Does Your Generic Drug Make the Grade?

by Eve B. Scheffenacker

The promotion of generic drugs marks one of the more successful attempts to lower the cost of health care. Generic drugs cost from 30% to 80% less than their brand equivalents. The average retail price of brand-name drugs is about $111, while generics average a little more than $32. That represents real savings to consumers of more than $15 billion a year.

In 1984, the Hatch-Waxman Act opened the way for generic drugs by making it easier and less expensive for companies to make them and get Food and Drug Administration (FDA) approval. Sales didn't really take off until the high cost of prescription drugs led insurers to design health-care plans that paid higher benefits for generic drugs.

Sales of generics are growing by 5% a year. In 2006, pharmacists used generics for more than a billion prescriptions, 65% of all prescriptions filled in the U.S. Those numbers will rise even higher in the next couple of years as patents expire on blockbuster brand drugs such as Zoloft, Zocor, and Pravachol.

Nevertheless, studies show that at least 20% of consumers doubt the safety of generics. Doctors, meanwhile, report that they believe generics are equivalent to brand-name drugs. However, fewer than half actively prescribe them. Instead, they let pharmacists make the substitution. This suggests that physicians, too, have doubts.

These doubts were more valid 15 years ago, in the early days of generics. Quality standards then were less than optimal. Today we have stricter standards, improved oversight, and advanced testing methods for generic drugs. So if you buy generic drugs while harboring doubts about their quality, read on.

Generic vs. brand

The starting point for any discussion about generic drugs is the comparison with their original brand drugs. Generic drugs are "copies" of brand-name drugs on which the patent has expired. They are subject to FDA standards that are as stringent as those for brand-name drugs. (For a moment, set aside any skepticism you have about that process. Though imperfect, it is very effective.)

All generic drugs on the market are essentially the same as the brands they copy, and all have FDA approval. They are as safe and effective as the brand when used in the approved dosage.

What does "essentially the same" mean? First, generics are pharmaceutically and therapeutically equivalent to brands. This standard requires a generic to have the same active ingredients as the brand, as well as the same dosage form (for example, tablet or liquid) and strength. Also, the maker must meet certain standards set by the FDA for manufacturing and labeling the drugs. (A number of the companies making generic drugs are owned by the maker of the brands they copy.)

Next, the FDA considers the generic drug's "bioequivalence," that is, how it acts in your body compared with the original drug. In other words, how quickly the body absorbs the drug. The generic doesn't have to mimic the brand exactly, but it does have to meet strict FDA guidelines. This is the standard that separates some generic drugs—the roughly 4% that isn't proven bioequivalent—from the others.

A vs. B generics

This brings us to how generics compare with each other. The FDA has a coding system to help practitioners know which generic drugs can be safely substituted for which brand name drugs. Under the system, each generic drug has a two-letter code. The first letter relates to a drug's bioequivalence:

1. A drug--The FDA has tested it and proven it bio-equivalent with another product.
2. B drug--The FDA has identified an actual or possible bioequivalence issue between the generic and the brand.

These A and B codes imply that one group of generics (the A's) is better and safer than another. Not so. B does not stand for Bad. If it did, the FDA would not approve any B drug. Rather, B simply signals a difference between two products that may or may not be significant. Along with the second letter of the code, it tells your doctor or pharmacist that a particular generic may have slightly different side effects than the brand. Or it may produce the desired effect at a different rate. A B drug should not be more harmful than the brand, as long as you use it as it's prescribed. (The same is true of any drug--brand, generic, or over the counter.)

Indeed, many of the bioequivalence differences that have been found in B generics are very, very small--so small that neither patients nor their doctors can detect them. Most differences are detected in the laboratory, and then only because modern tests can detect miniscule variances.

Older generic drugs make up another group of B generics. People have used them safely for years. However, they have not gone through the newer, more rigorous tests. They may well be bioequivalent. Lacking that proof positive, however, the FDA assumes that a difference could exist.

Making the substitution

The last piece of the generic picture falls in place at your pharmacy. Often, the pharmacist--not the doctor--is the one who decides what generic drug to substitute for a prescribed brand drug. This is not always an obvious choice. A pharmacist often has more than one generic drug to choose from. Then he or she relies on the A and B coding system and a tome called the "Orange Book" (formally titled the "Approved Drug Products with Therapeutic Equivalence Evaluations"). This resource lists approved drugs, using the FDA coding system to indicate their equivalency status. The FDA updates this resource monthly and now provides it online.

You can trust your pharmacist to decide which is the appropriate generic. Pharmacists specialize in medication like doctors specialize in surgery or family medicine. They work with the array of drugs on the market and the coding system every day.

Each state regulates how much authority pharmacists have to select drugs on their own. Some states require pharmacists to use only A drugs as substitutions; many give them more flexibility. Whatever the rules in your state, you always can ask the pharmacist to use only A generics for your prescriptions.

The quality standards for generic drugs have come a long way since they first appeared in the marketplace. Today when you buy a generic drug, you're getting far more than you're paying for. For at every step from the manufacturer to the pharmacy, there are regulations, tests, and guidelines to ensure that they are as safe and effective as their brand originals. If you have any questions about generics, your pharmacist is the best person to take them to.

Published August 27, 2007

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