Approximate number of chimpanzees: 0; previously 11
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the Food and Drug Administration (FDA) in Silver Spring, Maryland, regulates such things as food, cosmetics, human and nonhuman animal medicines, medical devices, and radiation-emitting consumer products. (1) According to their mission statement, “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” (2)
Historically, the FDA “grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001.” (3) Currently, the FDA is “an agency within the Department of Health and Human Services and consists of nine centers/offices.” (4)
In January 2009, NEAVS sent a Freedom of Information Act (FOIA) inquiry to the FDA requesting a complete listing of all chimpanzees housed at the various FDA facilities. We received a written response from the FDA saying there were “no programs in the Center for Veterinary Medicine, FDA that use or house chimpanzees…; therefore we have no listing as you requested.” Four other FDA centers verbally responded, saying they too had no records in response to our request. In the past, the FDA used chimpanzees in Hepatitis C virus vaccine research. According to NIH’s former Computer Retrieval of Information on Scientific Projects (CRISP) database, the last of these studies took place in 2003. Chimpanzees were also used in polio research by FDA researcher Konstantin Chumakov.
In terms of animal research, the FDA “reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective.” (5) They then monitor products after they are available to the public and respond to problems or new risks that arise. “The agency receives more than 400,000 problem reports a year.” (6)
In a statement to the Institute of Medicine in 2011, the FDA stated: its policy is not to request data from chimpanzee studies; it has received just seven applications that included chimpanzee data in the past five years, none of which the FDA asked for or recommended in its guidance; none of this data were toxicological; it discourages chimpanzee studies, if asked; and it believes that, if chimpanzee data were no longer available, this would have “no discernable effect” on adequate and timely review of applications. (7)
Within the FDA, the Center for Biologics Evaluation & Research (CBER) was the primary department involved with the hepatitis C research on chimpanzees. CBER regulates vaccines, xenotransplantation products, and other biological products. Biological products “include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. (8) Xenotransplantation is a “procedure that involves the transplantation, implantation or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.” According to the FDA, “the use of xenotransplantation raises concerns regarding the potential infection of recipients with both recognized and unrecognized infectious agents and the possible subsequent transmission to their close contacts and into the general human population. Of public health concern is the potential for cross-species infection by retroviruses, which may be latent and lead to disease years after infection. Moreover, new infectious agents may not be readily identifiable with current techniques.” (9)
The FDA’s website claims that the agency works “at a cost to taxpayers of about $3 a person.” (10) The FDA requested a total budget of $2.1 billion for FY2008. (11) For FY 2009, the FDA requested a total budget of $2.4 billion, or $129.7 million more than FY 2008, which represented a 5.7% budget increase. (12) For FY 2010, the FDA requested a total budget of $3.2 billion, which was $511 million more than the previous year, and represented a 19% budget increase. (13) For FY 2011, the FDA requested a total budget of $4 billion, which represented an increase of $756 million for FDA programs. (14) For FY2012, the FDA requested a total budget of $4.4 billion, (15) and finally, the FDA requested $4.5 billion for FY2013. (16)
(7) June 30, 2011 email from David Jacobson-Kram Ph.D., DABT, in the Office of New Drugs Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, to members of the Institute of Medicine of the National Academies Committee on the Use of Chimpanzees in Biomedical and Behavioral Research.