What This Bill Does
This bill extends certain time periods for orphan drugs (medicines for rare diseases) that had applications submitted during the COVID-19 emergency. The bill adds 180 days to several protection periods that drug companies rely on when developing these medicines.
Who It Affects
Companies developing orphan drugs that submitted applications during the COVID-19 emergency period will be affected. The Food and Drug Administration and the Public Health Service will implement these changes.
Key Provisions
- For covered orphan drugs, the 12-year protection period gets extended by 180 days as long as it has not already expired (Sec. 2(a)(1))
- For covered orphan drugs, the 5-year protection period gets extended by 180 days as long as it has not already expired (Sec. 2(a)(2))
- For covered orphan drugs, the 3-year protection periods get extended by 180 days as long as they have not already expired (Sec. 2(a)(3))
- For covered orphan drugs, the 7-year protection period gets extended by 180 days as long as it has not already expired (Sec. 2(a)(4))
- For covered orphan drugs with certain patent documents filed, patent-related approval delays get extended by 180 days (Sec. 2(a)(5))
What Changes
If this law passes, companies with covered orphan drugs will receive an extra 180 days of exclusivity (protection from competing drugs) during certain periods. These extensions apply to drugs that are not yet expired and had applications submitted between December 1, 2019 and a date not later than 120 days before the COVID-19 emergency ends.
Important Definitions
- "Covered orphan drug": An orphan drug that had an investigational application submitted during the COVID-19 emergency period, that later received approval, and has only been approved for rare diseases or conditions (Sec. 2(c)(1))
- "Orphan drug": A medicine the Secretary of Health and Human Services designated as a drug for a rare disease or condition (Sec. 2(c)(3))
- "COVID-19 emergency period": The time beginning December 1, 2019 and ending not later than 120 days before the COVID-19 emergency officially ends (Sec. 2(c)(4))
- "Rare disease or condition": As defined in section 526 of the Federal Food, Drug, and Cosmetic Act (Sec. 2(c)(5))
Effective Date
The law takes effect on the date it is enacted, regardless of whether the Secretary has issued guidance or regulations (Sec. 2(d))
I
118TH CONGRESS
1ST SESSION H. R. 1805
To mitigate the effects of the COVID–19 pandemic on incentives under
the Federal Food, Drug, and Cosmetic Act for the development of orphan
drugs, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 27, 2023
Mr. GOTTHEIMER (for himself and Mr. BACON) 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 incen-
tives under the Federal Food, Drug, and Cosmetic Act
for the development of orphan drugs, and for other pur-
poses.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as ‘‘Leo’s Law’’.
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•HR 1805 IH
SEC. 2. MITIGATION OF EFFECTS OF COVID–19 PANDEMIC
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ON ORPHAN-DRUG DEVELOPMENT INCEN-
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TIVES.
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(a) IN GENERAL.—In the case of a covered orphan
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drug, each of the following exclusivity periods is deemed
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to be extended by 180 days, so long as such period is not
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expired:
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(1) The 12-year period referred to in subpara-
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graph (A) of section 351(k)(7) of the Public Health
9
Service Act (42 U.S.C. 262(k)(7)).
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(2) The 5-year period referred to in subsection
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(c)(3)(E)(ii) and subsection (j)(5)(F)(ii) of section
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505 of the Federal Food, Drug, and Cosmetic Act
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(21 U.S.C. 355).
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(3) The 3-year period referred to in each of
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clauses (iii) and (iv) of subsection (c)(3)(E) and
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clauses (iii) and (iv) of subsection (j)(5)(F) of sec-
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tion 505 of the Federal Food, Drug, and Cosmetic
18
Act (21 U.S.C. 355).
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(4) The 7-year period referred to in section
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527(a) of the Federal, Food, Drug, and Cosmetic
21
Act (21 U.S.C. 360cc).
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(5) In the case of a covered orphan drug with
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one or more certifications specified in clauses (ii),
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(iii), and (iv) of section 505(b)(2)(A) of the Federal
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Food,
Drug,
and
Cosmetic
Act
(21
U.S.C.
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•HR 1805 IH
355(b)(2)(A)), or in subclauses (II), (III), and (IV)
1
of section 505(j)(2)(A)(vii) of such Act (21 U.S.C.
2
355(j)(2)(A)(vii)), each corresponding patent-related
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approval-delay period (other than a patent for which
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the information required pursuant to subsection (b)
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or (c) of section 505 of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 355) has not been filed).
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(b) CONFORMING EXTENSIONS.—In addition to the
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periods extended under subsection (a) for a covered or-
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phan drug, the following periods are each deemed to be
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extended by 180 days:
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(1) The 4-year period referred to in subpara-
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graph (B) of section 351(k)(7) of the Public Health
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Service Act (42 U.S.C. 262(k)(7)).
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(2) The 4-year, 48-month, and 7 and one-half-
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year periods referred to in subsection (c)(3)(E)(ii)
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and subsection (j)(5)(F)(ii) of section 505 of the
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Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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355).
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(c) DEFINITIONS.—In this section:
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(1) The term ‘‘covered orphan drug’’ means an
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orphan drug for which—
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(A) an application is submitted under sec-
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tion 505(i) of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 355(i)) during the
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•HR 1805 IH
COVID–19 emergency period (without regard
1
to whether the same applicant has submitted
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such applications for the same drug before De-
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cember 1, 2019, for a different rare disease or
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condition);
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(B) an application under section 505(b) of
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the Federal Food, Drug, and Cosmetic Act or
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under section 351(a) of the Public Health Serv-
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ice Act (or a supplemental application, as the
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case may be) is approved pursuant to the inves-
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tigational new drug application referred to in
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paragraph (1); and
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(C) there is no approved indication that is
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not for a rare disease or condition.
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(2) The term ‘‘corresponding patent-related ap-
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proval delay period’’, with respect to a covered or-
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phan drug, means the period ending with the last
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applicable date for the approval of an application
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within the meaning of subparagraph (A), (B), or (C)
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of section 505(c)(3) of the Federal, Food, Drug, and
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Cosmetic Act (21 U.S.C. 355(c)(3)), or clause (i),
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(ii), or (iii) of section 505(j)(5)(B) of such Act (21
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U.S.C. 355(j)(5)(B)), whichever applies pursuant to
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the applicable patent certification.
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•HR 1805 IH
(3) The term ‘‘orphan drug’’ means a drug that
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the Secretary has designated as a drug for a rare
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disease or condition under section 526(a) of the
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Federal, Food, Drug, and Cosmetic Act (21 U.S.C.
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360bb(a)).
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(4) The term ‘‘COVID–19 emergency period’’
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means the period beginning on December 1, 2019,
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and ending on the date that is not later than 120
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days before the date on which the emergency period
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(as defined in section 1135(g)(1)(B) of the Social
10
Security Act (42 U.S.C. 1320b–5(g)(1)(B))) termi-
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nates.
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(5) The term ‘‘rare disease or condition’’ has
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the meaning given such term in section 526 of the
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Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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360bb).
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(d) EFFECTIVE DATE.—This section takes effect
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upon the date of the enactment of this Act, without regard
18
to whether the Secretary has issued guidance or regula-
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tions regarding the implementation of this Act.
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Æ
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