Generic Drugs: Everything You Need to Know About It

Generic Drugs

With the cost of prescription drugs skyrocketing today, generic drugs provide a much cheaper equivalent for consumers. Yet many people do not understand how generic drugs differ from brand-name medication, or how to talk about generics with their doctor and pharmacist.

In the United States, 9 out of 10 prescriptions (88 percent of all prescriptions) are filled annually for generic drugs, according to the U.S. Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD).

According to the FDA, a generic drug is a medication created to be the same as an existing, approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. Generic drugs are copies of brand medication that must meet the same FDA requirements as the brand.

“Brand medications are produced by manufacturers who conduct extensive research to identify and develop new drugs,” says Craig K. Svensson, PharmD, PhD, dean emeritus and professor of medicinal chemistry and molecular pharmacology at Purdue University College of Pharmacy in West Lafayette, Indiana.

“It is estimated that it costs around $2 billion to bring a new drug to the market,” says Dr. Svensson. “To stimulate investment in this type of innovation, patent laws allow a period of exclusivity on the market.”

“After expiration of the patent,” he explains, “generic drug manufacturers can seek to have their product approved [by the FDA] for sale.”

So why are generics cheaper than brand-name counterparts? “Since generic companies do not invest in research and development, they can make these drugs at a much lower cost — which means generics cost consumers less money,” Svensson says.

Can Generic Drugs be Trusted?

Patients accustomed to brand-name medication may at first be skeptical about the effectiveness and safety of generic options.

“While one can find many anecdotal claims of generic drugs not being as effective as brand name drugs, evidence to support these claims is lacking,” says Elan Rubinstein, PharmD, MPH, principal at pharmaceutical consultancy EB Rubinstein Associates in Oak Park, California.

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When filling prescriptions, pharmacists can substitute a less expensive generic unless the prescribing doctor specifies that a brand name must be dispensed.

According to Dr. Rubinstein, pharmacy law in some states requires that pharmacists dispense an equivalent generic when a branded drug is prescribed. However, the prescribing doctor can specify “do not substitute,” meaning that a brand name must be dispensed.

“While a pharmacist isn’t going to ignore ‘do not substitute’ on a prescription, in the absence of a valid reason, the third party [insurer] is likely to require the patient to pay a higher cost share for that branded prescription than they would have paid for the generic,” says Rubinstein.

Do Generics Always Work Like the Brand Name?

“It’s not uncommon for folks to think generic drugs work differently,” says Peter J. Rice, PharmD, PhD, professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus in Aurora.

“Interchangeable brand and generic products contain the same active ingredient in the same amount,” he adds. “In theory, they are equal in quality and entirely interchangeable.”

However, Dr. Rice notes that patients may have a different response to a generic, saying “I think it’s more difficult to control how rapidly the drug is released with generic medications.”

Considering Generics? Do Your Own Due Diligence

To protect yourself with any prescribed medication when considering generics, Rice suggests the following:

Check the generic formulation in the FDA Orange Book (Approved Drug Products With Therapeutic Equivalence Evaluations). You can search the Orange Book’s prescription or over-the-counter (OTC) section using the brand name to determine its ingredients. Then use the Ingredient Search for all approved medicines that contain these ingredients. “Theoretically, pharmacies substitute only products that are approved for substitution with the prescriber’s and patient’s permission,” says Rice. “Most patients do not realize that with a valid prescription they can always receive the brand name product if they are willing to pay for it.”

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Let your doctor or pharmacist know if you notice any changes or symptoms when switching to a generic drug. Feeling light-headed or dizzy? Nauseated? Call your doctor or pharmacist. “The FDA allows some difference between the brand and generic product — let’s say 10 percent [though this differs depending on the drug],” Rice says. “A patient moves from the brand to a generic which might be 10 percent lower in effect; not much of a problem with a 10 percent change. But if the patient now switches to a generic with 10 percent greater effect than the brand drug, the effect is 20 percent different than the previous generic, often [causing] a noticeable change.”

Ask your pharmacist about the rate of absorption of the drug. “Differences in the rate of absorption can affect the response a patient has to a drug,” says Rice. “For example, if a drug enters faster, side effects are more likely, and the drug effects may not last as long.”

Check the inactive ingredients in a generic drug. If you are sensitive to an ingredient, then you could have a bad experience with whichever formulations contain it, either brand or generic. “We rarely see lactose used as a filler anymore, but imagine if a patient were lactose intolerant. They could take whichever formulations did not have lactose in them,” Rice says. “We find patients who are sensitive to certain dyes or to gluten [contained in some generics].”

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Read the label of over-the-counter generic drugs. Some generic products, like stomach, arthritis, and headache medicines, are easily confused. Rice recommends that all consumers read the label to make sure that nonprescription generic products contain the same amount of active ingredients.

Make sure you are getting the lowest prices on your medicine — generic or brand name. Brand name prices can be up to 10 times the price of a generic. Always ask your pharmacist if it would be cheaper to purchase your medicine without using your insurance or using an in-store discount or coupon. Rice says insurance plans are sometimes driven by “rebates” that require the pharmacy to use a more expensive drug because the insurance company will later receive money back from the drug manufacturer.

According to the Federal Trade Commission (FTC), some drug companies have used a tactic known as “pay-for-delay,” in which generic companies are paid to keep their lower-cost alternative drugs off the market. The FTC estimates that these anti-competitive deals cost consumers and taxpayers $3.5 billion in higher drug costs every year. The agency has filed several lawsuits and is seeking legislation to stop pay-for-delay deals.

The bottom line: Talk to your physician or pharmacist about generic equivalents of any brand-name drugs that you’re taking. If you do make the switch, let them know if you notice any changes or side effects.

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