I 

116TH CONGRESS 

1ST SESSION H. R. 5497 

To amend the Federal Food, Drug, and Cosmetic Act to establish a timelimited conditional approval pathway, subject to specific obligations, for 

certain drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 19, 2019 

Mr. WESTERMAN (for himself, Mr. GALLAGHER, and Mr. BURCHETT) 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 

establish a time-limited conditional approval pathway, 

subject to specific obligations, for certain 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 the ‘‘Conditional Approval 

5 Act’’. 


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1 SEC. 2. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS. 

2 (a) IN GENERAL.—Subchapter A of chapter V of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

4 et seq.) is amended by adding at the end the following: 

5 ‘‘SEC. 524B. CONDITIONAL AND TIME-LIMITED APPROVAL 

6 PATHWAY FOR NEW DRUGS. 

7 ‘‘(a) PATHWAY REQUIREMENTS.—The Secretary 

8 shall, at the request of the sponsor of a new drug, grant 

9 provisional and time-limited approval of such drug under 

10 this section, if the Secretary determines— 

11 ‘‘(1) it is likely that the sponsor will be able to 

12 provide comprehensive clinical data after such drug 

13 is conditionally approved; 

14 ‘‘(2) such drug is intended for the treatment, 

15 prevention, or medical diagnosis of a seriously debili16 tating disease, a life-threatening disease, or a chron17 ic condition; 

18 ‘‘(3) the expected benefits of the drug outweigh 

19 the potential risks to patients, taking into account 

20 the fact that additional data are still required to as21 sess the drug and the severity of the underlying dis22 ease or condition the drug is intended to treat; 

23 ‘‘(4) there are no existing meaningful treat24 ments for the disease or condition that the drug is 

25 intended to treat; 


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1 ‘‘(5) confirmatory clinical trials are difficult or 

2 costly to conduct; and 

3 ‘‘(6) such drug is intended to treat a disease or 

4 condition for which no more than 2 meaningful 

5 treatments currently exist. 

6 ‘‘(b) APPROVAL REQUIREMENTS.— 

7 ‘‘(1) IN GENERAL.—Not later than 180 days 

8 after the date on which the Secretary receives a re9 quest for conditional approval under subsection (a) 

10 with respect to a new drug, the Secretary shall re11 quire the sponsor of such drug to— 

12 ‘‘(A) complete in a timely manner clinical 

13 investigations to provide full demonstration of 

14 safety and effectiveness as described under sec15 tion 505 of the Federal Food, Drug, and Cos16 metic Act or section 351 of the Public Health 

17 Service Act, as applicable; 

18 ‘‘(B) conduct clinical trials other than con19 firmatory trials, to demonstrate a certain de20 gree of safety and efficacy of the drug; and 

21 ‘‘(C) demonstrate that necessary post-mar22 ket surveillance and risk-management tools are 

23 in place with respect to the drug. 

24 ‘‘(2) PERIOD OF CONDITIONAL APPROVAL.— 

25 The period of conditional approval for a drug under 


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1 this section is effective for a 1-year period and is 

2 thereafter renewable by the Secretary annually for 

3 up to 4 additional 1-year terms. A conditional ap4 proval shall be in effect for no more than 5 years 

5 from the date of approval under this section. 

6 ‘‘(3) TIME LIMITATION.—If any conditionally 

7 drug approved under this section is not brought to 

8 market within 3 years of the conditional approval, 

9 any conditional approval granted under this section 

10 with respect to such drug shall be deemed invalid. 

11 ‘‘(4) REQUIREMENTS.—As a condition on re12 ceipt of conditional approval under this section, the 

13 Secretary shall require the sponsor of the drug to 

14 agree to the following: 

15 ‘‘(A) Complete in a timely manner such 

16 clinical investigations to provide a full dem17 onstration of effectiveness as the Secretary de18 termines to be necessary for approval of the 

19 drug under section 505 of this Act or section 

20 351 of the Public Health Service Act, as appli21 cable. 

22 ‘‘(B) Submit to the Secretary an annual 

23 report on the progress of the sponsor in con24 ducting the clinical investigations required 

25 under this section. 


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1 ‘‘(C) Ensure that all labeling and pro2 motional materials for the drug bear the state3 ment ‘conditionally approved by the FDA pend4 ing a full demonstration of effectiveness under 

5 applicable lll’ (specifying the application 

6 number assigned by the Secretary in place of 

7 the blank). 

8 ‘‘(5) APPLYING FOR FULL APPROVAL.—The 

9 sponsor of a drug granted conditional approval pur10 suant to this section may, at any point, submit an 

11 application for full approval as described under sec12 tion 505 of the Federal Food, Drug, and Cosmetic 

13 Act or section 351 of the Public Health Service Act, 

14 as applicable. 

15 ‘‘(6) UTILIZATION OF REAL WORLD EVIDENCE

16 TO SUPPORT FULL APPROVAL.—The Secretary shall 

17 allow the use of real world evidence, as defined in 

18 section 505F(b), and collected by the sponsor of a 

19 drug during the duration of conditional approval 

20 granted approval to this subsection, to supplement 

21 an application for full approval, in addition to other 

22 post-approval studies. 

23 ‘‘(c) LIMITATION ON LIABILITY.— 

24 ‘‘(1) IN GENERAL.—With respect to any claim 

25 under State law alleging that a drug sold or otherVerDate Sep 11 2014 19:13 Dec 21, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5497.IH H5497

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1 wise made available pursuant to a grant of condi2 tional approval under this section is unsafe or inef3 fective, no liability in a cause of action shall lie 

4 against a sponsor or manufacturer, unless the rel5 evant conduct constitutes reckless or willful mis6 conduct, gross negligence, or an intention tort under 

7 any applicable State law. 

8 ‘‘(2) RULE OF CONSTRUCTION.—Except as set 

9 forth in subparagraph (A), nothing in this sub10 section shall be construed to modify or otherwise af11 fect the right of any person to bring private action 

12 under any Federal or State product liability, tort, 

13 consumer protection, or warranty law. 

14 ‘‘(d) DEFINITIONS.—In this Act: 

15 ‘‘(1) SERIOUSLY DEBILITATING DISEASES.— 

16 The term ‘severely debilitating diseases’ means dis17 eases or conditions that cause major irreversible 

18 morbidity. 

19 ‘‘(2) LIFE-THREATENING DISEASES.—The term 

20 ‘life-threatening diseases’ means— 

21 ‘‘(A) a disease or condition where the like22 lihood of death is high unless the course of the 

23 disease is interrupted; or 


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1 ‘‘(B) a disease or condition with potentially 

2 fatal outcomes, where the end point of clinical 

3 trial analysis is survival. 

4 ‘‘(3) CHRONIC CONDITION.—The term ‘chronic 

5 condition’ means a disease or condition that— 

6 ‘‘(A) usually lasts for 3 months or longer; 

7 and 

8 ‘‘(B)(i) requires ongoing medical attention; 

9 or 

10 ‘‘(ii) limits activities of daily living.’’. 

11 (b) REGULATIONS AND GUIDANCE.—Not later than 

12 1 year after the date of the enactment of this Act, the 

13 Secretary of Health and Human Services shall issue final 

14 regulations and guidance for carrying out section 524B 

15 of the Federal Food, Drug, and Cosmetic Act. 

16 (c) CONFORMING AMENDMENT.—Section 505(a) of 

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

18 355(a)) is amended by inserting ‘‘, or there is in effect 

19 a conditional approval under section 524B with respect 

20 to such drug’’ before the period. 

Æ 


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