United States · Amendment · HAMDT
HAMDT 285 (104th)
An amendment to prohibit the award of punitive damages against the manufacturer or seller of a drug that either was approved by the FDA or is generally recognized as safe and effective under FDA conditions and regulations, unless the company intentionally misrepresented the product to the FDA or bribed an FDA employee to secure approval. The amendment also prohibits the award of punitive damages against the drug manufacturer for any injury related to the packaging or labeling of its products, unless there is "clear and convincing evidence" that those practices are substantialy out of compliance with federal regulations.
Introduced
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Last action
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Status
On agreeing to the Oxley amendment (A009) Agreed to by voice vote.
Sponsors
Rep. Oxley, Michael G. [R-OH-4]
Subjects
Discovery layer
Source updated
15 August 2021
Records
Official amendment HAMDT 285 (104th) from United States at United States Congress. Status: On agreeing to the Oxley amendment (A009) Agreed to by voice vote..
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Sponsors
- Rep. Oxley, Michael G. [R-OH-4] · R · Sponsor
Related records
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/amendment/104th-congress/hamdt-285
- Open data entity: https://api.congress.gov/v3/amendment/104/hamdt/285
- us · 104-hamdt-285 · source updated 15 August 2021