Title: SAVE Act
Policy area: Health

Summary:
Safe Authorization for Vaccines during Emergencies Act or the SAVE Act
This bill imposes requirements related to the emergency authorization of a vaccine during a declared public health emergency.
If a sponsor of a product seeks Food and Drug Administration (FDA) authorization to use the product as a vaccine to address the threat causing the declared public health emergency, both the FDA and the product sponsor must meet with, and present product-related data and information to, the Vaccines and Related Biological Products Advisory Committee. The Department of Health and Human Services may make an exception to this requirement if convening a meeting would not be in the public interest.
To receive an emergency authorization, the product sponsor must agree to seek FDA market approval for the vaccine within a certain time period.
After an emergency authorization, the Advisory Committee on Immunization Practices shall report recommendations regarding the vaccine to Congress and the Centers for Disease Control and Prevention.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4427 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4427

 To provide for transparency in emergency use authorization of vaccine 
                   products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 4, 2020

 Ms. Hassan (for herself, Mr. Braun, and Ms. Murkowski) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To provide for transparency in emergency use authorization of vaccine 
                   products, 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. SHORT TITLE.

    This Act may be cited as the ``Safe Authorization for Vaccines 
during Emergencies Act'' or the ``SAVE Act''.

SEC. 2. TRANSPARENCY IN EMERGENCY USE AUTHORIZATION OF VACCINE 
              PRODUCTS.

    (a) Emergency Use Authorizations.--
            (1) In general.--Section 564 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb-3) is amended by adding at the 
        end the following:
    ``(n) Requirements With Respect to Vaccine Products During Public 
Health Emergencies.--
            ``(1) Emergency meeting and recommendations.--
                    ``(A) Emergency meeting.--During a public health 
                emergency declared by the Secretary under section 319 
                of the Public Health Service Act and with respect to a 
                request to authorize the use of an unapproved product 
                that is a vaccine or an unapproved use of an approved 
                product that is a vaccine intended to address the 
                public health threat that is the subject of such public 
                health emergency, prior to authorizing use of such 
                product, subject to subparagraph (B), the Secretary 
                shall convene a meeting at which the Food and Drug 
                Administration and the sponsor of the product present 
                data and information on the product to the Vaccines and 
                Related Biological Products Advisory Committee for the 
                purpose of reviewing and providing recommendations with 
                respect to emergency use of the product.
                    ``(B) Exception.--If the Secretary, in consultation 
                with the Commissioner, determines that a meeting under 
                subparagraph (A) with respect to a product described in 
                such subparagraph would not be in the public interest, 
                the Secretary may make a determination not to convene 
                such a meeting. In the event that the Secretary 
                determines not to convene such a meeting pursuant to 
                this subparagraph, the Secretary shall issue a report 
                to the Committee on Health, Education, Labor, and 
                Pensions of the Senate and the Committee on Energy and 
                Commerce of the House of Representatives that includes 
                justification and relevant public health grounds for 
                such determination.
            ``(2) Requirement to seek licensure.--An authorization 
        under this section with respect to an unapproved product that 
        is a vaccine or an unapproved use of an approved product that 
        is a vaccine shall be conditioned on the sponsor seeking 
        licensure of the product, or the use, as applicable, under 
        section 351 of the Public Health Service Act, at the discretion 
        of the Secretary, within a time period determined by the 
        Secretary.''.
            (2) Confidential information.--Section 564(h)(1) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3(h)(1)) 
        is amended--
                    (A) by inserting ``, including a summary review,'' 
                after ``data or information'';
                    (B) by striking ``505(i), 512(j), or 520(g)'' and 
                inserting ``505, 510(k), 512(j), 513(f), 515, 520(g), 
                or 564 of this Act or section 351 of the Public Health 
                Service Act''; and
                    (C) by striking ``may indirectly reveal the 
                existence of such application'' and inserting ``, 
                including a summary review, may indirectly reveal the 
                existence of such application or contain data or 
                information submitted in an application under such 
                sections''.
    (b) Recommendations With Respect to Vaccines To Address a Public 
Health Emergency.--Section 319 of the Public Health Service Act (42 
U.S.C. 247d) is amended by adding at the end the following:
    ``(c) Recommendations.--During a public health emergency declared 
by the Secretary under subsection (a), not later than 15 days after the 
authorization under section 564 of the Federal Food, Drug, and Cosmetic 
Act of an unapproved product that is a vaccine or an unapproved use of 
an approved product that is a vaccine intended to address the public 
health threat that is the subject of such public health emergency, the 
Advisory Committee on Immunization Practices shall submit to the 
Director of the Centers for Disease Control and Prevention, the 
Secretary, the Committee on Health, Education, Labor, and Pensions of 
the Senate, and the Committee on Energy and Commerce of the House of 
Representatives--
            ``(1) recommendations regarding vaccination, including 
        prioritization of populations for which the vaccine is 
        authorized; or
            ``(2) a report recommending that the Secretary seek 
        additional data or information in order for the committees to 
        develop recommendations described in paragraph (1).''.
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