Animal biotech drug labels are about to get more detailed, due to USDA rule change

vaccine
The USDA is implementing comprehensive new rules on the labeling of vaccines and other biotech drugs for animals.

As of October 31, manufacturers of veterinary biotech drugs will be held to new, strict standards on labeling. Although companies will have between four and six years to comply, the changes will ultimately help clarify treatment risks and benefits for veterinarians, pet owners and food producers.

In the past, the labels of vaccines and other biotechnology drugs for animals only had to describe the approved indications, according to the Journal of the American Veterinary Medical Association (JAVMA). Once the rule change has been implemented, those labels will include many more details, such as vaccination schedules, routes of administration and the minimum age of the animals targeted for treatment, according to the USDA. Some labels will also include pregnancy and fetal health risks.

The American Veterinary Medical Association (AVMA) is applauding one particular change on the labeling rules for vaccines, which pertains to recommendations that booster shots be given. In the future, any such recommendation must be supported by data approved by the USDA.

Furthermore, vaccine makers will have to disclose whether or not they have the evidence to support revaccination. That’s important, the AVMA says in its journal, because veterinarians are well aware that some vaccines protect animals for longer than one year.

Several of the required labeling changes will help the USDA track the potential causes of adverse reactions to biotech drugs. Going forward, biologics manufacturers will have to supply unique product code numbers for different drugs that are being marketed under the same name. For example, if a dye is added to one version of a drug, a new product code would also need to be established, explains Laurel Gershwin, immunology representative and vice chair for the AVMA Council on Biologic and Therapeutic Agents, in the JAVMA. Then, if there are reports of adverse reactions, that distinct code could help investigators track down which version of the product is causing the problem.

The USDA is requiring several other changes that are designed to reduce confusion among consumer and veterinarians reading biologics labels. For example, the use of abbreviated names will be streamlined. And manufacturer contact information, including phone numbers, will be provided for consumers.

The veterinary biologics industry has doubled in value since 2006 to $4.6 billion, according to the USDA, which makes the need for these labeling changes all the more pressing. “Although the science of immunology and our understanding of how veterinary biologics work have advanced substantially in recent years, communicating such information to consumers and veterinarians by way of updated labeling claims, cautions, and warnings is a top priority,” the USDA writes in its summary of the new rules.

- read more at JAVMA
- access the USDA’s rule changes here

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