Animal Health & Drugs

Recent History and Achievements
by Food and Drug Administration (FDA)

(Page 3 of 3)

Improvements to the Federal FD&C Act continue. Within the past 20 years, Congress has passed five major laws that make the CVM even more effective in protecting human and animal health.

In 1988, a generic animal drug act allowed the FDA to approve generic versions of drugs for animals without requiring companies to duplicate research done to prove the safety and effectiveness of the drugs. This law enables companies to offer lower-cost alternatives to brand-name animal pharmaceuticals to the public.

In 1994, the Animal Medicinal Drug Use Clarification Act (AMDUCA) gave veterinarians more flexibility in using their professional judgment to treat animals. The AMDUCA makes it legal for veterinarians, under certain circumstances, to prescribe drugs "off-label," or "extra-label." This means they can legally treat animals with drugs that have been approved for people but not for animals, or with drugs approved for other species, for other diseases and conditions, or at different dosage levels from those listed on the drug label.

In 1996, the enactment of the Animal Drug Availability Act (ADAA) gave the CVM the flexibility to streamline the requirements for approving animal drugs and medicated feeds without compromising public health.

In 2003, the Animal Drug User Fee Act (ADUFA) authorized the FDA to collect fees from sponsors of new animal drugs, and obligated the FDA to meet specific deadlines. "ADUFA helps FDA expedite and improve its review of applications, so that safe and effective products will be available more quickly," says Sundlof.

In 2004, Congress passed the Minor Use/Minor Species (MUMS) Animal Health Act to make more medications legally available to veterinarians and animal owners to treat minor animal species and uncommon diseases in major animal species. A minor species is any animal species other than cattle, horses, pigs, chickens, turkeys, dogs, and cats, which are classified as major species. "Before passage of MUMS, drug companies could rarely afford to bring to market drugs for minor species because the markets were too small to generate an adequate financial return," says Andrew Beaulieu, D.V.M., director of the CVM's Office of MUMS. "The new law provides flexibility and incentives to drug companies to get these limited-use drugs to market."

The MUMS Act is expected to benefit agricultural groups such as fish farmers, sheep and goat producers, and beekeepers, says Beaulieu. "It will also help people who own pets such as guinea pigs or ornamental fish, and it will likely be a great help to zoo veterinarians."

In October 2005, the FDA approved the first minor species drug that was designated under the MUMS Act and thus qualified for seven years of exclusive marketing rights. Aquaflor (florfenicol) is an antibiotic to treat enteric septicemia, a bacterial disease that kills catfish. The disease results in significant economic losses to the U.S. catfish industry. Aquaflor is the first new antimicrobial approved for fish in over 20 years.

Preventing Mad Cow Disease

As the regulators of animal feed, the CVM is a key player in protecting U.S. cattle from bovine spongiform encephalopathy (BSE), also called mad cow disease, and protecting the health of people who consume cattle products. BSE is believed to be caused by abnormal proteins called prions in animal feed, and cattle may contract the disease by eating feed that contains these infectious proteins. People may get a human form of the disease, variant Creutzfeldt-Jakob disease, by eating foods from BSE-infected cows.

In 1997, the CVM adopted a BSE feed regulation that prohibits the feeding of certain mammalian proteins to cattle and other ruminants, such as sheep and goats. Since the feed regulation was established, the CVM and state inspectors have conducted more than 37,000 inspections involving more than 15,000 firms that handle animal feed. More than 99 percent of these facilities are in compliance with the regulation.

After 2003, when federal officials diagnosed the first BSE-infected cow in the United States, the CVM worked to further strengthen the feed regulation. In October 2005, the FDA proposed an amendment to the regulation that requires the removal of certain high-risk materials from all animal feed - not just ruminant feed - to prevent accidental access by cattle to potentially infectious feed.

Counterterrorism

There is widespread concern that terrorists could introduce toxic agents in the food chain to harm human and animal health. In addition, natural disasters or human error could result in contaminated food. The CVM is working with other parts of the FDA and with other federal agencies to help the nation prepare for a biological emergency, natural disaster, or terrorist attack by making sure there are safe and adequate supplies of animal drugs and animal feeds.

CVM scientists are developing rapid tests to detect contaminants and threat agents in animal feed. "CVM is also working with laboratories that have the capabilities to identify and measure levels of anthrax and other select agents that might be used in an agricultural terrorist attack," says Sundlof.

A Look Ahead

CVM regulators must keep pace with scientific advances that will affect animal and consumer health. One of the CVM's biggest challenges, says Sundlof, is preparing to regulate animal products developed through genetic engineering and through new assisted reproductive technologies such as cloning.

Animal clones, such as prime beef-producing cattle, and genetically engineered animals, such as fast-growing salmon, are part of a growing global effort to produce less expensive, high-quality food.

Researchers also are looking to animal cloning as a means to expand populations of livestock with naturally occurring desirable characteristics such as the ability to thrive in harsh climates, or spread natural resistance to animal diseases through herds rapidly. Genetic engineers are investigating broader ranges of applications in animals - from developing BSE-resistant cattle, to producing pigs as sources of organ transplants, and making animals that can produce human drugs and vaccines.

"There is a revolution unfolding before us," says Sundlof. "I think that in the future we'll be seeing changes in animal agriculture to benefit both animal and human health."

The FDA continues to work toward gaining a thorough understanding of the scientific and risk issues that the field of animal biotechnology presents, and to develop the expertise, regulations, and guidance needed to ensure that products derived from these animals are safe and effective, and that food from these animals is safe, nutritious, and wholesome.

While breeders and genetic engineers are focusing on animals as sources of food, other veterinary researchers continue to develop products to improve the health of pets. In 2004, the CVM approved Vetsulin, the first FDA-approved veterinary insulin for the treatment of dogs with diabetes mellitis. "We expect progress in disease and drug research to generate new drugs for our companion animals," says Sundlof. "We're seeing the same type of research to develop drugs for pets as for humans, such as treatments to improve the quality of life for older dogs and cats."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.