Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

Organization

The FDA is an agency within the United States Department of Health and Human Services responsible for protecting and promoting the nation's public health. The FDA is headquartered in Rockville, MD with 223 field offices supported by 13 laboratories located throughout the United States, the U.S. Virgin Islands, and Puerto Rico. In recent years the agency began undertaking a large-scale effort to consolidate its DC-metro area operations from its main headquarters in Rockville and several fragmented office buildings in the vicinity to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, MD. When FDA arrived, the site was renamed from the White Oak Naval Surface Warfare Center to the White Oak Federal Research Center. The first building, a Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. The project is slated to be completed by 2013.

The agency is organized into the following major subdivisions, each focused on a major area of regulatory responsibility:

• The Office of the Commissioner (OC)
• The Center for Drug Evaluation and Research (CDER)
• The Center for Biologics Evaluation and Research (CBER)
• The Center for Food Safety and Applied Nutrition (CFSAN)
• The Center for Devices and Radiological Health (CDRH)
• The Center for Veterinary Medicine (CVM)
• The National Center for Toxicological Research (NCTR)
• The Office of Regulatory Affairs (ORA)
• The Office of Criminal Investigations (OCI)

While most of the Centers are located around the Washington, D.C., area as part of the Headquarters divisions, ORA and OCI are primarily field offices, with their workforce spread across the country. ORA is considered the "eyes and ears" of the agency, conducting the vast majority of the field work the Agency. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 13 districts. Districts are based roughly on the geographic divisions of the Judicial System. Each district comprises a main district office, and a number of Resident Posts, which are FDA offices located away from the district office to serve a particular geographic area. ORA also includes the Agency's network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.

OCI was established in 2002 to help relieve ORA of the burden of pursuing and proving criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and are not focused on the technical aspects of whether a regulated product meets the standards under the law. Rather, OCI agents pursue and develop cases where criminal actions have occurred, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI will pursue cases where Title 18 (18 USC XXXX) violations have occurred (e.g. conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act (21 USC XXX). OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the FBI, US Assistant Attorney Generals, and even Interpol. OCI will receive cases from a variety of sources, including ORA, local agencies, and the FBI, and will work with ORA investigators to help develop the technical and science-based aspects of a case. OCI is a much smaller branch, comprising of about 200 agents nationwide.

The FDA frequently works in conjunction with other Federal agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work in cooperation with the FDA to provide regulatory inspections and enforcement action.

Scope and funding

The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.

The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007. In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding - about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million for FY 2009.

Legal authority

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. in many cases these responsibilities are shared with other federal agencies.

Important enabling legislation for the FDA includes:

• 1902 Biologics Control Act
• 1906 Pure Food and Drug Act
• 1938 Federal Food, Drug, and Cosmetic Act
• 1944 Public Health Service Act
• 1951 Food, Drug, and Cosmetics Act Amendments PL 82–215
• 1962 Food, Drug, and Cosmetics Act Amendments PL 87–781
• 1966 Fair Packaging and Labeling Act PL 89–755
• 1976 Medical Device Regulation Act PL 94–295
• 1987 Prescription Drug Marketing Act
• 1988 Anti–drug Abuse Act PL 100–690
• 1990 Nutrition Labeling and Education Act PL 101–535
• 1992 Prescription Drug User Fee Act PL 102–571
• 1994 Dietary Supplement Health and Education Act
• 1997 Food and Drug Modernization Act 105-115
• 2002 Bioterrorism Act 107-188
• 2002 Medical Device User Fee and Modernization Act (MDUFMA) PL 107-250
• 2003 Animal Drug User Fee Act PL 108-130
• 2007 Food and Drug Administration Amendments Act of 2007

Regulatory programs

The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.

Food and dietary supplements

The Center for Food Safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of nearly all food products in the United States. One exception is meat products derived from traditional domesticated animals, such as cattle and chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. Products which contain minimal amounts of meat are regulated by FDA, and the exact boundaries are listed in a memorandum of understanding between the two agencies. However, medicines and other products given to all domesticated animals are regulated by the FDA through a different branch, the Center for Veterinary Medicine. Other consumables which are not regulated by the FDA include beverages containing more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives in the Department of Justice), and non-bottled drinking water (regulated by the United States Environmental Protection Agency (EPA)).

CFSAN's activities include establishing and maintaining food standards, such as standards of identity (for example, what the requirements are for a product to be labeled, "yogurt") and standards of maximum acceptable contamination. CFSAN also sets the requirements for nutrition labeling of most foods. Both food standards and nutrition labeling requirements are part of the Code of Federal Regulations.

The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat, diagnose, cure, or prevent disease and must include a disclaimer on the label.

Bottled water is regulated in America by the FDA. State governments also regulate bottled water. Tap water is regulated by state and local regulations, as well as the United States EPA. FDA regulations of bottled water generally follow the guidelines established by the EPA, and new EPA rules automatically apply to bottled water if the FDA does not release an explicit new rule.

Drugs

The Center for Drug Evaluation and Research has different requirements for the three main types of drug products: new drugs, generic drugs and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to "new molecular entities": drugs which are not based on existing medications.

New drugs

New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drugs are available only by prescription by default. A change to Over the Counter (OTC) status is a separate process and the drug must be approved through an NDA first.

A drug that is approved is said to be "safe and effective when used as directed."

Advertising and promotion

The FDA reviews and regulates prescription drug advertising and promotion. (Other kinds of advertising, including for over-the- counter drugs, are regulated by the Federal Trade Commission). The drug advertising regulation contains two key requirements. Under most circumstances, a company may only advertise a drug for the specific indication or medical use for which it was approved. "Off-label use", using a drug for other than its approved purpose, is common in medical practice. Also, an advertisement must contain "fair balance" between the benefits and risks of a drug.

The term "off-label", often now used with a vaguely pejorative connotation, actually may mean only that the pharmaceutical company did not choose to invest in the lengthy and costly regimen of clinical trials required by the FDA in order to be able to add the particular application to the "uses" listed on the label. However it is entirely legal and professionally proper for physicians to prescribe the medication for any use for which there exists sufficient scientific research from any source, indicating it is or may be efficacious for that purpose. The test of propriety for off-label uses is whether the prescription meets the "standard of practice" among physicians.

Post market safety surveillance

After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called '"spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases the FDA requires risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities.

Generic drugs

Generic drugs are chemical equivalents of name-brand drugs whose patents have expired. Generally they are less expensive then their name brand counterparts, are manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable or therapeutically equivalent with the originally approved drug. This is called an "ANDA" (Abbreviated New Drug Application).

Over-the-counter drugs

Over-the-counter (OTC) drugs are drugs and combinations that do not require a doctor's prescription. The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision.

Vaccines, blood and tissue products, and biotechnology

The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a pre-market approval process similar to that for drugs. The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.

Medical and radiation-emitting devices

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable brain pacemakers. CDRH also oversees the safety performance of non-medical devices which emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.

CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.

Cosmetics

Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not generally subject to pre-market approval by the FDA unless they make "structure or function claims" which make them into drugs (see Cosmeceutical). However, all color additives must be specifically approved by the FDA before they can be included in cosmetic products sold in the U.S. The labeling of cosmetics is regulated by the FDA, and cosmetics which have not been subjected to thorough safety testing must bear a warning to that effect.

See also

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Medicines and Healthcare products Regulatory Agency (UK)
• The Food Defect Action Levels, an FDA publication

Further reading

• Michael Givel (December 2005) Philip Morris’ FDA Gambit: Good for Public Health? Journal of Public Health Policy (26): pp. 450–468.
• Philip J. Hilts. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred E. Knopf, 2003. ISBN 0-375-40466-X
• Thomas J. Moore. Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet. New York: Simon & Schuster, 1998. ISBN 0-684-82998-3.

External links

• Article at Wikipedia
• Food and Drug Administration Home Page
• FDA Recalls Finder
• FDA: A History, a comprehensive history of the FDA
• Strategic Plan (in XML) - from StratML
• Biologics Centennial: 100 Years of Biologics Regulation from the Food and Drug Administration Home Page
• U.S. FDA CDER Home Page the Center for Drug Evaluation and Research
• CBER - Center for Biologics Evaluation and Research, FDA
• Past FDA Commissioners
• Communication of FDA Advice on Consumption of Fish Like Tuna and Swordfish

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