text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Promise for Antibiotics and 
  Therapeutics for Health Act'' or the ``PATH Act''.
  
  SEC. 2. LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL DRUGS.
  
      Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
  356) is amended--
              (1) by transferring subsection (e) so that it appears 
          before subsection (f); and
              (2) by adding at the end the following:
      ``(g) Limited Population Pathway for Antibacterial Drugs.--
              ``(1) In general.--The Secretary shall establish a program 
          under which the Secretary may, at the request of a sponsor, 
          approve an antibacterial drug, alone or in combination with one 
          or more drugs, as a limited population antibacterial drug, upon 
          a determination that such drug is intended to treat a serious 
          or life-threatening disease, condition, or infection and 
          address an unmet medical need for such disease, condition, or 
          infection within an identifiable limited population.
              ``(2) Limited population pathway.--
                      ``(A) 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 drug, as required under section 
                  505(d) or section 351(a) of the Public Health Service 
                  Act, for the intended use of the drug. The Secretary 
                  shall determine the safety and effectiveness of an 
                  antibacterial drug under the limited population pathway 
                  for antibacterial drugs in accordance with subparagraph 
                  (B). An antibacterial drug shall be eligible for 
                  approval under the limited population pathway only upon 
                  the request of the sponsor.
                      ``(B) Considerations.--
                              ``(i) 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 population, taking into account the 
                          severity, rarity, or prevalence of the 
                          infection the drug is intended to treat and the 
                          availability or lack of alternative treatment 
                          for such infection. 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 population.
                              ``(ii) Types of evidence.--In determining 
                          whether to approve a drug under the limited 
                          population pathway, the Secretary--
                                      ``(I) shall rely on sufficient 
                                  evidence, which may include traditional 
                                  endpoints, alternate endpoints, or a 
                                  combination of traditional and 
                                  alternate endpoints, and, as 
                                  appropriate, small clinical data sets; 
                                  and
                                      ``(II) may rely on supplemental 
                                  data, including preclinical evidence, 
                                  pharmacologic or pathophysiologic 
                                  evidence, nonclinical susceptibility, 
                                  pharmacokinetic data, and other such 
                                  confirmatory evidence as the Secretary 
                                  determines appropriate.
              ``(3) Requirements.--With respect to a drug approved 
          through the limited population pathway, the Secretary shall 
          require--
                      ``(A) the labeling of such antibacterial drug, such 
                  as through a logo or other means, 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 
                  population; and
                      ``(B) the sponsor to submit copies of all 
                  promotional materials related to the limited population 
                  antibacterial drug, at least 30 days prior to 
                  dissemination of the materials.
              ``(4) 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 (a), (b), and (c), and sections 505E and 524.
              ``(5) Guidance.--Not later than 18 months after the date of 
          enactment of the Promise for Antibiotics and Therapeutics for 
          Health Act, the Secretary shall issue draft guidance describing 
          criteria, processes, 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 infections. The Secretary may approve 
          antibacterial drugs through such limited population pathway 
          prior to issuing guidance under this paragraph.
              ``(6) Postapproval monitoring programs for antibacterial 
          drugs.--The Secretary, in consultation with the Commissioner 
          and other relevant heads of agencies, 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 drugs, 
          including drugs approved under this pathway.
              ``(7) 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 population.
              ``(8) Termination of limitations.--If, after approval of a 
          drug through the limited population pathway for antibacterial 
          drugs, the Secretary approves a broader indication for such 
          drug for which the sponsor applies under section 505(b) or 
          section 351 of the Public Health Service Act, the Secretary may 
          remove any postmarketing conditions, including requirements 
          with respect to labeling and review of promotional materials 
          under paragraph (3) and postapproval monitoring under paragraph 
          (6), applicable to the approval of the drug through the limited 
          population pathway for antibacterial drugs.
              ``(9) Rules of construction.--
                      ``(A) 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 Act, 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 
                  Act.
                      ``(B) Prescribing authority.--Nothing in this 
                  subsection shall be construed to restrict the 
                  prescribing of antibiotics or other products, including 
                  drugs approved under the limited population pathway, by 
                  health care professionals, or to limit the practice of 
                  health care.
              ``(10) Expansion of pathway.--Beginning on October 1, 2016, 
          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 illness. The approval of such 
          drugs shall be subject to the considerations and requirements 
          described in this subsection, 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 infections.''.
target: Promise for Antibiotics and Therapeutics for Health Act or the PATH Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to establish a program to approve an antibacterial drug intended to treat a serious medical condition and address an unmet medical need within an identifiable limited population as a limited population antibacterial drug. Requires the sponsor of a drug eligible for approval as a limited population antibacterial drug to demonstrate the safety and effectiveness of the drug for its intended use. Requires an HHS determination of the safety and effectiveness of a limited population antibacterial drug to reflect the drug's benefit-risk profile in the intended limited population. Prohibits a lack of evidence of a favorable benefit-risk profile in a broader population from resulting in a denial of approval. Directs HHS to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination. Directs HHS to describe considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas. Requires HHS to conduct postapproval monitoring programs to study how antibacterial drugs approved through the limited population pathway are used and to monitor changes in bacterial drug resistance. Allows HHS to remove the labeling, marketing, and postapproval monitoring requirements of a limited population antibacterial drug if the drug is approved for broader use. Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.
feat_title: PATH Act