FDA Ethics Act of 2022
This bill establishes several requirements for entities that contract with the Food and Drug Administration (FDA) relating to conflicts of interest, including requiring contractors to disclose conflicts of interest on an ongoing basis and prohibiting the FDA from hiring consultants who simultaneously provide services to drug manufacturers or other entities that are regulated by the FDA.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8828 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 8828
To address potential conflicts of interest among entities serving as
Food and Drug Administration contractors, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 14, 2022
Ms. Kuster introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To address potential conflicts of interest among entities serving as
Food and Drug Administration contractors, 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 ``FDA Ethics Act of 2022''.
SEC. 2. REQUIREMENTS REGARDING ONGOING REPORTING OF CONTRACTOR
CONFLICTS OF INTEREST.
(a) In General.--The Secretary of Health and Human Services shall
require entities that contract with the Food and Drug Administration--
(1) to disclose, on an ongoing basis during the term of the
contract, any information related to potential and actual
conflicts of interest, including conflicts of interest
concerning the contractor's personnel, consultants, and
subcontractors; and
(2) during the term of the contract, to refrain from
entering into consulting or other contractual arrangements with
any person to perform work that may reasonably create a
potential or actual conflict of interest, without receiving the
written approval of the contracting officer before the
execution of the contractual arrangement.
(b) Regulations.--Not later than 18 months after the date of
enactment of this Act, the Secretary, in consultation with the Federal
Acquisition Regulatory Council, shall issue regulations to carry out
subsection (a).
SEC. 3. REQUIREMENTS REGARDING WAIVERS RELATING TO ORGANIZATIONAL
CONFLICTS OF INTEREST.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, not later
than 14 days after awarding a contract relating to the Food and Drug
Administration, publish, on the website of the Food and Drug
Administration, a notification of any waiver of any requirements
regarding a potential or actual organizational conflict of interest
granted to the contractor. Such notification shall be made publicly
available in an easily accessible format, and shall include the name of
the contract, the contractor receiving the waiver, the other contracts
or clients that created the potential or actual organizational conflict
of interest, and the efforts that the contractor plans to take to
mitigate the potential or actual organizational conflict of interest.
(b) Regulations.--Not later than 18 months after the date of
enactment of this Act, the Secretary, in consultation with the Federal
Acquisition Regulatory Council, shall issue regulations to carry out
subsection (a).
SEC. 4. RESTRICTIONS ON CONSULTING FIRMS SERVING AS FDA CONTRACTORS.
(a) Prohibition Against Certain Contracts.--
(1) In general.--Subject to paragraph (2), the Secretary of
Health and Human Services (referred to in this section as the
``Secretary'') shall not award a contract relating to the
duties of the Food and Drug Administration to any person
providing consulting services (referred to in this section as a
``consulting firm'') unless such contract provides that, during
the restricted period described in paragraph (3), subject to
paragraph (2), no individual employee or subcontractor of such
consulting firm may provide services to both--
(A) the Food and Drug and Administration under the
consulting firm's contract; and
(B)(i) a person engaged in the development or
manufacturing of a device, drug, or biological product;
or
(ii) any other private entity engaged in activities
regulated by the Food and Drug Administration.
(2) Exception.--
(A) In general.--The Secretary may issue an
exception to the requirement under paragraph (1) with
respect to an employee or subcontractor of a consulting
firm only if the Secretary or designee determines in
writing that there is a compelling reason to award a
contract with such consulting firm with such exception.
The Secretary shall not delegate the authority to issue
exceptions under this subparagraph below the level of
head of a contracting activity.
(B) Reporting.--Not later than 14 days after
issuing an exception under subparagraph (A), the
Secretary shall publish, on the website of the Food and
Drug Administration, a notification of the exception.
Such notification shall be made publicly available in
an easily accessible format, and shall include--
(i) the name of the contract;
(ii) the consulting firm receiving the
exception, and the employee or subcontractor to
whom the exception applies;
(iii) the other contracts or clients that
would, in the absence of the exception, cause
the consulting firm to be in violation of
paragraph (1); and
(iv) the efforts that the consulting firm
plans to take to mitigate any potential or
actual conflict of interest arising from the
other work of its employees or subcontractors.
(3) Restricted period.--
(A) In general.--For purposes of paragraph (1), the
restricted period is the period that--
(i) begins when the applicable employee or
subcontractor of the consulting firm first
provides services under the consulting firm's
contract; and
(ii) ends not less than the applicable
period specified in subparagraph (B) after the
last date on which such employee or
subcontractor provides services under the
consulting firm's contract.
(B) Applicable period specified.--For purposes of
subparagraph (A)(ii), the applicable period specified
in this subparagraph is--
(i) 30 days; or
(ii) such longer period of time as the
Secretary may specify after consultation with
the Federal Acquisition Regulatory Council,
which shall apply with respect to all
exceptions issued under paragraph (2).
(b) Regulations.--Not later than 18 months after the date of
enactment of this Act, the Secretary, in consultation with the Federal
Acquisition Regulatory Council, shall issue regulations to carry out
subsection (a).
(c) Definition.--In this section, the term ``consulting
services''--
(1) means providing advice or recommendations to improve
organizational effectiveness; and
(2) does not include services provided pursuant to a
contract related to regulatory science research, public health
surveillance, or information technology, or services provided
by a small business concern.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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