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"We must have the best science underpinning all of our decisions. From the researcher in our food labs, to the reviewer in our drug divisions, the inspectors in the field, or any employee articulating a new policy -- all decisions should be based on the most recent scientific developments and knowledge."
Commissioner of Food and Drugs Jane E. Henney, M.D., September 27, 1999.
The central significance of science in regulatory decisions is now universally recognized. Today, FDA's scientific expertise is more important than ever as the Agency sets standards, evaluates sophisticated products and inspects state-of-the-art production facilities that utilize the latest developments in molecular biology, clinical pharmacology, physics, and electrical engineering.
FDA is responsible for ensuring the safety of 75 percent of the national food supply and is gatekeeper for the multitude of new food products and technologies. To help FDA scientists and the food industry address rapid technological advances in food science and detect emerging hazards in the area of food safety, the Illinois Institute of Technology in 1998 joined FDA, the University of Illinois and 70 members of the food industry in establishing the National Center for Food Safety and Technology, also called the Moffett Center.
The Center, located in Chicago, is a research partnership where scientists from government, academia and industry cooperate in resolving scientific and engineering issues bearing on the safety of food processing and packaging technologies. To learn more about the Moffett Center, visit www.iit.edu/~ncfs/.
In 1996, FDA and the University of Maryland established the Joint Institute for Food Safety and Applied Nutrition or JIFSAN. The Institute provides the foundation for partnerships with other federal and state agencies, academic institutions, industry, consumer and trade groups and international organizations. Its primary focus is to establish sound risk analysis as the basis of FDA's food safety policy. In 1999, FDA and JIFSAN held an international conference on enhancing the safety of fresh produce that was attended by participants from 24 countries. The workshop initiated the development of a food safety-oriented education and outreach program for growers and producers. Research collaborations through JIFSAN are also investigating potential risks to human health represented by exposure to antibiotic resistant bacteria present in food. These projects are investigating antibiotic resistance in animals and the distribution of resistant organisms in retail food items. To learn more about JIFSAN, visit ww.jifsan.umd.edu.
The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative effort among the FDA, USDA and CDC that monitors susceptibility to 17 antimicrobial drugs in foodborne pathogens from human and animal clinical specimens, healthy farm animals and carcasses of food-producing animals at slaughter.
Because FDA regulates in a global market place, collaborative efforts, such as NARMS, must extend beyond our domestic borders. FDA and USDA recently met with medical microbiologists from hospitals in Mexico and Guatemala who are interested in initiating an antimicrobial resistance monitoring program. This collaboration, between U.S. NARMS officials and the Mexican antimicrobial surveillance group, represents the beginning of the first international human and animal monitoring system for foodborne antimicrobial drug susceptibility surveillance in the Americas. This cooperation will lead to improvements in the Mexican Surveillance Program which, in turn, will reduce the possibility that contaminated food products will be shipped to the U.S. FDA is hopeful that this collaboration will also lead to an international database on antimicrobial resistance.
In 1999, FDA continued the expansion of NARMS in its effort to enhance the safety of imported food products.
The Imported Foods Action Plan, as announced by President Clinton in his December 11, 1999, radio address, was developed by FDA and the U.S. Customs Service to enhance border surveillance to protect consumers from unsafe imported food. The Plan will be implemented in 2000.
Strong science is critical for FDA's ability to make sound regulatory decisions ensuring the quality of drugs. Last year, FDA joined the American Association of Pharmaceutical Scientists and six drug-related associations in founding the Product Quality Research Institute, Inc., or PQRI, whose purpose is to identify the best practices for manufacturing advanced, high quality drugs. FDA's goal in participating in this research is to improve the current processes for building quality into drug products and increase the Agency's efficiency in regulating these products. To learn more about PQRI visit www.pqri.org.
Our nation's blood supply is safer than it ever has been, and still continues to be improved. In 1997, FDA initiated a Blood Action Plan to increase the effectiveness of its scientific and regulatory actions by working with state health and regulatory authorities to identify and respond to potential threats to blood safety and supply. Implementation of the Blood Action Plan has greatly improved the regulatory oversight and safety of the nation's blood supply. For more information visit www.fda.gov/cber/blood/bap.htm.
FDA's Biologics Center has three additional action plans - tissue, xenotransplantation, and devices, initiated to increase the Agency's scientific and regulatory effectiveness in these areas. For more information on these action plans visit:
FDA's National Center for Toxicological Research, better known as NCTR, is a unique facility located in Pine Bluff, Arkansas. NCTR's scientists provide expert scientific consultation and training in a wide variety of disciplines to support complex regulatory judgements by FDA reviewers. A major focus of this state-of-the-art facility is to find better ways to assess the cancer-causing potential of FDA-regulated products. For more about NCTR visit www.fda.gov/nctr/.
FDA scientists participate in various fellowship programs to strengthen the Agency's scientific and technical know how and to share their expertise with the academic community, thereby helping advance scientific education. Staff fellowships strengthen the research community and assure a continuous exchange of talent between the FDA and other scientific institutions.
The Agency has initiated a series of industry training programs on new and emerging technologies. These special programs bring FDA scientists, field investigators and lab analysts together with industry scientists, in a spirit of cooperation, to discuss the newest technologies, FDA requirements and how best to bring new technologies into the marketplace. Specific FDA-regulated products are not discussed. The courses, designed by FDA and industry scientists and conducted at various locations throughout the United States, cover a wide range of issues concerning FDA-regulated products.
Four training courses have been conducted since September 1999. Course topics covered the use of barrier isolation to sterilize drug products; use of rapid screening methods for allergens and microbiological hazards; microarray or gene chip technology; and nucleic acid amplification testing of blood. Future courses include new trends in sterility testing of medical devices and new veterinary biopharmaceuticals.
The industry and consumers as well will benefit from this series of FDA/Industry training courses. This joint project will lead to more efficient application reviews and inspections for products using the new technologies, thus bringing these unique new products into the marketplace and to consumers and patients faster.
For more information on FDA/Industry Training, contact FDA's Office of Science.
FDA cannot maintain its effectiveness and credibility unless its scientists are on the cutting edge of their specialties. Despite declining budgets, the Agency devotes substantial resources to its scientific projects, to attracting and retaining highly qualified scientists and physicians, and to giving its specialists opportunities to keep current in their disciplines.
. . . that good science and scientific expertise play an essential role in FDA's ability to promote public health. Consumers, health professionals, trade and professional associations, and others continue to express strong support for FDA's efforts to embrace modern science and to retain highly qualified scientists.
PricewaterhouseCoopers and the University of California recently conducted a survey of the working relationship between the life sciences industry and the FDA. The survey's findings, while generally favorable to FDA, highlighted the importance of recruitment, training, and retention of highly qualified FDA personnel. In the opinion of many surveyed industrial officials, delays in new product approvals are frequently related to inadequate technical expertise by FDA reviewers and to Agency personnel turnover.
Last year, FDA met this FDAMA goal by compiling a list of 110 mechanisms it is using or plans to use to meet the deadlines for review of product applications. (For details, see www.fda.gov/ope/fdama/objEintro.html). The goal of these review mechanisms is to make products that meet FDA standards quickly available to patients and consumers.
FDA reviews new drug and medical devices before they can be marketed to make sure they are safe and effective when properly used. The process is rigorous, and in the past, it often took years. In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), which provided funds for salaries, support and equipment of additional reviewers. The law greatly strengthened the Agency's drug program and changed the way FDA and the industry relate to each other. The new atmosphere is marked by increased cooperation, communication, openness, and a commitment to timeliness without compromising the standards and quality of FDA's reviews.
Thanks to the additional resources, review times for new drugs and biological products covered by PDUFA have improved dramatically. The median approval time is down to 12 months, and approval times for priority applications -- those for products that promise significant therapeutic gains -- are down to 6 months.
But FDA review is just the final hurdle a new drug must clear. The testing
phase that takes place before an application can be submitted may take 5-10
years or more. FDA has been helping industry reduce this long lead time by
advising firms on how to design effective clinical trials, with apparent success.
According to a study released last year by the Tufts Center for the Study of
Drug 
Development,
since 1992, the total drug development time in the U.S. has dropped by 18 percent.
FDAMA, which extended PDUFA for 5 additional years, seeks to shorten total
development times even more by setting new goals that stress openness and responsiveness
to sponsors' requests for consultations. Last year FDA tracked more than 4,000
actions against these new goals and exceeded all performance targets.
Approval times for medical devices are also improving. Last year, although FDA received the highest number of applications in years, the average approval of a new medical device took only 12.5 months, 25 percent quicker than in FY97. Average clearance for devices that require premarket notification took 102 days, the shortest time in nearly a decade.
Food additives that make food safer by acting against microbes that may be present now receive expedited review. FDA published guidance on these new procedures in the Federal Register on January 5, 1999. In 1999, four food additive petitions for antimicrobial agents were approved under expedited review.
Last year, FDA approved important new products for serious conditions and diseases including osteoarthritis, influenza, obesity, HIV, and diabetes. The Agency approved a home-use test kit for hepatitis C, an imaging device for the diagnosis of breast cancer, and a device for removing blood clots from blocked arteries. Important biological approvals included vaccines for Lyme disease and rheumatoid arthritis; clotting agents for patients with hemophilia A; and a treatment for non-Hodgkins lymphoma. In addition, there were 5 new over-the-counter products and many new animal drugs, including breakthrough medications for dogs and cats.
Under priority programs that focus on products for rare or serious diseases, FDA approved two AIDS drugs, six so-called "humanitarian use" devices, and the 200th "orphan" drug. The last two categories of products serve exceptionally small patient populations. In all, 19 orphan drugs were approved for marketing in 1999, including treatments for neoplastic meningitis, ovarian cancer and hemophilia. FDA, working with a coalition of animal health organizations, is drafting legislation to increase the availability of animal drugs for minor species and minor use.
FDA is conducting research to advance and accelerate regulatory and related scientific procedures. To reduce the need for testing new drugs on humans and animals, FDA is a lead player in developing computer-based systems to predict human toxicity.
The Agency is also developing information systems that will make possible electronic processing of premarket approval applications. FDA's centers for drugs and biological products already meet FDAMA's goals of being able to process and review electronic marketing applications and plan to be able to reach the final FDAMA target of paperless processing of both new and investigational new human drug and biologics applications by 2002.
In a major departure from FDA's traditional self-reliance, Commissioner Henney last year endorsed the recommendation of an Agency task force for the adoption of leveraging as FDA's primary operating strategy.
The new approach, whose effectiveness has been demonstrated by FDA's partnerships and collaborative ventures in the past, will become as much a part of FDA's regulatory culture as the Agency's credibility, integrity, transparency and independence.
Leveraging is defined as "the creation of relationships or agreements with others outside FDA that will enhance the Agency's ability to meet public health challenges." The new approach is designed to generate collaborative synergies to reinforce FDA's limited resources; to provide the Agency with the state-of-the-art skills needed to find answers to increasingly complex public health issues; and to build effective partnerships with all members of the health care community -- industry, academia, health care professionals and consumers -- who share the responsibility for the protection of public health.
The basic tenets of FDA's leveraging program include the pursuit of public health aims rather than mere resource-savings, continued FDA responsibility for oversight and other regulatory functions, and goals of mutual interest that bring benefits to all collaborating parties.
Last year, the new strategy was exemplified in the founding of the Product Quality Research Institute, a joint venture of FDA, the American Association of Pharmaceutical Scientists and six other large drug-related associations. The new Institute is a neutral forum where scientists from the Agency, academia and industry are conducting collaborative research on regulatory and production issues involving pharmaceutical products. The results of these studies will be made available to all interested parties. PQRI has established a web site (http://www.pqri.org).
Another example of FDA's leveraging policy is the Agency's recognition of 13 outside review bodies as eligible to provide third party reviews of 154 types of low-risk devices whose evaluations by the Agency lagged behind the mandated timeframes.
Since Objectives E and F are directly related, they were combined in the FDAMA Plan. The strategies followed to achieve Objective E will also eliminate review backlogs. Data on the number of backlogged or overdue applications were included in Appendix D of the FDAMA Plan. These data are updated in Appendix A of this report.
Table of Contents | Objectives (part 1) | Objectives (part 2) | Appendices