The FDA’s Office of Criminal Investigations staged 130 counterfeit drug busting operations between 2016 and 2021, according to a new report published in the journal Annals of Pharmacotherapy. But one expert says all of those operations "barely scratch the surface" of the problem and that serious safety risks remain.
The agency's efforts involved arrests, product confiscations or the breakup of counterfeiting rings themselves, C. Michael White, the study’s author, wrote in an accompanying article for nonprofit media network The Conversation.
All told, about 65% of the FDA’s enforcement actions centered on phony products sold over the internet. In about 85% of the FDA’s operations, patients could obtain the counterfeit drugs—often controlled substances like opioids, stimulants and benzodiazepines—without a prescription, White said.
Counterfeiters most frequently forged knockoffs of painkillers, ADHD meds, drugs for anxiety and sleep, erectile dysfunction meds and more, he added.
China was the country most frequently supplying pharmaceutical forgeries to U.S. consumers, followed by India, Turkey, Pakistan and Russia, the study author continued.
The sham drugmaking operations were elaborate, too, involving tens of millions of pills and hundreds of millions of dollars in sales, White said.
With more than 11,000 rogue pharmacy sites peddling drugs on the internet, according to White, the FDA’s 130 counterfeiting counteroffenses “barely scratch the surface.”
Further, the FDA rarely touched on the safety implications of these counterfeit meds in its public enforcement announcements, White pointed out.
For controlled substances such as opioids and stimulants, which already pose overdose and addiction risks when they contain the proper ingredients, counterfeiters often substitute the intended active ingredient with dangerous alternatives such as fentanyl, White said.
The U.S. Drug Enforcement Administration (DEA) in September said the number of fentanyl-tainted counterfeit pills it had seized jumped nearly 430% from 2019. Further, DEA testing showed two out of five pills with fentanyl harbored a potentially lethal dose. Also of concern, “methamphetamine is increasingly being pressed into counterfeit pills,” DEA said in a release late last fall.
Beyond the potential for counterfeit drugs to contain dangerous and undeclared ingredients, bootleg medicines may not live up to the same quality standard as authentic drugs. The finished products of falsified drugs may not have the correct amount of active ingredient or may contain impurities.
Aside from the FDA and DEA, branded drugmakers themselves have taken steps to strike back at counterfeit drugs.
Back in August, Gilead Sciences put out a warning that its HIV meds Biktarvy and Descovy had been supplanted by counterfeits at some pharmacies. Unauthorized distributors had managed to sell fake drugs to retailers, after which “genuine Gilead bottles” were loaded up with fake tablets, the company said at the time.
Gilead flagged the issue to potentially affected pharmacies and said it was working with the FDA, pharmacies and legal authorities to rout the bootleg meds from circulation.
The company also filed a lawsuit against a small network of drug distributors in July, claiming they put patients at risk by peddling more than $250 million in counterfeit versions of Biktarvy and Descovy.
In April, Johnson & Johnson followed suit, literally, taking aim at distributors and pharmacies that were also reportedly dispensing counterfeit HIV medications. The U.S. government has been looking into the counterfeiting situation since late 2021, The Wall Street Journal reported earlier this year.