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.

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 au- thorized 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 03:14 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3705.IH H3705 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3705 IH SECTION 1. SAFE HARBOR FOR COMMUNICATIONS ABOUT 1 VACCINES AUTHORIZED FOR EMERGENCY 2 USE. 3 (a) IN GENERAL.—The Federal Food, Drug, and 4 Cosmetic Act is amended by inserting after section 502 5 (21 U.S.C. 352) the following: 6 ‘‘SEC. 502A. SAFE HARBOR FOR COMMUNICATIONS ABOUT 7 VACCINES AUTHORIZED FOR EMERGENCY 8 USE. 9 ‘‘(a) IN GENERAL.—The communication of informa- 10 tion (through written or oral means), described in sub- 11 section (b), with respect to the use of a vaccine authorized 12 for emergency use under section 564 provided or distrib- 13 uted to a covered health care entity shall not be a basis 14 for treating such vaccine as, or be treated as evidence that 15 such vaccine is— 16 ‘‘(1) misbranded under subsection (a) or (f) of 17 section 502; or 18 ‘‘(2) in violation of section 505 or 564 of this 19 Act or subsection (a) or (k) of section 351(a)(1) of 20 the Public Health Service Act, as applicable. 21 ‘‘(b) INFORMATION DESCRIBED.—Information de- 22 scribed in this subsection is any information relating to 23 a use of a vaccine authorized for emergency use under sec- 24 tion 564 within the scope of that authorization that— 25 VerDate Sep 11 2014 03:14 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3705.IH H3705 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3705 IH ‘‘(1) is neither false nor misleading, when meas- 1 ured objectively against the information available at 2 the time the statement is made; 3 ‘‘(2) is accompanied, as required, by an appro- 4 priate disclaimer, including— 5 ‘‘(A) a statement identifying any dif- 6 ferences between the information and any au- 7 thorized labeling of the vaccine; 8 ‘‘(B) a statement identifying contradictory 9 evidence; and 10 ‘‘(C) such other information as may be re- 11 quired by regulation; and 12 ‘‘(3) is based on competent and reliable sci- 13 entific evidence, as described in subsection (e). 14 ‘‘(c) COVERAGE NOT EXCLUDED.—The distribution 15 of information that otherwise meets the requirements of 16 this section shall not fail to meet the requirements of sub- 17 section (a) because the manufacturer or distributor of the 18 vaccine about which information is being distributed has— 19 ‘‘(1) knowledge that such vaccine is being used 20 by patients or health care practitioners in a manner 21 not described in any authorized labeling of the vac- 22 cine, as applicable; or 23 VerDate Sep 11 2014 03:14 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3705.IH H3705 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3705 IH ‘‘(2) objective or subjective intent that such 1 vaccine be used in a manner inconsistent with any 2 labeling, as applicable, of such vaccine. 3 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec- 4 tion shall be construed— 5 ‘‘(1) to limit communication to which this sec- 6 tion does not specifically apply; or 7 ‘‘(2) to alter or expand the authority of the Sec- 8 retary to enforce the provisions of this Act of section 9 351 of the Public Health Service Act, except with 10 respect to the communication of information to 11 which this section specifically applies. 12 ‘‘(e) DEFINITIONS.—In this section: 13 ‘‘(1) COMPETENT AND RELIABLE SCIENTIFIC 14 EVIDENCE.— 15 ‘‘(A) IN GENERAL.—In this section, the 16 term ‘competent and reliable scientific evidence’ 17 means evidence established through scientific 18 methods that are widely accepted by experts in 19 the relevant field and followed pursuant to a 20 clear and well-described protocol, as scientif- 21 ically appropriate, regardless of whether such 22 evidence is supported by 2 adequate and well- 23 controlled clinical studies. 24 VerDate Sep 11 2014 03:14 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3705.IH H3705 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3705 IH ‘‘(B) INCLUSIONS.—Such term may in- 1 clude information— 2 ‘‘(i) derived from clinical trials, obser- 3 vational studies, clinical studies or bench 4 tests that describe performance, database 5 reviews, registries, patient utilization pro- 6 jections, and modeling techniques, and the 7 data, inputs, and components of such in- 8 formation; 9 ‘‘(ii) about the effects of a vaccine in 10 subgroups defined by demographic or other 11 variables, including groups defined by race, 12 sex, risk factors, or other variables, such 13 as genomic features or disease severity; 14 ‘‘(iii) related to the authorization for 15 emergency use under section 564, as appli- 16 cable; and 17 ‘‘(iv) relating to the safety, effective- 18 ness, or benefit of a use or treatment that 19 is authorized for emergency use under sec- 20 tion 564 for a vaccine, including informa- 21 tion regarding— 22 ‘‘(I) health outcomes, patient or 23 caregiver experience, or other quality 24 metrics; and 25 VerDate Sep 11 2014 03:14 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3705.IH H3705 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 3705 IH ‘‘(II) the comparative effective- 1 ness of a vaccine relative to other 2 products, other health care interven- 3 tions, program and quality improve- 4 ment interventions, or no intervention. 5 ‘‘(2) COVERED HEALTH CARE ENTITY.—The 6 term ‘covered health care entity’ means a health 7 care provider, health care institution, payor, for- 8 mulary committee, or other similar entity carrying 9 out responsibilities for making drug coverage, reim- 10 bursement, or usage decisions on a population 11 basis.’’. 12 Æ VerDate Sep 11 2014 03:14 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H3705.IH H3705 kjohnson on DSK79L0C42PROD with BILLS