The Truth about Generic Drugs

When you go to the grocery store, you can often buy “brand X” or the store’s own version of a variety of products ranging from potato chips, salsa and packaged or fresh cheese to bread, paper goods, laundry detergent, cosmetics and much more. These “generic” products are of varying quality, sometimes as good as the name-brand items you may have been purchasing for years, sometimes not as good. The price difference, however, is usually significant, and it’s often well worth the savings.

Can the same comparison be made for generic drugs?  Yes – but with a huge caveat:  What makes generic food and paper supplies different from generic drugs and medicines is strict federal oversight. The generic drugs often are being made by the same pharmaceutical companies as their more expensive brand-name cousins, or by other companies once patents on the brand-name drugs have expired. Proven quality, consistency, strength and testing by the Federal Food and Drug Administration (FDA) assures the consumer that the generic being substituted for the brand-name drug is safe, effective and just what the doctor ordered.

In fact, eight out of 10 brand-name drugs are now available in generic equivalents. Generics are, on average, 80 percent to 85 percent cheaper than brand-name drugs, saving U.S. consumers close to $200 billion annually.

Pharmaceutical companies mark up their proprietary brands to reflect the upfront costs involved in research, testing, clinical trials, manufacturing, distribution and marketing and advertising. Marketing and promotion is a huge expense, which is reflected in the purchase cost of brand-name drugs. Drug manufacturers are allowed to protect that brand for a certain number of years to recoup their investments. Once that patent protection expires, other companies are allowed to produce the product without the costly start-up charges or advertising, and the price drops due to competition.

When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand-name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable, and monitors those differences.

Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand-name product. Generic drugs do not need to contain the same inactive ingredients as the brand-name product, though.

To ensure quality and performance, the generic drug manufacturer must prove its drug is the same as (or bioequivalent to) the brand-name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand-name product is used, the generic drug will work the same. Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand-name product. This standard applies to all generic drugs, whether immediate or controlled release.

Additionally, all generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs, and the generic products must meet the same exacting specifications as any brand-name product. In fact, many generic drugs are made in the same manufacturing plants as brand-name drug products.

When to be cautious

With the proliferation and availability of drugs sold online, consumers must be careful that the products they’re buying – especially those created and shipped from other countries – meet the same standards as American generic drugs. It’s one thing to apply an adhesive bandage made abroad, another to ingest a medicine critical to your recovery from an illness, maintenance meds for a chronic condition, or vitamins and supplements that could be harmful or result in death.

The reason for caution is that the FDA often does not regulate, review or test these drugs that come from potentially nefarious sources in India, China, South America and the Far East.  Oftentimes, drugs that are advertised “made in Canada,” for example, actually come from other countries. And manufacturers are expert at using similar-sounding names for better-known drugs to confuse consumers. They also prey on the elderly, less-educated and needy.

The cash price for online drugs might be right, but the physical price could be extremely costly. When in doubt, consumers can visit the U.S. Food and Drug Administration website for safety information, alerts and pharmaceutical product details.

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