According to regulatory steps proposed under the Minor Use and Minor Species Animal Health Act of 2004:

• The FDA will determine whether the drug is eligible for indexing.
• An expert FDA-qualified panel will determine efficacy and safety.
• The FDA will review the panel’s report and determine whether the product may be included on the index list.
• If included, the product must be labeled in a specific manner to indicate that the product is not approved by FDA, but it is legally marketed as an FDA-indexed product.

In the initial eligibility determination, the company requesting indexing must demonstrate that:
• There is reasonable certainty that the target animal will not be consumed by humans or food-producing animals.
• There are no environmental issues.
• There are no safety concerns for individuals producing or using the drug.
• There is an understanding of current Good Manufacturing Practices and established, appropriate specifications for the manufacture of the drug.

The lengthy document also spells out the specific procedures for getting eligible products indexed.

Because the markets for drugs to treat minor animal species and uncommon diseases in major animal species are so small, there is little economic incentive for sponsors to conduct the traditional studies needed for drug approval. The proposed regulatory procedures are intended to make more drugs legally available to veterinarians and animal owners for the treatment of those species and conditions while still ensuring appropriate safeguards for animal and human health.

At press time, the American Pet Products Manufacturers Association (Greenwich, Conn.) expected to submit comments regarding the proposed rule.

Comments are due to the FDA by Nov. 20, 2006. [November 2006 PET AGE]