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U.S. Department of Health and Human Services

Animal & Veterinary

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AAVPT Hosts CVM Workshop on the Veterinary Drug Life Cycle

by Carmela Stamper, DVM, Center for Veterinary Medicine, FDA

Based on the need to share regulatory science knowledge, the planning committee had several goals in mind while organizing the workshop:

  • Educating industry, researchers, and CVM reviewers about the animal drug approval process and the complete life cycle of an approved animal drug;
  • Using the workshop as a springboard for the future development of new reviewer training at CVM;
  • Ensuring better data submissions from the drug industry to CVM by providing the scientific and regulatory justifications for the animal drug approval process requirements;
  • Creating a non-stressful, open forum for industry, researchers, and CVM to discuss regulatory science; and
  • Completing one of the 10 required workshops under ADUFA II (Animal Drug User Fee Act II1). 

More than a year’s hard work came to fruition when CVM experts participated in a workshop from February 28 to March 4, 2011, at the Bolger Center in Potomac, Md. The workshop, called the “AAVPT Veterinary Drug Regulatory Life Cycle (A to Z),” covered the life cycle of an approved animal drug from the drug’s early development to its life on a veterinarian’s pharmacy shelf and its use in animals.

The American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) sponsored and organized the event. Drs. Michele Sharkey and Sanja Modric from CVM developed the scientific program, while Drs. Ralph Claxton, Carol Davis and Anthony Lucas from AAVPT handled the workshop’s logistics.

Approximately 100 members from the drug industry and research organizations, representing 41 groups, attended the workshop. Because attendance space was at a premium, FDA’s CDRH (Center for Devices and Radiological Health) Studios created a CVM-only web link for CVM employees unable to attend in person, and videotaped the workshop for future posting on the Center’s website. The general public may view the proceedings online as part of CVM’s outreach and education program. For more information, see AAVPT Veterinary Drug Regulatory Life Cycle Course.

Regulatory Science 101

Many people working in the animal drug industry and in animal drug research are unfamiliar with FDA’s role in protecting and promoting animal health; therefore, the workshop began with a brief welcome and introduction to CVM’s history by Dr. Bernadette Dunham, CVM Director. Other CVM experts discussed the center’s role in regulating animal health products and compared FDA’s animal and human drug approval processes.

CVM experts then took attendees through an in-depth look at the complexities of the animal drug life cycle, from a drug’s first steps in the approval process through its approval, marketing, and post-approval monitoring. They also made themselves available for question-and-answer sessions throughout the week. Attendees were very engaged and provided insightful, challenging questions for the Center’s experts.

 Presentation topics included:

  • Pre-Approval Administrative Topics
  • Chemistry, Manufacturing, and Controls
  • Effectiveness
  • Target Animal Safety
  • Human Food Safety
  • Environmental Safety
  • Generic Drugs
  • Drugs for Minor Uses or Minor Species
  • Medicated/Non-Medicated Feeds
  • Compliance Activities
  • Post-Approval Marketing Requirements
  • Animal Drug Surveillance
  • Research at CVM
  • Regulation of Biotechnology Products
  • Unapproved Animal Drugs Initiative
     

The regulatory science behind the animal drug approval process and post-approval activities are complex, and in many aspects, unique to veterinary medicine. CVM’s drug reviewers and those outside the Center who are researching or developing new products need to be well-educated in basic regulatory science. This common education may allow the Center’s reviewers and drug researchers and developers to work together more efficiently to get new approved products to the marketplace with fewer post-approval issues.

Encore, Encore!

Attendees provided overwhelmingly positive feedback on their workshop evaluation forms. Attendees noted the open, non-adversarial atmosphere of the workshop. Dr. Sanja Modric, a meeting organizer, said attendees were impressed by the friendliness of the CVM experts and their willingness to communicate with industry.

Will the course be offered again? The answer, according to Dr. Modric, is “yes”. The organizing committee is evaluating the attendees’ written feedback to determine the extent and frequency of future course offerings.

The successful week-long “AAVPT Veterinary Drug Regulatory Life Cycle (A to Z)” workshop addressed a recognized need for educating CVM reviewers, the drug industry, and drug researchers in basic regulatory science. Congratulations to all involved with this well-organized workshop! 
 

 

 

 

1 The Animal Drug User Fee Act (ADUFA) amended the Federal Food, Drug, and Cosmetic Act to authorize FDA to collect fees from the drug industry. FDA uses the fees to hire, support, and maintain personnel for the review of new animal drug applications to ensure safe and effective animal drugs reach the marketplace more quickly. ADUFA originally passed in 2003 and was to expire on September 30, 2008; however, ADUFA was extended to 2013. Among the new performance goals was that CVM and regulated industry participate in 10 public workshops by the end of fiscal year 2013 on mutually agreed-upon topics.

 

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Helpful Links

The following links provide more information about the “AAVPT Veterinary Drug Regulatory Life Cycle (A to Z)” workshop and the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT).

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