,,ii #aacth ,,congress #b;d ,session ,s4 #biif ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #aj1 #bjad ,mr4 ,bennet 7for himself and ,mr4 ,hatch7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,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