Years of Advocacy Pays Dividends for MUMS Drugs

By Dr. David Scarfe, Assistant Director, Scientific Activities Division

Many years of providing comments on emerging FDA regulations and working with Congress to refine legislative language are beginning to bear fruit. As a result, new drugs are being made available for minor species and minor uses (MUMS) in major species such as dogs, cats, horses, cattle, turkeys, swine and chickens. This is exemplified by the recent announcement by FDA of a grant program to support the development of new MUMS drugs.

Since the passage of the Minor Use and Minor Species Animal Health Act of 2004, much has been accomplished to boost the therapeutic armament against diseases and conditions. The need for these products was solidified in a 1997 report by a MUMS working group that formed during the passage of the Animal Drug Availability Act of 1996 (ADAA). The passage of the MUMS Act in 2004 modified the Federal Food, Drug and Cosmetic Act in three key ways:

• Through MUMS designation, a process similar to designating "Orphan Drugs" for humans was developed to help pharmaceutical firms develop drugs for limited human uses. This designation provides incentives for approval including grants to support safety and effectiveness testing, and seven years of marketing exclusivity once added to the MUMS Drug Designation List. To date, 64 new animal drugs for diseases or conditions in a large number of finfish species as well as shrimp, goats, sheep, cats, dogs and horses have been designated as MUMS drugs
  
  
• By allowing the FDA-CVM to grant "conditional approval" to make the drug available before collecting all necessary effectiveness data, but only after proving the drug is safe. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the required effectiveness data. In 2007, FDA approved the first conditionally approved drug, Aquaflor^®-CA1 (florfenicol), a Type A medicated feed for the control of columnaris disease in catfish.
  
  
• Through "indexing" drugs for which there is a potential minor species market that is too small to ever support the costs of the drug approval process, even under a conditional approval. Subsequent to finalizing the regulations for these drugs in late 2007 two new indexed drugs for use with ornamental (pet) finfish have been added to what is technically referred to as the "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species" – Ovaprim® (a gonadotropin releasing hormone analog for use as a spawning aid in ornamental finfish broodstock), and Aquacalm^TM (useful for sedation and anesthesia).

The FDA-CVM Office of Minor Use and Minor Species (MUMS) Animal Drug Development, established after the passage of the Act, has been responsible for developing and implementing MUMS regulations. The OMUMS also provides guidance on numerous issues including a Compliance Policy Guide clarifying the extralabel use of medicated feeds for minor species. With strong support from the AVMA and many others on several issues (e.g. defining a "small number" of animals for minor use designation, or proposed index regulations), a great deal has been accomplished in filling the therapeutic needs of minor species and minor diseases in major species.

Do you have expertise to offer for AVMA consideration? Send your feedback to the Scientific Activities Division at scientificissues@avma.org.