Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Summary: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an &ldquo;orphan disease&rdquo;). Allows the FDA to revoke an extension if the application for the new indication contained an untrue material statement. Requires the sponsor of a product receiving an extension to notify the FDA one year prior to discontinuing production for commercial reasons. Requires the FDA to notify the public of products that receive this extension and patents related to those products. Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions. Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Orphan Product Extensions Now 
Accelerating Cures and Treatments Act of 2015''.

SEC. 2. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A NEW 
              INDICATION FOR A RARE DISEASE OR CONDITION.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 505E of such Act (21 U.S.C. 
355f) the following:

``SEC. 505F. 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 for marketing 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) 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;
                    ``(C) the application or supplemental application 
                for the new indication contains--
                            ``(i) a request for designation of the drug 
                        under this section;
                            ``(ii) the consent of the applicant to 
                        notice being given by the Secretary under 
                        paragraph (4) respecting the designation of the 
                        drug; and
                            ``(iii) in the case of a drug for which an 
                        extension is sought under subsection (b)(3), a 
                        list specifying each patent--
                                    ``(I) which claims the drug or a 
                                method of using the drug; and
                                    ``(II) with respect to which a 
                                claim of patent infringement could 
                                reasonably be asserted if a person not 
                                licensed by the owner engaged in the 
                                manufacture, use, or sale of the drug; 
                                and
                    ``(D) the Secretary approves the application or 
                supplemental application.
            ``(2) Revocation of designation.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), a designation under this subsection 
                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) Notification prior to discontinuance of production 
        for solely commercial reasons.--A designation of a drug under 
        paragraph (1) shall be subject to the condition that the 
        sponsor of the drug will notify the Secretary of any 
        discontinuance of the production of the drug for solely 
        commercial reasons at least one year before such 
        discontinuance.
            ``(4) Notice to public.--Notice respecting the designation 
        of a drug under paragraph (1)--
                    ``(A) shall be made available to the public; and
                    ``(B) shall include any listing of patents under 
                subsection (a)(1)(C)(iii).
    ``(b) Extension.--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)--
            ``(1)(A)(i) the 4-, 5-, and 7\1/2\-year periods described 
        in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, 
        and 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, 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, as applicable, shall be extended by 6 
        months; and
            ``(B) the 7-year period described in section 527, as 
        applicable, shall be extended by 6 months;
            ``(2) if, at the time a drug is designated under subsection 
        (a)(1)--
                    ``(A) 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 subsections 
                (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
                    ``(B) 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); and
            ``(3) if the drug is a biological product, the Secretary 
        shall not grant final effective approval for any application 
        submitted under section 351(k)(1) of the Public Health Service 
        Act for a biosimilar biological product that cites such drug as 
        its reference product until the date that is 6 months after the 
        expiration of every patent that, as of the date on which the 
        drug is designated under subsection (a)(1), is listed for such 
        drug pursuant to subsection (a)(1)(C)(iii), except that, if a 
        court from which no appeal (other than a writ of certiorari) 
        has been or could be taken rules a listed patent invalid or not 
        infringed, then such patent shall no longer be considered for 
        purposes of this paragraph.
    ``(c) Relation to Pediatric and Qualified Infectious Disease 
Product Exclusivity.--Any extension under subsection (b) 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.
    ``(d) Limitations.--The extension described in subsection (b) shall 
not apply if the drug designated under subsection (a)(1) has previously 
received an extension by operation of subsection (b).
    ``(e) Regulations.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of this section, the Secretary shall adopt final 
        regulations implementing this section.
            ``(2) Procedure.--In promulgating a regulation implementing 
        this section, the Secretary shall--
                    ``(A) issue a notice of proposed rulemaking that 
                includes the proposed regulation;
                    ``(B) provide a period of not less than 60 days for 
                comments on the proposed regulation; and
                    ``(C) publish the final regulation not less than 30 
                days before the effective date of the regulation.
            ``(3) Restrictions.--Notwithstanding any other provision of 
        law, the Secretary shall promulgate regulations implementing 
        this section only as described in paragraph (2), except that 
        the Secretary may issue interim guidance for sponsors seeking 
        to submit an application or supplemental application described 
        in subsection (a) prior to the promulgation of such 
        regulations.
            ``(4) Designation prior to regulations.--The Secretary 
        shall designate drugs under subsection (a) prior to the 
        promulgation of regulations under this subsection, if such 
        drugs meet the criteria described in subsection (a).
    ``(f) Definition.--In this section:
            ``(1) The terms `biological product', `biosimilar', and 
        `reference product' have the meanings given to such terms in 
        section 351(i) of the Public Health Service Act.
            ``(2) The term `rare disease or condition' has the meaning 
        given to such term in section 526(a)(2).''.
    (b) Application.--Section 505F 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 subparagraphs (B) and (C) of subsection (a)(1) of such section 505F 
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 subsection (b)(1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in subsection (b)(1) shall be 
        in addition to any extensions under section 505F.''; 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 subsection (c)(1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in subsection (c)(1) shall be 
        in addition to any extensions under section 505F.''.
            (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 or 505F''.
            (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 505F.''.