The Food and Drug Administration

The Food and Drug Administration (FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for overseeing and regulating commercially available food and drugs, as well as enforcing interstate public health and sanitation regulations.

History

Until the late 19th century there were few regulations on the content of commercial foods and pharmaceuticals. This changed due to several factors, including muckraking journalism, such as Upton Sinclair’s The Jungle, and the advocacy of the Department of Agriculture’s (USDA) chief chemist Harvey Washington Wiley.

Growing public awareness resulted in the Food and Drug Act of 1906. The act sought to regulate tampering with food and pharmaceutical products, especially products from companies using harmful chemical additives in food. Initially overseen by the USDA chemistry department, its powers were reorganized in 1927, resulting in the creation of a new regulatory body: the Food and Drug Administration.

The FDA’s regulatory power has increased since the 1930s to address new concerns over unsafe food practices and untested drugs. Under Franklin Roosevelt’s authority the FDA was given additional power to review the safety of drugs before they reached the market. This power was expanded in the 1960s with laws requiring drug manufacturers to demonstrate “substantial evidence” of a drug’s efficiency before being marketed.

Organization

The FDA is administered by the Commissioner of Food and Drugs, who is appointed by the President and reports to the Secretary of Health and Human Services. The commissioner oversees the nine official centers and offices of the FDA. These centers are responsible for everything from drug evaluation and equipment safety to veterinary research and enforcement of food and drug laws.

Funding

The FDA’s budget for the 2011 fiscal year was $3.8 billion, nearly half coming from industry user fees. According to the FDA, the majority of these fees are paid by pharmaceutical companies seeking to speed up the drug review process. Other sources of fees include food registrations and inspections and food or feed exports.

Current initiatives

There are several major initiatives currently being overseen by the FDA. Many attempt to modernize and streamline the FDA’s regulatory process, while others are intended to promote innovation and increased collaboration between scientists and the regulatory body:

• Innovation Pathway is an initiative helping to reduce the time it takes for breakthrough medicines and technologies to be available to the patients who need them.
• The FDA Food Safety Modernization Act, signed into law in 2011, encourages a shift in focus from response to contamination outbreaks to contamination prevention.
• Medical Countermeasures is an initiative where the FDA collaborates with other federal offices in promoting emergency preparedness and response.
• Sentinel Initiative is the FDA’s new national electronic system which will enable the FDA to monitor and track effectively the safety of devices and medicines that have reached the market.

Additional Resources

The links below include resources for agencies, offices and initiatives closely connected to the FDA’s mission.

• The Center for Biologics Evaluation and Research regulates biological products designed for human use.
• The Center for Devices and Radiological Health provides access to safe radiological equipment and information for consumers.
• The Center for Drug Evaluation and Research makes sure that safe and effective drugs are available to consumers.
• The Center for Food Safety and Applied Nutrition is the product-oriented regulatory center for domestic and imported food.
• The Office of Criminal Investigations works closely with the FBI and other law enforcement agencies to investigate criminal cases identified by the FDA, such as counterfeiting drugs.
• The Center for Tobacco Products oversees the implementation of the Family Smoking Prevention and Tobacco Control Act.
• The Center for Veterinary Medicine oversees regulation of food additives and medicines for animals.
• INTERPOL is the international law enforcement agency, which the FDA works closely with to prevent food and drug related crime throughout the world.
• The Office for Regulatory Affairs oversees all FDA field activity through inspections and sample analysis.
• USDA is another executive level agency overseeing food and feed production and conditions throughout the U.S.
• USDHHS is the executive agency responsible for health and human services and the parent office of the FDA.

Official logo of the FDA.

(Image in Public Domain. Courtesy of Wikimedia Commons.)