Most (but not all) pharmacists routinely tell patients that generic drugs are identical to brand name medications. That is hardly surprising. This is what pharmacy students are told during their education process. It is also what the FDA states on its website:
“A generic drug is identical–or bioequivalent–to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.”
Now we don’t know about you, but when we see the word identical we assume that means exactly the same as. Here is how Dictionary.com defines the word identical:
“1. Similar or alike in every way
2. being the very same
3. agreeing exactly
Related Words for: identical
Indistinguishable, one and the same, selfsame
1. Exactly equal and alike
2. Of or relating to a twin or twins developed from the same fertilized ovum and having the same genetic makeup and closely similar appearance; monozygotic.”
In our opinion, the FDA’s use of the word identical, when describing generic drugs, is misleading. First, the inactive ingredients (colors, binders, fillers, etc) do not have to be “alike in every way” to the brand name product. In fact, they are often quite different. These so-called inactive ingredients or “excipients” may influence how the product affects patients. For example, a patient who is allergic to a particular color may develop a rash when switched to a generic product.
The formulation may also differ dramatically from the brand name. Many pharmacists may be unaware that the physical characteristics or release properties of a brand name drug often stay under patent even after the active ingredient becomes available generically. This is especially problematic for slow-release or long-acting medications. Generic manufacturers may have to come up with different technologies to deliver the active ingredients. This means that the products are not always “indistinguishable or one and the same.”
To see this for yourself, visit the FDA’s website and report on the antidepressant bupropion XL.
If you look at the graph the FDA provides you will discover that the mean plasma concentration of the two drugs is certainly NOT identical! The generic formulation (which uses a matrix technology to release the active ingredients) produced peak blood levels in 1.5 to 2.5 hours, whereas the brand name product (using a membrane technology) produced peak blood levels around 5 hours. This kind of information for other generic formulations is not always easy to access.
Here is something else a pharmacist might not realize. According to the FDA, 80 percent of the active and inactive ingredients in our pharmaceuticals come from abroad. It is estimated that 40 percent of the finished pills come from abroad including countries such as India, China, Brazil and Mexico. It is also very clear that the FDA does not have the resources to inspect all or even many of the manufacturing plants producing either the raw materials or finished products millions of Americans take every day. That means that there is no verification system that the pills are exactly what they say they are.
We have seen manufacturing problems with some of the most prestigious drug companies in the U.S. (Johnson & Johnson and GSK). These problems occurred at plants where the FDA visits on a regular basis. Do we really believe that chemical companies in China that are not inspected are producing perfectly identical generic drugs at cutthroat prices?
Perhaps it is time for pharmacists to acknowledge that there are no guarantees when it comes to generic drugs. Pharmacists must be the patients’ allies and advocates. When patients experience problems with certain generic formulations, pharmacists should offer a sympathetic ear and report the problems directly to the FDA’s website (MedWatch). Perhaps if pharmacists insisted that the FDA do a better job both approving and monitoring generic drugs, patients would have more confidence in these money-saving pills.