Title: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Policy area: Health

Summary:
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
This bill 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 orphan disease). The FDA may revoke an extension if the application for the new indication contained an untrue material statement. The FDA must notify the public of products that receive this extension and patents related to those products. Products may receive only one of these extensions. This extension is in addition to other extensions. Only products approved after enactment of this bill for a new indication that is a rare disease or condition are eligible for an extension.
For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1509 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                S. 1509

   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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 29, 2017

Mr. Hatch (for himself and Mr. Menendez) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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 Products Extension Now 
Accelerating Cures and Treatments Act of 2017''.

SEC. 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:

``SEC. 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 (3) 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\1/2\-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.''.

SEC. 3. ORPHAN DRUGS.

    (a) In General.--Section 527 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc) is amended--
            (1) in subsection (a), in the matter following paragraph 
        (2), by striking ``such drug for such disease or condition'' 
        and inserting ``the same drug for the same disease or 
        condition'';
            (2) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``If an application'' and all that follows 
                through ``such license if'' and inserting ``During the 
                7-year period described in subsection (a) for an 
                approved application under section 505 or license under 
                section 351 of the Public Health Service Act, the 
                Secretary may approve an application or issue a license 
                for a drug that is otherwise the same, as determined by 
                the Secretary, as the already approved drug for the 
                same rare disease or condition if'';
                    (B) in paragraph (1), by striking ``notice'' and 
                all that follows through ``assure'' and inserting ``of 
                exclusive approval or licensure notice and opportunity 
                for the submission of views, that during such period 
                the holder of the exclusive approval or licensure 
                cannot ensure''; and
                    (C) in paragraph (2), by striking ``such holder 
                provides'' and inserting ``the holder provides''; and
            (3) by adding at the end the following:
    ``(c) Condition of Clinical Superiority.--
            ``(1) In general.--If a sponsor of a drug that is 
        designated under section 526 and is otherwise the same, as 
        determined by the Secretary, as an already approved or licensed 
        drug is seeking exclusive approval or exclusive licensure 
        described in subsection (a) for the same rare disease or 
        condition as the already approved drug, the Secretary shall 
        require such sponsor, as a condition of such exclusive approval 
        or licensure, to demonstrate that such drug is clinically 
        superior to any already approved or licensed drug that is the 
        same drug.
            ``(2) Definition.--For purposes of paragraph (1), 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 
        efficacy, greater safety, or by providing a major contribution 
        to patient care.
    ``(d) Regulations.--The Secretary may promulgate regulations for 
the implementation of subsection (c). Beginning on the date of 
enactment of the Orphan Products Extension Now Accelerating Cures and 
Treatments Act of 2017, until such time as the Secretary promulgates 
regulations in accordance with this subsection, the Secretary may apply 
any definitions set forth in regulations that were promulgated prior to 
such date of enactment, to the extent such definitions are not 
inconsistent with the terms of this section, as amended by such Act.
    ``(e) Demonstration of Clinical Superiority Standard.--To assist 
sponsors in demonstrating clinical superiority as described in 
subsection (c), the Secretary--
            ``(1) upon the designation of any drug under section 526, 
        shall notify the sponsor of such drug in writing of the basis 
        for the designation, including, as applicable, any plausible 
        hypothesis offered by the sponsor and relied upon by the 
        Secretary that the drug is clinically superior to a previously 
        approved drug; and
            ``(2) upon granting exclusive approval or licensure under 
        subsection (a) on the basis of a demonstration of clinical 
        superiority as described in subsection (c), shall publish a 
        summary of the clinical superiority findings.''.
    (b) Rule of Construction.--Nothing in the amendments made by 
subsection (a) shall affect any determination under sections 526 and 
527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 
360cc) made prior to the date of enactment of the Orphan Products 
Extension Now Accelerating Cures and Treatments Act of 2017.

SEC. 4. PEDIATRIC INFORMATION ADDED TO LABELING.

    Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a(o)) is amended--
            (1) in the subsection heading, by striking ``Under Section 
        505(j)'';
            (2) in paragraph (1)--
                    (A) by striking ``under section 505(j)'' and 
                inserting ``under subsection (b)(2) or (j) of section 
                505''; and
                    (B) by striking ``or by exclusivity under clause 
                (iii) or (iv) of section 505(j)(5)(F)'' and inserting 
                ``, or by exclusivity under clause (iii) or (iv) of 
                section 505(j)(5)(F), clauses (iii) and (iv) of section 
                505(c)(3)(E), or section 527(a), or by an extension of 
                such exclusivity under this section or section 505E'';
            (3) in paragraph (2), in the matter preceding subparagraph 
        (A)--
                    (A) by inserting ``clauses (iii) and (iv) of 
                section 505(c)(3)(E), or section 527,'' after ``section 
                505(j)(5)(F),''; and
                    (B) by striking ``drug approved under section 
                505(j)'' and inserting ``drug approved pursuant to an 
                application submitted under subsection (b)(2) or (j) of 
                section 505''; and
            (4) by amending paragraph (3) to read as follows:
            ``(3) Preservation of pediatric exclusivity and other 
        provisions.--This subsection does not affect--
                    ``(A) the availability or scope of exclusivity 
                under--
                            ``(i) this section;
                            ``(ii) section 505 for pediatric 
                        formulations; or
                            ``(iii) section 527;
                    ``(B) the question of the eligibility for approval 
                of any application under subsection (b)(2) or (j) of 
                section 505 that omits any other conditions of approval 
                entitled to exclusivity under--
                            ``(i) clause (iii) or (iv) of section 
                        505(j)(5)(F);
                            ``(ii) clause (iii) or (iv) of section 
                        505(c)(3)(E); or
                            ``(iii) section 527; or
                    ``(C) except as expressly provided in paragraphs 
                (1) and (2), the operation of section 505 or section 
                527.''.
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