Are Generic Drugs a Smart and Healthy Choice?
Taking a brand name prescription drug for your medical condition is becoming a rare commodity for many as insurance companies are increasingly chipping away at our medical benefits forcing us to replace our brand name medications for less expensive generic drugs. When a letter arrives in the mail informing us that by such and such date if we do not switch over to a generic version of a brand name drug, that we will have to pay (a typically exorbitant) full sale price. Our initial gut response is that we are getting less to avoid paying more for the Insurer’s benefit. But is this necessarily true? Are we being shortchanged health-wise by being made to switch to generic forms of brand name drugs? According to Consumer Reports—with a few rare exceptions—we need not worry.
In the August 2012 issue of Consumer Reports on Health, guest writer Vinod P. Shah, Ph.D. a pharmaceutical scientist and consultant for the U.S. Pharmacopeia who has 30-years of experience working for the Food and Drug Administration developing guidelines for the testing and approval processing of generic drugs, tells us that when it comes to the active ingredients—brand name and generics are the same.
According to Dr. Shah, for a generic version of a brand name drug to gain approval for sale to the public it must get FDA approval just as the brand name drug did when it was first introduced as a pharmaceutical. To gain this approval, the makers of generic drugs must demonstrate the following to the FDA’s satisfaction:
1. The generic must possess the same active ingredient
2. The active ingredient must be identical in strength, dosage form, route of administration and labeling.
3. It must be bioequivalent, which means that once introduced into the body, its rate and extent of absorption must not differ significantly from the brand name medication in comparison.
4. The generic must meet the same requirements as the brand name drug for purity and manufacturing quality.
Dr. Shah also explains that the generics are validated with human volunteers who have their blood drawn and quantitatively analyzed to ensure that the generic drugs are biochemically equivalent to their brand name versions.
However, there are differences. The primary one being that the inactive or inert components of the generic drug are typically different from the brand name drug as it is usually protected proprietary company formulations that do not have to be divulged. These inactive ingredients are the components that bind the active ingredient in a pill form and control its release as the pill disintegrates in the body.
Dr. Shah explains that the differences in formulations may be responsible for some cases where individuals report that they experience difficulty in switching to the generic form. In these cases he refers to the problem that is called “narrow therapeutic index (NTI) where drugs such as some anti-seizure meds, blood thinners and thyroid hormone replacements are not delivering at the exact, specific concentration that worked previously with the brand name version. In other words, the generic is close per FDA standards and reported testing, but may not be close enough for some individual patients and their conditions.
For instances like this, the patient needs to go back to his or her physician and investigate as to whether there is an alternative generic within the same class of drugs that may work better for the patient. Dr. Shah advises readers that it may not be a good idea to switch back and forth between brand name and generics, or between generics, because their formulation characteristics will likely differ and may affect your blood concentration levels.
Aside from being a smart choice for health, choosing a generic even when you do not have to can save you a significant amount of money and be a smart choice economically.
To give you an idea of how much savings can be involved, Consumer Reports lists the common cholesterol drug Zocor as costing a patient without insurance approximately $175 per month. Replacing Zocor with the generic Simvastatin, the cost is much lower at approximately $70 per month. Furthermore, if you have insurance with a co-pay, the generic Simvastatin may only cost approximately $20 per month. In comparison to the brand name and with and without drug insurance, that’s a savings of $155 and $105 respectively—and that’s just with one medication. Multiply that by a typical 3-4 meds per day and we’re talking serious savings.
To help consumers find the best deal toward buying their generic drugs and with helpful information, recommendations and video resources about many medications, Consumer Reports offers exceptional assistance at Consumer Reports Best Buy Drugs for making a smart and healthy choice.
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Consumer Reports on Health (August 2012)
Consumer Reports Generic Drugs: “The Same Medicine for Less Money”
Consumer Reports Best Buy Drugs