,,ii #aafth ,,congress #b;d ,session ,s4 #cede ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ai1 #bjbj,mr4 ,cruz 7for himself1 ,mr4 ,lee1 and ,mr4 ,braun7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for reciprocal marketing approval of certain drugs1 biological products1 and devices that are authorized to be lawfully marketed abroad1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,reciprocity ,ensures ,streamlined ,use of ,lifesaving ,treatments for ,coronavirus ,patients ,act of #bjbj4 #b4 ,reciprocal marketing approval for certain drugs1 biological products1 and devices ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ebd;,a of such ,act 7#ba ,u4,s4,c4 #cfjn-#a7 the following3 #ebd;,b4 ,reciprocal marketing approval 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 or clearance is in effect under section #eje7;c71 #eaj7k71 or #eae 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 authorized to be lawfully marketed in one or more of the countries included in the list under section #hjb7;b77#a7 for the treatment or prevention the coronavirus or another disease of epidemic potential2 7,b7 absent reciprocal marketing approval1 the covered product is not approved or cleared 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the ,secretary has not1 because of any concern relating to the safety or effectiveness of the covered product1 rescinded or withdrawn any such approval or clearance2 7,d7 the authorization to market the covered product in one or more of the countries included in the list under section #hjb7;b77#a7 has not1 because of any concern relating to the safety or effectiveness of the covered product1 been rescinded or withdrawn2 7,e7 the covered product is not a banned device under section #eaf2 and 7,f7 there is a public health or unmet medical need for the covered product in the ,united ,states4 7c7 ,safety and effectiveness 7#a7 ,in general ,the ,secretary-- 7,a7 may decline to grant reciprocal marketing approval under this section with respect to a covered product if the ,secretary affirmatively determines that the covered product-- 7i7 is a drug that is not safe and effective2 or 7ii7 is a device for which there is no reasonable assurance of safety and effectiveness2 and 7,b7 may condition reciprocal marketing approval under this section on the conduct of specified postmarket studies1 which may include such studies pursuant to a risk evaluation and mitigation strategy under section #eje-a4 7#b7 ,report to ,congress ,upon declining to grant reciprocal marketing approval under this section with respect to a covered product1 the ,secretary shall-- 7,a7 include the denial in a list of such denials for each month2 and 7,b7 not later than the end of the respective month1 submit the list to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7d7 ,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 deems necessary to determine whether the criteria listed in subsection 7b77#b7 are met2 and 7#b7 include1 with respect to each country included in the list under section #hjb7;b77#a7 where the covered product is authorized to be lawfully marketed1 as described in subsection 7b77#b77;,a71 an ,english translation of the dossier issued by such country to authorize such marketing4 7e7 ,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 ,an order issued under this subsection shall take effect subject to ,congressional disapproval under subsection 7g74 7f7 ,labeling2 device classification ,during the #cj-;day period described in subsection 7e7-- 7#a7 the ,secretary and the sponsor of the covered product shall expeditiously negotiate and finalize the form and content of the labeling for a covered product for which reciprocal marketing approval is to be granted2 and 7#b7 in the case of a device for which reciprocal marketing approval is to be granted1 the ,secretary shall-- 7,a7 classify the device pursuant to section #eac2 and 7,b7 determine whether1 absent reciprocal marketing approval1 the device would need to be cleared pursuant to section #eaj7k7 or approved pursuant to section #eae to be lawfully marketed under this ,act4 7g7 ,congressional disapproval of ,,fda orders 7#a7 ,in general ,a decision of the ,secretary to decline to grant reciprocal marketing approval under this section shall not take effect if a joint resolution of disapproval of the decision is enacted4 7#b7 ,procedure 7,a7 ,in general ,subject to subparagraph 7,b71 the procedures described in subsections 7b7 through 7g7 of section #hjb of title #e1 ,united ,states ,code1 shall apply to the consideration of a joint resolution under this subsection4 7,b7 ,terms ,for purposes of this subsection-- 7i7 the reference to section #hja7;a77#a7 in section #hjb7;b77#b77;,a7 of title #e1 ,united ,states ,code1 shall be considered to refer to subsection 7c77#b72 and 7ii7 the reference to section #hja7;a77#a77;,a7 in section #hjb7;e77#b7 of title #e1 ,united ,states ,code1 shall be considered to refer to subsection 7c77#b74 7#c7 ,effect of ,congressional disapproval ,reciprocal marketing approval under this section with respect to the applicable covered product shall take effect upon enactment of a joint resolution of disapproval under this subsection4 7h7 ,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 or clearance of an application or premarket notification under section #eje7;c71 #eaj7k71 or #eae of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable1 is in effect4 7i7 ,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 or clearance under section #eje7;c71 #eaj7k71 or #eae of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable4 7j7 ,outreach ,the ,secretary shall conduct an outreach campaign to encourage the sponsors of covered products that are potentially eligible for reciprocal marketing approval to request such approval4 7k7 ,definitions ,in this section-- 7#a7 the term coronavirus means ,,sars-,co,v-#b1 ,,covid-#ai1 or another coronavirus with epidemic potential2 and 7#b7 the term covered product means a drug1 biological product1 or device that is intended to treat or prevent the coronavirus or another disease with epidemic potential4 4