The history and contemporary challenges of the US Food and Drug Administration.
BACKGROUND
The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide.


OBJECTIVE
The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs.


METHODS
Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further.


RESULTS
The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation.


CONCLUSIONS
As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.
Borchers
Andrea T
AT
Division of Rheumatology, Allerg and Clinical Immunology, University of California at Davis School of Medicine, Davis, California 95616, USA.
Hagie
Frank
F
Keen
Carl L
CL
Gershwin
M Eric
ME
D003415:Crime / Q000266:history / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000266:history / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000266:history / Q000331:legislation & jurisprudence; D005506:Food Contamination / Q000331:legislation & jurisprudence; D049672:History, 19th Century; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history* / Q000331:legislation & jurisprudence* / Q000458:organization & administration
D004364:Pharmaceutical Preparations