hornpharmd
5,000+ Posts
www.cnn.com/2012/09/01/health/germany-thalidomide-apology/index.html?hpt=hp_t1
This is just an example. There are many important functions for government. The FDA serves an important purpose and without it who knows what our healthcare system would look like today and how risky it would be to purchase medications.
In 1938 the Federal Food, Drug, and Cosmetic Act was passed which required drugs to be proven safe to be sold. It gave the FDA inspection authority and increased regulatory authority.
In 1951 the Durham -Humphrey Ammendment passed which created the OTC and legend drug category distinctions. No longer could all medications be purchased over the counter.
In 1962 the Kefauver-Harris Ammendment passed which now required informed consent for clinical trials, required manufacturers to show effectiveness as well as safety, required adverse event reporting to the FDA. It also required manufacturers to submit a new drug approval (NDA) to get drug approval for marketing purposes. It increased manufacturing inspections to once every 2 years. This was sparked by the European Thalomid concerns.
These are some of the earliest most important legislative actions taken to strengthen the FDA and improve safety for consumers. A summary of other actions can be found here:
As I continue to hear tea party candidates and elected officials discuss how they would like to get rid of the FDA or other government programs that protect consumers, I can only think of what country we would have without those laws and agencies to protect us. Of course many of these politicians will not come out and say straight out that they want to completely remove some of these agencies but they would like to severely weaken them so that they will not be able to execute their responsibilities effectively. We have already seen this happen with the SEC....do we really want it to happen with the FDA?
I wish we were having more discussions on the real issues such as the budget, the deficit, the war, healthcare, and what functions should government be doing and what should they leave to the private sector. Instead we are talking about Clint Eastwood and Ann Romney.
This is just an example. There are many important functions for government. The FDA serves an important purpose and without it who knows what our healthcare system would look like today and how risky it would be to purchase medications.
In 1938 the Federal Food, Drug, and Cosmetic Act was passed which required drugs to be proven safe to be sold. It gave the FDA inspection authority and increased regulatory authority.
In 1951 the Durham -Humphrey Ammendment passed which created the OTC and legend drug category distinctions. No longer could all medications be purchased over the counter.
In 1962 the Kefauver-Harris Ammendment passed which now required informed consent for clinical trials, required manufacturers to show effectiveness as well as safety, required adverse event reporting to the FDA. It also required manufacturers to submit a new drug approval (NDA) to get drug approval for marketing purposes. It increased manufacturing inspections to once every 2 years. This was sparked by the European Thalomid concerns.
These are some of the earliest most important legislative actions taken to strengthen the FDA and improve safety for consumers. A summary of other actions can be found here:
As I continue to hear tea party candidates and elected officials discuss how they would like to get rid of the FDA or other government programs that protect consumers, I can only think of what country we would have without those laws and agencies to protect us. Of course many of these politicians will not come out and say straight out that they want to completely remove some of these agencies but they would like to severely weaken them so that they will not be able to execute their responsibilities effectively. We have already seen this happen with the SEC....do we really want it to happen with the FDA?
I wish we were having more discussions on the real issues such as the budget, the deficit, the war, healthcare, and what functions should government be doing and what should they leave to the private sector. Instead we are talking about Clint Eastwood and Ann Romney.
