History of the Food and Drug Administration
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the "United States Pharmacopoeia" or the "National Formulary". The act also banned "misbranding" of food and drugs. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.
Copper IUDs
The ParaGard T 380A was developed in the 1970s by the Population Council and Finishing Enterprises Inc. (FEI). The Population Council's ParaGard new drug application (NDA) was approved by the U.S. Food and Drug Administration (FDA) and FEI began manufacturing it for distribution outside the United States in 1984. GynoPharma (originally GynoMed) began marketing it in the U.S. in May 1988. On August 2, 1995, Ortho-McNeil acquired GynoPharma and began marketing ParaGard in the U.S. On January 1, 2004, FEI Women's Health acquired the patent from the Population Council and U.S. marketing rights from Ortho-McNeil. On November 10, 2005, Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, acquired FEI Women's Health and ParaGard. On July 18, 2008, it was announced that Teva Pharmaceutical Industries Ltd. would acquire Barr Pharmaceuticals.