[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8641 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 8641
To mitigate the effects of the COVID-19 pandemic on incentives under
the Federal Food, Drug, and Cosmetic for the development of orphan
drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 2, 2022
Mr. Gottheimer (for himself, Mr. Bacon, and Ms. Dean) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To mitigate the effects of the COVID-19 pandemic on incentives under
the Federal Food, Drug, and Cosmetic for the development of orphan
drugs, 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 Drug COVID-19 Mitigation Act
of 2022''.
SEC. 2. MITIGATION OF EFFECTS OF COVID-19 PANDEMIC ON ORPHAN-DRUG
DEVELOPMENT INCENTIVES.
(a) In General.--In the case of a covered orphan drug, each of the
following exclusivity periods is deemed to be extended by 180 days, so
long as such period is not expired:
(1) The 12-year period referred to in subparagraph (A) of
section 351(k)(7) of the Public Health Service Act (42 U.S.C.
262(k)(7)).
(2) The 5-year period referred to in subsection
(c)(3)(E)(ii) and subsection (j)(5)(F)(ii) of section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
(3) The 3-year period referred to in each of clauses (iii)
and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of
subsection (j)(5)(F) of section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355).
(4) The 7-year period referred to in section 527(a) of the
Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 360cc).
(5) In the case of a covered orphan drug with one or more
certifications specified in clauses (ii), (iii), and (iv) of
section 505(b)(2)(A) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)(2)(A)), or in subclauses (II), (III), and
(IV) of section 505(j)(2)(A) of such Act (21 U.S.C.
355(j)(2)(A)), each corresponding patent-related approval-delay
period (other than a patent for which the information required
pursuant to subsection (b) or (c) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) has not been
filed).
(b) Conforming Extensions.--In addition to the periods extended
under subsection (a) for a covered orphan drug, the following periods
are each deemed to be extended by 180 days:
(1) The 4-year period referred to in subparagraph (B) of
section 351(k)(7) of the Public Health Service Act (42 U.S.C.
262(k)(7)).
(2) The 4-year, 48-month, and 7 and one-half-year periods
referred to in subsection (c)(3)(E)(ii) and subsection
(j)(5)(F)(ii) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355).
(c) Definitions.--In this section:
(1) The term ``covered orphan drug'' means an orphan drug
for which--
(A) an application is submitted under section
505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)) during the COVID-19 emergency period
(without regard to whether the same applicant has
submitted such applications for the same drug before
December 1, 2019, for a different rare disease or
condition);
(B) an application under section 505(b) of the
Federal Food, Drug, and Cosmetic Act or under section
351(a) of the Public Health Service Act (or a
supplemental application, as the case may be) is
approved pursuant to the investigational new drug
application referred to in paragraph (1); and
(C) there is no approved indication that is not for
a rare disease or condition.
(2) The term ``corresponding patent-related approval delay
period'', with respect to a covered orphan drug, means the
period ending with the last applicable date for the approval of
an application within the meaning of subparagraph (A), (B), or
(C) of section 505(c)(3) of the Federal, Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)(3)), or clause (i), (ii), or
(iii) of section 505(j)(5)(B) of such Act (21 U.S.C.
355(j)(5)(B)), whichever applies pursuant to the applicable
patent certification.
(3) The term ``orphan drug'' means a drug that the
Secretary has designated as a drug for a rare disease or
condition under section 526(a) of the Federal, Food, Drug, and
Cosmetic Act (21 U.S.C. 360bb(a)).
(4) The term ``COVID-19 emergency period'' means the period
beginning on December 1, 2019, and ending on the date that is
not later than 120 days before the date on which the emergency
period (as defined in section 1135(g)(1)(B) of the Social
Security Act (42 U.S.C. 1320b-5(g)(1)(B))) terminates.
(5) The term ``rare disease or condition'' has the meaning
given such term in section 526 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bb).
(d) Effective Date.--This section takes effect upon the date of the
enactment of this Act, without regard to whether the Secretary has
issued guidance or regulations regarding the implementation of this
Act.
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