Changing the Culture of the FDA Act
Source: Congress.gov ·
280 words in original text
What This Bill Does
This bill directs the Secretary of Health and Human Services to change the mission statement of the Food and Drug Administration (FDA). The change adds language about considering the dangers of addiction and overdose death from prescription opioid medications when approving and regulating these drugs.
Who It Affects
The Food and Drug Administration and the Secretary of Health and Human Services are directly responsible for making this change. Patients who use prescription opioid medications and the public health system are indirectly affected.
Key Provisions
• The Secretary of Health and Human Services, working through the Commissioner of Food and Drugs, must amend the FDA's mission statement to include a statement about the agency's responsibility to strongly consider addiction and overdose death dangers when approving opioid medications (Sec. 2)
• The amended mission statement must also address how the FDA regulates the manufacturing, marketing and distribution of opioid medications with consideration of these dangers (Sec. 2)
What Changes
The FDA's official mission statement will be updated to explicitly include language about considering addiction and overdose risks when making decisions about prescription opioid medications.
Important Definitions
None defined in bill text.
Important: This plain English summary was generated by AI and is provided for informational purposes only.
It is not legal advice. Always consult the official bill text on Congress.gov
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