FDA takes aim at online pharmacies

SILVER SPRING, Md. — Working with international law enforcement agencies and regulators, the Food and Drug Administration recently acted against some 500 websites selling illegal and unapproved versions of such prescription drugs as opioids, epinephrine injections and antibiotics directly to American patients.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances,” FDA commissioner Dr. Scott Gottlieb said. “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.”

The actions —including warning letters to the operators of targeted sites and the confiscation of certain websites in partnership with internet registrars — were part of Operation Pangea X, led by Interpol as part of the 10th International Internet Week of Action, which seeks to combat the illegal online sale and distribution of possibly counterfeit or substandard medical products.

“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,” Gottlieb said. “Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”

As part of the agency’s broader effort to fight illegal online pharmacies, Gottlieb said the FDA is developing a comprehensive Enforcement Operations Work Plan aimed at combating foreign unapproved drugs being sold to U.S. consumers and increasing the scope of the agency’s operations related to these operations.