,,ii #aadth ,,congress #b;d ,session ,s4 #cchg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bb1 #bjaf ,mr4 ,cotton introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide for the fast track review of certain generic drugs4 #a4 ,short title ,this ,act may be cited as the ,safely ,advancing ,valuable and ,inexpensive ,new ,generic ,solutions ,act or the ,,savings ,act4 #b4 ,fast track review for certain generic drugs ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#aa7 7,a7 ,notwithstanding any other provision of law1 the ,secretary shall prioritize the review of a qualifying application under this subsection and shall1 within #aej days of the initial receipt of such qualifying application1 take final agency action on the application4 7,b7 ,for purposes of this paragraph1 the term qualifying application means an application-- 7i7 that does not contain a certification under subclause 7,,iv7 of paragraph 7#b77;,a77vii72 7ii7 that may contain a certification under subclause 7,,iii7 of paragraph 7#b77;,a77vii7 only if such certification asserts that an existing patent will expire not more than #e months after the date of such certification2 7iii7 for a drug where the reference drug is a drug for which there is no exclusivity period in effect1 including an exclusivity period under paragraph 7#e77;,f71 or under section #eje;,a1 section #ebg1 or section #eje;,e2 and 7iv7 for a drug where the reference drug has not been the reference drug for more than one other drug that-- 7,i7 is approved under this subsection2 and 7,,ii7 has been introduced into interstate commerce in the #c-month period preceding the date of the qualifying application4 7,c7 ,notwithstanding any other provision of this paragraph and regardless of the date of submission1 a qualifying application shall lose status as an application for priority review1 and the ,secretary's timeline for taking action on such an application described in subparagraph 7,a7 shall no longer apply1 if the application no longer meets the definition of a qualifying application4 4 #c4 ,transparency 7a7 ,in general ,not later than #f months after enactment and every #f months thereafter1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives containing the information described in subsection 7c74 7b7 ,definition ,in this section the term generic fast track review means review under paragraph 7#aa7 of section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 as added by section #b of this ,act4 7c7 ,contents of report ,the report described in subsection 7a7 shall include the following information3 7#a7 ,the number of applications in the most recent #f-month period that are subject to generic fast track review1 and which of those applications-- 7,a7 are for a drug where the reference drug has not been the reference drug for any other application that is approved under subsection 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 7,b7 are for a drug where the reference drug has been the reference drug for not more than one other application that is approved under subsection 7j7 of such section2 and 7,c7 are for a drug that is on the drug shortage list established under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e74 7#b7 ,the average and median time before an applicant receives an approval decision for an application subject to generic fast track review4 7#c7 ,the number of applications subject to generic fast track review that were approved4 7#d7 ,at the time such report is submitted1 the number of applications subject to fast track review-- 7,a7 that have been withdrawn by the applicant2 7,b7 that have been granted tentative approval2 7,c7 with respect to which the ,food and ,drug ,administration has requested additional information from the sponsor of the application2 7,d7 that are awaiting review by the ,food and ,drug ,administration after additional information has been supplied1 as described in subparagraph 7,c72 and 7,e7 with respect to which the ,food and ,drug ,administration has recorded reception of the application but has yet to contact the sponsor regarding the status of the application4 7#e7 ,a prediction of how long the ,food and ,drug ,administration will take to respond to such applications that are awaiting review with either an approval or a rejection1 and how many of such applications are expected to be withdrawn by the applicant4 7#f7 ,the average review time for such applications that are receiving generic fast track review versus the standard review period4 7#g7 ,the information described in paragraphs 7#a7 through 7#f7 with respect to applications for drugs under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 that are subject to another form of priority review or fast-track review4 7#h7 ,an annual accounting of how the ,food and ,drug ,administration has spent the fees it has received under part #g of subchapter ,c of chapter ,,vii of such ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 to include the proportion of such fees that such ,administration has spent on personnel costs4