I 115th CONGRESS 1st Session H. R. 1223 IN THE HOUSE OF REPRESENTATIVES February 27, 2017 Mr. Bilirakis (for himself, Mr. Butterfield , and Mr. McCaul ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, 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 condition, and for other purposes.

1. Short title This Act may be cited as the Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act . 2. Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition (a) In general The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F of such Act ( 21 U.S.C. 355g ) the following: 505G. Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition (a) Designation (1) In general The Secretary shall designate a drug as a drug approved for a new indication to prevent, diagnose, or treat a rare disease or condition for purposes of granting the extensions under subsection (b) if— (A) prior to approval of an application or supplemental application for the new indication, the drug was approved or licensed under section 505(c) of this Act or section 351(a) of the Public Health Service Act but was not so approved or licensed for the new indication; (B) (i) 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 prevent, diagnose, or treat the rare disease or condition; and (ii) the Secretary approves the application or supplemental application; and (C) the application or supplemental application for the new indication contains the consent of the applicant to public notice under paragraph (4) with respect to the designation of the drug. (2) Revocation of designation (A) In general Except as provided in subparagraph (B), a designation under paragraph (1) shall not be revoked for any reason. (B) Exception The Secretary may revoke a designation of a drug under paragraph (1) if the Secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact. (3) Notice to public The Secretary shall provide public notice of the designation of a drug under paragraph (1). (b) Extension (1) In general If the Secretary designates a drug as a drug approved for a new indication for a rare disease or condition, as described in subsection (a)(1)— (A) (i) the 4-, 5-, and 7 ½ -year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, and the 7-year period described in section 527, as applicable, shall be extended by 6 months; or (ii) the 4- and 12-year periods described in subparagraphs (A) and (B) of section 351(k)(7) of the Public Health Service Act and the 7-year period described in section 527, as applicable, shall be extended by 6 months; and (B) (i) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions); or (ii) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions). (2) Relation to pediatric and qualified infectious disease product exclusivity Any extension under paragraph (1) of a period shall be in addition to any extension of the periods under sections 505A and 505E of this Act and section 351(m) of the Public Health Service Act, as applicable, with respect to the drug. (c) Limitations Any extension described in subsection (b)(1) shall not apply if the drug designated under subsection (a)(1) has previously received an extension by operation of subsection (b)(1). (d) Definition In this section, the term rare disease or condition has the meaning given to such term in section 526(a)(2). . (b) Application Section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug for which an application or supplemental application described in subsection (a)(1)(B)(i) of such section 505G is first approved under section 505(c) of such Act ( 21 U.S.C. 355(c) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) on or after the date of the enactment of this Act. (c) Conforming amendments (1) Relation to pediatric exclusivity for drugs Section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ) is amended— (A) in subsection (b), by adding at the end the following: (3) Relation to exclusivity for a drug approved for a new indication for a rare disease or condition Notwithstanding the references in paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in paragraph (1) shall be in addition to any extensions under section 505G. ; and (B) in subsection (c), by adding at the end the following: (3) Relation to exclusivity for a drug approved for a new indication for a rare disease or condition Notwithstanding the references in paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in paragraph (1) shall be in addition to any extensions under section 505G. . (2) Relation to exclusivity for new qualified infectious disease products that are drugs Subsection (b) of section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f ) is amended— (A) by amending the subsection heading to read as follows: Relation to pediatric exclusivity and exclusivity for a drug approved for a new indication for a rare disease or condition.— ; and (B) by striking any extension of the period under section 505A and inserting any extension of the periods under sections 505A and 505G, as applicable, . (3) Relation to pediatric exclusivity for biological products Section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) is amended by adding at the end the following: (5) Relation to exclusivity for a biological product approved for a new indication for a rare disease or condition Notwithstanding the references in paragraphs (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in such paragraphs shall be in addition to any extensions under section 505G. .