Archive 2005 2006 2007 2008

Is a Generic Good Enough?

Brand-name drugs are expensive because many are still under patent, and thus only one company can make each medication. Healthy competition re-enters the marketplace when the patent expires and generic versions are produced. In the last two years many major drugs became available as generics, including the cholesterol drug simvastatin (brand name Zocor), the antidepressant sertraline (Zoloft), and the sleeping pill zolpidem (Ambien). More blockbuster brands will soon join the list. About two-thirds of prescriptions in the U.S. are now for generic drugs. The shift to generics has trimmed billions of dollars from the nation’s rising health-care costs.

Insurers and government health plans very strongly encourage or require the use of generics. Even if your prescription form says a brand name, your pharmacist is likely to give you the generic version if one is available—some states even mandate this—unless your doctor specifies “brand only,“ “do not substitute,” or “dispense as written.” But most states also allow patients to request that the pharmacist not substitute the generic.

Some people fear that switching to a generic is risky. Here’s the lowdown.

How close is a generic to the original?

Generics are required by the FDA (as well as Health Canada) to measure up to the original in every respect—dose, safety, strength, efficacy, quality control, and purity. They must act just as fast and meet the same rigorous standards. Indeed, about half of all generics come from the same companies that make the name brands. Generics can differ from the originals in shape, color, and inactive ingredients, such as preservatives and fillers.

The FDA tests the bio-equivalence of each generic in small groups of people to make sure that blood levels of the active ingredient are within 20% of the brand-name drug. FDA reviews of generic drugs have found they differed by only about 3 or 4%, on average, from the brand names—about the same difference seen among batches of brand-name drugs.

But do generics really work as well as brand-name drugs?

Many studies have shown that generic drugs are equivalent biologically and therapeutically to the brand names. Some researchers, however, suggest there are small differences for certain drugs—for instance, a few anti-seizure medications—which may cause problems in some people. Furthermore, though the active ingredients are exactly the same, the composition of the products may differ. A generic tablet may be harder or softer, which could affect how quickly it dissolves and is absorbed. This is rarely of consequence. But the FDA has received reports of problems, for instance, when some people switched from certain formulations of the antidepressant Wellbutrin to the generic, buproprion, and a 2007 analysis by ConsumerLab.com suggested that at least one company’s extended-release generic (buproprion XL 300) released the active ingredient much faster than the original drug.

Can switching to a generic cause new side effects?

It’s possible, but unlikely. Sometimes switching from a brand name to a generic increases side effects, perhaps because of different inactive ingredients. But that can also happen if you switch from one brand-name drug to another, or from one generic to another made by a different company.

Why are some generics still expensive?

During the first six months after their release, the price may drop only 20 or 30%, since initially one generic maker is granted exclusive marketing rights. As other generic makers step in, the price can eventually drop 70 or 80% or even more. If you’re paying out of pocket, shop around, since prices can vary a lot among drugstores. But if you have insurance that covers drugs, your generic co-pay will be low from the start. One problem: generics may not save you money if the medication becomes both generic and nonprescription, since insurance won’t pay for over-the-counter drugs.

Why does it take so long for a generic to come on the market?

The patent life is usually 20 years from the time a drug company submits its request to the government. Plus, companies have many ways to delay the expiration in order to prevent generics from being marketed.

Aren’t newer prescription versions better than the generics?

Not necessarily. As patents run out, many pharmaceutical companies simply market a slightly different version of the brand-name drug (sometimes called a “me-too drug”) and then aggressively advertise it as being better than the old drug, now a generic. This is what happened, for instance, when Claritin went generic as loratadine—its maker started aggressively marketing a new version, Clarinex. Another example is the ulcer drug omeprazole, a generic of Prilosec. The original maker now pushes Nexium—an almost identical drug, but available only by prescription, and much more costly. Usually the therapeutic differences are minimal.

A few years ago a study by the National Institute for Health Care Management Foundation found that two-thirds of newly approved drugs were modified versions of existing drugs—not new at all. This helps delay the threat of competition from generics. It also stymies innovation, since instead of looking for new drugs, companies look for new ways to market old ones.

Bottom line: There are thousands of generic drugs on the market that are safe, effective, and well tolerated. If you take a brand-name prescription medication, ask your doctor or pharmacist if there is a generic (they should tell you, in any case). If you take an over-the-counter drug, choose the generic or store brand, if there is one. If your brand is not available as a generic, talk to your doctor or pharmacist about switching to a similar drug that is generic. If you do experience problems or side effects with any drug, tell your doctor and/or pharmacist. They should file a MedWatch report to the FDA, but in case they do not, you should. To file your report by mail or fax, call MedWatch at 800-332-1088 for the form. Or download it here.

UC Berkeley Wellness Letter, July 2008