FDA Targets Over 500 Online Pharmacies to Curb Distribution of Counterfeit Drugs

Unregulated online pharmacies represent a major threat to public health as many have been found to be selling expired or counterfeit drugs, often without a prescription. In response to this growing threat, the US Food and Drug Administration (FDA) recently targeted 500 websites that sold medications, such as opioids and injectables, to patients in the US.

The actions were part of a program called Operation Pangea X, whose mission is to curb the sale of illegals medications online. Led by Interpol, the efforts included the FDA along with other regulatory and law enforcement bodies from 115 countries around the world.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances,” said FDA Commissioner Dr. Scott Gottlieb, in a news release about the operation. “Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety.”

According to a 2016 poll conducted by the Kaiser Family Foundation, eight percent of respondents admitted that they, or someone in their household, had imported drugs in the past. As many online pharmacies claim to be located in countries like Canada where pharmaceuticals are often much less expensive, consumers who purchase products from these sites are essentially importing those medications into the US.

Operation Pangea X also ties in nicely with the FDA’s efforts to curb the opioid epidemic as many of the online pharmacies targeted were selling illegal opioid products. According to the FDA, this ease of access to narcotic drugs is contributing to opioid abuse in the US, where nearly 150 individuals die each day as a result of an overdose.

“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country,” said Gottlieb. “Some of the websites sold unapproved versions of multiple prescription opioids directly to US consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”

In all, the FDA send warning letters to the operators behind 401 websites hosting online pharmacies. Their operation also included the seizure of almost 100 domain names in an effort to shut down the unauthorized drug sellers.

In collaboration with other federal agencies, the FDA increased screening of suspect packages at several major international mail facilities (IMFs) in New York, Chicago and Miami. This effort identified nearly 500 packages which were detained for further inspection by the regulator.

Despite the success of the operation, the FDA Commissioner is adamant that much more must be done in order to prevent potentially harmful drugs from reaching the hands of unsuspecting consumers.

“Our work to fight illegal online pharmacies is not over,” said Gottlieb. “As part of a broader effort to target this illegal activity, in addition to the operation that we are announcing today, the FDA is also working on a comprehensive Enforcement Operations Work Plan that’s focused on combating the sale of foreign unapproved drugs to U.S. consumers and aimed at increasing the scope of our operations related to these risks.”