AARP Hearing Center
Brand Name vs. Generic Medications: What’s the Difference?
Generic drugs can be far cheaper — but are they as effective?
Kyle Hilton
Generic products can carry a certain level of suspicion: A no-name soft drink may not taste like the real thing, and a generic detergent might not tackle the tough stains like the big brands. But when it comes to medication, does it really matter?
It’s easy to assume that a generic over-the-counter painkiller or cold medicine won’t work as well as the brand names we all know. The lower price tag can make it seem even less reliable. But it turns out that generic medications are strictly regulated by the U.S. Food and Drug Administration (FDA), and manufacturers must prove that they work just as well as their branded counterparts.
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The history of generics
One reason brand medications are more expensive is that they must undergo rigorous testing, including clinical studies, to demonstrate they are effective and generally safe. This can take years and requires companies to make major investments. Early on, generic drugs had to replicate all that testing after the original patent expired, which led to long delays and high prices.
Congress passed the Hatch-Waxman Act in 1984 to lift some of the testing requirements and make it easier for generics to come to the market in a timely fashion and at better prices for consumers. Unfortunately, scandal arose almost immediately: Generic drug companies flooded the FDA with applications and received approvals too easily. It turned out that FDA officials at the time were taking bribes to allow unsafe and ineffective products on to shelves.
What followed was a much stronger law. In 1992, the Generic Drug Enforcement Act required greater proof that the products were equivalent to brands and gave the FDA the ability to block dishonest companies. Since that time, according to pharmacist Mary Ghaffari, senior director for medication utilization and practice management at University of Maryland Medical System, consumers can be assured that generic medications have gone through strict protocols.
Are generic drugs the same as brand-name meds?
Generic medications must be bioequivalent to their branded counterparts to be FDA-approved. That means the generic drug delivers the same amount of active ingredient at the same rate and to the same extent as the brand-name drug. The active ingredient is the component in medication that makes the drug work.
It must also be delivered in the same manner (liquid, pill or chewable, for example). While a generic medication may look different in color or shape, it still contains the same active ingredient.
The only differences allowed are in the inactive ingredients: things like fillers, preservatives and binding agents.
For many, these differences won’t cause a problem. However, inactive ingredients, such as dyes, gluten or lactose, that might be in the generic version could make the drug harder for some people to tolerate, says pharmacist Thomas So, senior manager of Consumer Drug Information Group at First Databank, a health care information company.
Artificial sweeteners, like aspartame and sucralose, or sugar alcohols like sorbitol and xylitol, can also cause digestive side effects.
Flavorings and coatings can be different, too, which means you might like the flavor more or less, and a medication could be harder or easier to swallow or chew.
If you have a known allergy or intolerance, know this: Medications often list all their ingredients on the packaging. You can also search Daily Med for drug label information in larger fonts than you’ll see on small bottles.
Serious side effects from inactive ingredients are rare but possible even if you’ve never noticed a sensitivity before. If you believe you’re having a bad reaction to any drug, check in with your doctor or pharmacist.
Some generics are subject to stricter regulations
A few medications, such as anti-seizure drugs, warfarin and antiarrhythmics, have what’s termed a “narrow therapeutic index.” This means “there’s a very narrow range where they’re safe and effective in doing what they’re supposed to do,” Ghaffari says. Because of this, they’re subject to tighter regulations.
Doctors still routinely prescribe generics in these categories, but they need to monitor any patient switching from a brand to a generic or vice versa because even slight differences can matter.
Why you must continue reading labels
Even when the front of the box looks familiar, it’s important to double-check the ingredients, dosage and warnings.
Many drugs are available in different strengths, which can throw you off if you’re not sure how much active ingredient your usual branded product contains. For instance, acetaminophen (Tylenol) is available in 325-, 500-, and 650-milligram tablets and capsules, as well as chewables and liquids. If you’re accustomed to Extra Strength Tylenol caplets, you’d look for a generic that also contains 500 milligrams of the active ingredient.
Drug formulations also change, whether brand or generic. In recent years, So says, it’s been harder to manage over-the-counter products because manufacturers have changed the active ingredients in some known products.
“An example is Kaopectate, which is an old-time drug used to treat diarrhea,” So says. “It used to be kaolin [a clay mineral] and pectin [a fruit derivative], but now it’s actually the same ingredient that you find in Pepto-Bismol, with different warnings [from the previous version of Kaopectate].”
Getting a prescription filled? It’s most likely a generic
Nowadays, the vast majority — about 90 percent — of all prescription drugs filled are generics. Sometimes people don’t even realize they’re taking a generic because they’re aware of the chemical name rather than the brand name.
“Not everybody knows what the brand name of a drug necessarily is because they’re really relying on the doctor to tell them what medication they need,” So says.
Insurance companies often provide better coverage for generics (meaning that you might have a higher copay for a brand drug, or it might not be covered at all unless a doctor provides a compelling reason). All states have “generic substitution” laws that govern how a pharmacist may switch a generic for a brand-name prescription, with some states requiring substitutions unless the doctor writes “DAW 1” (meaning “dispense as written”) on the prescription, or the consumer objects. This is to cut costs and drive competition in the marketplace.
Vitamins and supplements are not the same
Ghaffari warns that vitamins and supplements are not regulated by the FDA in the same way as medications and are not reviewed for their safety and effectiveness. They’re considered part of the nutrition division of the FDA, not the medication division.
“That approval process is not as stringent as the medication arm, so you do have to be concerned about differences in product when it comes to natural supplements or herbal medications or vitamins,” Ghaffari says.
Studies have often shown that supplement manufacturers misrepresent what’s on their labels. The FDA maintains a Health Fraud Database with more than 2,000 entries detailing issues such as false health claims and undisclosed ingredients.
Check with your pharmacist or doctor
Here’s a reassuring bit of advice: Both Ghaffari and So emphasize that pharmacists are happy to talk to customers about not only prescription drugs but over-the-counter ones as well, including what to look for on generic labels.
“We want to make sure that we have a comprehensive profile of everything that you are taking, so we can help make the most important decisions and discussions with you and with your provider,” Ghaffari says. “Never hesitate to talk to your pharmacist.”
So agrees, saying, “Pharmacists live to actually give patient education to the patients. Even though they’re busy, they’re really happy to answer questions for patients to help them.”
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