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FDA & Aspirin

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PostPosted: Dec Fri 15, 2006 9:48 pm    Post subject: FDA & Aspirin Reply with quote

FDA & Aspirin

You all may remember some time back I reported that I was searching for information about aspirin never being "approved" by the FDA--but rather, grandfathered in. Well, I received the following post today. Wanted to share it. -Deana Persson

Dear Mrs. Persson,
Allow me to introduce myself. My name is Zachary Campbell and I am a student at West Virginia University's School of Pharmacy. As for the question about Aspirin, actually aspirin is a special case. First let me explain, as best I can, about drug regulation in the Unites States. Up until the late 1800s basically "anything goes" was the order of the day. In roughly 1890 congress passed a bill preventing the import of adulterated or misbranded products.

This was to prevent impure products from making it to the general public and so that the public could be assured of what was in a properly labeled bottle.

Unfortunately this "regulation" functioned via misadventure. The law did not have severe penalties and could not check products before they went to market.

Then in 1938 due to deaths involved with a drug called sulfanilamide, the congress made the "Federal Food, Drug, and Cosmetic act (FD&C) Act". Its purpose was two fold: (1)to ensure public safety (2) the FDA was established.

Next it was amended in 1951 to separate drugs into two classes, namely over the counter (OTC) products and prescription only products. If you have ever gotten a prescription and seen the phrase "Federal Law Prohibits Dispensing of this Medication Without a Prescription", this amendment is where it came from. (This amendment was the result of a drug called "Thalidomide" and the major birth defects it caused). In 1962 the congress added the Kefauver-Harris Amendment to make drug makers show efficacy (that it actually worked).

So with all this where is aspirin you say... Well Aspirin was the discovery of a German company. Notably a Pre-War German company! It is my understanding that the US and other countries (after the war) did not officially recognize the patent on aspirin and allowed manufacturers in the US to make aspirin under various brand names. This happened so fast that the German company could not stay in business any longer and went bankrupt. This is why there really isn't one true "Brand" of aspirin

An interesting side note - any drugs on the market before 1938 received "Grandfather" status. They did not have to show efficacy. The 1962 amendment said that to stay on the market they did. In 1984 the Waxman-Hatch Act was passed as a piece of economic legislation. It allows companies only a certain time limit before their patent on a drug expires. Then generics can be made, often be the same company...but that is another story (if you are interested).
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