,,ii ,calendar ,no4 #dbe #aadth ,,congress #b;d ,session ,s4 #ahe ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #af1 #bjae,mr4 ,hatch 7for himself1 ,mr4 ,bennet1 ,ms4 ,ayotte1 ,mr4 ,isakson1 ,mr4 ,kirk1 ,mr4 ,carper1 and ,mr4 ,blumenthal7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,april #ah1 #bjaf,reported by ,mr4 ,alexander1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to create a limited population pathway for approval of certain antibacterial drugs4 #a4 ,short title ,this ,act may be cited as the ,promise for ,antibiotics and ,therapeutics for ,health ,act or the ,,path ,act4 #b4 ,limited population pathway for antibacterial drugs ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended-- 7#a7 by transferring subsection 7e7 so that it appears before subsection 7f72 and 7#b7 by adding at the end the following3 7g7 ,limited population pathway for antibacterial drugs 7#a7 ,in general ,the ,secretary shall establish a program under which the ,secretary may1 at the request of a sponsor1 approve an antibacterial drug1 alone or in combination with one or more drugs1 as a limited population antibacterial drug1 upon a determination that such drug is intended to treat a serious or life-threatening disease1 condition1 or infection and address an unmet medical need for such disease1 condition1 or infection within an identifiable limited population4 7#b7 ,limited population pathway 7,a7 ,in general ,the sponsor of an antibacterial drug that the ,secretary determines to be eligible for approval as a limited population antibacterial drug shall be required to demonstrate the safety and effectiveness of such drug1 as required under section #eje7;d7 or section #cea7;a7 of the ,public ,health ,service ,act1 for the intended use of the drug4 ,the ,secretary shall determine the safety and effectiveness of an antibacterial drug under the limited population pathway for antibacterial drugs in accordance with subparagraph 7,b74 ,an antibacterial drug shall be eligible for approval under the limited population pathway only upon the request of the sponsor4 7,b7 ,considerations 7i7 ,benefit-risk profile ,the ,secretary's determination of safety and effectiveness of a limited population antibacterial drug shall reflect the benefit-risk profile of the drug in the intended limited population1 taking into account the severity1 rarity1 or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment for such infection4 ,approval of a drug under the limited population antibacterial drug pathway shall not be denied due to a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population4 7ii7 ,types of evidence ,in determining whether to approve a drug under the limited population pathway1 the ,secretary-- 7,i7 shall rely on sufficient evidence1 which may include traditional endpoints1 alternate endpoints1 or a combination of traditional and alternate endpoints1 and1 as appropriate1 small clinical data sets2 and 7,,ii7 may rely on supplemental data1 including preclinical evidence1 pharmacologic or pathophysiologic evidence1 nonclinical susceptibility1 pharmacokinetic data1 and other such confirmatory evidence as the ,secretary determines appropriate4 7#c7 ,requirements ,with respect to a drug approved through the limited population pathway1 the ,secretary shall require-- 7,a7 the labeling of such antibacterial drug1 such as through a logo or other means1 to indicate that the drug has been approved for use only in a limited population and that the safety and efficacy of the drug has been demonstrated only with respect to such limited population2 and 7,b7 the sponsor to submit copies of all promotional materials related to the limited population antibacterial drug1 at least #cj days prior to dissemination of the materials4 7#d7 ,other programs ,a sponsor of a drug that seeks approval of a drug through the limited population pathway for antibacterial drugs may also seek approval of such drug under subsections 7a71 7b71 and 7c71 and sections #eje;,e and #ebd4 7#e7 ,guidance ,not later than #ah months after the date of enactment of the ,promise for ,antibiotics and ,therapeutics for ,health ,act1 the ,secretary shall issue draft guidance describing criteria1 processes1 and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs and how the pathway can be expanded to other therapeutic areas in addition to antibacterial infections4 ,the ,secretary may approve antibacterial drugs through such limited population pathway prior to issuing guidance under this paragraph4 7#f7 ,postapproval monitoring programs for antibacterial drugs ,the ,secretary1 in consultation with the ,commissioner and other relevant heads of agencies1 shall conduct postapproval monitoring programs to study how antibacterial drugs approved through the pathway under this subsection are used and to monitor changes in bacterial resistance to drugs1 including drugs approved under this pathway4 7#g7 ,advice ,the ,secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval through the limited population pathway for antibacterial drugs to enable the sponsor to plan a development program to obtain the necessary data for approval of such drug through the limited population pathway for antibacterial drugs and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population4 7#h7 ,termination of limitations ,if1 after approval of a drug through the limited population pathway for antibacterial drugs1 the ,secretary approves a broader indication for such drug for which the sponsor applies under section #eje7;b7 or section #cea of the ,public ,health ,service ,act1 the ,secretary may remove any postmarketing conditions1 including requirements with respect to labeling and review of promotional materials under paragraph 7#c7 and postapproval monitoring under paragraph 7#f71 applicable to the approval of the drug through the limited population pathway for antibacterial drugs4 7#i7 ,rules of construction 7,a7 ,standards of evidence and authority of ,secretary ,nothing in this subsection shall be construed to alter the standards of evidence applicable to the review and approval of a drug under this ,act or the ,public ,health ,service ,act1 or to modify or limit the authority of the ,secretary to approve or monitor drugs pursuant to this ,act or the ,public ,health ,service ,act as authorized prior to the date of enactment of the ,promise for ,antibiotics and ,therapeutics for ,health ,act4 7,b7 ,prescribing authority ,nothing in this subsection shall be construed to restrict the prescribing of antibiotics or other products1 including drugs approved under the limited population pathway1 by health care professionals1 or to limit the practice of health care4 7#aj7 ,expansion of pathway ,beginning on ,october #a1 #bjaf1 the limited population pathway for antibiotic drugs may be expanded to apply to approval of other drugs intended to treat a serious or life-threatening illness4 ,the approval of such drugs shall be subject to the considerations and requirements described in this subsection1 unless the ,secretary delivers a report to ,congress prior to that date explaining why such pathway should not be used for other therapeutic areas in addition to antibacterial infections4 4 #a4 ,short title ,this ,act may be cited as the ,promise for ,antibiotics and ,therapeutics for ,health ,act or the ,,path ,act4 #b4 ,antibacterial resistance monitoring ,section #cai;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is amended-- 7#a7 by redesignating subsections 7f7 and 7g7 as subsections 7k7 and 7l71 respectively2 and 7#b7 by inserting after subsection 7e71 the following3 7f7 ,monitoring at ,federal health care facilities ,the ,secretary shall encourage reporting on aggregate antibacterial drug use and bacterial resistance to antibacterial drugs and the implementation of antibiotic stewardship programs by health care facilities of the ,department of ,defense1 the ,department of ,veterans ,affairs1 and the ,indian ,health ,service and shall provide technical assistance to the ,secretary of ,defense and the ,secretary of ,veterans ,affairs1 as appropriate and upon request4 7g7 ,report on antibacterial resistance in humans and use of antibacterial drugs ,not later than #a year after the date of enactment of this subsection1 and annually thereafter1 the ,secretary shall prepare and make publically available data and information concerning-- 7#a7 aggregate national and regional trends of bacterial resistance in humans to antibacterial drugs1 including those approved under section #ejf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#b7 antibacterial stewardship1 which may include summaries of ,state efforts to address bacterial resistance in humans to antibacterial drugs and antibacterial stewardship2 and 7#c7 coordination between the ,director of the ,centers for ,disease ,control and ,prevention and the ,commissioner of ,food and ,drugs with respect to the monitoring of-- 7,a7 any applicable resistance under paragraph 7#a72 and 7,b7 drugs approved under section #ejf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7h7 ,information related to antibiotic stewardship programs ,the ,secretary shall1 as appropriate1 disseminate guidance1 educational materials1 or other appropriate materials related to the development and implementation of evidence-based antibiotic stewardship programs or practices at health care facilities1 such as nursing homes and other long-term care facilities1 ambulatory surgical centers1 dialysis centers1 and community and rural hospitals4 7i7 ,supporting state-based activities to combat antibacterial resistance ,the ,secretary shall continue to work with ,state and local public health departments on statewide or regional programs related to antibacterial resistance4 ,such efforts may include activities to related to-- 7#a7 identifying patterns of bacterial resistance in humans to antibacterial drugs2 7#b7 preventing the spread of bacterial infections that are resistant to antibacterial drugs2 and 7#c7 promoting antibiotic stewardship4 7j7 ,antibacterial ,resistance and ,stewardship activities 7#a7 ,in general ,for the purposes of supporting stewardship activities1 examining changes in bacterial resistance1 and evaluating the effectiveness of section #ejf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 the ,secretary shall-- 7,a7 provide a mechanism for facilities to report data related to their antimicrobial stewardship activities 7including analyzing the outcomes of such activities72 and 7,b7 evaluate-- 7i7 antimicrobial resistance data using a standardized approach2 and 7ii7 trends in the utilization of drugs approved under such section #ejf7;g7 with respect to patient populations4 7#b7 ,use of systems ,the ,secretary shall use available systems1 including the ,national ,healthcare ,safety ,network or other systems identified by the ,secretary1 to fulfill the requirements or conduct activities under this section4 7#c7 ,availability of data ,the ,secretary shall make the data collected pursuant to this subsection public4 ,nothing in this subsection shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 #c4 ,limited population pathway for antibacterial drugs ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended-- 7#a7 by transferring subsection 7e7 so that it appears before subsection 7f72 and 7#b7 by adding at the end the following3 7g7 ,limited population pathway for antibacterial drugs 7#a7 ,in general ,the ,secretary may approve an antibacterial drug1 alone or in combination with one or more other drugs1 as a limited population drug pursuant to this subsection only if-- 7,a7 the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs2 7,b7 the standards for approval under section #eje7;c7 and 7d71 or the standards for licensure under section #cea of the ,public ,health ,service ,act1 as applicable1 are met2 and 7,c7 the ,secretary receives a written request from the sponsor to approve the drug as a limited population drug pursuant to this subsection4 7#b7 ,benefit-risk consideration ,the ,secretary's determination of safety and effectiveness of a limited population antibacterial drug shall reflect the benefit-risk profile of the drug in the intended limited population1 taking into account the severity1 rarity1 or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such limited population4 ,such drug may be approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population4 7#c7 ,additional requirements ,a drug approved under this subsection shall be subject to the requirements of this paragraph1 in addition to any other applicable requirements of this ,act3 7,a7 ,labeling ,to indicate that the safety and effectiveness of a drug approved under this subsection has been demonstrated only with respect to a limited population-- 7i7 all labeling and advertising of an antibacterial drug approved under this subsection shall contain the statement ,limited ,population in a prominent manner and adjacent to1 and not more prominent than-- 7,i7 the proprietary name of such drug1 if any2 or 7,,ii7 if there is no proprietary name1 the established name of the drug1 if any1 as defined in section #ejc7;e77#c71 or for drugs which are biological products1 the proper name1 as defined by regulation2 and 7ii7 the prescribing information for such antibacterial drug required by section #bja4eg of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 shall also include the following statement3 ,this drug is indicated for use in a limited and specific population of patients44 7,b7 ,promotional material ,the sponsor of an antibacterial drug subject to this subsection shall submit to the ,secretary copies of all promotional materials related to such drug at least #cj calendar days prior to dissemination of the materials4 7#d7 ,other programs ,a sponsor of a drug that seeks approval of a drug under this subsection for antibacterial drugs may also seek designation or approval1 as applicable1 of such drug under other applicable sections or subsections of this ,act of the ,public ,health ,service ,act4 7#e7 ,guidance ,not later than #ah months after the date of enactment of the ,promise for ,antibiotics and ,therapeutics for ,health ,act1 the ,secretary shall issue draft guidance describing criteria1 processes1 and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs4 ,the ,secretary shall publish final guidance within #ah months of the close of the public comment period on such draft guidance4 ,the ,secretary may approve antibacterial drugs under this subsection prior to issuing guidance under this paragraph4 7#f7 ,advice ,the ,secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval under this subsection for antibacterial drugs to enable the sponsor to plan a development program to obtain the necessary data for approval of such drug under this subsection for antibacterial drugs and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population4 7#g7 ,termination of limitations ,if1 after approval of a drug under this subsection1 the ,secretary approves a broader indication for such drug for which the sponsor applies under section #eje7;b7 or section #cea7;a7 of the ,public ,health ,service ,act1 the ,secretary may remove any postmarketing conditions1 including requirements with respect to labeling and review of promotional materials under paragraph 7#c71 applicable to the approval of the drug under this subsection4 7#h7 ,rules of construction ,nothing in this subsection shall be construed to alter the authority of the ,secretary to approve drugs pursuant to this ,act and section #cea of the ,public ,health ,service ,act1 including the standards of evidence1 and applicable conditions1 for approval under such ,acts1 the standards of approval of a drug under this ,act or the ,public ,health ,service ,act1 or to alter the authority of the ,secretary to monitor drugs pursuant to this ,act or the ,public ,health ,service ,act4 7#i7 ,reporting and accountability 7,a7 ,biannual reporting ,the ,secretary shall report to ,congress not less often than once every #b years on the number of requests for approval1 and the number of approvals1 of an antibacterial drug under this subsection4 7,b7 ,gao report ,not later than ,december #bjba1 the ,comptroller ,general of the ,united ,states shall report on the coordination of activities required under section #cai;,e of the ,public ,health ,service ,act1 a review of such activities1 and the extent to which the use of the pathway established under this subsection has streamlined premarket approval for antibacterial drugs for limited populations1 if such pathway has functioned as intended1 if such pathway has helped provide for safe and effective treatment for patients1 if such premarket approval would be appropriate for other categories of drugs1 and if the authorities under this subsection have affected antibiotic resistance4 4 #d4 ,prescribing authority ,nothing in this ,act1 or an amendment made by this ,act1 shall be construed to restrict the prescribing of antibacterial drugs or other products1 including drugs approved under section #ejf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;g771 by health care professionals1 or to limit the practice of health care4 ,april #ah1 #bjaf,reported with an amendment