Many people naturally have concerns regarding generic drugs. Are they safe? Are they efficacious? How do they differ from brand name drugs?
The Food and Drug Administration (FDA) does have an evaluation process for the approval of generic drugs. For products to be considered pharmaceutical equivalents, they must contain the same active ingredient, in the same dosage form and strength, and be given by the same route of administration. Generic products must have studies showing that they have a comparable rate and extent of absorption, therefore being bioequivalent. FDA sets acceptable ranges for these values. The FDA continues to monitor this standard and has stated that there is no new information that would compel them to readdress this issue for generics. They also cite a study in which it was found that most generics have only a mean difference in bioavailability of 3.5% compared to the brand name drug. Additionally, generic manufacturing facilities must pass the same rigorous inspection standards as brand manufacturers to ensure quality and purity.
Products that are pharmaceutically equivalent and bioequivalent are considered therapeutically equivalent by the FDA and can be substituted at the point of dispensing. However, there may be differences in appearance and inactive ingredients between generics and brands. Rarely, an individual may experience an allergy or intolerance to a dye or inactive ingredient. For most patients, generic and brand drugs should perform the same way in the body.
According to the FDA website, about 90% of all prescriptions in the United States are filled with approved generics. Generic drugs can be promoted with confidence that they are safe and efficacious. They are less expensive and can help keep healthcare more affordable for all. Patients should always discuss any medication concerns with their physician or other healthcare professional, but asking whether a generic is available for a certain condition is a good place to start.
United States Food and Drug Administration. Office of Generic Drugs. Available at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-generic-drugs. Accessed on November 3, 2020.