FDA Regulatory Update: International Crack Down on Online Pharmacies Identifies Over 1,900 Websites Selling Unapproved or Potentially Counterfeit Drugs to U.S. Consumers
By participating in the organized, global action known as Operation Pangea VII, the U.S. Food and Drug Administration (“FDA”) made good on its promise to continue working with the international community to investigate online pharmacies that sell potentially unapproved, counterfeit, or adulterated drugs and medical devices. (To read the full text of FDA’s press release, please click here.) Between May 13 and May 20, 2014, the FDA partnered with the U.S. Customs and Border Protection (“CBP”), the U.S. Department of Homeland Security, INTERPOL and over 111 law enforcement, customs, and regulatory authorities around the world in targeting websites that sell potentially dangerous, unapproved prescription drugs to consumers. (For additional media coverage of Operation Pangea VII, please click here, here, and here.) This world-wide collaborative effort brought together even more countries than in previous years and required participating countries to carry out “extensive examinations at U.S.-based international mail facilities.” (To read INTERPOL’s summary of Operation Pangea VII, please click here and here.)
Operation Pangea VII resulted in the detention or seizure of 19,618 packages containing over 9.4 million unapproved or suspected counterfeit drugs, including insulin, estrogen, bimatroprost, tramadol, and sildenafil citrate. A large number of these packages claimed to contain medicines from Australia, the United Kingdom, New Zealand, and Canada. Upon further investigation, however, many of those packages were found to contain unapproved or suspected counterfeit drugs from other countries, such as India, China, Singapore, Taiwan, Mexico, Laos, and Malaysia. The total value of these seized and detained products amounted to approximately $36 million.
Based on these findings, regulators and customs authorities across the globe ordered more than 10,000 websites to shut down their operations and remove over 19,000 advertisements for these medicines on social media. Through these efforts, the FDA identified over 1,975 websites as selling products in violation of U.S. law and notified related internet service providers and domain name registrars of the websites’ allegedly violative practices.
Together, the participating countries launched roughly 1,235 investigations and made 239 arrests in connection with online operations for the sale of potentially dangerous or unapproved prescription drugs. Furthermore, INTERPOL’s report explained that Operation Pangea VII “identifi[ed] and dismantle[d] three illicit laboratories in Colombia” and “targeted the main areas exploited by organized crime in the illegal online medicine trade: rogue doman name registrars, electronic payment system and delivery services.” (To read the full text of INTERPOL’s announcement, please click here.)
As we previously reported here, after 2012’s Operation Pangea V, which targeted over 4,100 internet pharmacies and required 18,000 pharmacy websites to shut down their operations, the FDA launched a new website, BeSafeRx: Know Your Online Pharmacy, to provide consumers with information about the dangers of purchasing medicine from online pharmacies. Last year, the FDA participated in Operation Pangea VI, which resulted in the shutdown of over 9,600 websites and seizure of more than $41 million worth of illegal medicines worldwide. (To read the FDA’s announcement regarding Operation Pangea VI, please click here.) The FDA’s continued participation in Operation Pangea sends a strong signal to industry that the FDA does not plan to back down anytime soon. Rather, it seems clear that the FDA intends to closely monitor online pharmacies and will continue to actively enforce drug and medical device regulations.
Fuerst Ittleman David & Joseph, PL will continue to monitor the regulation of online pharmaceutical drug companies. The attorneys in the Food, Drug, and Life Sciences practice group are well-versed in the complex regulatory framework for prescription drugs and medical devices. If you have any questions or would like more information, please email us at email@example.com or call us at (305) 350-5690.