Some happenings at USDA and FDA that may impact your business are noteworthy.

On November 16, 2018 FDA released for public comment “proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.”

Bioequivalence studies are required before drugs are approved by FDA (for humans or animals) as safe and efficacious.

“The proposed study will measure the bioequivalence of the approved antiparasitic drugs ivermectin and praziquantel by in vitro dissolution compared to blood levels that indicate how the drug is dissolving in the body (also known as blood-level pharmacokinetics), with the goal of validating these laboratory-based alternative (i.e., surrogate) endpoints. Ivermectin is used in dogs to treat heartworm, a potentially fatal infection. Praziquantel treats tapeworms, an internal parasite that lives primarily in the gastrointestinal tract but can form cysts in liver and other organs.

Comments to the proposed white paper, Alternative Methods for Evaluating Locally Acting, Nonsystemically Absorbed Drugs in Canine Disintegrating or Chewable, Single Layer Combination Drug Products, are available here.

To date, 46 comments are posted.

Recently the Secretary of the Department of Veterans Affairs expressed continued support for the use of dogs in certain research, without which significant gains in medical care for people and pets would not be possible.

On October 30, 2018 FDA announced “the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission.”

The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.

Titled, the “Veterinary Innovation Program (VIP)” the program is designed to “guide sponsors [of certain veterinary products] through the regulatory process . . .”

“Some of these innovations involve genome editing in animals, and exciting new frontier that will benefit humans and animals alike.

As reported by USDA Research, Education & Economics Information System a project titled “Improvement of Dairy animal Well-Being By Genetic Dehorning,” sponsored by the National Institute of Food and Agriculture “will evaluate gene-editing as a means for genetically dehorning cattle without crossbreeding in three steps.”

“First we will introduce the polled genetics into dairy cattle by gene-editing and determine if it has the same effect as crossbreeding. Second, we will determine if there are any unintended effects on the animals; and third, we will evaluate the feasibility of deploying this technology in a variety of breeds to enable broad acceptance and rearing of genetically dehorned cattle.

The project end date is April 14, 2019.

Finally, as United States Cattlemen’s Association recently announced, USDA and FDA “will jointly oversee the regulation of cell-cultured food products from cell lines of livestock and poultry.”

“FDA will oversee cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry.

USCA noted that their pending petition for rule making to define “beef” and “meat” remains outstanding and should be addressed to ensure truth in labeling for consumers.

More to come about all these programs.

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