Publication: FDA Consumer
Publication Date: 01-SEP-06
Delivery: Immediate Online Access
Author: Meadows, Michelle ; Weitzman, Mitchell
Article Excerpt
Whether the goal is ensuring the safety of the food supply or speeding the development of new medical treatments, the Food and Drug Administration often depends on its strong relationships with other organizations. Health care providers, regulated industry, members of academia, other government agencies, and consumers all contribute their expertise and experiences when the FDA tackles complex scientific issues.
"Our collaborations are an essential part of the FDA's long-term strategy to promote and protect the public health," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "By making effective use of collective resources, each party can achieve much more than it ever would alone."
The FDA regulates products that represent almost 25 percent of all consumer spending. This total includes 80 percent of the nation's food supply and all human drugs, vaccines, medical devices, cosmetics, tissues for transplantation, radiation-emitting equipment, and animal drugs.
"In order to truly meet the emerging needs of patients and other populations that we serve, the FDA cannot function in a vacuum," von Eschenbach says. "As we carry out our leadership role, we must remain sensitive to the changes occurring around us and work with others in the public and private sector who are also committed to building a healthier nation."
In one example, a partnership with the National Alliance for Hispanic Health, the FDA ensures that public health alerts are available in Spanish. In another, the FDA and Health Canada share analytical tools to prevent medication errors due to similar-sounding drug names. The FDA's collaborations range from informal work agreements on projects of mutual interest to financial partnerships that support state-of-the-art medical technology. Here's a look at some of the major partnerships in which the FDA is involved.
FISH MEDICINE AND RESEARCH
Aquaculture, also called fish farming, involves raising fish in enclosed areas to be sold as food. The FDA is interested in ensuring that farmed fish are safe for human consumption, says Renate Reimschuessel, V.M.D., Ph.D., a research biologist who joined the Center for Veterinary Medicine (CVM) in 1999 to develop an aquaculture research program. "More vaccines are needed to prevent infectious diseases in fish, and more drugs are needed to treat fish that get sick," says Reimschuessel.
Examples of diseases that are a threat to the fish farming industry are infectious salmon anemia and enteric septicemia of catfish, a bacterial infection that can cause rashes and bleeding. Only seven drugs are approved by the FDA to treat diseases in farm-raised fish. And, as the aquaculture industry grows, there is a need to develop safer and more effective drugs for fish diseases.
Reimschuessel and Badar Shaikh, Ph.D., a research chemist in the CVM, are collaborating on a project with Andrew Kane, Ph.D., associate professor at the University of Maryland School of Medicine and director of the university's Aquatic Pathobiology Center in College Park.
Shaikh is leading a study at the CVM to investigate the metabolic profiles of model drugs in various fish species. The study will be used to determine the marker residues for which analytical methods will be developed to measure drug residues in aquaculture-raised fish. This research should help with regulatory monitoring so that fish destined for human consumption are safe.
Kane is looking at liver enzyme patterns in different fish in response to the same model drugs. This research collaboration, as a potential way to spur drug development, is funded through the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a partnership between the FDA and the University of Maryland.
"We are researching profiles to characterize and predict drug residues in fish, which includes collecting data to model the relationship between the fish species and their metabolic capacity," Kane says. "We are looking closely at how the fish metabolize and excrete the drugs. And the FDA wants to make sure that drug residues in the fish don't wind up in the fillet on your plate."
The FDA has a facility in Laurel, Md., for conducting state-of-the-art aquaculture research. The facility has four fish culture rooms totaling about 4,600 square feet and a specialized aquatic research laboratory of 600 square feet. A computer system monitors the water system temperature.
There are several steps in the development of methods to test for drug residues in fish. The first step involves feeding the fish a drug, sometimes by putting capsules in gel food. Then researchers take tissues from the fish and process the samples. For example, researchers may separate the serum from a blood sample. Frequently, muscles are frozen and blended with dry ice to create a uniform powder. When samples are taken, the general health of the fish is also examined and recorded, including the clarity of the eyes, the quality of the scales, and any areas of discoloration.
Researchers then put the processed samples in an instrument to detect the drug. "The testing method depends on the type of drug, tissue, and what kind of analytical equipment you are using," Reimschuessel says.
Kane says part of the research focuses on "species grouping"--the process of classifying species of fish based on similarities in anatomy, physiology, and drug metabolism. "Developing a new drug protocol for a single fish species costs millions of dollars, which fish farmers don't have," Kane says. "It will be beneficial if we find a new drug that could get rid of a bacterial pathogen in not only salmon, but also trout." Kane studies channel catfish, largemouth bass, rainbow trout, and other species.
The goal of the research is to improve...
NOTE: All illustrations and photos have been removed from this article.
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