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.
Bill: H.R.3705 | Sponsor: Rep. Griffith, H. Morgan (R-VA)
Policy area: Health

Summary:
This bill prohibits using certain communications to establish that a vaccine authorized for emergency use violates specified laws relating to drug safety, such as laws concerning drug misbranding and the authorization of new drugs.
Specifically, the bill applies to certain communications about the use of such a vaccine that has been provided to certain health care entities. Such a communication must be (1) neither false nor misleading when measured objectively against the available information at the time; (2) accompanied by certain disclaimers, if required, including a statement identifying any differences between the communicated information and the vaccine's authorized labeling; and (3) based on competent and reliable scientific evidence.

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SAFE HARBOR FOR COMMUNICATIONS ABOUT VACCINES AUTHORIZED FOR 
              EMERGENCY USE.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 502 (21 U.S.C. 352) the following:

``SEC. 502A. SAFE HARBOR FOR COMMUNICATIONS ABOUT VACCINES AUTHORIZED 
              FOR EMERGENCY USE.

    ``(a) In General.--The communication of information (through 
written or oral means), described in subsection (b), with respect to 
the use of a vaccine authorized for emergency use under section 564 
provided or distributed to a covered health care entity shall not be a 
basis for treating such vaccine as, or be treated as evidence that such 
vaccine is--
            ``(1) misbranded under subsection (a) or (f) of section 
        502; or
            ``(2) in violation of section 505 or 564 of this Act or 
        subsection (a) or (k) of section 351(a)(1) of the Public Health 
        Service Act, as applicable.
    ``(b) Information Described.--Information described in this 
subsection is any information relating to a use of a vaccine authorized 
for emergency use under section 564 within the scope of that 
authorization that--
            ``(1) is neither false nor misleading, when measured 
        objectively against the information available at the time the 
        statement is made;
            ``(2) is accompanied, as required, by an appropriate 
        disclaimer, including--
                    ``(A) a statement identifying any differences 
                between the information and any authorized labeling of 
                the vaccine;
                    ``(B) a statement identifying contradictory 
                evidence; and
                    ``(C) such other information as may be required by 
                regulation; and
            ``(3) is based on competent and reliable scientific 
        evidence, as described in subsection (e).
    ``(c) Coverage Not Excluded.--The distribution of information that 
otherwise meets the requirements of this section shall not fail to meet 
the requirements of subsection (a) because the manufacturer or 
distributor of the vaccine about which information is being distributed 
has--
            ``(1) knowledge that such vaccine is being used by patients 
        or health care practitioners in a manner not described in any 
        authorized labeling of the vaccine, as applicable; or
            ``(2) objective or subjective intent that such vaccine be 
        used in a manner inconsistent with any labeling, as applicable, 
        of such vaccine.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
            ``(1) to limit communication to which this section does not 
        specifically apply; or
            ``(2) to alter or expand the authority of the Secretary to 
        enforce the provisions of this Act of section 351 of the Public 
        Health Service Act, except with respect to the communication of 
        information to which this section specifically applies.
    ``(e) Definitions.--In this section:
            ``(1) Competent and reliable scientific evidence.--
                    ``(A) In general.--In this section, the term 
                `competent and reliable scientific evidence' means 
                evidence established through scientific methods that 
                are widely accepted by experts in the relevant field 
                and followed pursuant to a clear and well-described 
                protocol, as scientifically appropriate, regardless of 
                whether such evidence is supported by 2 adequate and 
                well-controlled clinical studies.
                    ``(B) Inclusions.--Such term may include 
                information--
                            ``(i) derived from clinical trials, 
                        observational studies, clinical studies or 
                        bench tests that describe performance, database 
                        reviews, registries, patient utilization 
                        projections, and modeling techniques, and the 
                        data, inputs, and components of such 
                        information;
                            ``(ii) about the effects of a vaccine in 
                        subgroups defined by demographic or other 
                        variables, including groups defined by race, 
                        sex, risk factors, or other variables, such as 
                        genomic features or disease severity;
                            ``(iii) related to the authorization for 
                        emergency use under section 564, as applicable; 
                        and
                            ``(iv) relating to the safety, 
                        effectiveness, or benefit of a use or treatment 
                        that is authorized for emergency use under 
                        section 564 for a vaccine, including 
                        information regarding--
                                    ``(I) health outcomes, patient or 
                                caregiver experience, or other quality 
                                metrics; and
                                    ``(II) the comparative 
                                effectiveness of a vaccine relative to 
                                other products, other health care 
                                interventions, program and quality 
                                improvement interventions, or no 
                                intervention.
            ``(2) Covered health care entity.--The term `covered health 
        care entity' means a health care provider, health care 
        institution, payor, formulary committee, or other similar 
        entity carrying out responsibilities for making drug coverage, 
        reimbursement, or usage decisions on a population basis.''.
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