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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8211 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8211
To amend title 18, United States Code, to prohibit former employees of
covered health agencies from serving on the board of entities involved
in development and research of a drug, biological product, or device
and from profiting from a drug, biological product, or device, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 1, 2024
Mrs. Lesko (for herself, Mr. Biggs, Mr. Steube, Mrs. Harshbarger, Mr.
LaMalfa, Mr. Wilson of South Carolina, and Mr. Bishop of North
Carolina) introduced the following bill; which was referred to the
Committee on the Judiciary
_______________________________________________________________________
A BILL
To amend title 18, United States Code, to prohibit former employees of
covered health agencies from serving on the board of entities involved
in development and research of a drug, biological product, or device
and from profiting from a drug, biological product, or device, 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 ``Fixing Administrations Unethical
Corrupt Influence Act'' or the ``FAUCI Act''.
SEC. 2. PROHIBITION AGAINST SERVICE BY FORMER EMPLOYEES OF COVERED
HEALTH AGENCIES ON BOARDS OF ENTITIES INVOLVED IN
DEVELOPMENT AND RESEARCH OF A DRUG, BIOLOGICAL PRODUCT,
OR DEVICE.
(a) Prohibition Against Service on Boards of Entities.--Title 18,
United States Code, is amended by inserting after section 207 the
following:
``Sec. 207A. Prohibition against service by former employees of covered
health agencies on boards of entities involved in
development and research of a drug, biological product,
or device
``(a) Definitions.--In this section:
``(1) Biological product.--The term `biological product'
has the meaning given such term in section 351(i) of the Public
Health Service Act (42 U.S.C. 262(i)).
``(2) Covered health agency.--The term `covered health
agency' means any of the following:
``(A) The National Institutes of Health.
``(B) The Food and Drug Administration.
``(C) The Centers for Disease Control and
Prevention.
``(3) Device; drug.--The terms `device' and `drug' have the
meanings given those terms in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321).
``(4) Top official.--The term `top official' means--
``(A) any officer or employee in the executive
branch who occupies a position classified at or above
GS-13 of the General Schedule or, in the case of any
position not under the General Schedule, for which the
rate of basic pay is equal to or greater than the
minimum rate of basic pay payable for GS-13 of the
General Schedule; or
``(B) any employee of the Federal Government who
directly or indirectly has input or any authority to
determine or help determine the authorization for use
or emergency use authorization of a drug, biological
product, or device.
``(b) Prohibition Against Service by Former Employees of Covered
Health Agencies on Boards of Entities Involved in Development and
Research of a Drug, Biological Product, or Device.--Any person who is a
top official of a covered health agency of the United States, and who,
within 8 years after the termination of the service or employment of
the top official with the United States, serves as an officer or member
of the board of any association, corporation, or entity that directly
manufactures or researches a drug, biological product, or device shall
be punished as provided in section 216 of this title.
``(c) Prohibition Against Profiting From a Drug, Biological
Product, or Device by Former Employees of Covered Health Agencies
Involved in the Approval of Related Grant Applications.--Any person who
is a former Federal employee of a covered health agency who profits
from a drug, biological product, or device if such employee at any
point during the course of service or employment with the United States
was directly involved in determining whether a grant application for
such drug, biological product, or device was approved shall be subject
to a civil penalty of $250,000 and imprisoned for not more than five
years nor less than one year.''.
(b) Penalties and Injunctions.--Section 216(a) of title 18, United
States Code, is amended, in the matter preceding paragraph (1), by
inserting ``207A,'' after ``207,''.
(c) Table of Chapters.--Chapter 11 of title 18, United States Code,
is amended by inserting after the item relating to section 207 the
following:
``207A. Prohibition against service by former employees of covered
health agencies on boards of entities
involved in development and research of a
drug, biological product, or device.''.
(d) Effective Date.--Except as provided in subsection (d), the
amendments made by this section shall apply with respect to an
individual whose service or employment with the United States
terminates on or after the date of the enactment of this Act.
(e) Special Rule for Certain Former Federal Employees of Covered
Health Agencies.--
(1) Application.--Section 207A(c) of title 18, United
States Code, as added by subsection (a), shall apply to an
individual who at any point served or was employed with the
United States.
(2) Compliance period.--With respect to the prohibition
under section 207A(c) of title 18, United States Code, as added
by subsection (a), the compliance period for a former Federal
employee whose service or employment with the United States
terminated prior to the date of enactment of this Act shall be
6 months from such date of enactment.
SEC. 3. PROHIBITION AGAINST OWNERSHIP OR FINANCIAL INTEREST IN CERTAIN
PATENTS.
Section 208 of title 18, United States Code is amended by adding at
the end the following:
``(e) Prohibition Against Ownership or Financial Interest in
Certain Patents.--
``(1) Definitions.--In this subsection:
``(A) Biological product.--The term `biological
product' has the meaning given such term in section
351(i) of the Public Health Service Act (42 U.S.C.
262(i)).
``(B) Covered patent.--The term `covered patent'
means a patent issued by the United States for a drug,
biological product, or device.
``(C) Device; drug.--The terms `device' and `drug'
have the meanings given those terms in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321).
``(D) Top official.--The term `top official'
means--
``(i) each officer or employee in the
executive branch who occupies a position
classified at or above GS-13 of the General
Schedule or, in the case of any position not
under the General Schedule, for which the rate
of basic pay is equal to or greater than the
minimum rate of basic pay payable for GS-13 of
the General Schedule; or
``(ii) any employee of the Federal
Government who directly or indirectly has input
or any authority to determine or help determine
the authorization for use or emergency use
authorization of a drug, biological product, or
device.
``(2) In general.--A person who is a top official may not
submit an application for a covered patent (or be included in
the application for a covered patent)--
``(A) in the case of a drug, biological product, or
device invented by the person during the course of
employment as a top official, at any point during
employment as a top official; and
``(B) in the case of a drug, biological product, or
device invented by the person outside the course of
employment as a top official, at any point during
employment as a top official.
``(3) Disclosure.--
``(A) Requirement as of date of enactment of the
fauci act.--A person who is a top official or a spouse
of a top official on the date of enactment of the FAUCI
Act shall disclose not later than 180 days after the
date of enactment of such Act any ownership of, or any
rights or interest in, a covered patent.
``(B) Requirement after date of enactment of the
fauci act.--A person who is a top official or a spouse
of a top official after the date of enactment of the
FAUCI Act shall disclose not later than 90 days after
becoming a top official or the spouse of a top official
any ownership of, or any rights or interest in, a
covered patent.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on the Judiciary.
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