[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1421 Introduced in Senate (IS)]
114th CONGRESS
1st Session
S. 1421
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 SENATE OF THE UNITED STATES
May 21, 2015
Mr. Hatch (for himself and Ms. Klobuchar) 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 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 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 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 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
``(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)(A) 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
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) 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).
``(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) 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 and 505F, 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 505F.''.
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