Brand Names Versus Generics
Once the pharmaceutical company has released the drug to the consumer market, the race is on. Recouping its financial investment and making a profit before the patent expires is essential, since the day after the patent expires, generic drugs will show up on the drugstore shelves.
Before 1995 a drug patent was effective for 17 years. Legislation passed that year, however, extended the term to 20 years. Since patents are often obtained before the drugs are ready to market, the actual patent term is frequently less.
What the FDA Requires of Generics
Even though generics aren't bound by the same procedures of development as innovator drugs, there are still some requirements:
The generic must contain the same active ingredients as the innovator drug.
The generic must be identical in strength, dosage form, and route of administration.
The generic must have the same use indications.
The generic must be bioequivalent to the innovator drug.
The generic must meet the same batch requirements for identity, strength, purity, and quality.
The generic must be manufactured under the same strict standards the FDA requires of innovator drugs.
So, what's the problem? Sure sounds good enough. Generics are cheaper, and that's important. A generic is the same as the brand name drug, right? Wrong.
The term for the inactive agents in a drug is excipient. Additional excipients used include binders, emollients, lubricants, and preservatives. Common excipients include cornstarch, lactose, talc, magnesium stearate, sucrose, gelatin, calcium stearate, silicon dioxide, shellac, and glaze. Among their functions: They keep a drug from dissolving too soon or breaking into particles when handled.
A Small World of Difference
First of all, since the law requires that you need to be able to visually distinguish the generic from the innovator drug, its appearance will vary slightly. Next, the inactive ingredients — the flavors, fillers, and dyes — may be different from the brand name drug. Just because something is inactive doesn't mean you won't react to it.
If your body doesn't absorb the fillers used in generic products the same way it handles name brand drugs, you may get different amounts of the medication than you did when you used the brand name product. Also, since you don't know what those inactive ingredients are, it's possible that you may be allergic to one or more of them.
Don't Make Assumptions
The FDA assumes that generic drug manufacturers will abide by the same constraints as the innovator drug companies. In fact, some of these innovators have bought into the generic market, to ensure they will be able to continue profiting from their research investment. Most American companies do conform, but if your generic drug is manufactured outside the United States, you can't be sure of anything.
There's a loophole for the generic companies, and it's big enough to drive a truck through. The FDA uses the plus or minus 20 percent test to determine blood serum availability. That means the amount of the active ingredients in your bloodstream, after you have ingested a generic drug, has to come within plus or minus 20 percent of what those levels would be if you had ingested the innovator drug. Twenty percent may not be important or medically significant for certain conditions, but it can be of vital significance in others. Also, the math gets more complex once you analyze what can happen.
Suddenly, It's Serious
Here's a scenario to chew on. Suppose you are on heart medication, and your physician has had you on a specific brand name drug. That drug was produced at the higher end of the plus or minus 20 percent allowability. Your insurance company has balked at paying for the brand name and will only cover a generic.
So, you have your next prescription filled with the generic. If that generic had been produced at the lower end of the plus or minus 20 percent allowability, you are now getting 40 percent less medication than previously. The same scenario could have the numbers flip-flopped, so now you're getting 40 percent more than you should. This can be extremely dangerous for you.
Equivalence Doesn't Mean Equal
All the generic company has to do in order to meet FDA requirements is to produce a drug that has chemical equivalence (similar quantities and availability of the active ingredients to the innovator drug) and bioequivalence (defined by absorption parameters that fall within the plus or minus 20 percent regulation).
Similar and equivalent do not mean the same as. If you need an example of this, just think: margarine is similar to butter. It's got a similar color, caloric equivalence, and similar uses. Or, how about siblings? If you have a brother or a sister, you probably share some similarities.
In fact, the list can be quite long; however, are you the same person? Are you different enough to make those differences statistically significant? Even if you are an identical twin, there are differences enough between you to tell you apart as individuals. The drug descriptors work exactly the same way.
What to Do?
Your physician knows what the therapeutic level of your prescription must be. Before you decide to go generic, discuss this with your doctor to see if it's a good move on your part or an invitation for problems.
If the generic will work for you and not be a source of potential problems, it may be a logical choice. If it won't do the job, however, hold your ground. Your health is what's important and, at the very least, your prescription medications should first and foremost do you no harm.