November 01, 2016


 Biologics labels to get more instructions, warnings

Posted Oct. 12, 2016

Veterinary biologics makers will adjust product labels and packaging to meet expanded requirements on instructions, warnings, and disclosures.

The Department of Agriculture’s Animal and Plant Health Inspection Service will implement the more stringent standards over the next four years, although manufacturers granted exemptions could take up to six years to adopt the changes, according to an Aug. 30 Federal Register notice.

“These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product,” the notice states.

The updated federal regulations state that biologics product labels must contain full use instructions with indications, target species, minimum ages for administration, routes of administration, vaccination schedules, product license restrictions, and warning and caution statements. Those provisions replace one that mandated only a description of approved indications.

The agency also is adding requirements for descriptions of product safety established in pregnant animals as well as warnings about fetal health risks associated with administering modified-live virus vaccines to pregnant animals when those vaccines have both potential reproductive effects and acceptable pregnant animal safety data.

The updates also added statements that recommendations for annual boosters must be supported by data acceptable to APHIS officials, and products need to note the absence of such data and recommend veterinarian consultation.

Dr. Laurel Gershwin, immunology representative and vice chair for the AVMA Council on Biologic and Therapeutic Agents, said the disclosures about testing in pregnant animals and statements about health of fetuses are important changes, as are the requirements that companies disclose whether they have evidence to establish a revaccination schedule.

On the latter subject, she said those working in veterinary immunology understand some vaccines provide protection much longer than one year. Practitioners also may know of scientific literature that provides proof of longer durations of immunity for a particular product.

Biologics manufacturers also must provide product code numbers that can be used to differentiate separate products that are sold under the same name, and overlapping serial number sequences.

Requiring those product codes could be valuable, Dr. Gershwin said. Citing an example given by APHIS in justifying the change, she said the addition of a dye is among slight changes that could be connected with adverse reactions. Having the distinct product codes could aid an investigation.

She also said a change that will require that biologics manufacturers list all product preservatives, rather than only antimicrobial preservatives, will provide similar help in identifying the causes of adverse responses or avoiding them when sensitivities are known. Knowing biologics contents also will help veterinarians with proper product disposal.

Dr. Gershwin further noted that APHIS is requiring that labels for panleukopenia vaccines recommend that, when a healthy cat is vaccinated before 12 weeks of age, that cat should receive a second dose no earlier than 16 weeks of age.

She described some of the changes as minor, such as those that are intended to reduce confusion when assigning abbreviated product names or provide a consumer contact number for use to report adverse events.

The agency also will require that manufacturers list a standardized biologics storage temperature range of 2-8ºC or 35-46º F.

The agency had proposed the changes in January 2011 and accepted comments through March 2011.

The AVMA submitted one of the six comments on the proposal. In that comment, Dr. Ron DeHaven, then CEO, expressed support for the changes, suggested additional changes, and noted that the Association had advocated for improvements in biologics labels.

The proposal and comments are available for viewing here.

 The August 2016 Federal Register notice indicates the veterinary biologics industry has grown from a $2.3 billion industry in 2006 to one with values ranging between $4.3 billion and $4.6 billion from 2010-2014.