Clara di Tella, BSc, Pharm QA
Regulatory Affairs Specialist, Dicentra
The United States Food and Drug Administration along with regulatory agencies from 80 other countries have completed the International Internet Week of Action (IIWA) supported by INTERPOL. This year’s IIWA, was called OPERATION PANGEA IV and ran from September 20 to 27. The operation was the largest Internet-based action of its kind in support of the International Medical Products Anti-Counterfeiting Taskforce. It focused on websites supplying illegal and dangerous medicines. The goal of this project was to disrupt the criminal networks and activities related to online selling of counterfeit medicinal products, and to also increase public awareness of potential safety issues and risks of purchasing medicines online. The week resulted in websites being shut down, dozens of arrests and the worldwide seizure of products worth 6.3 million USD.
During the International Week of Action, the FDA focused on websites selling unapproved drugs such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. These unapproved drugs can be detrimental to public health. The drugs for sale on the sites were available without a prescription and not approved by the FDA.
Warning letters were sent to the website operators and notices were sent informing that the websites were in violation of United States Law. Of the 717 websites addressed in the Warning Letters, a total of 578 have been suspended or no longer offer pharmaceuticals for sale. The FDA is continuing to work with their international counterparts to address the remaining websites selling these drug products.
For further information on scientific and regulatory affairs please contact our experts at Dicentra.
Dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com