Sunshine Act: Affordable Care Act Component

Sunshine Act: Full Disclosure

Federal regulation is nothing new in the business of pharmaceutical manufacturing and sales. Since the recognition of disease, man has been promoting the use of chemicals and compounds as remedies. According to Lembit Rago in his book Drug Benefits and Risks: International Textbook of Clinical Pharmacology, As early as 120 BC, Mithridates, King of Pontus, promoted a compound called “Mithridatium” made up of forty-one separate components, as a panacea for countless diseases and it remained popular until the 1780’s. In 1540, one of the earliest regulatory actions affecting drugs was introduced when a British statute called The Apothecaries Wares, Drugs and Stuffs Act was introduced and attempted to put controls on medicines like mithridatium and others. Other such actions of the time did more to regulate the apothecaries since this is where most all compounds and remedies were made. These actions such as the proclamation of Frederick II of Sicily, aimed at insuring that remedies were prepared in the same way every time (Rago, Lembit 65). Advances in chemistry, life sciences, physiology and pharmacology in the 19th century would change the regulatory scene forever.

As mentioned before, early regulation by the Federal government focused on the pharmacies in The United States. In 1820 eleven doctors set up the U.S. Pharmacopeia and published a list of standard drugs. This could be seen as the infancy of the modern day Food and Drug Administration (FDA). In 1905 The American Medical Association (AMA) began a voluntary drug approval system that would remain in effect as the primary tool for drug approval until decades later. In order for a manufacturer to advertise their drugs in AMA and related journals, they would be required to show that the drug treated what the manufacturer suggested it would. Again this was a completely voluntary system and manufacturers were not required by law to conform. In 1937 tragedy would prompt...