text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Stop Tampering of Prescription Pills 
  Act of 2015''.
  
  SEC. 2. ABUSE-DETERRENT TECHNOLOGY.
  
      (a) Definition.--Section 201 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
  following:
      ``(ss) The term `abuse-deterrent drug' means a drug that--
              ``(1) contains as an active moiety a controlled substance 
          that has been classified as opium, an opiate, or a derivative 
          thereof, as such terms are defined or used in section 102 of 
          the Controlled Substances Act;
              ``(2) has been formulated for oral administration; and
              ``(3)(A) exhibits physicochemical properties (demonstrated 
          by in vitro, in vivo, or other testing, or some combination 
          thereof, as determined appropriate by the Secretary) that make 
          product manipulation significantly more difficult or 
          ineffective in altering the characteristics of the drug for 
          purposes of misuse or abuse when compared to drugs without such 
          properties; or
              ``(B) contains one or more additional active or inactive 
          ingredients that are intended to deter abuse through potential 
          pharmacological effects, the effectiveness of which has been 
          demonstrated by at least one adequate and well-controlled 
          investigation.''.
      (b) Required Information in Application for Approval of Brand Name 
  Drugs.--Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 
  U.S.C. 355(b)) is amended by adding at the end the following:
              ``(7) Abuse-deterrent drugs.--If an application submitted 
          under this subsection is potentially subject to refusal under 
          subsection (d)(7), the application shall include such 
          information as the Secretary determines necessary to 
          demonstrate that the application is not subject to such 
          refusal.''.
      (c) Approval of New Brand Name Drugs.--Section 505(d) of the 
  Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended--
              (1) by inserting ``(7)(A) such drug has been formulated for 
          oral administration; (B) such drug contains as an active moiety 
          a controlled substance that has been classified as opium, an 
          opiate, or a derivative thereof, as such terms are defined or 
          used in section 102 of the Controlled Substances Act; (C) such 
          drug is not an abuse-deterrent drug; and (D) the Secretary has 
          previously approved pursuant to an application submitted under 
          subsection (b) or (j) a drug that (i) contains the same active 
          moiety; (ii) is an abuse-deterrent drug, and (iii) has not been 
          discontinued from marketing; or'' after ``(6) the application 
          failed to contain the patent information prescribed by 
          subsection (b); or'';
              (2) by striking ``(7) based on fair'' and inserting ``(8) 
          based on fair'';
              (3) by striking ``clauses (1) through (6)'' and inserting 
          ``paragraphs (1) through (7)''; and
              (4) by inserting ``The Secretary may issue an order 
          approving an application, even if paragraph (7) applies, upon a 
          finding that paragraphs (1) through (6) and paragraph (8) do 
          not apply and that such approval is necessary either to prevent 
          or alleviate a drug shortage or to otherwise address a 
          significant unmet public health need.'' before ``As used in 
          this subsection and subsection (e)''.
      (d) Generic Drugs.--Section 505(j) of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 355(j)) is amended--
              (1) in paragraph (2)--
                      (A) subparagraph (A)--
                              (i) in clause (vii), by striking ``and'' at 
                          the end;
                              (ii) in clause (viii), by striking the 
                          period at the end and inserting ``; and'';
                              (iii) by inserting after clause (viii) the 
                          following:
                      ``(ix) if the listed drug is an abuse-deterrent 
                  drug due to its physicochemical properties, information 
                  from comparative in vitro, in vivo, or other testing, 
                  or some combination thereof, as appropriate based on 
                  the type of data submitted for the listed drug, that 
                  demonstrates the new drug resists manipulation or the 
                  effect of manipulation to a degree at least comparable 
                  to the listed drug.''; and
                              (iv) in the continuation text at the end of 
                          the subparagraph, by striking ``clauses (i) 
                          through (viii)'' and inserting ``clauses (i) 
                          through (ix)'';
                      (B) in subparagraph (C)--
                              (i) in clause (i), by striking ``or'' at 
                          the end;
                              (ii) in clause (ii), by striking the period 
                          at the end and inserting ``; or''; and
                              (iii) by adding at the end the following:
                      ``(iii) that the listed drug is an abuse-deterrent 
                  drug and one or more of the new drug's active moieties 
                  differ in any material respect (in amount or otherwise) 
                  from those of the listed drug.'';
              (2) in paragraph (5), by adding at the end the following:
              ``(G) If a drug has been approved pursuant to an 
          application submitted under paragraph (2), and thereafter the 
          listed drug referred to in the application becomes an abuse-
          deterrent drug, the drug so approved shall not be considered to 
          be bioequivalent to, or to have the same therapeutic effect as, 
          the listed drug (as described in paragraph (2)(A)(iv)) unless 
          and until the drug so approved has been found by the Secretary 
          to meet the requirements of paragraph (2)(A)(ix).''; and
              (3) in paragraph (6)--
                      (A) by striking ``(6) If a drug'' and inserting 
                  ``(6)(A) If a drug'';
                      (B) by striking ``(A) for the'' and inserting ``(i) 
                  for the'';
                      (C) by striking ``(B) if the'' and inserting ``(ii) 
                  if the''; and
                      (D) by adding at the end the following:
              ``(B) For purposes of this paragraph and paragraph (7)(C), 
          a withdrawal or suspension of a drug formulated for oral 
          administration shall be considered to have been for safety or 
          effectiveness reasons if--
                      ``(i) the approval of a listed drug, which is not 
                  an abuse-deterrent drug, is withdrawn or suspended, or 
                  a listed drug, which is not an abuse-deterrent drug, is 
                  withdrawn from sale; and
                      ``(ii) the Secretary has previously approved 
                  pursuant to an application under subsection (b) a drug 
                  that--
                              ``(I) is in the same dosage form;
                              ``(II) contains the same controlled 
                          substance as an active moiety;
                              ``(III) is an abuse-deterrent drug; and
                              ``(IV) has not been discontinued from 
                          marketing.''.
      (e) Withdrawal of Previously Approved Brand Name and Generic 
  Drugs.--Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 
  U.S.C. 355(e)) is amended--
              (1) by inserting ``or (6)(A) the drug contains as an active 
          moiety a controlled substance that has been classified as 
          opium, an opiate, or a derivative thereof, as such terms are 
          defined or used in section 102 of the Controlled Substances 
          Act; (B) the drug is formulated for oral administration; (C) 
          the drug is not an abuse-deterrent drug; and (D) the Secretary 
          has previously approved pursuant to an application submitted 
          under subsection (b) or (j) a drug that contains the same 
          active moiety, is an abuse-deterrent drug, and has not been 
          discontinued from marketing'' before ``: Provided,''; and
              (2) by adding at the end the following: ``The Secretary may 
          waive the application of paragraph (6) of the first sentence of 
          this subsection in the case of a drug intended for use in a 
          special needs population. In withdrawing (under paragraph (6) 
          of the first sentence of this subsection) the approval of an 
          application with respect to any drug, the Secretary shall, on a 
          case-by-case basis, delay the effective date of such withdrawal 
          for a period deemed sufficient by the Secretary to give the 
          sponsor an opportunity to obtain approval under this section 
          for a formulation of the drug meeting the criteria described in 
          paragraph (2) of the definition of a''abuse-deterrent drug`` in 
          section 201(ss).''.
      (f) Listed Drugs.--Section 505(j)(7) of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the 
  following:
              ``(D) Beginning 60 days after the date of the enactment of 
          the Stop Tampering of Prescription Pills Act of 2015, the 
          Secretary shall--
                      ``(i) include in the list under subparagraph (A) a 
                  list of each drug or category of drugs which the 
                  Secretary has found to be abuse-deterrent drugs; and
                      ``(ii) update the list under subparagraph (A)--
                              ``(I) to remove from the list of abuse-
                          deterrent drugs any drug the Secretary later 
                          determines is not an abuse-deterrent drug; and
                              ``(II) as required by subparagraph (C) to 
                          reflect the application of paragraph (6)(B) to 
                          drugs that are withdrawn or suspended.''.
target: Stop Tampering of Prescription Pills Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to deny approval to a new oral opioid (a drug with effects similar to opium, such as morphine) that does not have properties that make the drug significantly more difficult to abuse if an abuse-deterrent drug containing the same opioid is available. The FDA may approve an opioid drug that is not abuse-deterrent if approval is necessary to prevent or alleviate a drug shortage or to address a significant unmet public health need. To be approved by the FDA, a generic version of an abuse-deterrent brand name drug must be at least comparably abuse-deterrent and its active components must not differ in any material respect from the brand name drug. An approved generic drug is not bioequivalent to, and does not have the same therapeutic effect as, a brand name drug that becomes abuse-deterrent unless the generic drug is at least comparably abuse-deterrent. Approval of a generic oral opioid is withdrawn if the brand name drug is not abuse-deterrent and not available and there is an approved abuse-deterrent drug available that contains the same opioid in the same dose. Approval of an oral opioid is withdrawn if the drug is not abuse-deterrent and there is an approved abuse-deterrent drug available that contains the same opioid. Withdrawal of approval may be waived by the FDA for a drug intended for a special needs population. The FDA must delay withdrawal to give the drug sponsor an opportunity to obtain approval for an abuse-deterrent formulation of the drug.
feat_title: Stop Tampering of Prescription Pills Act of 2015