,i #aafth ,,congress #ast ,session ,h4 ,r4 #eddd ,,in ,,the ,,house ,,of ,,representatives ,december #ag1 #bjai,ms4 ,underwood 7for herself1 ,ms4 ,schakowsky1 ,mr4 ,guthrie1 ,mr4 ,kelly of ,pennsylvania1 and ,mr4 ,levin of ,michigan7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,biologics ,price ,competition and ,innovation ,act of #bjji to streamline the transition of certain products from approval as a drug to licensure as a biological product1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,lower ,insulin ,costs ,now ,act4 #b4 ,streamlining the transition of biological products ,section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 is amended-- 7#a7 by striking ,an approved application and inserting the following3 7,a7 ,in general ,an approved application 2 and 7#b7 by adding at the end the following3 7,b7 ,treatment of certain applications 7i7 ,in general ,with respect to an application for a biological product submitted under subsection 7b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 that is filed not later than ,march #bc1 #bjai1 and is not approved as of ,march #bc1 #bjbj1 the ,secretary shall continue to review such application under such section #eje1 after ,march #bc1 #bjbj4 7ii7 ,effect on listed drugs ,only for purposes of carrying out clause 7i71 with respect to any applicable listed drug with respect to such application1 the following shall apply3 7,i7 ,any drug that is a biological product that has been deemed licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 pursuant to subparagraph 7,a7 and that is referenced in an application described in clause 7i71 shall continue to be identified as a listed drug on the list published pursuant to section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and the information for such drug on such list shall not be revised after ,march #bj1 #bjbj1 until-- 7aa7 such drug is removed from such list in accordance with subclause 7,,iii7 or subparagraph 7,c7 of such section #eje7;j77#g72 or 7bb7 this subparagraph no longer has force or effect4 7,,ii7 ,any drug that is a biological product that has been deemed licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 pursuant to subparagraph 7,a7 and that is referenced in an application described in clause 7i7 shall be subject only to requirements applicable to biological products licensed under such section4 7,,iii7 ,upon approval under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act of an application described in clause 7i71 the ,secretary shall remove from the list published pursuant to section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act any listed drug that is a biological product that has been deemed licensed under section #cea of the ,public ,health ,service ,act pursuant to subparagraph 7,a7 and that is referenced in such approved application1 unless such listed drug is referenced in one or more additional applications described in clause 7i74 7iii7 ,deemed licensure ,upon approval of an application described in clause 7i71 such approved application shall be deemed to be a license for the biological product under section #cea of the ,public ,health ,service ,act4 7iv7 ,rule of construction 7,i7 ,application of certain provisions 7aa7 ,patent certification or statement ,an application described in clause 7i7 shall contain a patent certification or statement described in1 as applicable1 section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or clauses 7vii7 and 7viii7 of section #eje7;j77#b77;,a7 of such ,act and1 with respect to any listed drug referenced in such application1 comply with related requirements concerning any timely filed patent information listed pursuant to section #eje7;j77#g74 7bb7 ,date of approval ,the earliest possible date on which any pending application described in clause 7i7 may be approved shall be determined based on-- 7,,aa7 the last expiration date of any applicable period of exclusivity that would prevent such approval and that is described in section #eje7;c77#c77;,e71 #eje7;j77#e77;,b77iv71 #eje7;j77#e77;,f71 #eje;,a1 #eje;,e1 or #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,,bb7 if the application was submitted pursuant to section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and references any listed drug1 the last applicable date determined under subparagraph 7,a71 7,b71 or 7,c7 of section #eje7;c77#c7 of such ,act1 or1 if the application was submitted under section #eje7;j7 of such ,act1 the last applicable date determined under clause 7i71 7ii71 or 7iii7 of section #eje7;j77#e77;,b74 7,,ii7 ,exclusivity ,nothing in this subparagraph shall be construed to affect section #cea7k77#g77;,d7 of the ,public ,health ,service ,act4 7v7 ,listing ,the ,secretary may continue to review an application after ,march #bc1 #bjbj1 pursuant to clause 7i71 and continue to identify any applicable listed drug pursuant to clause 7ii7 on the list published pursuant to section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 even if such review or listing may reveal the existence of such application and the identity of any listed drug for which the investigations described in section #eje7;b77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act are relied upon by the applicant for approval of the pending application4 ,nothing in this subparagraph shall be construed as authorizing the ,secretary to disclose any other information that is a trade secret or confidential information described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7vi7 ,sunset ,beginning on ,october #a1 #bjbb1 this subparagraph shall have no force or effect and any applications described in clause 7i7 that have not been approved shall be deemed withdrawn4 4