Area of Interaction III: History & Government
Historical Context of Drugs
Lunsford Richardson was a pharmacist from North Carolina that created medicine, specializing in treating cold symptoms. Lunsford was experimenting in his small, family drug store when he came across the mixture for vapor rub. Lunsford before that moment had created and patented about twenty-one medicines but his business would begin to start thriving on the production of vapor rub in1898 (Tomlin). Lunsford from that moment decided to switch lanes from the retail business to wholesale pharmaceuticals.
Lunsford had a son name H. Smith Richardson who had been a part of the family business at a very young age. Smith ...view middle of the document...
but the attempt was unsuccessful. This trend of challenging obstacles continued to arouse over the years but due to illness diseases, such as the Spanish influenza, the company began to get back on its feet. Around the 1930's is when NyQuil became more demanded by its consumers. Eventually the company was sold to Procter & Gamble in the 1980's and has remained the manufacturer for various Vicks and NyQuil products (Tomlin).
Federal Context of Drug
The FDA (Food and Drug Administration) is a United States agency that was formed in 1906 and is the oldest administration in the United States (About FDA). It was originally formed to regulate the products that Americans consume on a daily basis. The FDA was created in order to enforce the Pure Foods and Drugs Act, which consisted of 100 laws, was passed. The Federal Food and Drug Administration plays a big part in decided what drugs and foods are allowed to be sold to the consumers in the United States. The FDA falls under the Department of Health and Human Services which falls in the Executive branch of the government, which is mainly known for daily administration of the United States. All drugs have to go through an approval process that helps identify if they are hazardous for consumption or not. The FDA’s Center for Drug Evaluation and Research or the CDER is where most drugs are evaluated. A company must first run a series of test on the drug that it wishes to sell because the CDER is not responsible for testing clinical drugs; it just verifies the results that were handed to them (Development of Drugs). A team of specialist will complete a full analysis on the drug and see if the benefits outweigh the risks in which then a judgment is given to see if the drug is approved or not.
The patents which protect drugs are governed by the FDA and patent laws. The Drug Price Competition and Patent Term Restoration of 1984 or as its commonly known as the “Hatch-Watchman Act”, proposed by senators Orrin Hatch and Henry A. Waxman; caused many changes in the pharmaceutical industry by introducing the creation of generic drugs, therefore causing patents for drugs to last longer due to the lengthy time it takes for a drug to be approved by the FDA (Baltazar). Also generic drugs could now submit an Abbreviated New Drug Application which stated that a company only needed to show that they were the same as brand name drug to help submit an application for new clinical drugs. These forms can be filled when the brand name drugs patent is expired and the generic drug cannot go out on the market to be sold until then. Due to the Hatch Watchman Act the number of generic drugs available to consumers has increased exponentially, making name brand drugs lose approximately 40% of their revenue year-round.
About FDA. (2013, May 29). History. Retrieved February 23, 2014, from http://www.fda.gov/aboutfda/whatwedo/history/default.htm