Food and Drug Administration

	Food and Drug Administration; - FDA -
State level	Federation
Supervisory authority (s)	Ministry of Health ( United States Department of Health and Human Services )
Consist	since 1927
Headquarters	Silver Spring , Maryland , United States;
FDA Commissioner	Stephen Hahn
Employee	approx. 13,500 (2012)
Website	www.fda.gov

The US Food and Drug Administration ( FDA , German authority for food and drugs ) is the food control and drug authority of the United States . As such, it reports to the US Department of Health . The FDA was 1927 founded and its registered office is in Silver Spring ( Maryland , USA). The current head of the agency (FDA Commissioner) is Scott Gottlieb . There are four directors responsible for the main duties of the agency.

Your job is to protect public health in the United States . The FDA controls the safety and efficacy of human and veterinary medicinal products , biological products, medical products , foods and radiation-emitting devices. This applies to both US-made and imported products.

All drugs approved in the USA must be manufactured by pharmaceutical manufacturers who have been inspected by the FDA and whose manufacturing facilities comply with the regulations. The same applies to manufacturers of medical devices.

history

The establishment and growth of an agency for the purpose of consumer protection in drug use should be seen in the context of various legislative responses to drug incidents , in particular the diphtheria antitoxin incident of 1901, the sulfanilamide disaster of 1937 and the thalidomide incident of 1960.

1901 ill a horse named Jim whose blood serum in the US for the production of anti- diphtheria - antisera was used to tetanus . Shortly afterwards, 13 children died of tetanus. The Woman's Christian Temperance Union then launched a public campaign to create a law against food contamination and medicines in use at the time. On July 1, 1902, the Biologics Control Act was signed.

In 1906, President Theodore Roosevelt signed the Pure Food and Drug Act (or Wiley Act ), which prohibited the movement of adulterated food or pharmaceuticals between states. The Bureau of Chemistry was responsible for monitoring ; this was subordinate to the Ministry of Agriculture . In 1927, the oversight function of the Bureau of Chemistry was merged into a new agency, the Food, Drug, and Insecticide Administration , which was renamed the Food and Drug Administration (FDA) in 1930 .

The sulfanilamide disaster led to the passage of the Food, Drug, and Cosmetic Act in 1938, which required pre-market testing of drugs, banned misleading therapeutic claims, and gave the FDA far-reaching powers of intervention. To date, this law is the basis of most FDA regulations.

After the thalidomide scandal , the Food, Drug, and Cosmetic Act 1962 was expanded to include the Kefauver Harris Amendment , which obliges pharmaceutical companies to prove the efficacy and safety of new drugs.

In February 2020 (at the time the danger of the COVID-19 pandemic in the United States was not yet recognized and Trump had repeatedly claimed it was under control ) Stephen Hahn, the head of the FDA, put rules into force that paradoxically hospitals, Private clinics and companies made it difficult to use diagnostic tests (e.g. COVID-19 tests) in emergencies. At that time, other countries were already doing tens of thousands of tests a day, in the USA it was fewer than 100 a day. At the end of February 2020, rules were relaxed.

Task of the FDA

The FDA is also responsible for improving public health. This happens u. a. by supporting or accelerating innovations that can make pharmaceuticals and foods more effective, safer and more affordable. Through accelerated approval procedures, new types of drugs can be made accessible to patients more quickly. B. to be able to better treat previously untreated diseases. While supporting independent experts , the FDA in the decision on the approval or rejection of new drugs. The FDA also publishes accurate, scientifically based information about the use of drugs and foods to improve overall health. In view of the limited meaningful information on drug safety at the time of approval, despite the considerable research effort, some scientists suggested that the approval system be redesigned: A combination of more frequent conditional approvals and improved independent drug monitoring after approval should lead to better drug safety overall.

Food supplements

In 1994 the Dietary Supplement Health and Education Act (DSHEA) was passed. This regulates the classification of certain dietary supplements as food and not as pharmaceuticals . Because of this, they no longer need to be approved by the FDA. Today, a dietary supplement must first be considered harmful before the FDA can intervene.

organization

The four directors are responsible for the following main tasks:

Medical Products and Tobacco
Foods
Global Regulatory Operations and Policy
Operations (enforcement and organizational matters)

The FDA has numerous departments, centers, and offices that report either directly to the management or to one of the four directors. This includes:

Office of the Commissioner (OC)
National Center for Toxicological Research (NCTR, National Center for Toxicological Research)
Center for Food Safety and Applied Nutrition (CFSAN, Center for Food Safety and Applied Nutrition )
Center for Veterinary Medicine (CVM, Center for Veterinary Medicine )
Office of Regulatory Affairs (ORA)
Center for Biologics Evaluation and Research (CBER, Center for Biologics Evaluation and Research)
Center for Devices and Radiological Health (CDRH, Center for Medical Devices and Radiation Safety Compliance)
Center for Drug Evaluation and Research (CDER, Center for Drug Evaluation and Research)

Head of Authority

Walter Gilbert Campbell , who held office from 1921 to 1924 and 1927-1944, was the long-standing director during the founding period .

Surname	Appointed	Dismiss	Acting President
Donald Kennedy	1977	1979	Jimmy Carter
David Aaron Kessler	November 8, 1990	February 28, 1997	George HW Bush Bill Clinton
Jane E. Henney	January 17, 1999	January 19, 2001	Bill Clinton
Mark McClellan	November 14, 2002	March 26, 2004	George W. Bush
Lester Crawford	July 18, 2005	September 23, 2005	George W. Bush
Andrew von Eschenbach	December 13, 2006	January 20, 2009	George W. Bush
Margaret Hamburg	May 22, 2009	April 1, 2015	Barack Obama
Stephen Ostroff	February 2015	January 2016	Barack Obama
Robert Califf	February 2016	May 2017	Barack Obama
Scott Gottlieb	May 2017		Donald Trump