Written by Kiersten Roth and Rachel James, Ohio State University College of Pharmacy Students, Class of 2018
Many parents are hesitant when their doctor offers a generic medication for their children, rather than the brand-name version. They may be concerned that it is not the same medication and won’t have the same effect. They might also think the dramatic difference in price is an indication of decreased quality. Some parents also fear that certain side effects are associated with the generic drug but not the brand-name medication.
In reality, generic drugs are required to be just as safe and effective as the name-brand product. All medications have two main components: an active ingredient and inactive ingredients. The active ingredient provides the therapeutic benefit, while inactive ingredients are added for various reasons, including look and flavor.
In order for a generic medication to be approved by the Food and Drug Administration, it must meet specific criteria. First, it must have the same active ingredient as the brand-name version. The generic medicine must also be taken the same way and have the same strength and dosage as the brand-name product. That means generic medications deliver the same amount of drug as the brand-name version. The only difference is in the inactive ingredients.
In rare cases, inactive ingredients can cause reactions in patients switching from one manufacturer of a drug to another. These unlikely events can occur whether the patient is switching between the brand and a generic or between different generic manufacturers. However, in a vast majority of cases, the patient cannot tell the difference.
With so many similarities, why are generic medications often 80-85% cheaper than the brand-name product? The difference can be concerning to parents who believe “you get what you pay for.”
In order for a new medication to make it to the market, it has to go through a long and costly process. The manufacturer must develop the drug and put it through multiple phases of clinical trials. If the drug is found to be safe and effective, the manufacturer submits an application to the FDA for it to be approved and put on the market. This process can last upwards of 20 years and costs hundreds of millions of dollars.
When a medication first reaches the market, it is protected under a patent and can only be sold by the original manufacturer under the brand name. Once the patent expires, the “recipe” for the drug becomes available for other manufacturers to use so that they can develop a generic equivalent. Since they are not starting from scratch or testing in clinical trials, production costs for generic medications are significantly less. Generic manufacturers also spend little to no money on advertising, since many people and insurance plans will automatically switch to a generic because of the price difference. Overall, a cheaper process for the manufacturer translates into savings for the patient.
Parents should understand that generic drugs are not of lesser quality, and are overall beneficial to both patients and the entire healthcare system. They provide cost savings and more access to medication for patients and their insurance companies. Ultimately, the availability of generics is an indication of a safe and successful drug.
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