[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5750 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5750

  To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-
month extension of certain exclusivity periods in the case of approved 
 drugs that are subsequently approved for a new indication to prevent, 
diagnose, or treat a rare disease or condition, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 20, 2014

   Mr. Bilirakis (for himself, Mr. Butterfield, Mr. McCaul, and Mr. 
Hastings of Florida) 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 a 6-
month extension of certain exclusivity periods in the case of approved 
 drugs that are subsequently approved for a new indication to prevent, 
diagnose, or treat a rare disease or condition, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Orphan Product Extensions Now 
Accelerating Cures and Treatments Act of 2014''.

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)(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 notice being given by the Secretary under 
                paragraph (4) respecting the designation of the drug.
            ``(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) shall be made available to the 
        public.
    ``(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) the 4-, 5-, and seven and one-half 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
            ``(B) 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
            ``(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).
    ``(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, 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 subsection (a)(1)(B)(i) 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.''.
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