FDA is responsible for protecting public health by ensuring the safety and efficacy of medical products marketed in the United States—including drugs, medical devices, and biologics—and the safety of nearly all food products other than meat and poultry, regardless of whether they were manufactured domestically or overseas. The agency’s responsibilities for overseeing food and medical products are divided among the following five FDA product centers, each responsible for specific types of products:  The Center for Biologics Evaluation and Research (CBER) is responsible for regulating biologics for human use, such as blood, blood products, vaccines, and allergenic products, and ensuring that biologics are safe and effective.  The Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture and import medical devices and for ensuring that radiation-emitting products, such as lasers and x-ray systems, meet radiation safety standards.  The Center for Drug Evaluation and Research (CDER) is responsible for regulating over-the-counter and prescription drugs for human use, including generic drugs.  The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for ensuring the safety of most foods for humans (except meat and poultry and processed egg products, which are regulated by the U.S. Department of Agriculture), including dietary supplements.  The Center for Veterinary Medicine (CVM) is responsible for regulating the manufacture and distribution of drugs, devices, and food given to, or used by animals. Among other things, the centers monitor the safety and effectiveness of marketed medical products and the safety of food, formulate regulations and guidance, conduct research, communicate information to industry and the public, and set their respective program priorities. In addition to the work of the five centers, FDA’s Office of Regulatory Affairs (ORA) conducts field work for the product centers to promote compliance with agency requirements and applicable laws. ORA field activities include inspecting domestic and foreign manufacturing facilities, examining products offered for import, collecting and analyzing samples, and taking enforcement action. ORA’s Office of Criminal Investigations is responsible for investigating potential criminal violations involving FDA- regulated products and may refer cases to the Department of Justice for prosecution. FDA’s Office of the Commissioner is responsible for providing leadership and direction to the product centers and ORA. FDA’s Office of International Programs is responsible for leading, managing, and coordinating all of FDA’s international activities and its recently established overseas offices. In July 2011, FDA created “directorates” that align similar functions under common leadership within the Office of the Commissioner—the Office of Medical Products and Tobacco, which oversees CBER, CDER, and CDRH, as well as the Center for Tobacco Products; the previously established Office of Foods, which oversees CFSAN and CVM; and the Office of Global Regulatory Operations and Policy, which oversees ORA and the Office of International Programs. In recent years, we have reported on a variety of concerns related to FDA’s resource management, strategic planning, and internal communications and coordination. Specifically, in June 2009, we found that FDA was unable to provide complete and reliable estimates of its resource needs for its medical products. In February 2010, we reported on management challenges the agency faces and FDA’s difficulties in using practices for effective strategic and workforce planning. Coordinating internally among its centers and offices and externally with outside experts were among the agency’s major management challenges. Also, in September 2010, we reported on FDA’s overseas offices and the need for better coordination among the centers. For a list of these and other related reports, see Related GAO Products at the end of this report. The Federal Food, Drug, and Cosmetic Act prohibits the introduction of adulterated food, drugs, and medical devices into interstate commerce. However, the act does not define or use the term “economic adulteration” or “economically motivated adulteration.” The act includes, but is not limited to, the following:  A food is deemed to be adulterated if, among other circumstances, it bears or contains any added poisonous or deleterious substance that may render it injurious to health. A food is also deemed to be adulterated (1) if any valuable constituent has been omitted in whole or in part, or (2) if any substance has been substituted wholly or in part, or (3) if damage or inferiority has been concealed in any manner, or (4) if any substance has been added so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.  A drug is deemed to be adulterated if it purports to be a drug whose name is recognized in an official compendium and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. If a drug does not purport to be a drug listed in an official compendium, it is deemed to be adulterated if its strength differs from, or its purity or quality falls below, that which it purports to possess. A drug is also deemed to be adulterated if, among other circumstances, any substance has been (1) mixed or packed with it so as to reduce its quality or strength or (2) substituted wholly or in part.  A device is deemed to be adulterated if it is, or purports to be or is represented as, a device which is subject to a performance standard established or recognized under the act unless such device is in all respects in conformity with such standard. It is also deemed adulterated if, among other circumstances, the device was not manufactured, packed, stored, or installed in conformity with good manufacturing practices. Economic adulteration is not a new problem and ranges from simple actions, such as adding material to increase a product’s weight, to more sophisticated substitutions or additions that are designed to avoid detection by tests known to be used to authenticate ingredients or products. Economic adulteration differs from other forms of intentional adulteration, such as bioterrorism or sabotage, whose primary purpose is to cause harm. Because economic adulteration is intentional, it also differs from unintentional adulteration, such as adulteration through failure to follow good manufacturing practices. Although the primary driver of economic adulteration is financial gain rather than causing harm, it can pose a variety of public health risks. The actual risks will vary depending on the adulterant used, the person who consumes the product, and the length of use or exposure. There is a direct and immediate threat to public health when the adulterant is a toxic or lethal substance, as was the case in the melamine and heparin incidents. There are also risks that arise as a result of long-term, low- dosage exposure to a contaminant or as a result of using a product whose nutritional value or efficacy has been compromised by an adulterant. Certain populations, such as infants, the elderly, and persons with compromised immune systems are particularly vulnerable to these risks. In some cases, an adulterant may only pose a public health risk for those who are allergic to it, such as fish substituted with a less expensive fish to which a person is allergic. Furthermore, economic adulteration that poses no known health risk may expose a vulnerability in the supply chain—the network of handlers, suppliers, and middlemen involved in the production of food and drugs—that could be further exploited in the future, with serious consequences. Following the melamine and heparin incidents, FDA formed an internal work group focused on predicting and addressing what the agency referred to as “economically motivated adulteration.” The work group, comprising representatives from FDA’s food and medical product centers and ORA, held a May 2009 public meeting on the topic. For purposes of the meeting, FDA developed a working definition of economically motivated adulteration. The meeting, attended by representatives of academia, industry, and consumer groups, was designed to raise awareness about the potential for this problem and gather information on how to better predict, prevent, and address it. According to FDA officials, the work group stopped meeting shortly after the public meeting was held. FDA made a transcript of the meeting publicly available, but issued no report. FDA primarily approaches economic adulteration as part of its broader efforts to detect and prevent adulteration of food and medical products in general. In addition, CDER, ORA, CFSAN, and CBER have undertaken efforts specific to economic adulteration, while CVM and CDRH have not. However, agency entities have missed opportunities to communicate and coordinate efforts specifically directed at economic adulteration and identify potential public health risks. According to FDA officials, the agency primarily approaches economic adulteration as part of its broader efforts to combat adulteration in general. Such efforts include, for example, the agency’s actions to ensure the safety of imported products. According to FDA officials, these broad efforts to combat adulteration could also combat economic adulteration. Agency officials noted that the Federal Food, Drug, and Cosmetic Act does not distinguish among motives or require motive to be established to determine whether a product is adulterated. FDA adopted a working definition of economically motivated adulteration for the purposes of discussing the topic at its May 2009 public meeting. In its written comments on our draft report, HHS told us that the recently formed FDA Working Group on Economically Motivated Adulteration will use the working definition proposed at the public meeting, enabling FDA centers to focus their discussions and encouraging communication and collaboration. According to an FDA official, the agency generally does not expend resources to distinguish between economic and other motives for adulteration.