(From Nick Palladino, TODAY Associate Producer)
In response to a July 25th TODAY segment and live discussion on the topic of brand name vs. generic drugs, WATCH VIDEO the Generic Pharmaceutical Association, a trade organization that represents the manufacturers and distributors of finished generic pharmaceutical products, provided TODAY with a list of points that they would like consumers to know about generic drugs:
- By federal law, generic medicines must contain the identical amount of active ingredient as the brand.
- Federal law also requires a generic to be identical to the brand in terms of dosage form, route of administration and strength. For example, if the brand product is a 12-hour extended release product, then the equivalent generic product must also be an identical 12-hour extended release product, which is supported by medical and scientific data.
- Generics pharmaceuticals must be absorbed, metabolized, and eliminated at the same rate and extent as the brand. In other words, they must perform in a person’s body in the same way, for the same amount of time, as the brand name drug, yielding the same safety and efficacy profile as the brand.
- The Food and Drug Administration (FDA) has repeatedly and officially stated that generic, or therapeutically equivalent, drugs can be substituted with the full expectation by the patient and the doctor that they will have the same clinical effect and safety profile as the innovator drug.
- Narrow Therapeutic Index drugs are drugs that must be closely monitored by a physician because too much or too little medicine could produce serious adverse health conditions; this is true regardless of whether the product is brand or generic.
- Studies have shown that when consumers with chronic conditions use generics, they are more likely to continue with their treatments because the medicines are more affordable.
- All generics must undergo a rigorous approval process by FDA and meet the same high standards for quality, purity and safety as the brands.