BENEFIT Act of 2023
Source: Congress.gov ·
336 words in original text
What This Bill Does
This bill changes how the Food and Drug Administration (FDA) considers patient experience data when deciding whether to approve new drugs. The bill requires the FDA to use patient experience data as part of its benefit-risk assessment, which weighs the good effects of a drug against its harmful effects.
Who It Affects
The FDA, drug manufacturers and sponsors who submit new drugs for approval, and patients who use new medications.
Key Provisions
• The FDA must consider patient experience data submitted by drug manufacturers or other parties as part of the benefit-risk assessment framework during the new drug approval process (Sec. 2)
• The FDA must describe in its reports how patient experience data and information were considered in the benefit-risk assessment (Sec. 2)
What Changes
The law adds patient experience data as a required part of how the FDA reviews new drug applications. The FDA must now explain in its official reports how it used this patient data when making approval decisions.
Important Definitions
"Patient experience data" is mentioned but not defined in the 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
or a qualified attorney for legal matters.