How are drugs invented, tested and manufactured before they make it to store shelves? What exactly are “generic” drugs? The following article provides detailed answers to those questions and several others you may have about medications.
The drug marketing process
From the moment a potential medication is discovered to the time it makes it to the market, an average of 7 to 9 years have passed. In addition, to identify the element that will make the drug effective, researchers study an average of 10,000 molecules.
That is why producing medication takes so much time and costs so much!
Here are the different steps normally involved in marketing a drug and the order in which they occur:
- Laboratory studies
- Testing on animals
- Clinical trials on healthy humans
- Clinical trials on humans with a medical condition
Together, these studies help to ensure the effectiveness and safety.
Even if drugs are extensively studied, it is nearly impossible to predict all the potential adverse effects. For example, a drug might cause an adverse reaction once in a million, an outcome that studies might have failed to detect.
Drugs also continue to undergo post-market research even after their introduction. If unanticipated side effects occur following use by a given patient, the drug company will withdraw the product from the market.
A generic drug is identical to the original drug. In fact, it is a “copy” of the original product and contains the exact same “active ingredients. The only difference is the price. A generic drug is usually less expensive to produce because all the research on it has already been done.
New drugs are protected by patents. The developer of any given drug has exclusive rights to the formula for a period of 11 to 13 years and sometimes even longer. When the patent has expired, other companies can start commercializing the same product. And that’s what is called a generic drug.
A patient can request the generic drug. Your pharmacist is authorized to offer you the generic version of a drug instead of the original. But you can choose to use the original. It’s entirely up to you!