Generics: Balancing Quality and Cost

Generic medicine may have a low cost but that does not always mean low quality

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Cheap cost may often equal cheap quality. But in the case of generic medicines, cheap cost may not mean anything at all about quality.

The US Food and Drug Administration (FDA) said that generics are just as good as brand name medicines.

The FDA monitors both generic and brand name medicines to make sure that they are safe and effective. The agency said that the lower cost of generics is largely due to the fact that generic manufacturers don’t spend as much developing and marketing their drugs as brand name makers.

So, the FDA concluded that people shouldn’t shy away from generics just because they are so much cheaper than the brand name versions.

"Ask your pharmacist if generics are right for you."

Brand name versions of a prescription can cost hundreds of dollars a month. Generic versions of those same medicines are usually much cheaper – often less than $20 a month.

The FDA says that this price difference seems to help drive people’s choices at the pharmacy. So they wanted to set the record straight.

First, the FDA requires that makers of generic versions seek approval from the FDA before they can sell to patients. In the FDA comment, Lawrence Yu, PhD, from the Office of Generic Drugs, provided a summary of the process.

Dr. Yu said that a generic medicine must have the same active ingredient and must function in the same way as the brand name version.

To gain approval, a generic drug must also come in the same form as the original. If the original was a pill, then the generic must be as well. The doses of the generic must also match those of the brand name medication.

The FDA looks at studies of the generic to see that it works just as well and is just as safe as the original, brand name version.

Second, the FDA monitors generics after they are approved. So, if a generic medicine is linked to problems with quality, safety or effectiveness, the FDA looks into it. Just like brand name drugs, if a generic is shown to have a problem, the FDA removes it from the market or issues additional safety warnings.

The FDA said that generics are, in most cases, just as good as the brand name versions.

The agency explained that the cost difference between generics and brand names occurs because makers of generic drugs do not have to spend money developing the drug from scratch. Also, generic manufacturers don’t usually advertise. Together, this means generic manufacturers can pass along the savings to the consumer because they can still make a profit even with the lower sales price.

The FDA story was published February 21.

Reviewed by: 
Review Date: 
February 25, 2013
Last Updated:
August 15, 2013