Amendment104th Congress
Amendment adds "FDA defense" provisions that bar punitive damages for the sale or manufacture of drugs or devices which have been approved by the Food and Drug Administration.
- Amendment Number
- 285
- Description
- Amendment adds "FDA defense" provisions that bar punitive damages for the sale or manufacture of drugs or devices which have been approved by the Food and Drug Administration.
- Purpose
- 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.
- Congress
- 104
- Type
- HAMDT
- Latest Action Date
- Mar 9, 1995
- Latest Action Text
- On agreeing to the Oxley amendment (A009) Agreed to by voice vote.
- Latest Action Time
- 17:52:16
- Submitted Date
- Mar 9, 1995
- Chamber
- House of Representatives
- Update Date
- Aug 15, 2021