FDA Targets 465 Websites that Illegally Sell Prescription Drugs
What You Need to Know About This Latest FDA Regulatory Action … and Immediate Steps to Take if You’ve Been Issued a Warning Letter
The U.S. Food and Drug Administration (FDA) has sent warning letters to “seven different online networks that were operating a total of 465 websites offering misbranded and unapproved drugs to U.S. Customers.” Those warning letters can be viewed here. FDA’s actions were part of “Operation Pangea XI,” the eleventh annual International Internet Week of Action (IIWA). Operation Pangea is an international week of action coordinated by INTERPOL targeting the online sale of counterfeit and illicit medications.[i] In the FDA Press Release, Commissioner Scott Gottlieb, M.D. stated, “The illegal online pharmacies that we’re taking action against are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including potentially counterfeit medicines and controlled substances both on the surface and dark web.” Operation Pangea XI resulted in several criminal investigations initiated by the FDA’s Office of Criminal Investigations (OCI). Due to the complexity of these online operations, OCI focused its efforts on credit card processors involved in “transaction laundering” or “factoring.”[ii] Through these methods, the business operations would process payments for the illegal online drug networks through shell companies, such as clothing stores or florists, in an effort to hide the conspiracy.[iii]
The Opioid Epidemic has been a major concern for the FDA overall the past few years. “I’m particularly concerned about the ease with which consumers can gain access to controlled substances and prescription opioids online. This is one reason why we’ve stepped up our efforts, both from a policy and enforcement standpoint, to take these bad actors down,” said Commissioner Gottlieb.[iv] OCI’s efforts recently lead to the arrest and indictment of “The Drug Llama,” a San Diego resident who allegedly shipped over 50,000 tablets containing fentanyl throughout the U.S. utilizing the dark web as well as other means.[v] According to the National Institute on Drug Abuse, Fentanyl is 50 to 100 times more potent than morphine.[vi] Due to its extreme potency, Fentanyl greatly increases the risk of overdose, especially when the user is unaware that the drug they are ingesting has been laced with Fentanyl.[vii] The Center for Disease Control estimates that in 2017 72,287 people died from overdoses, with Fentanyl being responsible for killing over 29,000 of those individuals.[viii]
In addition to focusing on the credit card processors, screening sessions were conducted at Chicago’s O’Hare International Airport, New York’s John F. Kennedy International Airport and in San Francisco.[ix] During these screening sessions, FDA investigators examined 626 packages and refused entry to 794 products. “Sixty-two products were identified as being purchased from internet sites operating in the United Kingdom, Canada and India.”[x]
If you’ve received a warning letter relating to Operation Pangea XI or any other alleged FDA violation or potential criminal matter, the choices you make moving forward are crucial. Be sure you have competent legal representation immediately. Our firm is extremely well versed in handling complex matters involving regulatory agencies, including the FDA. Rick Collins, a founding partner of Collins Gann McCloskey & Barry PLLC, has successfully defended clients in a variety of matters involving counterfeit or misbranded prescription medicines across the country. If you’ve received a warning letter or are under criminal investigation for any alleged wrongdoing, you or your lawyer should feel free to call us for help. The firm of Collins Gann McCloskey & Barry PLLC is available at 516-294-0300. CGMB can be reached 24 hours, 7 days a week for emergencies.