About James R. Harris PhD Expertise Can answer questions regarding pharmaceutical manufacturing, FDA, GMP, validation, regulatory compliance, pharmaceutical technology, process containment, economics, training, manufacturing facilities, materials management, computer validation, and virtually anything that is related to the development, regulation, and manufacture of pharmaceutical products.
Experience
Past/Present clients too numerous to mention - - have clients in the US, Europe, and Asia.
Question Hi James,
I'm an "allexperts.com" expert in the Roofing area.
Background: Kaiser is now boosting the cost for non-generic medications. I take dilantin. I understand that Phenytoin is the generic name, but the clerk at the Kaiser Pharmacy said there may be some differences between the brand name, Dilantin, and the generic Phenytoin. I'm going in soon for my annual check up and I'm inclined to press for the generic.
My two questions...
Are there any real differences between phenytoin and Dilantin?
Can you recommend a website that discusses the differences, please?
Thanks for the help.
Your roofer with a keyboard,
Stan Skarbek
Answer Hi Stan!
You ask a difficult question.
Our government created the generic drug "monster" on the theory that anyone should be able to make a product that is therapeutically equivalent to the brand name. With this thought in mind, our politicians decreed that when a drug patent expires, any manufacturer can make a copy. The application to FDA needed to gain approval to sell this copy may rely almost entirely on the information contained in the originator's New Drug Application. All the generic manufacturer needs to do is to submit data showing that the availability of the drug in the body is similar to that of the originator.
There are numerous problems with this concept.
1. The generic manufacturer may not be honest. For example, I have had telephone calls from FDA asking questions about drugs we manufacture. On two separate occasions, it turned out that a generic company took our product, covered it with a coating of another color, and submitted it a sample of their product.
2. Generic manufacturers tend to take shortcuts to save money. For example, the product that they use to gather data may not be producable on a large scale. Thus, when the product is marketed, the formulation, method of manufacture, etc. may be changed. These changes can, and often do affect the effectiveness of the product.
3. Quality control is an area that the generic manufacturers cut corners on. This means that the product quality can ofter fluctuate greatly from batch to batch.
In response to your question, the simple answer is that theoretically, the generic products are equivalent but practically, they vary all over the map. Even the product from a supposedly reputable generic manufacturer often varies so much that one batch may be fine and the next may not work.
Kaiser buys the lowest cost product available at the moment they need to re-order. The manufacturer will vary from time to time. Are they all the same? The politicians say yes. I say no. Unfortunately, the variation is so great that it is almost impossible to know whether the dose you are taking now is good or not.
To make matters worse, Dilantin is one of the products that has a lot of variability in the generic products. If you have to go with the generic, good luck! If you can possibly afford the brand name, this is a situation where I would strongly recommend it.
This has been a long answer to a short question, but I wanted to give you the reasoning behind my answer. I may be wrong, but my guess is that there are many roofing materials that appear to be made of the same materials, but there are certain brands that you have found to be of consistent quality and that simply work better. The same is true with pharmaceuticals.
