,,ii #aaeth ,,congress #ast ,session ,s4 #aeji ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bi1 #bjag,mr4 ,hatch 7for himself and ,mr4 ,menendez7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to authorize an extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,orphan ,products ,extension ,now ,accelerating ,cures and ,treatments ,act of #bjag4 #b4 ,extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje;,f of such ,act 7#ba ,u4,s4,c4 #cee;g7 the following3 #eje;,g4 ,extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition 7a7 ,designation 7#a7 ,in general ,the ,secretary shall designate a drug as a drug approved for a new indication to prevent1 diagnose1 or treat a rare disease or condition for purposes of granting the extensions under subsection 7b7 if-- 7,a7 prior to approval of an application or supplemental application for the new indication1 the drug was approved or licensed under section #eje7;c7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act but was not so approved or licensed for the new indication2 7,b7 7i7 the sponsor of the approved or licensed drug files an application or a supplemental application for approval of the new indication for use of the drug to prevent1 diagnose1 or treat the rare disease or condition2 and 7ii7 the ,secretary approves the application or supplemental application2 and 7,c7 the application or supplemental application for the new indication contains the consent of the applicant to public notice under paragraph 7#c7 with respect to the designation of the drug4 7#b7 ,revocation of designation 7,a7 ,in general ,except as provided in subparagraph 7,b71 a designation under paragraph 7#a7 shall not be revoked for any reason4 7,b7 ,exception ,the ,secretary may revoke a designation of a drug under paragraph 7#a7 if the ,secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact4 7#c7 ,notice to public ,the ,secretary shall provide public notice of the designation of a drug under paragraph 7#a74 7b7 ,extension 7#a7 ,in general ,if the ,secretary designates a drug as a drug approved for a new indication for a rare disease or condition1 as described in subsection 7a77#a7-- 7,a7 7i7 the #d-1 #e-1 and #g-year periods described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje1 the #c-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f7 of section #eje1 and the #g-year period described in section #ebg1 as applicable1 shall be extended by #f months2 or 7ii7 the #d- and #ab-year periods described in subparagraphs 7,a7 and 7,b7 of section #cea7k77#g7 of the ,public ,health ,service ,act and the #g-year period described in section #ebg1 as applicable1 shall be extended by #f months2 and 7,b7 7i7 if the drug is the subject of a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77ii7 or 7j77#b77;,a77vii77,,ii7 of section #eje or a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iii7 or 7j77#b77;,a77vii77,,iii7 of section #eje1 the period during which an application may not be approved under section #eje7;c77#c7 or section #eje7;j77#e77;,b7 shall be extended by a period of #f months after the date the patent expires 7including any patent extensions72 or 7ii7 if the drug is the subject of a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iv7 or 7j77#b77;,a77vii77,,iv7 of section #eje1 and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed1 the period during which an application may not be approved under section #eje7;c77#c7 or section #eje7;j77#e77;,b7 shall be extended by a period of #f months after the date the patent expires 7including any patent extensions74 7#b7 ,relation to pediatric and qualified infectious disease product exclusivity ,any extension under paragraph 7#a7 of a period shall be in addition to any extension of the periods under sections #eje;,a and #eje;,e of this ,act and section #cea7m7 of the ,public ,health ,service ,act1 as applicable1 with respect to the drug4 7c7 ,limitations ,any extension described in subsection 7b77#a7 shall not apply if the drug designated under subsection 7a77#a7 has previously received an extension by operation of subsection 7b77#a74 7d7 ,definition ,in this section1 the term rare disease or condition has the meaning given to such term in section #ebf7;a77#b74 4 7b7 ,application ,section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 applies only with respect to a drug for which an application or supplemental application described in subsection 7a77#a77;,b77i7 of such section #eje;,g is first approved under section #eje7;c7 of such ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 on or after the date of the enactment of this ,act4 7c7 ,conforming amendments 7#a7 ,relation to pediatric exclusivity for drugs ,section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 is amended-- 7,a7 in subsection 7b71 by adding at the end the following3 7#c7 ,relation to exclusivity for a drug approved for a new indication for a rare disease or condition ,notwithstanding the references in paragraph 7#a7 to the lengths of the exclusivity periods after application of pediatric exclusivity1 the #f-month extensions described in paragraph 7#a7 shall be in addition to any extensions under section #eje;,g4 2 and 7,b7 in subsection 7c71 by adding at the end the following3 7#c7 ,relation to exclusivity for a drug approved for a new indication for a rare disease or condition ,notwithstanding the references in paragraph 7#a7 to the lengths of the exclusivity periods after application of pediatric exclusivity1 the #f-month extensions described in paragraph 7#a7 shall be in addition to any extensions under section #eje;,g4 4 7#b7 ,relation to exclusivity for new qualified infectious disease products that are drugs ,subsection 7b7 of section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is amended-- 7,a7 by amending the subsection heading to read as follows3 ,relation to pediatric exclusivity and exclusivity for a drug approved for a new indication for a rare disease or condition4--2 and 7,b7 by striking any extension of the period under section #eje;,a and inserting any extension of the periods under sections #eje;,a and #eje;,g1 as applicable14 7#c7 ,relation to pediatric exclusivity for biological products ,section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 is amended by adding at the end the following3 7#e7 ,relation to exclusivity for a biological product approved for a new indication for a rare disease or condition ,notwithstanding the references in paragraphs 7#b77;,a71 7#b77;,b71 7#c77;,a71 and 7#c77;,b7 to the lengths of the exclusivity periods after application of pediatric exclusivity1 the #f-month extensions described in such paragraphs shall be in addition to any extensions under section #eje;,g4 4 #c4 ,orphan drugs 7a7 ,in general ,section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended-- 7#a7 in subsection 7a71 in the matter following paragraph 7#b71 by striking such drug for such disease or condition and inserting the same drug for the same disease or condition2 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking ,if an application and all that follows through such license if and inserting ,during the #g-year period described in subsection 7a7 for an approved application under section #eje or license under section #cea of the ,public ,health ,service ,act1 the ,secretary may approve an application or issue a license for a drug that is otherwise the same1 as determined by the ,secretary1 as the already approved drug for the same rare disease or condition if2 7,b7 in paragraph 7#a71 by striking notice and all that follows through assure and inserting of exclusive approval or licensure notice and opportunity for the submission of views1 that during such period the holder of the exclusive approval or licensure cannot ensure2 and 7,c7 in paragraph 7#b71 by striking such holder provides and inserting the holder provides2 and 7#c7 by adding at the end the following3 7c7 ,condition of clinical superiority 7#a7 ,in general ,if a sponsor of a drug that is designated under section #ebf and is otherwise the same1 as determined by the ,secretary1 as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection 7a7 for the same rare disease or condition as the already approved drug1 the ,secretary shall require such sponsor1 as a condition of such exclusive approval or licensure1 to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug4 7#b7 ,definition ,for purposes of paragraph 7#a71 the term clinically superior with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy1 greater safety1 or by providing a major contribution to patient care4 7d7 ,regulations ,the ,secretary may promulgate regulations for the implementation of subsection 7c74 ,beginning on the date of enactment of the ,orphan ,products ,extension ,now ,accelerating ,cures and ,treatments ,act of #bjag1 until such time as the ,secretary promulgates regulations in accordance with this subsection1 the ,secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment1 to the extent such definitions are not inconsistent with the terms of this section1 as amended by such ,act4 7e7 ,demonstration of clinical superiority standard ,to assist sponsors in demonstrating clinical superiority as described in subsection 7c71 the ,secretary-- 7#a7 upon the designation of any drug under section #ebf1 shall notify the sponsor of such drug in writing of the basis for the designation1 including1 as applicable1 any plausible hypothesis offered by the sponsor and relied upon by the ,secretary that the drug is clinically superior to a previously approved drug2 and 7#b7 upon granting exclusive approval or licensure under subsection 7a7 on the basis of a demonstration of clinical superiority as described in subsection 7c71 shall publish a summary of the clinical superiority findings4 4 7b7 ,rule of ,construction ,nothing in the amendments made by subsection 7a7 shall affect any determination under sections #ebf and #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb1 #cfj;cc7 made prior to the date of enactment of the ,orphan ,products ,extension ,now ,accelerating ,cures and ,treatments ,act of #bjag4 #d4 ,pediatric information added to labeling ,section #eje;,a7o7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7o77 is amended-- 7#a7 in the subsection heading1 by striking ,under ,section #eje7;j72 7#b7 in paragraph 7#a7-- 7,a7 by striking under section #eje7;j7 and inserting under subsection 7b77#b7 or 7j7 of section #eje2 and 7,b7 by striking or by exclusivity under clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f7 and inserting 1 or by exclusivity under clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f71 clauses 7iii7 and 7iv7 of section #eje7;c77#c77;,e71 or section #ebg7;a71 or by an extension of such exclusivity under this section or section #eje;,e2 7#c7 in paragraph 7#b71 in the matter preceding subparagraph 7,a7-- 7,a7 by inserting clauses 7iii7 and 7iv7 of section #eje7;c77#c77;,e71 or section #ebg1 after section #eje7;j77#e77;,f712 and 7,b7 by striking drug approved under section #eje7;j7 and inserting drug approved pursuant to an application submitted under subsection 7b77#b7 or 7j7 of section #eje2 and 7#d7 by amending paragraph 7#c7 to read as follows3 7#c7 ,preservation of pediatric exclusivity and other provisions ,this subsection does not affect-- 7,a7 the availability or scope of exclusivity under-- 7i7 this section2 7ii7 section #eje for pediatric formulations2 or 7iii7 section #ebg2 7,b7 the question of the eligibility for approval of any application under subsection 7b77#b7 or 7j7 of section #eje that omits any other conditions of approval entitled to exclusivity under-- 7i7 clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 of section #eje7;c77#c77;,e72 or 7iii7 section #ebg2 or 7,c7 except as expressly provided in paragraphs 7#a7 and 7#b71 the operation of section #eje or section #ebg4 4