Increasing the Supply of Safe and Effective Drugs
One of CVM’s greatest challenges is to expeditiously approve quality, safe, effective, and properly labeled new animal drug products through a science-based approach in a regulatory environment. The Center is also tasked to facilitate the introduction of innovative products and processes, increasing the certainty of the regulatory pathway for those products.
ONSIOR (robenacoxib) – indicated for control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats.
PHENYLPROPANOLAMINE HCL – indicated for control of urinary incontinence due to urethral sphincter hypotonus in dogs.
PRASCEND (pergolide mesylate) – for control of clinical signs associated with pituitary pars intermedia dysfunction (equine Cushing’s Disease) in horses.
“InnoVation” Exploration Team (IVET)
FY 2011 accomplishments include:
Innovation Decision Tree Subgroup is developing a process for industry representatives to bring innovative products to the Office of New Animal Drug Evaluation, and a standardized decision tree to identify innovative products.
Ground Rules for Technical Team and Drug Sponsor Interactions Subgroup is working with Animal Health Institute members to discuss the process of establishing a technical (“tech”) team. The group is also developing a document that addresses how sponsors and CVM will interact during the pre-INAD process.
Long-Term Regulation Changes Subgroup is brainstorming potential changes to the statute or regulations that would help facilitate innovation, including possible incentives for innovative products.
The Office of New Animal Drug Evaluation also created a draft standard operating procedure for the development of tech teams and focus groups to address scientific and regulatory issues associated with innovative new animal drug products and platforms. Several tech teams and focus groups were formed during the year. A tech team is focused on a specific product or group of products, particularly those that may not have an applicable guidance document. A focus group concentrates on broad topics such as scientific issues, policy issues, or review processes.
The Office of New Animal Drug Evaluation is creating a file system which will house information gathered during the discovery phase (pre-INAD). This will allow us to retain pre-INAD information and discussions within CVM as well as with sponsors.
The Office of New Animal Drug Evaluation, Division of Human Food Safety is exploring alternative ways of evaluating the safety of new animal drugs, including possible changes in the way tolerances are set; use of study evaluations by other regulatory agencies or international expert organizations as alternatives for full data submissions by sponsors; and evaluation of new approaches to assess the human food safety of animal drugs that are proteins, peptides DNA, and RNA products. Where applicable, Guidance for Industry (GFI) documents will be developed.
The Office of New Animal Drug Evaluation developed standard operating procedures to identify questions and issues to be considered when evaluating stem cell products and oncology products for target animal safety and effectiveness. The development of the standard operating procedures will enable CVM to have consistent regulatory approaches to these new technologies.
Target Animal Safety and Effectiveness Protocol Development and Submission – Guidance for Industry #215
The recommendations are intended to reduce the time to protocol concurrence by:
- Recommending a path to protocol concurrence,
- Enhancing quality of protocol submissions by focusing on agreements on study design and statistical analysis, and
- Making use of opportunities to meet with CVM before and during protocol development.