Before a medical product can be approved by FDA, the sponsor must prove efficacy—that the product works. In some cases, such as developing medical countermeasures for potential bioterror threats, human challenge studies (exposing people to the threat agent) would not be ethical or feasible.
In these cases, FDA may grant approval based on well-controlled animal studies, when the results of those studies establish that the drug or biologic product is reasonably likely to produce clinical benefit in humans. The product sponsor must still demonstrate the product’s safety in humans.
Animal Rule Links
- October 28, 2015 Federal Register notice: Product Development Under the Animal Rule; Guidance for Industry
- February 2016 - Draft Guidance for Industry - Anthrax: Developing Antibacterial Drugs for Prophylaxis of Inhalational Anthrax (PDF - 565KB)
- Webcast recording: Product Development Under the Animal Rule - Revised Draft Guidance for Industry (June 3, 2014)
Activities to Encourage Development, Qualification, and Use of Animal Models Animal Rule Summary
- 21 CFR 314.600 (drugs)
- 21 CFR 601.90 (biological products)
PAHPRA's Provisions Related to Development of MCMs Under the Animal Rule Animal Model Qualification Program
- Animal Model Qualification: Frequently Asked Questions
- Countering Bioterrorism Questions and Answers from CBER
- FDA Basics: Why are animals used for testing medical products?
Product Approval Announcements
FDA news announcements for products approved under the Animal Rule
- March 18, 2016: FDA approves new treatment for inhalation anthrax (Anthim)
- November 23, 2015: FDA approves vaccine for use after known or suspected anthrax exposure (BioThrax)
- November 13, 2015: FDA approves new indication for use of Neulasta (pegfilgrastim) to treat adult and pediatric patients at risk of developing myelosuppression after a radiological/nuclear incident
- May 8, 2015: FDA approves additional antibacterial treatment for plague (Avelox)
- March 30, 2015: FDA approves Neupogen® for treatment of patients with radiation-induced myelosuppression following a radiological/nuclear incident
- March 25, 2015: FDA approves treatment for inhalation anthrax (Anthrasil, Anthrax Immune Globulin Intravenous (Human))
February 2, 2015: Ciprofloxacin - supplemental NDA approved to add indication for treatment and prophylaxis of plague due to Yersinia pestis in adults and pediatric patients
- February 5, 2003: FDA approves pyridostigmine bromide as pretreatment against nerve gas