,,ii #aafth ,,congress #ast ,session ,s4 #ahig ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #ai1 #bjai ,mr4 ,bennet 7for himself and ,mr4 ,enzi7 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,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a process for updating the labeling of certain drugs with outdated labeling4 #a4 ,process to update labeling for drugs with outdated labeling ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejc;,c the following3 #ejc;,d4 ,process to update labeling for drugs with outdated labeling 7a7 ,definitions ,for purposes of this section3 7#a7 ,the term covered drug means a drug approved under section #eje7;c7-- 7,a7 for which there are no unexpired patents included in the list under section #eje7;j77#g7 and no unexpired period of market exclusivity2 7,b7 for which the approval of the application has been withdrawn for reasons other than safety or effectiveness2 and 7,c7 for which1 with respect to the labeling-- 7i7 new scientific evidence is available regarding the conditions of use of the drug2 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 period of market exclusivity1 with respect to a drug approved under section #eje7;c71 means any period of market exclusivity 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;j7 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 scientific evidence that appears to the ,secretary to 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 changed4 7b7 ,identification of covered drugs ,the ,secretary may identify covered drugs for which labeling updates would provide a public health benefit4 ,to assist in identifying 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 scientific 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 new scientific evidence is available regarding the conditions of use for such drug1 by-- 7,a7 holding one or more 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 scientific evidence meets the standards under section #eje for adding or modifying information to the labeling or providing supplemental information to 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 scientific evidence meets the standards under section #eje for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection 7c72 7#b7 provides a clear statement regarding the additional1 modified1 or supplemental information for such labeling1 according to the determination by the ,secretary 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 covered 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 for a generic version of the selected drug shall-- 7#a7 agree to change the approved labeling to reflect the additional1 modified1 or supplemental information the ,secretary has determined to be appropriate2 or 7#b7 notify the ,secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted4 7f7 ,review of application holder's response 7#a7 ,in general ,upon receipt of the application holder's response1 the ,secretary shall promptly review each statement received under subsection 7e77#b7 and determine which labeling changes pursuant to the ,secretary's notice under subsection 7d7 are appropriate1 if any4 ,if the ,secretary disagrees with the reasons why such labeling changes are not warranted1 the ,secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect current scientific evidence1 and if so1 the content of such labeling changes4 7#b7 ,changes to labeling ,after considering all responses from the holder of an approved application under paragraph 7#a7 or 7#b7 of subsection 7e71 and any discussion under paragraph 7#a71 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 7f77#b71 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 any labeling change required under this section1 the generic version shall 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 ,any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved 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 labeling changes ordered by the ,secretary under subsection 7d77#b7 are required for a class of covered drugs1 such labeling changes shall be made for generic versions of such drug in that class4 7j7 ,rules of construction 7#a7 ,approval standards ,this section shall not be construed as altering the applicability of the standards for approval of an application under section #eje4 ,no order shall be issued under this subsection unless the evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section #eje4 7#b7 ,removal of information ,nothing in this section shall be construed to give the ,secretary additional authority to remove approved indications for drugs1 other than the authority to remove certain indications from the labels of certain covered drugs1 as described in this section4 7k7 ,reports ,not later than #d years after the date of the enactment of this section 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-- 7#a7 describes the actions of the ,secretary under this section1 including-- 7,a7 the number of covered drugs and description of the types of drugs the ,secretary has selected for labeling changes and the rationale for such recommended changes2 and 7,b7 the number of times the ,secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change1 if any2 and 7#b7 includes any recommendations of the ,secretary for modifying the program under this section4 4