Leo’s Law

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1805 Introduced in House (IH)]

&lt;DOC&gt;






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 incentives under 
the Federal Food, Drug, and Cosmetic Act 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 ``Leo's Law''.

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)(vii) of such Act (21 U.S.C. 
        355(j)(2)(A)(vii)), 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.
                                 &lt;all&gt;
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