Minor Animal Species Legislation
Minor Animal Species Remedies & the Minor Use and Minor Species Animal Health Act
What are minor animal species remedies? Minor animal species remedies are products intended to treat diseases and conditions in minor animal species. Minor animal species are animals other than "major species," identified by the US Food and Drug Administration as dogs, cats, horses, cattle, swine, chickens and turkeys. Many companion animals are included in minor animal species such as ornamental aquarium and garden pond fish, reptiles, birds, and small mammals such as hamsters and gerbils. Farmed fish, wildlife and zoo animals are also minor animal species.
While there is a great variety of minor animal species, they all share a significant need for pharmaceutical tools to improve their health and welfare. Due to the nearly complete absence of drugs to treat each of these minor animal species, most animals either go untreated or treatment is delayed. Delayed treatment leads to decreased treatment success. The result is increased suffering, loss of use, and loss of life. The emotional and economic impact of these losses for individual families and the public can be significant. The sheep industry loses nearly $45 million worth of sheep each year and the catfish industry estimates their losses at $60 million from disease conditions for which therapeutic medicines are unavailable. Internationally, the availability of drugs to treat minor animal species is much greater.
In the early 1990s, APPA became involved in this issue when it represented aquatic remedies manufacturers who came under federal scrutiny as a result of a barred sale of a tropical fish remedy to a food fish producer. At that time, the Aquatic Remedies Steering Committee was created. APPA members agreed to improve packaging and formulations of aquarium fish remedies in order to avoid the possibility of misuse by consumers. Specifically, packaging, formulations, labeling and other mechanisms are to be employed in order to discourage people from using the products for other than their intended purpose, i.e., for aquarium use only and not intended for human consumption or for consumption by food fish species.
The Minor Use and Minor Species Animal Health Act
A major step towards an alternative came in 1996 when Congress passed the Animal Drug Availability Act. This law directed the FDA to develop proposals that would encourage the approval of minor use and minor species drugs. FDA's proposals included a request for legislative change to the Federal Food, Drug and Cosmetic Act. APPA supported this change among other proposals. In fact, many other professional and trade associations, as well as, producer groups supported FDA's proposals.
Therefore, these organizations banded together to form the Minor Use/ Minor Species Coalition (the MUMS Coalition). This coalition has worked to create language which incorporated FDA's proposals into a Congressional bill, now a law identified as the Minor Use and Minor Species Animal Health Act (MUMS). This Act gives the FDA the authority to approve drugs for animals such as ornamental aquarium and garden pond fish, as well as, other pets such as reptiles, amphibians, small mammals and birds, so-called "minor animal species." With more drugs approved for these populations, animal welfare would be enhanced.
MUMS was signed into law by President George Bush on August 2, 2004. The Food Allergen Labeling and Consumer Protection Act, is included in the bill that was passed and will require labeling on foods that contain ingredients that are common food allergens. Click Here for text of the Act. The legislation creates the Office of Minor Use and Minor Animal Species Drug Development within the FDA. The law will modified the Federal Food, Drug and Cosmetic Act in three ways.
Indexing: A key component of MUMS is a drug index list whereby a sponsor can market a drug without going through the full registration process. This section applies where the potential market for a minor species drug is too small to support the cost of the drug approval process, even under conditional approval. This was contemplated to be especially significant to the ornamental aquarium industry where there are numerous species of animals. When placed on the index list, FDA would officially designate the drug as a legally marketed unapproved new animal drug. The drug index is specifically reserved for drugs to treat diseases or conditions in animals with no human food safety concerns. The final regulations under the Indexing provision of the Act were published in December 2007.
Conditional Approvals: The Act creates opportunity for drugs to be provisionally or conditionally approved for a short time during which efficacy data could be collected. The drug sponsor can keep the product on the market for up to five years, with annual renewals, while gathering data.
Designation: The Act also creates an orphan drug-like program that would provide limited funding to companies to help support drug development for minor animal species or uses. The FDA will promulgate regulations for this section of the Act first. Within 12 months the FDA is required to promulgate regulations to implement this section of the Act, with final regulations to be completed by 24 months. The final designation rules were published in July 2007.
The FDA has a MUMS Office for additional informationand has released a GUIDANCE FOR INDUSTRY SMALL ENTITIES COMPLIANCE GUIDE The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species