Counterfeit Drugs Remain a Significant Challenge

Shabbir J. Imber Safdar, executive director, Partnership for Safe Medicines, talks about efforts to address counterfeit drugs in the U.S. supply chain.

The International Criminal Police Organization (INTERPOL) has seized $11 million in counterfeit drugs and tests in its most recent effort to combat fraudulent online sales. In one week in June 2022, the 94 INTERPOL member countries coordinated a crackdown on illicit online pharmacies in Operation Pangea XV, seizing more than 7,800 illicit and misbranded medicines and healthcare products.

Nearly half (48%) of the packages inspected by law enforcement during the operation were found to contain counterfeit medicines, and about 40% were counterfeit erectile dysfunction medicines. Law enforcement in Australia, Argentina, Malaysia and the United States also seized more than 317,000 unauthorized COVID-19 test kits. The U.S. seizures alone are estimated to be worth nearly $3 million.

“Operation Pangea is specifically about disrupting online markets for medical products,” Shabbir J. Imber Safdar, executive director, Partnership for Safe Medicines, said in an interview with Formulary Watch. “They see counterfeit antibiotics, antidepressants, diabetes medication, counterfeit COVID tests, medicines for epilepsy, metabolic disorders and weight loss.”

Additionally, law enforcement:

  • Investigated more than 4,000 web links, mainly from social media platforms and messaging apps
  • Shut down or removed more than 4,000 web links containing adverts for illicit products
  • Inspected nearly 3,000 packages and 280 postal hubs at airports, borders and mail distribution or cargo mail centers
  • Opened more than 600 new investigations and issued more than 200 search warrants.

“Patients go online and think that they are knowledgeable enough to judge what looks like a safe pharmacy, but they end up ordering substandard or completely falsified medication,” Safdar said. “There also are complex white-collar criminals who sneak things into the drug supply chain by forging track-and-trace documentation and end up selling it to unsuspecting pharmacists. Even a pharmacist who handles something every day may not be able tell the difference. If with holograms or special color-changing ink on the packaging, the counterfeiters will figure it out.”

This was the case with Gilead’s HIV medications Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) earlier this year. In January 2022, Gilead announced that 85,247 bottles of these counterfeit medications were found in 17 pharmacies in eight states. In this case, pharmaceutical distributors not authorized by the company to sell Gilead medicine were selling drugs to pharmacies. The company reported that all seized products included counterfeit supply chain documentation, and many had additional counterfeit elements such as patient leaflets and/or caps.

Related: Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed

Counterfeit medicines can have serious consequences. It is estimated that more than 300,000 children worldwide have died from counterfeit anti-malarial medicines and fake or substandard antimicrobials, according to a paper published in The American Journal of Tropical Medicine and Hygiene. In the United States, the highest deaths come from fake opioids made with fentanyl and other deadly ingredients, Safdar said.

Lab testing done by the Drug Enforcement Agency has found that four of every 10 pills contain a lethal dose of fentanyl, which is commonly found in counterfeit opioids. In 2021, the DEA seized 20 million fake pills laced with fentanyl. They have been found in all 50 states and the District of Columbia.

Educating consumers is important, Safdar said, but “clean up the environment these criminals are working in. The DRUGS Act would the FDA and DEA block off access to some of these fake online pharmacies that are intentionally operating outside the United States to be harder to prosecute. The FDA and DEA need the power to make it hard for them to operate online,” he said.

In January 2022, U.S. Representatives Bobby L. Rush (D-Ill.) and David B. McKinley, P.E. (R-W.Va.) introduced the bipartisan Domain Reform for Unlawful Drug Sellers (DRUGS) Act, legislation to ensure that social media platforms and websites are held accountable for failing to prevent the sale of dangerous, illegal drugs on their platforms. Companion legislation has been introduced by U.S. Senators Marco Rubio (R-Fla.) and Amy Klobuchar (D-Minn.) in the Senate.

The DRUGS Act is modeled on the FDA and National Telecommunications and Information Administration’s 2020 “trusted notifier pilot program.” The pilot resulted in the removal of nearly 30 domain names used to offer illegal opioids online. The DRUGS Act would build on that by requiring Internet registries to delete or suspend a website if they receive notice from trusted notifiers — including the FDA, the Department of Justice, the Department of Homeland Security, State Attorneys General, State Boards of Pharmacy —that the site is used to sell drugs illegally.