Q: My insurance company stopped paying for the brand name medicine I have been taking for years because it’s now available as a generic. Within 2 weeks of starting on the generic version of my medicine my old symptoms started coming back. My doctor says that it’s the same medicine, but if that’s true, why do I feel different?
Generic medicines are considered equivalent to their brand name counterparts, but they are not identical. The Food And Drug Administration (FDA) requires that generic drugs meet the same standards as brand name products, but they don’t have to match them in every way.
Before they can sell a generic version of a medicine its manufacturer must show the FDA that their product contains the same active ingredient as the brand does at each strength. It comes in. The formulation (tablet, capsule, liquid or injection) and route of administration must also be the same as the original or “innovator” medicine. In addition, its manufacturing processes, quality control and testing must meet the same standards as any branded product. Many generics are actually made in the same facilities as their brand name equivalent.
The generic drug manufacturer must also prove to the FDA that its medicine is bioequivalent to the brand name drug. This is done by having volunteers each take standardized doses of the generic and brand name medicine with blood samples taken after each dose to measure the amount of each in their bloodstream compared to the other one. If the levels of the generic drug in the bloodstream are the same as the levels found when the brand name product is used, it is assumed that the generic drug will work the same in your body.
But there are differences between taking a generic and a brand name medicine. The biggest difference is in the price, with the average generic drug costing 80 percent less than the brand name version. According to a study of generic drug usage done by the US Government Accountability Office, in 2010 alone the use of FDA-approved generics saved $158 billion as prescriptions and in medicines used by hospitals. That’s an average of more than a billion dollars saved every other day.
Although the active ingredients have to be equivalent, the inactive ingredients don’t have to be. And may change the way some people absorb their medicine. For example, tablets contain more than their active ingredient, like meatballs often contain more than just meat. Most tablets of medicine also have diluents or fillers to make up the size of the tablet, similar to rice or oatmeal used in a meatball recipe. Examples of fillers used for tablets are lactose, sucrose, kaolin, starches and cellulose. Then there’s an adhesive compound added to the powdered medicine called a “binder” to help it all hold together, like an egg added to a meatball recipe helps the meat and rice “stick” together as you form it into a ball. And sometimes a dye is added to the powder to color the tablet, which can cause reactions in people who are sensitive to dyes.
Many generic manufacturers use less expensive versions of filler, binder and dyes than the branded medicine, which is perfectly allowable by the FDA as long as the active ingredient is the same concentration as the original product.
There are more extended release generic medicines available now than ever before, and generics for these are harder to get “right”. Even between different brands of similar products, there can be differences in how much of the medicine is released into the body over a period of time. The FDA received complaints about a generic version of Wellbutrin® XL causing headaches, nausea and a return of depressive symptoms in some people. In October 2012 the FDA reversed its approval because of a difference in how the generic was absorbed and asked its manufacturer, Teva to remove it from the market.
If you notice a difference between how you feel when taking a generic medicine and the brand it has replaced, ask your doctor to report it to the MedWatch program that is run by the FDA, which tracks adverse events caused by medicines. Your doctor may also consider adjusting your medicine, changing it to another medication, or asking the insurance company to approve using the brand name product for you because of your bad experience with the generic.
You can find more information about generic medicines at http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/default.htm.
