A Win for Ornamental Finfish; First New Animal Drug Added to MUMS Index

By Susan J. Matthees –

FDA announced last week that it had added the first unapproved new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (i.e., the Index) since the Agency began accepting submissions last February.  The drug, Ovaprim, is indicated “[f]or use as a spawning aid in ornamental finfish broodstock.”  Placement on the Index allows the sponsor, Western Chemical, to sell Ovaprim without having the drug approved by FDA. 

The Index was created as part of the Minor Use Minor Species ("MUMS") Animal Health Act of 2004, which was passed with the intention of making more drugs available for treatment of minor species and uncommon diseases in major animal species.  Minor species are all animals other than the 7 major species (dogs, cats, cattle, horses, swine, chickens, and turkeys).  The Act was intended to increase drug availability by modifying the Federal Food, Drug, and Cosmetic Act in three ways. 

First, the Act allows a company to ask FDA’s Center for Veterinary Medicine to grant “conditional approval” of a drug.  Conditional approval permits a sponsor to sell a drug for up to 5 years before collecting all necessarily efficacy data.  However, the sponsor must demonstrate that the drug is safe.  Second, for drugs that have a very limited potential for marketing, FDA can add a drug to the Index, as it did yesterday for Ovaprim.  Finally, FDA can grant an animal drug a similar designation as human Orphan Drugs.  Sponsors who receive this designation can receive up to 7 years of marketing exclusivity.

FDA granted the first conditional approval in early 2007, but the Agency has not announced any other conditional approvals.  FDA granted the first designation in 2005 for the drug Florfenicol (Aquaflor®), and has been actively granting designation over the past 4 years. 

It is difficult to draw many conclusions from yesterday’s announcement since it was the first time that FDA has accepted a drug for the Index, and it remains to be seen whether the Index will increase the number of drugs available for minor uses and minor species.  However, the Index may soon prove to be very popular among the ornamental finfish of the country.