7 treat an application for reciprocal allowance with respect to a qualified product under this section as meeting the criteria applicable to a submission under section #eje7;i77#b7 of this ,act 7or pursuant to section #cea7;a77#c7 of the ,public ,health ,service ,act7 with respect to beginning a clinical investigation of a new drug 7or biological product72 and 7#b7 pursuant to that treatment1 issue an order allowing1 or declining to allow1 a reciprocal allowance with respect to such qualified product not later than #cj days after the ,secretary's receipt of a request under subsection 7b7 for the product4 7d7 ,applicability of provisions ,the provisions of section #eje7;i7 of this ,act and section #cea7;a77#c7 shall apply with respect to an application for reciprocal allowance under this section to the same extent and in the same manner as such provisions apply to an investigational new drug application under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act4 7e7 ,protocol modifications ,the ,secretary may request1 before the end of the #cj-;day period specified in subsection 7c77#b71 that the manufacturer requesting a reciprocal allowance with respect to a clinical investigation under this section modify the protocols for such clinical investigation4 ,the ,secretary shall1 notwithstanding a request for modification of protocols under this subsection1 grant1 or decline to grant such reciprocal allowance within such #cj-;day period4 7f7 ,qualified product defined ,in this section1 the term qualified product means a covered product 7as defined in section #ebd;,b7 that is intended for use in the diagnosis1 treatment1 or mitigation of an immediately life-threatening disease or condition4 4