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New Rules for FDA Contractors: Transparency and Conflict of Interest Prevention

This act introduces new rules for companies working with the Food and Drug Administration (FDA). Its goal is to increase transparency and prevent situations where consulting firms might have conflicting interests, influencing decisions about drugs and medical devices. This helps ensure that FDA decisions are made without hidden influences, benefiting public trust.
Key points
Companies contracting with the FDA must continuously disclose any potential conflicts of interest, including those involving their personnel and subcontractors.
The FDA will publish information about any waivers granted regarding conflicts of interest, increasing public oversight.
Restrictions are placed on consulting firms to prevent their employees from simultaneously working for the FDA and for companies developing or manufacturing drugs or medical devices, aiming to prevent undue influence.
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Additional Information
Print number: 117_HR_8828
Sponsor: Rep. Kuster, Ann M. [D-NH-2]
Process start date: 2022-09-14