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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5773 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 5773

  To amend the Public Health Service Act to remove certain liability 
  protections for certain biological products and other drugs if the 
  sponsor thereof fails to disclose to the public all non-exempt data 
 within the biological product file or drug application, and for other 
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 27, 2023

  Mr. Posey introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
  To amend the Public Health Service Act to remove certain liability 
  protections for certain biological products and other drugs if the 
  sponsor thereof fails to disclose to the public all non-exempt data 
 within the biological product file or drug application, 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 ``Consumer Vaccine Safety and 
Protection Act of 2023''.

SEC. 2. DISCLOSURE OF NON-EXEMPT DATA REQUIRED FOR CERTAIN BIOLOGICAL 
              PRODUCTS AND OTHER DRUGS.

    Section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended by adding at the end the following:
    ``(j) Disclosure of Non-Exempt Data Required.--
            ``(1) Covered products.--In this subsection, the term 
        `covered product' means a covered countermeasure that--
                    ``(A) is a biological product or other drug; and
                    ``(B) is authorized for emergency use under section 
                564 of the Federal Food, Drug, and Cosmetic Act on or 
                after the date of enactment of the Consumer Vaccine 
                Safety and Protection Act of 2023, irrespective of 
                whether the biological product or drug later receives 
                approval or licensure under section 505 of the Federal 
                Food, Drug, and Cosmetic Act or section 351 of this 
                Act.
            ``(2) Disclosure by sponsors.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                sponsor of a covered product shall disclose to the 
                public, in an easily accessible location on the website 
                of the sponsor of the covered product--
                            ``(i) in the case of a biological product, 
                        all data and information available for public 
                        disclosure under section 601.51(e) of title 21, 
                        Code of Federal Regulations (or successor 
                        regulations); and
                            ``(ii) in the case of another drug, all 
                        data and information available for public 
                        disclosure under section 314.430 of title 21, 
                        Code of Federal Regulations (or successor 
                        regulations).
                    ``(B) Timing.--The sponsor of a covered product 
                shall, with respect to any data or information required 
                to be disclosed by subparagraph (A), make the 
                disclosure not later than 10 days after the later of--
                            ``(i) the date on which the Food and Drug 
                        Administration authorizes the emergency use of 
                        the covered product under section 564 of the 
                        Federal Food, Drug, and Cosmetic Act; and
                            ``(ii) the date on which the data or 
                        information becomes available to the sponsor.
                    ``(C) Exceptions.--The disclosure requirement in 
                subparagraph (A) does not apply with respect to--
                            ``(i) a trade secret or confidential 
                        commercial or financial information as defined 
                        in section 20.61 of title 21, Code of Federal 
                        Regulations (or successor regulations); or
                            ``(ii) personally identifiable information.
            ``(3) Disclosure by hhs.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Secretary shall--
                            ``(i) not later than 10 days after the Food 
                        and Drug Administration authorizes the 
                        emergency use of a covered product under 
                        section 564 of the Federal Food, Drug, and 
                        Cosmetic Act or approves or licenses a covered 
                        product under section 505 of such Act or 
                        section 351 of this Act, disclose to the 
                        public, in an easily accessible location on the 
                        website of the Department of Health and Human 
                        Services, all data and information required by 
                        paragraph (2) to be disclosed by the sponsor of 
                        the product; and
                            ``(ii) not later than 30 days after 
                        receiving any additional such data and 
                        information, so disclose such data and 
                        information.
                    ``(B) Exception.--The disclosure requirement in 
                subparagraph (A) does not apply with respect to data 
                and information exempted from disclosure by paragraph 
                (2)(C).
            ``(4) Enforcement against sponsors for failure to 
        disclose.--
                    ``(A) Exclusion from definition of `covered 
                countermeasure'.--Notwithstanding subsection (i)(1), a 
                covered product is deemed to be excluded from the 
                definition of a `covered countermeasure' for purposes 
                of the provisions of this section (other than this 
                subsection) and section 319F-4 if--
                            ``(i) the covered product is administered 
                        on or after the date of enactment of the 
                        Consumer Vaccine Safety and Protection Act of 
                        2023; and
                            ``(ii) the sponsor of the covered product 
                        is determined by the Secretary to have 
                        knowingly failed to make a disclosure required 
                        by paragraph (2) with respect to the covered 
                        product.
                    ``(B) Ineligibility for fda awards, funds, or other 
                benefits.--If the sponsor of a covered product is 
                determined by the Secretary to have knowingly failed to 
                make a disclosure required by paragraph (2) with 
                respect to the covered product, such sponsor shall be 
                treated as ineligible for the award of any grant, 
                cooperative agreement, or loan or for any new grant of 
                emergency use authorization, expanded access, or 
                approval or licensure of any product under section 351 
                of this Act or any provision of the Federal Food, Drug, 
                and Cosmetic Act so long as such sponsor continues to 
                be in violation of such requirement.
            ``(5) Enforcement against hhs for failure to disclose.--A 
        party injured by a covered product with respect to which the 
        Secretary failed to carry out the Secretary's duties under 
        paragraph (3) may bring an action in the appropriate district 
        court of the United States for appropriate relief, including 
        damages.''.
                                 <all>
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