Minor species stand to gain from law

WASHINGTON—A push to make more drugs legally available to DVMs to treat minor animal species and uncommon diseases in major species ended last month when President Bush signed the Minor Use and Minor Species Animal Health Act of 2004, commonly known as MUMS.

Guinea pigs, ferrets and ornamental fish typify species that stand to benefit from the law designed to provide means to bring drugs to small markets and aid pharmaceutical companies in circumventing financial roadblocks that often stifle the manufacture of limited-use products.

The passage of MUMS benefits all aspects of veterinary medicine, says Dr. Michael Chaddock, director of the American Veterinary Medical Association's (AVMA) Governmental Relations Division.

"It's been a long time coming," says Chaddock, who played a role in pushing MUMS through Congress. "We've been through six years and three congresses. Now the profession is gaining some much-needed flexibility to treat and prescribe for minor species."

CVM holds MUMS workshop

Inside MUMS

The new law modifies the Federal Food, Drug and Cosmetic Act in three key ways, the Food and Drug Administration (FDA) reports.

Conditional Approval: MUMS allows the sponsor of a veterinary drug to ask the FDA's Center for Veterinary Medicine (CVM) for conditional approval, allowing the sponsor to make the drug available before collecting all necessary effectiveness data, but after proving the drug safe. The drug sponsor is allowed five years to keep the drug on the market while collecting effectiveness data.

Indexing: In some cases, the potential market for a minor species drug is too small to ever support costs associated with the drug approval process. MUMS allows FDA to add the drug to an index of legally marketed unapproved new animal drugs for such cases.

Designation: This aspect of the legislation is similar to the Orphan Drug Act for humans, which aids pharmaceutical firms in developing drugs for limited human use. It provides incentives for approval. Grants to support safety and efficacy testing will be available. Companies that gain approval for designated new animal drugs will be granted seven years of marketing exclusivity.

Permanent fix

MUMS aims to mend a broken review process at CVM that virtually prohibits the manufacture of small-return drugs, says Ron Phillips, spokesman for the Animal Health Institute (AHI), which represents drug manufacturers.

"Over the past few years, this has become a crisis for many who have been looking for treatments for minor exotic species of animals," he says. "Hopefully what MUMS provides is a tool for CVM to address that problem."