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