Bill Summary: FDA Ethics Act of 2022 (H.R. 8828)

This bill aims to address potential conflicts of interest among entities that serve as contractors for the Food and Drug Administration (FDA). Its purpose is to ensure transparency and ethical practices in FDA contracting.

Section 1: Short Title

This section states that the bill may be referred to as the "FDA Ethics Act of 2022".

Section 2: Requirements Regarding Ongoing Reporting of Contractor Conflicts of Interest

This section requires the Secretary of Health and Human Services to ensure that entities contracting with the FDA disclose any information related to potential and actual conflicts of interest. This includes conflicts of interest involving the contractor's personnel, consultants, and subcontractors. It also prohibits contractors from entering into consulting or other contractual arrangements with anyone that may create a conflict of interest without written approval from the contracting officer.

Section 3: Requirements Regarding Waivers Relating to Organizational Conflicts of Interest

This section mandates that the Secretary of Health and Human Services publish a notification on the FDA's website within 14 days of awarding a contract, informing the public about any waivers granted to contractors regarding organizational conflicts of interest. The notification must include details about the contract, the contractor receiving the waiver, the other contracts or clients that caused the conflict of interest, and the steps the contractor plans to take to address the conflict.

Section 4: Restrictions on Consulting Firms Serving as FDA Contractors

This section prohibits the Secretary of Health and Human Services from awarding FDA contracts to consulting firms unless these firms agree that their employees or subcontractors will not provide services to both the FDA and any private entity engaged in activities regulated by the FDA. Exceptions can be made if there is a compelling reason, determined in writing by the Secretary, but these exceptions must be publicly announced on the FDA's website within 14 days. The section also provides definitions for "consulting services" and clarifies that certain services are exempt from these restrictions.

HB 8828 FDA Ethics Act of 2022

US Congress 117th Congress

Bill Texts

Introduced 09/17/2022

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Sponsors (1)

Rep. Ann Kuster

Primary Sponsor