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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Strategic Plan Announced

FDA Veterinarian Newsletter September/October 2003 Volume XVIII, No 5

On August 20, 2003, FDA Commissioner Dr. Mark McClellan announced FDA’s new Strategic Action Plan, calling it “an aggressive and dynamic plan, requiring hard work and dedication.” He added, “It’s a plan that we expect to execute within our current resources and budget proposals.”

There are five core goals described in the Action Plan. Each goal cuts across most if not all of FDA’s Centers, as well as the Commissioner’s office. The five goals are:

1 – EFFICIENT, SCIENCE-BASED RISK MANAGEMENT
2 – PATIENT AND CONSUMER SAFETY
3 – BETTER INFORMED CONSUMERS
4 – COUNTERTERRORISM
5 – A STRONG FDA

CVM’s Director, Dr. Steve Sundlof said the five goals “track very closely with CVM’s Back to Basics initiative.” He explained, “One key element of the Agency strategic plan is the use of efficient risk management in our policies and regulations to bring predictability to the drug development process. CVM is firmly committed to this goal, both in the drug review process and in the enforcement and compliance arenas. CVM is developing regulations and guidance to facilitate the review of new biotechnology products, to define the animal drug review process, and to apply risk management to the use of antimicrobial drugs. We are using risk analysis to establish our inspection and enforcement priorities and to frame our guidance on manufacturing practices. Risk analysis is an integral part of our regulatory decision making.”

CVM’s Back to Basics approach recognizes the importance of establishing strategies and processes for educating stakeholders on how CVM makes critical decisions. The second and third goals of the new FDA Action Plan are to improve patient and consumer healthcare through better information. CVM is working with veterinarians and professional associations to improve communication about drug use and risks.

CVM is also fully engaged in the Agency’s efforts to counter terrorism and assure the security of the food supply. CVM scientists are focusing efforts on detecting chemical and biological contaminants in animal feeds in CVM’s state-of-the-art research facilities.

You may read the FDA Strategic Action Plan on the FDA web.