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 incentives under the Federal Food, Drug, and Cosmetic Act 

for the development of orphan drugs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as ‘‘Leo’s Law’’. 


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1 SEC. 2. MITIGATION OF EFFECTS OF COVID–19 PANDEMIC 

2 ON ORPHAN-DRUG DEVELOPMENT INCEN3 TIVES. 

4 (a) IN GENERAL.—In the case of a covered orphan 

5 drug, each of the following exclusivity periods is deemed 

6 to be extended by 180 days, so long as such period is not 

7 expired: 

8 (1) The 12-year period referred to in subpara9 graph (A) of section 351(k)(7) of the Public Health 

10 Service Act (42 U.S.C. 262(k)(7)). 

11 (2) The 5-year period referred to in subsection 

12 (c)(3)(E)(ii) and subsection (j)(5)(F)(ii) of section 

13 505 of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 355). 

15 (3) The 3-year period referred to in each of 

16 clauses (iii) and (iv) of subsection (c)(3)(E) and 

17 clauses (iii) and (iv) of subsection (j)(5)(F) of sec18 tion 505 of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 355). 

20 (4) The 7-year period referred to in section 

21 527(a) of the Federal, Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 360cc). 

23 (5) In the case of a covered orphan drug with 

24 one or more certifications specified in clauses (ii), 

25 (iii), and (iv) of section 505(b)(2)(A) of the Federal 

26 Food, Drug, and Cosmetic Act (21 U.S.C. 


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1 355(b)(2)(A)), or in subclauses (II), (III), and (IV) 

2 of section 505(j)(2)(A)(vii) of such Act (21 U.S.C. 

3 355(j)(2)(A)(vii)), each corresponding patent-related 

4 approval-delay period (other than a patent for which 

5 the information required pursuant to subsection (b) 

6 or (c) of section 505 of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355) has not been filed). 

8 (b) CONFORMING EXTENSIONS.—In addition to the 

9 periods extended under subsection (a) for a covered or10 phan drug, the following periods are each deemed to be 

11 extended by 180 days: 

12 (1) The 4-year period referred to in subpara13 graph (B) of section 351(k)(7) of the Public Health 

14 Service Act (42 U.S.C. 262(k)(7)). 

15 (2) The 4-year, 48-month, and 7 and one-half16 year periods referred to in subsection (c)(3)(E)(ii) 

17 and subsection (j)(5)(F)(ii) of section 505 of the 

18 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 355). 

20 (c) DEFINITIONS.—In this section: 

21 (1) The term ‘‘covered orphan drug’’ means an 

22 orphan drug for which— 

23 (A) an application is submitted under sec24 tion 505(i) of the Federal Food, Drug, and 

25 Cosmetic Act (21 U.S.C. 355(i)) during the 


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1 COVID–19 emergency period (without regard 

2 to whether the same applicant has submitted 

3 such applications for the same drug before De4 cember 1, 2019, for a different rare disease or 

5 condition); 

6 (B) an application under section 505(b) of 

7 the Federal Food, Drug, and Cosmetic Act or 

8 under section 351(a) of the Public Health Serv9 ice Act (or a supplemental application, as the 

10 case may be) is approved pursuant to the inves11 tigational new drug application referred to in 

12 paragraph (1); and 

13 (C) there is no approved indication that is 

14 not for a rare disease or condition. 

15 (2) The term ‘‘corresponding patent-related ap16 proval delay period’’, with respect to a covered or17 phan drug, means the period ending with the last 

18 applicable date for the approval of an application 

19 within the meaning of subparagraph (A), (B), or (C) 

20 of section 505(c)(3) of the Federal, Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 355(c)(3)), or clause (i), 

22 (ii), or (iii) of section 505(j)(5)(B) of such Act (21 

23 U.S.C. 355(j)(5)(B)), whichever applies pursuant to 

24 the applicable patent certification. 


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1 (3) The term ‘‘orphan drug’’ means a drug that 

2 the Secretary has designated as a drug for a rare 

3 disease or condition under section 526(a) of the 

4 Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 

5 360bb(a)). 

6 (4) The term ‘‘COVID–19 emergency period’’ 

7 means the period beginning on December 1, 2019, 

8 and ending on the date that is not later than 120 

9 days before the date on which the emergency period 

10 (as defined in section 1135(g)(1)(B) of the Social 

11 Security Act (42 U.S.C. 1320b–5(g)(1)(B))) termi12 nates. 

13 (5) The term ‘‘rare disease or condition’’ has 

14 the meaning given such term in section 526 of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 360bb). 

17 (d) EFFECTIVE DATE.—This section takes effect 

18 upon the date of the enactment of this Act, without regard 

19 to whether the Secretary has issued guidance or regula20 tions regarding the implementation of this Act. 

Æ 


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