The U.S. Food and Drug Administration has extended its deadline for comments on its proposed regulations for implementing the “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species” from Nov. 30 until Dec. 20.

The extension came after some interested persons asked for additional time, claiming the initial 90-day comment period (initiated in late August) did not provide enough time to provide a “meaningful or thoughtful response” to the roughly 25 pages of proposed regulations. As of press time, no comments could be found.

The index itself, authorized by the Minor Uses Minor Species Act of 2004, would create a list of drugs that could be legally marketed for treatment of minor species, such as most pets, including reptiles, fish, birds and small mammals, other than dogs and cats.

In an effort to make more drugs legally available to veterinarians and animal owners, these minor species drugs would not need to undergo safety and efficacy testing like drugs for major species.
Rather, a requestor (drug maker) would obtain an FDA ruling on the eligibility of a drug to be indexed, based on requestor-provided information, including a list of ingredients, an overview of manufacturing processes, intended uses and species and an estimate of drug distribution if distributed.

Under the legislation, drugs would be indexed for specific uses and species but would not be allowed to be used extra-label for other purposes or species. The proposals call for an estimate of drug distribution, which would allow the government to tell if more of a product was being sold than the manufacturer expected. If sales were significantly greater than expected, it would suggest to the government that the indexed drug was being used for nonindexed purposes.
Once a requestor received eligibility for a drug’s indexing, it would then propose an expert panel to review the drug and advise the FDA accordingly. Under the proposal, panel members should not have any conflicts of interest or apparent conflicts of interest with the requestor unless that provision is waived by the FDA.

The FDA would rely heavily on, but would not be bound by, these panels’ recommendations under the proposals.

For more information or to submit comments, visit www.regulations.gov.