Today we are going to look more into the FDA or Food and Drug Administration. In Part I we looked at the primary location, including field offices in all 50 states and several countries. The most important aspect was the regulating power of the FDA. Much more powerful than most of us even understand.
Now let’s jump into the history of the FDA. It appears to have started in 1906 by President Theodore Roosevelt that signed into law the Food and Drug Act. This prevented seizure of food and goods along interstate transport. It also stopped movement of food and medications that had been changed from the standard. At the time it was looking at food with chemical addictives.
Later in 1927, the regulatory powers were reconstructed into a new organization. At the time it was called, USDA body, the Food, Drug, and Insecticide organization. The name became too cumbersome and was again changed to the FDA in 1930.
Additional control was given to this agency as additional problems, tragedies, and when reformation was required. Such tragedies include the Thalidomide deformity of 1959 where thousands of babies in Europe were born with deformities after their mother was given a medication to treat nausea. Continued growing problems involving food, vitamins, and cosmetic products increased the FDA control.
Drug testing is one of the larger aspects of the FDA control. A New Drug Application must be submitted to the FDA. Several rounds of testing, requirements, and follow ups are required during this process. Even after the drug has been approved and used by consumers, post market surveillance is required.
The FDA, as many other organizations, has their fair share of criticism. This barrage of attacks has come from both inside the government and outside. Typically it is from the over or under regulations that they are striving to hold. In some cases, it is believed that a certain sector it is not being regulated closely enough by the FDA.
A large criticism is in regards to drug safety. In 2006, a report sent out by the Institute of Medicine indicated that they believed that the regulatory powers were not constant and fair between companies to ensure the safety of drugs on the marked. This leads to a difficult time with drug approval and may lead to higher drug prices because of the over regulation and possible safety problems.
In the end, the FDA is essential to ensure the best products are given to you and I…The Consumers.
In addition to the best product, the safest, and ensure that manufactures aren’t doing what they say they are doing. As you eat your next piece of food, or take your next tablet of medication, imagine that you are taking something that isn’t really in the pill. You could be given anything and who would be the wiser. The FDA is a critical and important aspect of ensuring consumer satisfaction.
Criticism though needs to be addressed and a continued balance of regulatory powers is a must. A too overwhelming or controlling government may just as easily run a good product out of availability because of the regulatory process. It is an important and almost essential thing to have balance.