Are your cabinets stocked with name-brand or generic drugs? Here are five common myths about generic drugs dispelled with facts from the FDA.
If your medicine cabinet is full of generic drugs, it’s likely because you’ve noticed that they tend to be the less expensive choice compared to name-brand versions. Don’t forget that the brand usually has an “exclusive right” to manufacture and sell the drug for a specific period of time, under the U.S. patent system. However, once the patent period has expired, generic drug makers may enter the market and sell the same drug. This patent system seeks to reward innovation by giving the brand-name inventor/producer an exclusive period of time to recover its initial investment in researching and developing the drug, while balancing the needs of the public for reasonably-priced drugs.
Generic drug makers bring price competition to the drug market, but some patients prefer brand-name drugs to generics. Let’s look at five myths connected to generics, and then compare those myths with the facts offered by the U.S. Food and Drug Administration, which regulates the nation’s drug industry.
Myth #1: The active ingredients in generics are different from brand-name drugs, and generics go through a less stringent FDA approval process.
Fact: According to the FDA, “[G]eneric drugs are required to have the same active ingredient, strength, dosage form and route of administration as the brand-name product,” and the FDA approval process doesn’t change depending on whether the drug in question is a generic or a brand-name drug.
Myth #2: Generics somehow work differently in the human body as brand-name drugs.
Fact: The FDA requires the generic to prove “bioequivalency” with the brand-name drug, meaning it works on the body in the same way. For example, the generic producer must be able to prove, using a blood test, that the amount of the drug in a patient’s bloodstream is the same as the branded drug. “If the levels of the drug in the bloodstream are the same as the levels found when the brand-name product is used,” notes the FDA, “the generic drug will work the same.”
In fact, a study published in the Journal of the American Medical Association, called “Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis,” compared generic and brand-name drugs used against cardiovascular disease, finding zero evidence “that brand-name heart drugs worked any better than generic heart drugs,” notes the FDA website.
Myth #3: The standards for quality in the manufacturing of brand-name drugs are somehow higher than quality standards for the production of generics.
Fact: All generic drug producers are required to follow the same quality standards for making, testing and packaging their drugs as the brand-name drug manufacturers. In fact, many generic drugs are produced in exactly the same factory, following the same standards, as branded drugs.
Myth #4: The differences in price between the generic and brand-name drugs are slight, so you might as well play it safe and buy the brand name.
Fact: As shown above, the active ingredients are the same, and the standards for production quality are the same. What’s the major difference? The FDA notes that the generic drug price averages 80 to 85 percent less than the brand-name price.
Myth #5: Generic drug makers can sell at a vastly lower price because their quality is less.
Fact: The reason generic producers can sell at a lower price is simple: They don’t need to recover any initial investment in research and development, or expensive clinical trials, nor do they launch multimillion-dollar television commercials and marketing campaigns, as the branded drug producers typically do. The generic producers can pass these cost savings on to patients.
Generic drugs save the U.S. economy billions of dollars per week, according to the FDA. As the cost of healthcare continues to soar above the rate of inflation, generics are a rare source of healthcare savings. As the above list shows, there’s no difference in the effectiveness or quality manufacturing standards between generics and brand-name drugs. Indeed, they are both often produced in the exact same production plant under exactly the same conditions. While you may not feel any difference in your body, you can certainly feel it in your pocket.