3 Questions For ... Bernadette Dunham, DVM, PhD, Director, FDA Center for Veterinary Medicine

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Bernadette Dunham, DVM, PhD

Bovine Veterinarian: How do you see the AMDUCA ELDU privileges faring in the regulatory environment over the next few years?

Dunham: We recognize that it is very important that veterinarians have access to effective therapies for assuring the health and welfare of animals. The ability of veterinarians to use drugs in an extralabel manner, under the provisions of AMDUCA, is a critical mechanism for enabling access to such therapies. With this in mind, FDA carefully considers any decision to exercise its authority to limit extralabel use and, does so only when it believes it is necessary to protect the public health. We believe AMDUCA provides an important framework for extralabel use that is protective of both animal and human health.

BV: How does the 5th circuit court of appeals ruling affect the CVM approach to compounding pharmacies?

Dunham: The 5th Circuit Court of Appeals confirmed CVM's position that compounded animal drugs are new animal drugs and are subject to the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act. The only "legal" compounding of new animal drugs is done pursuant to FDA regulations covering the extralabel use of new animal drugs. In order to be exempt from the adulteration provisions of the Act, the compounded animal drug must have been compounded from approved human or animal drugs by a veterinarian or a pharmacist on the order of a veterinarian within the practice of veterinary medicine and only in cases where the health of the animal would be seriously threatened without the product. Nothing in FDA regulations permits compounding from bulk drugs.

For additional information on extralabel use, click here.

BV: There has been discussion of veterinarians taking on more responsibility for feed antimicrobials. In what form would you see that oversight expanding?

Dunham: Since many antimicrobial drugs currently approved for use in animal feed are available as over-the-counter products, veterinary involvement in their use may be limited. Veterinarians can play a critical role in the diagnosis of disease and in the decision-making process related to instituting measures to treat, control, or prevent disease. Such involvement is valuable for helping to ensure that these drugs are used as judiciously as possible in order to minimize antimicrobial resistance development. The Animal Drug Availability Act (ADAA) established the veterinary feed directive (VFD) as a framework for approving animal drugs intended for use in feed under the supervision of a licensed veterinarian.    

Is there someone you would like Bovine Veterinarian to ask three questions to? If so, e-mail Geni Wren at gwren@food360.com and let us know and we’ll try our best to get it done.



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