I 

117TH CONGRESS 

1ST SESSION H. R. 3705 

To amend the Federal Food, Drug, and Cosmetic Act to include a safe 

harbor for communication of information with respect to a vaccine authorized for emergency use under such Act that is provided or distributed 

to a health care provider, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 4, 2021 

Mr. GRIFFITH 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 

include a safe harbor for communication of information 

with respect to a vaccine authorized for emergency use 

under such Act that is provided or distributed to a 

health care provider, 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, 


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1 SECTION 1. SAFE HARBOR FOR COMMUNICATIONS ABOUT 

2 VACCINES AUTHORIZED FOR EMERGENCY 

3 USE. 

4 (a) IN GENERAL.—The Federal Food, Drug, and 

5 Cosmetic Act is amended by inserting after section 502 

6 (21 U.S.C. 352) the following: 

7 ‘‘SEC. 502A. SAFE HARBOR FOR COMMUNICATIONS ABOUT 

8 VACCINES AUTHORIZED FOR EMERGENCY 

9 USE. 

10 ‘‘(a) IN GENERAL.—The communication of informa11 tion (through written or oral means), described in sub12 section (b), with respect to the use of a vaccine authorized 

13 for emergency use under section 564 provided or distrib14 uted to a covered health care entity shall not be a basis 

15 for treating such vaccine as, or be treated as evidence that 

16 such vaccine is— 

17 ‘‘(1) misbranded under subsection (a) or (f) of 

18 section 502; or 

19 ‘‘(2) in violation of section 505 or 564 of this 

20 Act or subsection (a) or (k) of section 351(a)(1) of 

21 the Public Health Service Act, as applicable. 

22 ‘‘(b) INFORMATION DESCRIBED.—Information de23 scribed in this subsection is any information relating to 

24 a use of a vaccine authorized for emergency use under sec25 tion 564 within the scope of that authorization that— 


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1 ‘‘(1) is neither false nor misleading, when meas2 ured objectively against the information available at 

3 the time the statement is made; 

4 ‘‘(2) is accompanied, as required, by an appro5 priate disclaimer, including— 

6 ‘‘(A) a statement identifying any dif7 ferences between the information and any au8 thorized labeling of the vaccine; 

9 ‘‘(B) a statement identifying contradictory 

10 evidence; and 

11 ‘‘(C) such other information as may be re12 quired by regulation; and 

13 ‘‘(3) is based on competent and reliable sci14 entific evidence, as described in subsection (e). 

15 ‘‘(c) COVERAGE NOT EXCLUDED.—The distribution 

16 of information that otherwise meets the requirements of 

17 this section shall not fail to meet the requirements of sub18 section (a) because the manufacturer or distributor of the 

19 vaccine about which information is being distributed has— 

20 ‘‘(1) knowledge that such vaccine is being used 

21 by patients or health care practitioners in a manner 

22 not described in any authorized labeling of the vac23 cine, as applicable; or 


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1 ‘‘(2) objective or subjective intent that such 

2 vaccine be used in a manner inconsistent with any 

3 labeling, as applicable, of such vaccine. 

4 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec5 tion shall be construed— 

6 ‘‘(1) to limit communication to which this sec7 tion does not specifically apply; or 

8 ‘‘(2) to alter or expand the authority of the Sec9 retary to enforce the provisions of this Act of section 

10 351 of the Public Health Service Act, except with 

11 respect to the communication of information to 

12 which this section specifically applies. 

13 ‘‘(e) DEFINITIONS.—In this section: 

14 ‘‘(1) COMPETENT AND RELIABLE SCIENTIFIC

15 EVIDENCE.— 

16 ‘‘(A) IN GENERAL.—In this section, the 

17 term ‘competent and reliable scientific evidence’ 

18 means evidence established through scientific 

19 methods that are widely accepted by experts in 

20 the relevant field and followed pursuant to a 

21 clear and well-described protocol, as scientif22 ically appropriate, regardless of whether such 

23 evidence is supported by 2 adequate and well24 controlled clinical studies. 


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1 ‘‘(B) INCLUSIONS.—Such term may in2 clude information— 

3 ‘‘(i) derived from clinical trials, obser4 vational studies, clinical studies or bench 

5 tests that describe performance, database 

6 reviews, registries, patient utilization pro7 jections, and modeling techniques, and the 

8 data, inputs, and components of such in9 formation; 

10 ‘‘(ii) about the effects of a vaccine in 

11 subgroups defined by demographic or other 

12 variables, including groups defined by race, 

13 sex, risk factors, or other variables, such 

14 as genomic features or disease severity; 

15 ‘‘(iii) related to the authorization for 

16 emergency use under section 564, as appli17 cable; and 

18 ‘‘(iv) relating to the safety, effective19 ness, or benefit of a use or treatment that 

20 is authorized for emergency use under sec21 tion 564 for a vaccine, including informa22 tion regarding— 

23 ‘‘(I) health outcomes, patient or 

24 caregiver experience, or other quality 

25 metrics; and 


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1 ‘‘(II) the comparative effective2 ness of a vaccine relative to other 

3 products, other health care interven4 tions, program and quality improve5 ment interventions, or no intervention. 

6 ‘‘(2) COVERED HEALTH CARE ENTITY.—The 

7 term ‘covered health care entity’ means a health 

8 care provider, health care institution, payor, for9 mulary committee, or other similar entity carrying 

10 out responsibilities for making drug coverage, reim11 bursement, or usage decisions on a population 

12 basis.’’. 

Æ 


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