Regulatory Brief

 Making Additional Drugs Available for Minor Species and Minor Uses in Major Species


Formal title: Docket Number [2005N-0329] Designation of New Animal Drugs for Minor Uses or Minor Species


Brief Description:

The FDA proposes procedures whereby drug companies can request "designation" of drugs they intend to develop in order to receive incentives such as grants, exclusive marketing rights, and/or a conditional approval process.

When Congress passed the Minor Use and Minor Species Animal Health Act of 2004, it recognized that the markets for drugs intended to treat uncommon species, diseases, or conditions are so small that there are often insufficient economic incentives to motivate drug companies to develop data to support FDA drug approval.

The FDA proposal also seeks input on designation of "minor uses" of drugs in major species. These are uses in dogs, cats, horses, pigs, cows, chickens or turkeys that "occur infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually."

AVMA Response:

The AVMA, as a leader within the MUMS Coalition that lobbied for passage of the legislation, has significant interest in the development of appropriate regulations. AVMA requests an extension of the comment deadline, particularly to address the "minor use" provision.

Background Documents:

 
 

Status:

In response to requests received from the AVMA and other organizations, the FDA extended the comment period through January 27, 2006. The AVMA filed a response on that date and awaits FDA publication of a final rule.

View FDA Final Rule (PDF)