'Growing trend' of prescribers buying from 'rogue distributors,' says FDA executive

There is a growing trend of health care professionals and medical practice administrators buying prescription drugs from outside of the legitimate supply chain, according to Ilisa Bernstein, deputy director of the US Food and Drug Administration’s Center for Drug Evaluation and Research’s Office of Compliance, in a posting on the FDA website.

These drugs, acquired from “rogue” distributors, could be counterfeit, adulterated or unevaluated by the FDA for safety and efficacy. There is no way of knowing if the drugs were made using good manufacturing practices or contain harmful ingredients. The status of how they were stored is also unknown. Such distributors target doctors with aggressive marketing tactics, and offer medications at extremely discounted rates, but there are steps that buyers can take to ensure the drugs they purchase for their patients are safe, effective and meet US quality standards.

Buyers must, firstly, ensure they are receiving FDA-approved prescription drugs, purchased only from state-licensed distributors. Subsequent safety checks include making sure the packaging or product does not differ in any way from the FDA-approved packaging and product, and that the label is printed in English. At the end of the purchase and prescribing process, patient feedback can give a good indication as to whether there is a problem with a product, such as unexpected side-effects or lack of effect.