FDA conducts major global operation to protect consumers from potentially dangerous prescription dru

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

These actions were part of a major global operation that the FDA participated in to target illegal drugs being marketed online, and shipped and distributed through the postal system, directly to American consumers. Among other actions, the FDA also issued warning letters to the operators of a majority of the illegal websites that were targeted in the operation and worked with internet registrars to confiscate certain websites. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.

"These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. 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," said FDA Commissioner Scott Gottlieb, M.D. "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. 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 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."

This effort was part of Operation Pangea X, as part of the 10th annual International Internet Week of Action (IIWA), a global cooperative effort led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit or substandard medical products on the internet. The IIWA ran from Sept. 12 to Sept. 19, 2017. The goal of Operation Pangea X was to identify the makers and distributors of illegal prescription drug products and to remove these products from the supply chain. Commissioner Gottlieb joined efforts to kick off the operation with a visit he made to the International Mail Facility (IMF) in New York on Aug. 25, 2017.

During Operation Pangea X, the FDA sent 13 warning letters to the operators of 401 websites. The FDA also seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com. FDA inspectors, in collaboration with other federal agencies, screened packages suspected of containing illegal drug products at IMFs in Chicago, Miami and New York during the IIWA. These screenings resulted in nearly 500 parcels being detained for appropriate FDA compliance follow up. Parcels found in violation of the Federal Food, Drug, and Cosmetic Act will be refused entry into the country.

"The FDA is proud to partner with our international counterparts on this important operation," Commissioner Gottlieb said. "However, our work to fight illegal online pharmacies is not over. In addition to the multifaceted work plan we will soon unveil, we’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations. These efforts are part of a much broader work plan that the FDA is developing aimed at beefing up our efforts to interdict illegal drugs."

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA's Office of Criminal Investigation.

The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The IIWA is a collaborative effort between the FDA, the U.S. Attorney’s Office for the District of Colorado, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the European Heads of Medicines Agencies Working Group of Enforcement Officers, the U.S. Drug Enforcement Administration, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.