,,ii #aaeth ,,congress #b;d ,session ,s4 #ceai ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bg1 #bjah ,mr4 ,hatch 7for himself and ,mr4 ,bennet7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a process for the ,food and ,drug ,administration to determine whether to modify the labeling of drugs whose labeling may be outdated1 including drugs with accepted uses that are not reflected in the approved labeling4 #a4 ,short title ,this ,act may be cited as the ,making ,objective ,drug ,evidence ,revisions for ,new ,labeling ,act or the ,,modern ,labeling ,act4 #b4 ,process to update labeling for drugs with outdated labeling ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejc;,c the following3 #ejc;,d4 ,process to update labeling for drugs with outdated labeling 7a7 ,definitions ,for purposes of this section3 7#a7 ,the term covered drug means a drug approved under section #eje7;c7-- 7,a7 for which all patents and exclusivity periods under this chapter have expired2 7,b7 for which the approval of the label has been withdrawn2 and 7,c7 whose labeling potentially should be modified because-- 7i7 some aspects of the labeling of the drug may be outdated according to evidence that1 since the date on which the drug was so approved1 has become available regarding the conditions of use reflected in the approved labeling2 7ii7 there is a relevant accepted use in clinical practice that is not reflected in the approved labeling2 or 7iii7 the labeling of such drug does not reflect current legal and regulatory requirements4 7#b7 ,the term exclusivity period1 with respect to a drug approved under section #eje7;c71 means the period by which the effective date of the approval of an application for a different drug product could be delayed1 or the different drug product could otherwise be impacted1 under clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e71 clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f71 or section #eje;,a1 #eje;,e1 or #ebg4 7#c7 ,the term generic version means a drug approved under section #eje7;j71 whose reference drug is a covered drug4 7#d7 ,the term relevant accepted use means a use for a drug in clinical practice that is supported by evidence that could meet the standards for approval under section #eje4 7#e7 ,the term selected drug means a covered drug for which the ,secretary has determined through the process under subsection 7c7 that the labeling should be updated because aspects of such labeling are outdated according to evidence that has become available regarding the conditions of use reflected in the approved labeling or to reflect one or more relevant accepted uses4 7b7 ,identification of covered drug candidates for revision ,the ,secretary may consider requiring changes to the labeling of drugs where such updates would benefit the public health4 ,to assist in deciding whether to require labeling changes for covered drugs1 the ,secretary may do one or both of the following3 7#a7 ,enter into cooperative agreements or contracts with public or private entities to review the available evidence concerning such drugs4 7#b7 ,seek public input concerning such drugs1 including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether aspects of the labeling of such drugs is outdated according to evidence that has become available regarding the conditions of use reflected in the approved labeling by-- 7,a7 holding public meetings2 7,b7 opening a public docket for the submission of public comments2 or 7,c7 other means1 as the ,secretary determines appropriate4 7c7 ,selection of drugs for updating ,if the ,secretary determines1 with respect to a covered drug1 that the available evidence is sufficient to meet the standards under section #eje for adding information to the labeling or modifying information in the labeling regarding the use of the covered drug1 the ,secretary may initiate the process under subsection 7d74 7d7 ,initiation of the process of updating ,if the ,secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection 7c71 the ,secretary shall provide notice to the holders of approved applications for a generic version of such drug that-- 7#a7 summarizes the findings supporting the determination of the ,secretary that the available evidence is sufficient to meet the standards under section #eje for modifying the labeling of the drug pursuant to subsection 7c72 7#b7 states the modifications to the labeling that should be made in order to reflect such determination 7including1 as applicable1 modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug72 and 7#c7 states whether the statement under paragraph 7#b7 applies to the selected drug as a class of drugs or only as to a specific drug product4 7e7 ,response to notification ,within #cj days of receipt of notification provided by the ,secretary pursuant to subsection 7d71 the holder of an approved application shall-- 7#a7 agree to change the approved labeling to reflect the modifications the ,secretary has determined are appropriate2 or 7#b7 notify the ,secretary that the holder of the approved application does not agree that the requested modifications are warranted and submit a statement detailing the reasons why such modifications are not warranted4 7f7 ,review of application holder's response 7#a7 ,in general ,the ,secretary shall promptly review each statement received under subsection 7e77#b7 and determine which modifications to the ,secretary's notice under subsection 7d7 are appropriate1 if any4 7#b7 ,changes to labeling ,after considering a response from a holder of an approved application under paragraph 7#a7 or 7#b7 of subsection 7e71 the ,secretary may order such holder to make the labeling changes the ,secretary determines are appropriate4 ,such holder of an approved application shall-- 7,a7 update its paper labeling for the drug at the next printing of that labeling2 7,b7 update any electronic labeling for the drug within #cj days2 and 7,c7 submit the revised labeling through the form1 ,supplement--,changes ,being ,effected4 7g7 ,violation ,if the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection 7f71 such generic version of the selected drug shall be deemed to be misbranded under section #ejb4 7h7 ,limitations2 generic drugs 7#a7 ,in general ,with respect to the modification of the labeling sought through a supplemental application pursuant to subsection 7f77#b77;,c7 the manufacturer of any generic version shall1 by reason of the statement of the ,secretary under subsection 7d77#b71 be deemed to have the same conditions of use and the same labeling as a reference drug for purposes of clauses 7i7 and 7v7 of section #eje7;j77#b77;,a74 ,the approval of a supplemental application shall not have any legal effects for the applicant that are different than the legal effects that would have resulted if the supplemental application had been submitted to conform the labeling of the generic version to a change in the labeling of the reference drug4 7#b7 ,supplemental applications ,changes to labeling made in accordance with this paragraph shall not be eligible for an exclusivity period under this ,act4 7i7 ,drug product classes ,in the case of a selected drug for which the statement of the ,secretary under subsection 7d77#b7 applies to the selected drug as a class of drugs1 a supplemental application pursuant to subsection 7f77#b77;,c7 may be submitted for each such drug product4 7j7 ,rule of construction ,this section shall not be construed as altering the applicability of any substantive approval standard under section #eje4 7k7 ,reports ,not later than #d years after the date of the enactment of the ,making ,objective ,drug ,evidence ,revisions for ,new ,labeling ,act and every #d years thereafter1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report that describes the actions of the ,secretary under this section and that provides any recommendations of the ,secretary for modifying the program under this section1 including any recommendations on whether the program should apply to a broader scope of drugs4 ,each report under this subsection shall be made publicly available on the ,internet website of the ,food and ,drug ,administration4 4