text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Pharmaceutical Supply and Value 
  Enhancement Act'' or the ``Pharmaceutical SAVE Act''.
  
  SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION DRUGS.
  
      (a) Temporary Importation.--Section 506C of the Federal Food, Drug, 
  and Cosmetic Act (21 U.S.C. 356c) is amended--
              (1) by redesignating subsections (h) and (i) as subsections 
          (i) and (j), respectively; and
              (2) by inserting after subsection (g) the following:
      ``(h) Temporary Importation Authority.--
              ``(1) In general.--If, based on notifications described in 
          subsection (a) or any other relevant information, the Secretary 
          concludes that there is, or is likely to be, a drug shortage of 
          a drug described in subsection (a), except as provided in 
          paragraph (3), the Secretary shall authorize importation of 
          such drug for a period of up to 3 years if--
                      ``(A) the drug is a drug subject to section 
                  503(b)(1), other than a drug described in subparagraphs 
                  (A) through (F) of section 804(a)(3);
                      ``(B) the drug is authorized to be lawfully 
                  marketed in one or more of the countries included in 
                  the list under section 802(b)(1);
                      ``(C) the imported drug has the same active 
                  ingredient as the drug for which there is a shortage 
                  described in subsection (i)(2)(B) with respect to 
                  manufacturers in the United States;
                      ``(D) the manufacturer certifies to the Secretary 
                  that it intends to seek approval of the drug under 
                  section 505(j); and
                      ``(E) an importer (as defined in section 804(a)) 
                  files with the Secretary information--
                              ``(i) attesting that the requirements under 
                          subparagraphs (A) through (D) are satisfied;
                              ``(ii) identifying the drug the importer 
                          proposes to import and the manufacturer from 
                          whom the importer proposes to import such drug; 
                          and
                              ``(iii) requesting authority to import the 
                          drug.
              ``(2) Beginning date of importation.--If all of the 
          conditions under paragraph (1) are met, the Secretary shall 
          authorize importation of a drug in accordance with such 
          paragraph beginning not later than 60 days after receipt of the 
          information under paragraph (1)(E).
              ``(3) Discretionary denial of importation.--The Secretary 
          may deny importation of a drug otherwise qualified for 
          importation under paragraph (1) if the Secretary determines 
          that--
                      ``(A) the drug is not safe and effective;
                      ``(B) the drug is used in conjunction with a device 
                  for which there is no reasonable assurance of safety 
                  and effectiveness; or
                      ``(C) the authorization to market the drug in one 
                  or more of the countries included in the list under 
                  section 802(b)(1) has been rescinded or withdrawn 
                  because of any concern relating to the safety or 
                  effectiveness of the drug.
              ``(4) Termination of authority.--The authority to import a 
          drug pursuant to paragraph (1) shall terminate after 3 years, 
          or when the drug shortage no longer applies, whichever occurs 
          first.''.
      (b) Noncompetitive Drug Markets.--Chapter V of the Federal Food, 
  Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
  after section 506C-1 the following:
  
  ``SEC. 506C-2. NONCOMPETITIVE DRUG MARKETS.
  
      ``(a) In General.--If the Secretary determines under subsection (b) 
  that a noncompetitive market exists with respect to an applicable drug, 
  the Secretary--
              ``(1) shall treat such noncompetitive market as creating a 
          drug shortage for purposes of section 506C(g), and may expedite 
          the review of applications and inspections in accordance with 
          such subsection; and
              ``(2) shall treat such noncompetitive market as creating a 
          drug shortage for purposes of section 506C(h), and shall 
          authorize importation of the drug in accordance with such 
          subsection.
      ``(b) Determination of Noncompetitive Market.--
              ``(1) In general.--The Secretary shall determine that a 
          noncompetitive market exists with respect to an applicable drug 
          if--
                      ``(A) for at least 2 consecutive months prior to 
                  the determination, fewer than 5 drugs approved under 
                  section 505(c) (referred to in this paragraph as the 
                  `applicable listed drug') or under section 505(j) that 
                  reference the applicable listed drug were commercially 
                  available in the United States;
                      ``(B) the applicable listed drug was approved at 
                  least 10 years before such determination; and
                      ``(C) each patent which claims an active ingredient 
                  of the applicable listed drug has expired.
              ``(2) Commercially available.--
                      ``(A) In general.--For purposes of paragraph 
                  (1)(A), a drug is not commercially available in the 
                  United States if--
                              ``(i) the holder of an application approved 
                          under subsection (c) or (j) of section 505 has 
                          publicly announced that it has discontinued the 
                          manufacturing of the drug;
                              ``(ii) a drug approved under subsection (c) 
                          or (j) of section 505 has been withdrawn or 
                          discontinued; or
                              ``(iii) the Secretary has any other 
                          reasonable basis to conclude that a drug 
                          approved under subsection (c) or (j) of section 
                          505 is not competitively relevant.
                      ``(B) Holder of approved application.--In 
                  determining whether 5 drugs are commercially available 
                  under paragraph (1)(A), in the case of a single person 
                  who is the holder of more than 1 application approved 
                  as described in paragraph (1)(A) with respect to an 
                  applicable drug, only 1 such drug shall be considered 
                  to be commercially available.
      ``(c) Applicable Drug.--In this section, the term `applicable drug' 
  means a drug that is not a radio pharmaceutical drug product or any 
  other product as designated by the Secretary.''.
      (c) Annual Reporting on Drug Shortages.--Section 506C-1(a)(3)(B) of 
  the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(3)(B)) is 
  amended--
              (1) in clause (i), by striking ``; and'' and inserting 
          ``;'';
              (2) in clause (ii), by adding ``and'' after the semicolon; 
          and
              (3) by inserting after clause (ii) the following:
                      ``(iii) the number of drugs authorized for 
                  temporary importation under section 506C(h);''.
target: Pharmaceutical Supply and Value Enhancement Act or the Pharmaceutical SAVE Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness.  Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited inspections and review. A drug is in a noncompetitive market if: (1) there are fewer than five holders of approved applications for commercially available brand name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) patents on the active ingredient of the drug have expired. 
feat_title: Pharmaceutical Supply and Value Enhancement Act