FDA Ethics Act of 2022
Bill: H.R.8828 | Sponsor: Rep. Kuster, Ann M. (D-NH)
Policy area: Health

Summary:
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.

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.
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