The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, among the United States federal executive departments. The FDA is responsible for protecting and encouraging public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (estimated $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.
The FDA was empowered by the United States Congress to launch the Federal Food, Drug, and Cosmetic Act, which serves as the major focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These covers regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for helping reproduction.
The FDA is headed by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the present commissioner, who took over in May 2017.
The FDA has its main office in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories situated throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, covering China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
FDA set up the India Office in New Delhi in 2008, to ensure that food and medical products exported from India to the U.S. are safe, are of good quality, and are effective.
FDA’s objectives in India are to obtain information to help make better regulatory decisions about the products from India that are being developed and exported for the U.S. market. This covers medical products being reviewed for marketing authorization in the U.S., and the safety assessment of products that are already on the U.S. market. Additionally, the India Office assist to verify that foods being imported into the U.S. are safe.
FDA activities in India include:
- Organizing inspections of medical products and foods facilities that export to the U.S.
- Engaging with Indian regulatory authorities to construct confidence in each other and develop quality standards
- Partnering with Indian counterpart agencies on bilateral programmes
- helping and training Indian regulators, Indian pharmaceutical and foods industries and stakeholders on developing and maintaining the quality, safety, and effectiveness of medical products and foods
- Constructing and strengthening relationships with the government of India by supporting the mission of the U.S. Embassy