[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 971 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 971
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
February 13, 2015
Mr. Bilirakis (for himself, Mr. McCaul, and Mr. Butterfield) 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 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.''.
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