Are generic drugs safe?
A generic drug is a version of a brand name drug that has gone off patent, so it’s no longer legally protected, or if the generic company has successfully challenged the brand name in court and the FDA gives them permission to make a generic. It isn’t identical, but the central molecule which has already been tested for safety and efficacy is present. Additionally, the generic company must show the FDA that their testing has the same bio equivalency as that of the brand name drug with a small allowable variance from the original molecule. What the generic doesn’t have to show is whether their processes to reverse engineer and replicate the central molecule results in carcinogenic chemicals or other impurities that can show up in the final product.
Katherine Eban is a noted investigative reporter who has been researching the generic pharmaceutical industry since 2008. Repeated reports of the failure of generics to work as well as brand name drugs led her to write Bottle of Lies, which details some of the historical changes in the generic drug industry for the past 35 years and how a lack of oversight of generic drug companies mainly outside the U.S. are threatening our health.