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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM’s LEVERAGING ACTIVITIES

FDA Veterinarian Newsletter May/June 2001 Volume XVI, No III

FDA is exploring new opportunities to leverage its own assets by working with other organizations in order to carry out its public health mission effectively in the 21st Century. Leveraging is the creation of relationships and/or formal agreements with others outside the FDA that will ultimately enhance FDA’s ability to meet its public health mission. These collaborations are intended to have a larger net public health benefit to the American public than would be possible if FDA worked alone. The Agency is currently working closely with a diverse set of partners—including public health organizations, scientific experts, other Federal regulators, States, industry and consumers—to expand these benefits.

CVM has two strategic goals for carrying out leveraging efforts. The first goal is to increase the availability and diversity of safe and effective animal drugs and feeds.

FDA’s Animal Drugs and Feeds Program informs and assists product sponsors throughout the approval process starting with the pre-submission conference. The focus is to inform and assist firms in complying with the new legislation and streamline the product review process through phased review. Instead of waiting until all stages of product development are completed before contacting FDA, phased review helps industry stay on course through the drug development process by communicating requirements (or standards or criteria) for approval at each stage of development.

Staff College programs have been developed in FDA as a means of developing intellectual capital. The addition of a CVM Staff College will allow CVM to increase and maintain the scientific expertise in the Center, especially as it relates to animal science and veterinary medicine issues. The Staff College will use dollars to outsource the planning and implementation of training programs tailored to the needs of in-house scientists.

Collaboration with other agencies such as the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) is accomplished through interagency agreements. FDA also funds extramural research via contract and cooperative agreements and through collaboration with the University of Maryland known as the Joint Institute for Food Safety and Applied Nutrition (JIFSAN).

CVM’s second strategic goal is to reduce the risks associated with marketed animal products.

In order to assure that foods from animals are safe for human consumption, FDA works with other government agencies, State and local governments, and the private sector to take action to prevent or minimize potential public health hazards through development of early warning systems, investigations, risk assessment, scientific research, educational initiatives and regulatory action.

CVM partners with other Federal and State agencies, our stakeholders, and regulated industry to develop and sponsor workshops, symposia, and publications with a focus on prevention in order to assure the public that accurate information is disseminated and that marketed animal drugs and feeds are safe and effective.

CVM is making a strong effort to educate its partners in industry by publishing and disseminating guidance, training initiatives in targeted high-risk compliance areas, and in working more closely with industry to resolve problems.

FDA is also involved in international harmonization activities that will remove trade barriers while ensuring the American public that imported products meet FDA’s standards related to safety and efficacy. Part of the harmonization effort includes the development of Mutual Recognition Agreements (MRA’s) that will address international equivalency issues. FDA must be able to assure the public that the processes used in other countries are as good as the processes in this country and the resulting products are safe for the intended use. Harmonization activities have been initiated with the European Union and Japan. The assessment of Member State regulatory systems is essential to the harmonization process.

By choosing to work with other organizations that share our public health and safety goals, FDA can significantly amplify its public health impact, leverage the intellectual capital of others, and make wise use of its resources. FDA has been quite successful with its past collaborations and the agency intends to expand and build upon this solid foundation in developing new partnerships. Successful leveraging provides benefits and incentives to all participants, including consumers, industry, academia, health providers, and other government agencies. In addition, greater benefits are produced by sharing talent and material resources and achieving results through synergism. For further information about leveraging, please visit the web site. The following article relates to international collaboration between the U.S. and the European Union.