,,ii ,calendar ,no4 #ajh #aahth ,,congress #ast ,session ,s4 #aaad ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #cj1 #bjbc,ms4 ,smith 7for herself and ,mr4 ,braun7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,june #bb1 #bjbc,reported by ,mr4 ,sanders1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to the #ahj-;day exclusivity period4 #a4 ,short title ,this ,act may be cited as the ,expanding ,access to ,low-,cost ,generics ,act of #bjbc4 #b4 #ahj-;day exclusivity period 7a7 ,in general ,section #eje7;j77#e77;,b77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is amended-- 7#a7 in subclause 7,i7-- 7,a7 by inserting and subclause 7,,iii7 after subparagraph 7,d72 and 7,b7 by inserting before the period at the end the following3 or an applicant whose application was approved pursuant to subclause 7,,iii74 ,if an applicant described in subclause 7,,iii7 is eligible for effective approval on the same day a tentatively approved first applicant who has requested final approval is determined by the ,secretary to be eligible for effective approval by meeting all the approval requirements of this subsection1 such applicant described in subclause 7,,iii7 may not receive effective approval until #ahj days after the first applicant begins commercial marketing of the drug42 and 7#b7 by adding at the end the following new subclause3 7,,iii7 ,applicant approval ,the ,secretary may approve an application containing a certification described in paragraph 7#b77;,a77vii77,,iv7 that is for a drug for which a first applicant has submitted an application containing such a certification1 notwithstanding the eligibility of a first applicant for the #ahj-;day exclusivity period described in subclause 7,,ii77aa71 if each of the following conditions is met3 7aa7 ,the approval of such application could be made effective1 but for the eligibility of a first applicant for #ahj-;day exclusivity under this clause4 7bb7 ,the applicant of such application has submitted a certification to the abbreviated new drug application that there are no conditions that would prevent the applicant from commercial marketing within #ge days after the date of approval and that the applicant intends to so market the drug4 7cc7 ,at least #cc months have passed since the date of submission of an application for the drug by at least one first applicant4 7dd7 ,approval of an application for the drug submitted by at least one first applicant is not precluded under clause 7iii74 7ee7 ,no application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items 7aa71 7bb71 7cc71 and 7dd7 are all met and maintained4 4 7b7 ,special approval status rule for certain subsequent applicants ,section #eje7;j77#e77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee 7j77#e77;,d77 is amended at the end by adding the following3 7v7 ,special approval status rule for certain subsequent applicants ,an application that is approved pursuant to subclause 7,,iii7 of subparagraph 7,b77iv7 is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause 7,,iii7 on the date that is #gf days after the date on which the approval has been made effective pursuant to such subclause 7,,iii7 if the applicant fails to commercially market such drug within the #ge-;day period after the date on which the approval is made effective4 ,if the applicant of an application approved pursuant to such subclause 7,,iii7 submits a notification that it can no longer commence commercial marketing within #ge days after the date of approval1 as required under subparagraph 7,b77iv77,,iii77bb71 its application is deemed to be tentatively approved and to no longer be effectively approved on the date that such a notification is received4 ,if an applicant does not commence commercial marketing within the #ge-;day period1 it shall not be eligible for a subsequent effective approval for the application under subclause 7,,iii7 of subparagraph 7,b77iv7 unless1 in addition to meeting each of the conditions in such subclause 7,,iii71 it submits a certification to its abbreviated new drug application that an event that could not have been reasonably foreseen by the applicant prevented it from commencing commercial marketing and that it has fully resolved this issue4 ,the applicant shall submit notification to the abbreviated new drug application confirming that such applicant has commenced commercial marketing of the drug not later than one business day after commencing such marketing4 4 7c7 ,applicability ,the amendments made by subsections 7a7 and 7b7 shall apply only with respect to an application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 after the date of enactment of this ,act that identifies a listed drug for which no certification under paragraph 7#b77;,a77vii77,,iv7 of such section #eje7;j7 was made before such date of enactment4 #a4 ,short title ,this ,act may be cited as the ,expanding ,access to ,low-,cost ,generics ,act of #bjbc4 #b4 #ahj-;day exclusivity period 7a7 ,in general ,section #eje7;j77#e77;,b77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is amended-- 7#a7 in subclause 7,i7-- 7,a7 by inserting and subclause 7,,iii7 after subparagraph 7,d72 and 7,b7 by inserting before the period at the end the following3 or an applicant whose application was approved pursuant to subclause 7,,iii74 ,if an applicant described in subclause 7,,iii7 is eligible for effective approval on the same day a tentatively approved first applicant who has requested final approval is determined by the ,secretary to be eligible for effective approval by meeting all the approval requirements of this subsection1 such applicant described in subclause 7,,iii7 shall not receive effective approval until #ahj days after the first applicant begins commercial marketing of the drug42 and 7#b7 by adding at the end the following new subclause3 7,,iii7 ,applicant approval ,the ,secretary may approve an application containing a certification described in paragraph 7#b77;,a77vii77,,iv7 that is for a drug for which a first applicant has submitted an application containing such a certification1 notwithstanding the eligibility of a first applicant for the #ahj-;day exclusivity period described in subclause 7,,ii77aa71 if each of the following conditions is met3 7aa7 ,the approval of such application could be made effective1 but for the eligibility of a first applicant for #ahj-;day exclusivity under this clause4 7bb7 ,the applicant of such application has submitted a certification to its abbreviated new drug application that there are no conditions that would prevent the applicant from commercial marketing within #ge days after the date of approval and that the applicant intends to so market the drug4 7cc7 ,at least #cc months have passed since the date of submission of an application for the drug by at least one first applicant4 7dd7 ,approval of an application for the drug submitted by at least one first applicant is not precluded under clause 7iii74 7ee7 ,no application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items 7aa71 7bb71 7cc71 and 7dd7 are all met and maintained4 4 7b7 ,special approval status rule for certain subsequent applicants ,section #eje7;j77#e77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77 is amended at the end by adding the following3 7v7 ,special approval status rule for certain subsequent applicants ,an application that is approved pursuant to subclause 7,,iii7 of subparagraph 7,b77iv7 is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause 7,,iii7 on the date that is #gf days after the date on which the approval has been made effective pursuant to such subclause 7,,iii7 if the applicant fails to commercially market such drug within the #ge-;day period after the date on which the approval is made effective4 ,if the applicant of an application approved pursuant to such subclause 7,,iii7 submits a notification that it can no longer commence commercial marketing within #ge days after the date of approval1 as required under subparagraph 7,b77iv77,,iii77bb71 its application is deemed to be tentatively approved and to no longer be effectively approved on the date that such a notification is received4 ,if an applicant does not commence commercial marketing within the #ge-;day period1 it shall not be eligible for a subsequent effective approval for the application under subclause 7,,iii7 of subparagraph 7,b77iv7 unless1 in addition to meeting each of the conditions in such subclause 7,,iii71 it submits a certification to its abbreviated new drug application that an event that could not have been reasonably foreseen by the applicant prevented it from commencing commercial marketing and that it has fully resolved this issue4 ,the applicant shall submit notification to the abbreviated new drug application confirming that such applicant has commenced commercial marketing of the drug not later than one business day after commencing such marketing4 4 7c7 ,applicability ,the amendments made by subsections 7a7 and 7b7 shall apply only with respect to an application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 after the date of enactment of this ,act that identifies a listed drug for which no certification under paragraph 7#b77;,a77vii77,,iv7 of such section #eje7;j7 was made before such date of enactment4 #c4 ,increasing transparency in generic drug applications 7a7 ,in general ,section #eje7;j77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#c77 is amended by adding at the end the following3 7,h7 7i7 ,upon request 7in controlled correspondence or an analogous process7 by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is required by regulation to contain one or more of the same inactive ingredients in the same concentration as the listed drug referred to1 or for which the ,secretary determines there is a scientific justification for an approach that is in vitro1 in whole or in part1 to be used to demonstrate bioequivalence for a drug if such a drug contains one or more of the same inactive ingredients in the same concentration as the listed drug referred to1 or on the ,secretary's own initiative during the review of an application under this subsection for such a drug1 the ,secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug4 7ii7 ,notwithstanding section #cja7;j71 if the ,secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug1 the ,secretary shall identify and disclose to the person-- 7,i7 the ingredient or ingredients that cause the drug not to be qualitatively or quantitatively the same as the listed drug2 and 7,,ii7 for any ingredient for which there is an identified quantitative deviation1 the amount of such deviation4 7iii7 ,if the ,secretary determines that such drug is qualitatively and quantitatively the same as the listed drug1 the ,secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless-- 7,i7 the formulation of the listed drug has been changed and the ,secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness2 or 7,,ii7 the ,secretary makes a written determination that the prior determination must be changed because an error has been identified4 7iv7 ,if the ,secretary makes a written determination described in clause 7iii77,,ii71 the ,secretary shall provide notice and a copy of the written determination to the person making the request under clause 7i74 7v7 ,except as set forth in clauses 7i7 and 7ii71 nothing in this subparagraph shall be construed to authorize the disclosure of nonpublic qualitative or quantitative information about the ingredients in a listed drug1 or to affect the status1 if any1 of such information as trade secret or confidential commercial information for purposes of section #cja7;j7 of this ,act1 section #eeb of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7b7 ,guidance 7#a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance1 or update guidance1 describing how the ,secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug 7as such terms are used in section #eje7;j77#c77;,h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a771 including with respect to assessing p,h adjusters4 7#b7 ,process ,in issuing guidance under this subsection1 the ,secretary of ,health and ,human ,services shall-- 7,a7 publish draft guidance2 7,b7 provide a period of at least #fj days for comment on the draft guidance2 and 7,c7 after considering any comments received and not later than one year after the close of the comment period on the draft guidance1 publish final guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 applies beginning on the date of enactment of this ,act1 irrespective of the date on which the guidance required by subsection 7b7 is finalized4 ,june #bb1 #bjbc,reported with an amendment