FDA Experience with Medical Countermeasures under the Animal Rule
Author Information
Author(s): Paul Aebersold
Primary Institution: Quintiles, Inc.
Hypothesis
The study examines the effectiveness of the FDA's Animal Rule in approving medical countermeasures based on animal studies.
Conclusion
Despite significant investment, only two drugs have been approved under the Animal Rule, highlighting challenges in developing medical countermeasures.
Supporting Evidence
- The FDA's Animal Rule was established to expedite drug approval when human testing is unethical.
- Only two drugs have been approved under the Animal Rule in nine years.
- Massive federal investment has not led to a corresponding increase in approved medical countermeasures.
Takeaway
The FDA has a special rule that allows drugs to be approved based on animal tests instead of human tests when it's too dangerous to test on people. However, only a few drugs have been approved this way.
Methodology
The article reviews FDA approvals and discussions regarding medical countermeasures under the Animal Rule.
Limitations
The study notes that only two drugs have been approved under the Animal Rule despite extensive investment.
Digital Object Identifier (DOI)
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