,i #aacth ,,congress #ast ,session ,h4 ,r4 #dhf ,,in ,,the ,,house ,,of ,,representatives ,february #d1 #bjac ,mr4 ,keating 7for himself1 ,mr4 ,rogers of ,kentucky1 ,mr4 ,rahall1 ,mr4 ,lynch1 ,ms4 ,hanabusa1 and ,mr4 ,buchanan7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to incentivize the development of abuse-deterrent drugs4 #a4 ,short title ,this ,act may be cited as the ,stop ,tampering of ,prescription ,pills ,act of #bjac4 #b4 ,abuse-deterrent technology 7a7 ,definition ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended by adding at the end the following3 7ss7 ,the term abuse-deterrent drug means a drug that-- 7#a7 contains as an active moiety a controlled substance that has been classified as opium1 an opiate1 or a derivative thereof1 as such terms are defined or used in section #ajb of the ,controlled ,substances ,act2 7#b7 has been formulated for oral administration2 and 7#c7 7,a7 exhibits physicochemical properties 7demonstrated by in vitro1 in vivo1 or other testing1 or some combination thereof1 as determined appropriate by the ,secretary7 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 properties2 or 7,b7 contains one or more additional active or inactive ingredients that are intended to deter abuse through potential pharmacological effects1 the effectiveness of which has been demonstrated by at least one adequate and well-controlled investigation4 4 7b7 ,required information in application for approval of brand name drugs ,section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended by adding at the end the following3 7#g7 ,abuse-deterrent drugs ,if an application submitted under this subsection is potentially subject to refusal under subsection 7d77#g71 the application shall include such information as the ,secretary determines necessary to demonstrate that the application is not subject to such refusal4 4 7c7 ,approval of new brand name drugs ,section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d77 is amended-- 7#a7 by inserting 7#g77;,a7 such drug has been formulated for oral administration2 7,b7 such drug contains as an active moiety a controlled substance that has been classified as opium1 an opiate1 or a derivative thereof1 as such terms are defined or used in section #ajb of the ,controlled ,substances ,act2 7,c7 such drug is not an abuse-deterrent drug2 and 7,d7 the ,secretary has previously approved pursuant to an application submitted under subsection 7b7 or 7j7 a drug that 7i7 contains the same active moiety2 7ii7 is an abuse-deterrent drug1 and 7iii7 has not been discontinued from marketing2 or after 7#f7 the application failed to contain the patent information prescribed by subsection 7b72 or2 7#b7 by striking 7#g7 based on fair and inserting 7#h7 based on fair2 7#c7 by striking clauses 7#a7 through 7#f7 and inserting paragraphs 7#a7 through 7#g72 and 7#d7 by inserting ,the ,secretary may issue an order approving an application1 even if paragraph 7#g7 applies1 upon a finding that paragraphs 7#a7 through 7#f7 and paragraph 7#h7 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 need4 before ,as used in this subsection and subsection 7e74 7d7 ,generic drugs ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 subparagraph 7,a7-- 7i7 in clause 7vii71 by striking and at the end2 7ii7 in clause 7viii71 by striking the period at the end and inserting 2 and2 7iii7 by inserting after clause 7viii7 the following3 7ix7 if the listed drug is an abuse-deterrent drug due to its physicochemical properties1 information from comparative in vitro1 in vivo1 or other testing1 or some combination thereof1 as appropriate based on the type of data submitted for the listed drug1 that demonstrates the new drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug4 2 and 7iv7 in the continuation text at the end of the subparagraph1 by striking clauses 7i7 through 7viii7 and inserting clauses 7i7 through 7ix72 7,b7 in subparagraph 7,c7-- 7i7 in clause 7i71 by striking or at the end2 7ii7 in clause 7ii71 by striking the period at the end and inserting 2 or2 and 7iii7 by adding at the end the following3 7iii7 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 7in amount or otherwise7 from those of the listed drug4 2 7#b7 in paragraph 7#e71 by adding at the end the following3 7,g7 ,if a drug has been approved pursuant to an application submitted under paragraph 7#b71 and thereafter the listed drug referred to in the application becomes an abuse-deterrent drug1 the drug so approved shall not be considered to be bioequivalent to1 or to have the same therapeutic effect as1 the listed drug 7as described in paragraph 7#b77;,a77iv77 unless and until the drug so approved has been found by the ,secretary to meet the requirements of paragraph 7#b77;,a77ix74 2 and 7#c7 in paragraph 7#f7-- 7,a7 by striking 7#f7 ,if a drug and inserting 7#f77;,a7 ,if a drug2 7,b7 by striking 7,a7 for the and inserting 7i7 for the2 7,c7 by striking 7,b7 if the and inserting 7ii7 if the2 and 7,d7 by adding at the end the following3 7,b7 ,for purposes of this paragraph and paragraph 7#g77;,c71 a withdrawal or suspension of a drug formulated for oral administration shall be considered to have been for safety or effectiveness reasons if-- 7i7 the approval of a listed drug1 which is not an abuse-deterrent drug1 is withdrawn or suspended1 or a listed drug1 which is not an abuse-deterrent drug1 is withdrawn from sale2 and 7ii7 the ,secretary has previously approved pursuant to an application under subsection 7b7 a drug that-- 7,i7 is in the same dosage form2 7,,ii7 contains the same controlled substance as an active moiety2 7,,iii7 is an abuse-deterrent drug2 and 7,,iv7 has not been discontinued from marketing4 4 7e7 ,withdrawal of previously approved brand name and generic drugs ,section #eje7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;e77 is amended-- 7#a7 by inserting or 7#f77;,a7 the drug contains as an active moiety a controlled substance that has been classified as opium1 an opiate1 or a derivative thereof1 as such terms are defined or used in section #ajb of the ,controlled ,substances ,act2 7,b7 the drug is formulated for oral administration2 7,c7 the drug is not an abuse-deterrent drug2 and 7,d7 the ,secretary has previously approved pursuant to an application submitted under subsection 7b7 or 7j7 a drug that contains the same active moiety1 is an abuse-deterrent drug1 and has not been discontinued from marketing before 3 ,provided12 and 7#b7 by adding at the end the following3 ,the ,secretary may waive the application of paragraph 7#f7 of the first sentence of this subsection in the case of a drug intended for use in a special needs population4 ,in withdrawing 7under paragraph 7#f7 of the first sentence of this subsection7 the approval of an application with respect to any drug1 the ,secretary shall1 on a case-by-case basis1 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 7#b7 of the definition of a abuse-deterrent drug in section #bja7ss744 7f7 ,listed drugs ,section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7,d7 ,beginning #fj days after the date of the enactment of the ,stop ,tampering of ,prescription ,pills ,act of #bjac1 the ,secretary shall-- 7i7 include in the list under subparagraph 7,a7 a list of each drug or category of drugs which the ,secretary has found to be abuse-deterrent drugs2 and 7ii7 update the list under subparagraph 7,a7-- 7,i7 to remove from the list of abuse-deterrent drugs any drug the ,secretary later determines is not an abuse-deterrent drug2 and 7,,ii7 as required by subparagraph 7,c7 to reflect the application of paragraph 7#f77;,b7 to drugs that are withdrawn or suspended4 4