FDA Mission and Background

FDA history

The United States Department of Agriculture’s Division of Chemistry was established by President Abraham Lincoln in 1862. In 1901, the Division became the Bureau of Chemistry, which was led by Dr. Harvey Wiley, who has been described by some as the father of the FDA. Dr. Wiley was primarily responsible for enforcing the 1906 Food and Drug Act.

• In 1927, part of the Bureau became a separate agency called the Food, Drug and Insecticide Administration, which, 3 years later, became the Food and Drug Administration.



• Until 1940, the FDA and its forerunners resided in the Department of Agriculture. In 1940, the FDA became part of the Federal Security Agency and, in 1953, the FDA joined the new Department of Health, Education and Welfare. Fifteen years later, in 1968, the FDA became a part of the Department’s Public Health Service.



• In 1980, the Department of Education was created, and the department to which the FDA belongs was renamed the Department of Health and Human Services.

Mission

The Food and Drug Modernization Act states that the FDA has 4 roles:

• To promote health by reviewing research and approving new products



• To ensure foods and drugs are safe and properly labeled



• To work with other nations to “reduce the burden of regulation”



• To cooperate with scientific experts and consumers to effectively carry out these obligations

Organization

FDA Headquarters: The FDA is part of the Department of Health and Human Services, currently led by former Wisconsin Governor Tommy Thompson. The agency currently has roughly 9,500 full-time employees and is headquartered in Rockville, Maryland. The agency’s total budget in fiscal year 2002 was about $1.4 billion (the federal government’s fiscal year begins in September).

• The FDA consists of 5 Centers, the Office of the Commissioner, the Office of Regulatory Affairs, and the National Center for Toxicological Research. The Office of Regulatory Affairs works with state government agencies, trains field agents, helps enforce compliance with the FD&C Act, and, through its Office of Criminal Investigations, builds cases against those who violate the Act, for instance by tampering with FDA-regulated products or submitting false data to the agency. Each Center has jurisdiction over one or more areas such as devices, drugs, or dietary supplements.



• A Princeton, N.J.-based company, EduNeering, which has signed an agreement with the FDA to develop Web-based courses to train FDA staff, offers a free course available to consumers and others entitled A Tour of FDA. The interactive and illustrated course is a good introduction and describes in detail the functions of the various Centers and the FDA’s mission.



• The FDA is led by the Commissioner of Food and Drugs, who is appointed by the President and confirmed by the Senate. Dr. Mark McClellan, a physician with a doctorate in economics, was nominated to be commissioner by President George W. Bush in September 2002 and confirmed by the Senate in October. McClellan previously served as a member of the President’s Council of Economic Advisors and as a professor at Stanford University. The FDA's deputy commissioner Lester Crawford was appointed by the Bush Administration in March 2002. Crawford was formerly director of the Center for Veterinary Medicine, the US Department of Agriculture’s Food Safety and Inspection Service and the Virginia Tech-associated Center for Food and Nutrition Policy.

FDA role in government

The FDA is not a stand-alone agency and works closely with Congress, members of the scientific community, other federal agencies, and various industry and consumer groups.

• Congress: Several Congressional committees have oversight over FDA activities and may hold hearings where FDA personnel, consumer groups, and industry organizations provide testimony. The House Energy and Commerce Committee, the Senate’s Health, Education, Labor and Pensions, and the House and Senate Appropriations committees are among the most important. Congressional committee home pages, hearing schedules, enacted legislation, and bills introduced can be found on the Thomas Web site. More information about the jurisdiction of Congressional committees is available at the United States House of Representatives Web site.



• The White House: The FDA is an executive agency. Its commissioner and certain positions, such as the FDA chief counsel, are political appointees, who generally (but not always) will resign if the newly elected President is from another party. The White House probably exerts much of its influence indirectly through the Secretary of Health and Human Services, a member of the cabinet appointed by the President and confirmed by the Senate. Agency personnel may occasionally brief the President or high-level White House staff. In addition, the Office of Management and Budget (OMB), a part of the White House, reviews proposed agency regulations to ensure alternatives have been considered and that the cost and paperwork are not excessive. More recently, the OMB has taken to sending “prompt” letters to agencies suggesting they consider certain regulations. For instance, OMB has advised the FDA to require labeling of trans fatty acids.



• Federal agencies: The FDA interacts with other federal agencies that may have missions that affect FDA-regulated products. Federal agencies that the FDA works with closely include these:
  
  
  • The Agency for Healthcare Research and Quality works with the FDA to conduct research into drug utilization and health care quality issues. The 2 agencies jointly sponsor the Centers for Education and Research on Therapeutics (CERTs), 7 research centers that study drug interactions and risk management strategies.
  
  
  
  • The Environmental Protection Agency works with the FDA in regulating pesticides and biotechnology products.
  
  
  
  • The Federal Trade Commission helps regulate food and dietary supplement advertising and the sale of medical products through the Internet.
  
  
  
  • General Accounting Office: Conducts independent investigations of federal agency activities and important scientific and technical issues on behalf of the United States Congress.
  
  
  
  • The Centers for Disease Control and Prevention conducts disease surveillance and research. The department’s Office of the Inspector General may audit and evaluate the effectiveness of FDA programs.
  
  
  
  • The US Department of Agriculture helps inspect food and conduct research.
  
  
  
  • Various law enforcement agencies, such as the Bureau of Alcohol, Tobacco and Firearms, the Drug Enforcement Agency and the Federal Bureau of Investigation, and the US Customs Service collaborate on issues such as counterfeiting, counterterrorism, drug abuse, and product tampering,


• Trade Associations/Consumer Groups: The FDA also works with, and may be lobbied by, numerous consumer-, industry-, and professional-oriented groups and trade associations. These groups provide information to their members and the public about food and drug issues and may testify at Congressional hearings, lobby legislators, work with professional who interact with the FDA and write editorials or publish ads in various newspapers advocating certain points of view. There are numerous trade associations, professional organizations, and consumer groups with involvement in at least some areas affected by FDA regulation. Among the more significant organizations are these:
  
  
  • Academic: Center for Drug Development Science conducts research into the way drugs are developed.
  
  
  
  • The Center for Pharmaceutical Health Services Research is affiliated with Temple University and studies direct-to-consumer advertising and other issues.
  
  
  
  • The Center for Pharmacoeconomic Studies is affiliated with the University of Texas at Austin’s College of Pharmacy and conducts research into such issues as drug reimportation and costs.
  
  
  
  • Tufts Center for Drug Development studies new drug review and approval process and other issues such as the cost of developing new drugs.
  
  
  
  • Consumer-oriented: American Council on Science and Health provides information on environmental health, foods, pharmaceutical products, and tobacco and is often viewed as conservative.
  
  
  
  • The Center for Science in the Public Interest (CSPI) focuses on food safety and nutrition. For instance, the group opposed the FDA’s approval of the fat substitute, Olestra, which is marketed by Proctor and Gamble as Olean used in products such as Wow potato chips.
  
  
  
  • The National Consumers League works on a variety of issues, including foods and drugs.
  
  
  
  • The National Council Against Health Fraud speaks out against fraudulent medical devices, supplements, and other products.
  
  
  
  • The Public Citizen is perhaps the most important and effective of the consumer groups. It is the Ralph Nader-founded group and its Health Research Group, led by Dr. Sidney Wolfe, conducts original research, educates consumers, and lobbies the FDA. The group tends to be skeptical of industry and has lobbied for more FDA regulation.
  
  
  
  • Industry-oriented: The Animal Health Institute manufactures animal drug products.
  
  
  
  • The Biotechnology Industry Organization represents biotechnology companies, which tend to be smaller than established pharmaceutical companies.
  
  
  
  • The Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) represent medical device companies. AdvaMed generally represents the larger medical device companies and MDMA the smaller companies, although some firms are members of both.
  
  
  
  • The Consumer Healthcare Products Association is a trade association advocating on behalf of over-the-counter drug manufacturers and dietary supplement companies.
  
  
  
  • The Council for Responsible Nutrition is a trade association that represents dietary supplement companies.
  
  
  
  • The Generic Pharmaceutical Association represents generic drug companies whose interests may sometimes diverge from those of brand-name drug manufacturers. Some brand name drug companies also have generic drug manufacturing divisions.
  
  
  
  • Grocery Manufacturers of America represents major food and beverage companies.
  
  
  
  • The National Association of Chain Drug Stores represents retail pharmacies.
  
  
  
  • The National Food Processors Association represents the food processing industry.
  
  
  
  • The National Nutritional Foods Association represents health food and dietary supplement companies.
  
  
  
  • Pharmaceutical Research and Manufacturers of America is the major trade association of America’s pharmaceutical companies.
  
  
  
  • Professional: American Association of Pharmaceutical Scientists represents scientists employed in academia and industry.
  
  
  
  • The American College of Medical Toxicology represents physicians with specialty training in the diagnosis and care of poisoned patients and those suffering from adverse drug reactions.
  
  
  
  • The American Medical Association represents American physicians.
  
  
  
  • The American Veterinary Medical Association is a professional organization for veterinarians.
  
  
  
  • The Association of Food and Drug Officials is made up of members who work with federal, state, and/or local health agencies.
  
  
  
  • Drug Information Association members include clinical research professionals, physicians, pharmacists, and project managers.
  
  
  
  • The Regulatory Affairs Professional Society includes professionals who help to ensure that companies are compliant with FDA regulations and submit regulatory submissions to the FDA.


• Advisory committees: The FDA seeks scientific advice from 32 scientific advisory committees. Advisory committees include academic, industry, and consumer representatives. Recommendations from the committees are not binding, but the FDA takes the opinions of its advisory board members seriously. The FDA often seeks the advice of its advisory committees on controversial medical and scientific issues.



• Important legal terms: A statute is a law passed by Congress, while a regulation is a rule issued by a federal agency such as the FDA. Proposed FDA regulations are published in the Federal Register, providing the public with notice about the rule and opportunity to comment about the proposals. Once the rule becomes final, the Code of Federal Regulations will be amended to include the new law. Current editions of the Federal Register and Code of Federal Regulations are available through the Government Printing Office. The FDA also issues guidance documents that are intended to provide information about how to comply with FDA regulations. Guidance documents are not legally binding.

FDA Centers, ORA, Office of the Commissioner

• The Center for Drug Evaluation and Research (CDER): CDER is charged with reviewing and ensuring the safety of new drugs, generic drugs, and over-the-counter drugs. In 2002, CDER had roughly 1,900 full-time employees. Nearly $350 million was allocated toward human drug evaluation programs in fiscal year 2002, $107 million or 30% of which came from user fees.
  
  
  • The Center’s Office of New Drugs is organized into 5 offices, which are further subdivided into 15 divisions that review various types of drugs.
  
  
  
  • The Center also contains an Office of Drug Safety that helps the agency assess the risks and benefits of drugs, risk communication, and patient labeling.
  
  
  
  • Located within the Center’s Office of Medical Policy, the Division of Drug Advertising, Marketing and Communications, almost always referred to by its acronym DDMAC, ensures that advertisements and promotion, both to patients and physicians, are fair and accurate.
  
  
  
  • The Center’s Office of Pharmaceutical Science helps the FDA understand the drug manufacturing process and the effects of drugs on the body. This office includes the Office of Generic Drugs, which approves drugs that are equivalent to brand-name drugs when the patents for the brand name drugs have expired.
  
  
  
  • The Center’s Office of Compliance works with the Office of Regulatory Affairs to enforce and interpret good manufacturing practice regulations, and to help design inspections of drug manufacturing facilities.


• The Center for Devices and Radiological Health (CDRH): CDRH is charged with reviewing and regulating medical devices and radiation-emitting products, such as x-rays. CDRH has about 1,000 employees and device program areas received about $200 million in the fiscal year 2002 budget. Roughly $20 million of the Center’s budget was derived from user fees paid by mammography facilities.
  
  
  • The Center’s Office of Device Evaluation includes 6 divisions that help the FDA to assess the safety of devices: the Divisions of General, Restorative and Neurological Devices; Clinical Laboratory Devices; Cardiovascular and Respiratory Devices; Ophthalmic and Ear, Nose and Throat Devices; Reproductive, Abdominal and Radiological Devices; Dental, Infection Control, and General Hospital Devices.
  
  
  
  • The Office of In Vitro Diagnostic Device Evaluation and Safety, established in November 2002, has jurisdiction over many clinical laboratory tests and cholesterol, glucose, human immunodeficiency virus (HIV), pregnancy and other tests kits that can be purchased by consumers over-the-counter or readily performed by consumers at home.
  
  
  
  • The Center’s Office of Science and Technology conducts research on medical devices and helps keep the Center appraised of technological developments.
  
  
  
  • The Center’s Office of Surveillance and Biometrics helps monitor the safety of devices after they are approved for marketing.
  
  
  
  • Center’s Office of Compliance provides guidance to help ensure manufacturers understand FDA device regulations. The office includes the Center’s advertising and promotion staff and the bioresearch monitoring program, which helps to monitor clinical trials involving medical devices.


• The Center for Food Safety and Applied Nutrition: Foods account for 75% of the value of products regulated by the FDA, which, in turn, account for roughly 25 cents of every dollar. CFSAN has about 930 full-time employees, and roughly $320 million was allocated to CFSAN program areas in fiscal year 2002. The Center is housed at facilities in College Park, Maryland, rather than in Rockville.
  
  
  • The Center's Office of Cosmetics and Colors advises industry and consumers on the safety of cosmetic products.
  
  
  
  • The Center's Office of Premarket Approval ensures the safety of food and color additives and food packaging materials.
  
  
  
  • The Office of Seafood is responsible for coordinating the FDA's seafood safety programs.
  
  
  
  • The Office of Food Additive Safety conducts research on cosmetics, dietary supplements, foods, and food additives and ingredients.
  
  
  
  • The Center's Office of Constituent Operations helps communicate with the industry and public.
  
  
  
  • CFSAN's Office of Plant and Dairy Foods and Beverages handles food safety efforts with respect to these products.
  
  
  
  • Office of Nutritional Products, Labeling and Dietary Supplements leads the Center's efforts in the dietary supplement, labeling, and infant formula areas.


• Center for Biologics Evaluation and Research (CBER): CBER has 875 full-time employees, and CBER efforts were allocated about $155 million in fiscal year 2002. About 20% came from industry user fees. CBER has jurisdiction over blood and blood products, drugs derived from biological organisms, tissues, and allergen tests and extracts used for treatment.
  
  
  • The Office of Vaccine Research and Review evaluates potential vaccines and conducts research. It is divided into the Division of Bacterial, Parasitic and Allergenic Products, the Division of Viral Products, and the Division of Vaccine & Related Products Application.
  
  
  
  • The Office of Therapeutics Research and Review includes the Divisions of Application Review and Policy, Monoclonal Antibodies, and Therapeutic Proteins.
  
  
  
  • The Office of Cellular, Tissue & Gene Therapies regulates cell and gene therapy and human tissue products, including tissues used in transplants.
  
  
  
  • The Office of Blood Research and Review includes the Division of Blood Applications, Division of Hematology, and the Division of Emerging and Transfusion Transmitted Diseases.
  
  
  
  • The Office of Compliance and Biologics Quality helps inspect biologics facilities, publishes manufacturing guidance, and includes the Center’s advertising and promotion staff. As part of the Team Biologics initiative, the Office works closely with the Office of Regulatory Affairs to inspect products under CBER jurisdiction. In addition to biologic products, the Center regulates certain devices related to blood or cellular products.
  
  
  
  • The FDA recently announced that jurisdiction over certain biological therapeutic products, including cytokines, enzymes, interferons, monoclonal antibodies, and therapeutic proteins, will be transferred from the CBER to the CDER. The CBER will maintain continue to be responsible for the review and approval of blood and blood products, cell and gene therapy products, in vitro diagnostic products, and vaccines, according to agency documents. The CDER will receive roughly $30 million in additional funds in order to meet its new responsibilities and review personnel from CBER also may be reassigned to the CDER.


• The Center for Veterinary Medicine: The CVM has roughly 320 full-time employees and accounted for about $81 million of the agency’s fiscal year 2002 budget. The CVM is responsible for reviewing animal drugs, aquaculture research and regulation, ensuring in conjunction with the United States Department of Agriculture, the safety of animal feeds and feed ingredients, and coordinating the FDA’s policies for preventing bovine spongiform encephalopathy or “mad cow” disease and other animal diseases.
  
  
  • The Center’s Office of Surveillance and Compliance works with FDA field offices to ensure facilities producing medicated animal feed and using animal drugs and devices comply with FDA regulations.
  
  
  
  • The Center’s Office of Research studies animal diseases and drug residues that may be present in foods.
  
  
  
  • The Office of New Animal Drug Evaluation reviews animal drugs for marketing.
  
  
  
  • Even though biologics products intended for use in humans are regulated by the FDA, vaccines and other biologics products intended for use in animals are regulated by the USDA Animal Plant Health Inspection Services’ Center for Veterinary Biologics.


• The National Center for Toxicological Research (NCTR): The NCTR’s mission is to conduct "peer-reviewed scientific research" on such scientific issues as biotechnology, drug-resistant bacteria, food safety and toxicology and to "anticipate future research needs of the FDA" (Casciano, 2002). The NCTR has about 230 employees and received about $36 million in the FDA’s fiscal year 2002 budget. NCTR has several research programs. For instance, the NCTR is working on ways to test for food pathogens, to identify agents that could be used in terrorist attacks and to reduce the development of antimicrobial resistance in animals provided with antibiotics. In contrast to the other Centers, the NCTR’s major facilities are located in Jefferson, Arkansas, not the Washington, DC, area.



• The Office of Regulatory Affairs: The ORA may not directly approve medical products, but in some ways the ORA is the enforcement Center for the agency, supporting the FDA’s District Offices, shaping the FDA’s relationship with the states, working to enforce requirements with respect to products under the jurisdiction of the FDA Centers, setting policy for inspections and planning enforcement initiatives. The ORA consists of the Office of Regional Operations, the Office of Enforcement, the Office of Criminal Investigation, and Office of Regulatory Resource Management. The ORA publishes a number of important guides for staff and industry, including the Regulatory Procedures Manual, which instructs FDA employees about the agency’s policy and may be used as a reference by industry and consultants and attorneys as well as FDA staff; the Investigations Operation Manual (used as a reference by the agency’s investigators) and the Compliance Program Guidance Manual and Compliance Policy Guide, which provide details about FDA regulation. The ORA has about 3,500 employees, about 3,000 of whom work at various regional and District Offices that conduct inspections of FDA-regulated facilities, and the ORA headquarters and field staff received roughly $386 million in fiscal year 2002 to carry out inspections of FDA regulated facilities.
  
  
  • The Office of Regional Operations coordinates relations between the FDA and the states and works with the field offices to conduct field investigations and support the FDA’s field laboratories.
  
  
  
  • The Office of Enforcement handles enforcement matters for the agency such as Warning Letters and publishes guidance concerning regulatory compliance.
  
  
  
  • The Office of Criminal Investigation investigates criminal acts such as fraud or tampering and is staffed by roughly 170 special agents.
  
  
  
  • Regional/District Offices: The ORA maintains 6 regional offices, 19 District Offices (which coordinate import inspections along the Mexican border), 13 laboratories, and more than 120 residential inspection posts throughout the country. Regional offices are located in New York, Philadelphia, Atlanta, Dallas, and Oakland and are directed by Regional Food and Drug Directors. The Regional Offices direct the District Offices and report to ORA headquarters in Rockville. Many of the agency’s Warning Letters and enforcement activities are carried on at the District Office level. District Offices help conduct inspections of FDA-regulated facilities, recommend actions to promote compliance (or penalize noncompliance); and conduct laboratory research and analysis.


• The Office of the Commissioner: The Office of the Commissioner includes several offices that are crucial to the functioning of the agency:
  
  
  • The FDA’s Office of the Chief Counsel, which acts as the agency’s legal advisor, refers cases to the Department of Justice for possible prosecution and helps the DOJ investigate and prosecute cases; the Office of International Affairs, which helps administer memorandums of understanding with other nations to ensure imported products are safe, works to harmonize regulations and work with personnel in other countries; the Office of Communications and Constituent Relations, which includes the Office of Women’s Health and the Office of Special Health Issues, which works to help those with AIDS and cancer and to ensure the concerns of racial and ethnic groups are addressed.
  
  
  
  • Also in the Office of the Commissioner are the Office of Management and Systems, Office of Policy, Planning and Legislation, and the Office for Good Clinical Practices, which sets the FDA’s policies on clinical trial issues. Roughly 115 full-time FDA employees work in the Office of the Commissioner.