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FDA's primary challenge in the 21st Century is to minimize product risk to the consumer as the scientific complexity of these products grows exponentially, and as trade, regulation, new health threats, and consumption patterns continue to change. To meet this challenge, FDA must call upon the capabilities of its various stakeholder communities - regulators, health partners, industry, and consumers - to generate effective solutions to these complex public health and safety challenges.

During the past two years, FDA has engaged stakeholders in a series of dialogues to determine how to narrow the gap between current Agency performance and public expectations. FDA has listened closely to stakeholder suggestions and has incorporated these into many of the collaborative initiatives outlined in the FY 2003 Performance Plan. Examples of these initiatives are described in the following paragraphs.

Collaborative Institutes:

FDA is proposing in FY 2003 to establish a manufacturer college that will feature collaborations with industry to improve the medical device review process; and a virtual corporate university in cooperation with academic institutions to augment the Agency's scientific and technological expertise, also associated with medical devices. Both of these new institutional arrangements should enable FDA to realize scientific and regulatory synergies that could not be accomplished by the Agency and its stakeholder working independently.

The Product Quality Research Institute (PQRI) initiative will continue to be emphasized as a method of leveraging external scientific expertise to help support sound regulatory policymaking. PQRI is a nonprofit foundation that serves as a vehicle for FDA, industry and universities to collaborate on key issues in pharmaceutical product quality through research and expert group analysis. Participating members such as the American Association of Pharmaceutical Scientists, the Generic Pharmaceutical Industry Association, and the Nonprescription Drug Manufacturers Association work with FDA and other government and private organizations to determine the optimum type of information that should be submitted in drug approval requests.

FDA also continues to reap applied research benefits from its two food partnership institutes - the Joint Institute for Food Safety and Nutrition with the University of Maryland and the National Center for Food Safety and Technology in conjunction with the University of Illinois.

Risk Management Communication and Education:

About half of the patients who fill the nearly 3 billion prescriptions from their doctors each year don't take the medicine as prescribed, which can lead to serious health consequences. Under it's Take Time To Care program, FDA has partnered with the National Association of Chain Drugstores and 80 national organizations to distribute millions of copies of the brochure My Medicines to patients to educate themselves and their families about using medicines wisely. The brochure delivers four key messages: read the label, avoid problems, ask questions, and keep a record.

Targeted Collaboration on Critical Health Issues:

FDA scientists play key roles with many national, international and interagency organizations involved in establishing vaccine policy and practice. Examples are the National Vaccine Advisory Committee, the Committee on Infectious Diseases of the American Academy of Pediatrics; the World Health Organization; and the National Institute of Biological Standardization and Control (in the United Kingdom). FDA works on committees related to AIDS, such as the NIH HIV Vaccine Selection Committee, as well as working groups on Influenza Pandemic Preparedness, the Adult Immunization Plan, and the TB vaccine development plan.

FDA has key responsibilities for safety of the nation's blood supply. This includes standards setting and health education. The American Association of Blood Banks, the American Red Cross, state health agencies, NIH and CDC are among the partners in this effort.

Integrated/Shared Surveillance Networks:

FDA is working in several venues to realize synergies in multi-organizational surveillance systems. One area of emphasis in the FY 2003 plan is the further development of an integrated sentinel surveillance network to include hundreds of participating hospitals across the U.S. Through these sentinel systems a select group of reporting facilities with highly trained staff can provide high quality, informative reports representative of user facility device problems in general.

The National Antimicrobial Resistance Monitoring System (NARMS), initiated by FDA, CDC and the U. S. Department of Agriculture, helps detect whether foodborne pathogens are developing resistance to drug treatment. The system will be enhanced by increasing the number and source of bacterial isolates (human and animal) collected and the number of states covered by the system.

FDA will also continue to coordinate with the U.S. Customs Service to strengthen the Operational and Administrative System for Import Support. This is a monitoring system that screens unacceptable products from entry into U.S. commerce. As information on products and country of origin is further developed, FDA can improve their systematic profiling capabilities in order to more accurately target potential risk.

Cooperative International Standard Setting:

FDA will continue to participate in international forums to ensure that U.S. interests are upheld in establishing standards for products under the Agency's regulatory purview. The Agency will continue to collaborate with the International Conference on Harmonization, The International Standards Organization, Codex Alimentarius, and The World Health Organization among others, to achieve this goal.

The Agency will also continue to make progress in further refining provisions of the Mutual Recognition Agreement with the European Union, and in training overseas counterparts so that those provisions can be successfully implemented. To illustrate, FDA is recognizing an increasing number of international standards as a way to satisfy part of our 510(k) requirements (medical device approvals).

Third Party Review, Inspection, Testing:

FDA will continue to test the concept of utilizing third parties as independent reviewers, inspectors and testers of FDA-regulated products. The goal of these initiatives will be to outsource these functions where: a) there are no compromises to the health or safety guarantees associated with these products; and b) where the use of third parties is more cost-effective than carrying out the task inside FDA.

One example of successful third party inspections is the Mammography program. Over 90 percent of inspections of mammography facilities are conducted by states under contract to FDA. Another example is the expansion of third party reviews of medical devices. FDA has developed a third party review program and is expanding the number and types of devices that are eligible for third party review.

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