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FDA Mission Change: Stronger Focus on Opioid Addiction and Overdose Risk

This bill requires the Food and Drug Administration (FDA) to formally amend its mission statement. The FDA must now strongly consider the danger of addiction and overdose death associated with prescription opioid medications when approving and regulating these drugs. This change aims to enhance public safety and tighten control over powerful pain medications contributing to the opioid crisis.
Key points
The FDA must officially incorporate the risk of opioid addiction and overdose death into its core mission statement.
All decisions regarding the approval, manufacturing, and marketing of opioid medications must prioritize the danger of overdose and addiction.
The change is intended to increase public safety by tightening regulatory standards for opioid drugs.
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Additional Information
Changing the Culture of the FDA Act
Print number: S 604
Sponsor: Sen. Manchin, Joe, III [D-WV]
Process start date: 2023-03-01