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In 2006, the Food and Drug Administration (FDA) celebrated its 100th year of protecting and promoting the public health by modernizing many of its processes while continuing to safeguard the safety and high standards of a more than a trillion-dollars worth of products that are critical for the good health and quality of life of all Americans. An important part of these activities was focused on ensuring the safety and wholesomeness of 80 percent of the United States food supply and all animal products; on conducting vital toxicological research, and on maximizing compliance with U.S. public health standards.
"In 2006, FDA employees were at the forefront to protect our consumers against public health hazards from food and medical products," said Dr. Andrew C. von Eschenbach, Commissioner of Food and Drugs. "As the gold standards of the 20th century, the agency enters its second century of progress solidly anchored in science and embracing innovative technologies that will ensure continued progress as we serve the nation by protecting and promoting the public health."
Additional documents on this Web site describe:
Below are the missions and highlights of the 2006 accomplishments of FDA's key components that do not regulate human drugs and medical devices:
CFSAN is responsible for ensuring that 80 percent of the U.S. food supply -- all food except for poultry, meat and some egg products -- and all cosmetics are safe, secure, and truthfully and appropriately labeled.
In FY 2006, CFSAN played major role in investigating the source and mitigating the effects of a multi-state outbreak of E. coli O157:H7 associated with fresh, bagged spinach; published a draft "Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables," and developed a Lettuce Safety Initiative. CFSAN also reviewed the safety of 23 infant formulas, 49 new dietary ingredients, and 100 types of new contact materials for such uses as manufacturing and packaging food. To strengthen the security and safety of our food, CFSAN developed scientific methods to identify strains that could be used to intentionally contaminate food; created bioforensic tools to enable the detection, identification, and tracking of strains of E. coli, Shigella, and Salmonella pathogens; and developed genetic technologies applied to E. coli O157:H7 and multi-drug-resistant Salmonella pathogens.
CVM ensures the safety of animal feed and food additives used in animals, and the safety and effectiveness of veterinary drugs.
During the Fiscal Year (FY) 2006 (10/1/05-9/30/06), CVM issued 38 significant product approvals, 17 of which were for generic versions of pioneer animal drugs. The most important original approvals included Equioxx (firocoxib) for horses to control pain and inflammation due to osteoporosis; Cydectin (moxidectin) to treat and control internal parasites in sheep; Aquaflor (florfenicol) Type A to treat enteric septicemia of catfish; Aureomycin (chlortetracycline) and Bovatec (lasalocid), a combination drug to control various infections and increase feed efficiency in cattle; and Zilmax (zilpaterol hydrochloride) to improve feed efficiency in confined cattle. In addition, CVM completed an 800-page draft risk assessment addressing the safety of food derived from cloned animals and the health of animals affected by this type of assisted reproductive technology.
NCTR conducts peer-reviewed scientific research to define mechanisms underlying the toxicity of FDA-regulated products, and develops methods to improve the assessment of the associated human exposure, susceptibility and risk.
In 2006, NCTR scientists, working with other experts at FDA and in academia, published more than 150 peer-reviewed documents supporting FDA's risk-based regulatory decisions. NCTR also initiated .the MicroArray Quality Control project to explore the suitability of microarray chips for identifying genes for use in personalized medicine. As part of the study, 137 scientists from the public and private sectors performed 1,300 tests on 20 chips with DNA samples. The results of this program have important implications for streamlining the drug application process.
ORA protects consumers and enhances public health by maximizing compliance of FDA-regulated products and minimizing risks associated with those products.
As part of this mission, ORA in FY 2006 conducted nearly 20,000 inspections and, to further help ensure the safety and integrity of FDA-regulated products, made arrangements for additional 24,000 inspections by state authorities. ORA also supervised 4,266 recalls of substandard and illegal products; issued 538 "Warning" letters directing firms to cease improper or illegal activities and take corrective actions; and obtained 17 court injunctions to stop illegal activities and remove illegal products from the market. In addition to protecting Americans from unsafe or substandard food, drugs, biologicals, medical devices and other FDA-regulated products, ORA's successful enforcement efforts last year resulted in 323 arrests and 271 convictions with restitution payments and fines of well over $1 billion.
These results were achieved in addition to numerous other FDA activities to protect the health of our public. For example, to develop and disseminate evidence-based information on how to best use drugs, medical devices and biological products in the nation's youngest patients, the agency's Office of Pediatric Therapeutics held two meetings of the Pediatric Advisory Committee on the safety of 19 drugs; surveyed the needs for pediatric devices; held public hearings on exemption of children from informed consent in emergency research; cooperated with the European Medicines Agency (EMEA) on ethical approach to pediatric studies, and presented pediatric and ethical information at approximately 40 significant conferences.
To strengthen global regulatory cooperation on public health issues of mutual interest, FDA's Office of International Programs last year participated in five scientific consultations with EMEA and industry on optimizing product development; held formal bilateral discussions with regulatory agencies in China, Vietnam and Korea focused in part on issues related to the prevention of Avian flu; and concluded five new confidential information sharing agreements with counterpart agencies in Australia, France, Germany, Sweden and Israel.
FDA also continued the consolidation of its activities and staff in new quarters under construction at White Oak in Silver Spring, Md. By the end of 2006, the agency had transfered to White Oak 1861 employees, and by May, 2009 it expects to have completed the first half of this massive project.