FDA data highlights continuing threat from fake meds; study

An analysis of FDA enforcement operations reveals that US consumers remain exposed to counterfeit medicines despite dozens of actions against people and organisations involved in the illicit trade.

The study by Michael White of the University of Connecticut School of Pharmacy shows there were 130 unique enforcement actions involving falsified medicinal products, two thirds of which involved drugs sold via the Internet.

In most cases (85%), counterfeit medications could be obtained without a prescription, and in a third the drugs were being sold as dietary supplements, according to the results, which were harvested from the FDA Office of Criminal Investigation database.

The operations uncovered tens of millions of pills and more than a metric tonne of bulk active ingredients that have a estimated value of hundreds of millions of dollars, according to an article on the findings published by theconversation.com.

Sexual dysfunction, opioid, stimulant, muscle building, benzodiazepine, and dermatologic drugs were most counterfeited, according to the Annals of Pharmacotherapy paper, and China was the most common source country followed by India, Turkey, Pakistan, and Russia.

"This is the first report assessing enforcement actions against drug counterfeiters from the FDA Office of Criminal Investigation," writes White.

"The FDA is actively involved in identifying and prosecuting counterfeit drug rings, but the number of enforcement actions is smaller than the size of the problem."

While the US is implementing a national electronic track-and-trace system that allows a specific medication to be followed from the manufacturer to the pharmacy and makes the legitimate supply chain secure, there is still a clear threat from non-licensed sources.

A Kaiser Family Foundation survey in 2016 found that 19m people in the US obtained prescription medications that are likely fake through non-US licensed internet pharmacies or while traveling abroad.

"People buying controlled substances over the Internet are usually trying to circumvent physician control over the medication or the quantities they can receive, says White in theconversation.com piece.

"However, most people accessing noncontrolled substance counterfeit medications are simply trying to buy them at an affordable price. These trends make clear that the US needs a long-term strategy to lower the cost of prescription medications to diminish demand for counterfeit medications."