Title: OPEN Act
Policy area: Health

Summary:
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) 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).
HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.
HHS must notify the public of products that receive this extension and patents related to those products.
Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1223 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 1223

   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 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.

    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'' or the ``OPEN Act''.

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 (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\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.''.
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