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Increasing the Supply of Safe and Effective Drugs

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2011 Annual Report

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.


Challenges and Accomplishments

Significant Approvals

The FY 2011 significant approvals for new and supplemental new animal drug applications are listed in Appendix C of this report. Included in the 23 significant approvals this year are 8 new chemical entities, 2 original approvals, 6 original generics, 2 new combinations, 1 new minor species generic supplemental approval, and 4 supplemental approvals. The significant new chemical entity approvals included:

ONSIOR (robenacoxib) – indicated for control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats.
IMPROVEST (gonadotropin releasing factor-diphtheria toxoid conjugate) – for temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.
INCURIN (estriol) – for the control of estrogen-responsive urinary incontinence and ovariohysterectomized female dogs.

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.


Innovative Approaches to Facilitate Approval

“InnoVation” Exploration Team (IVET)
IVET was established in FY 2010 as a “think-tank” with the goal of facilitating the introduction of innovative products and processes into the Office of New Animal Drug Evaluation. Through the work of IVET, the Office of New Animal Drug Evaluation is establishing a pre-INAD process that will allow our review scientists to become familiar with innovative products early in the development phase. Proactive efforts prior to the establishment of an INAD can increase the predictability of the regulatory pathway for sponsors, maintain a low number of review cycles by reducing missteps, and reduce the overall time to approval for innovative new animal drugs.

FY 2011 accomplishments include:
The Office of New Animal Drug Evaluation established several new technology teams that worked intensively with drug sponsors to identify novel and predictable regulatory pathways for innovative new animal drugs. In addition, IVET and the Animal Health Institute have formed an Innovation Working Group to identify potential approaches for developing innovative products. The working group created the following subgroups to tackle key issues:

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.

Members of IVET met with members of the European Medicines Agency and the Veterinary Drug Directorate, our European and Canadian regulatory counterparts, during the year. Both the European Medicines Agency and the Veterinary Drug Directorate expressed interest in collaborating with CVM on alternative ways to evaluate innovative technologies. The groups intend to continue meeting on a quarterly basis.

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.


Other Approaches to Facilitate Approvals

CVM has taken other approaches to facilitate drug approvals. For instance, the Office of New Animal Drug Evaluation staff held a listening session with aquaculture stakeholders to identify ways that more information can be leveraged, and risk-based approaches t used to support aquaculture drug approvals. We formed a working group to enhance and facilitate the use of risk analysis principles in the evaluation of new animal drugs. The working group considered examples of the application of risk principles to help establish current baselines of knowledge. The information allowed the Office of New Animal Drug Evaluation to identify competencies needed for risk-based review approaches.

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

To facilitate the drug development process, CVM recommends that sponsors submit protocols to the Office of New Animal Drug Evaluation so that study designs can be reviewed before initiation of studies to support substantial evidence of effectiveness or target animal safety. A Guidance for Industry document issued in September 2011 makes recommendations to aid in the preparation of protocols used to generate data to support new animal drug applications.

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.



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