Today FDA announced a targeted operation that has prevented nearly 500 shipments of illegal, unapproved drugs and combination medical devices from entering the U.S. market. Operation Broadsword, a bilateral enforcement operation between the FDA and the Government of India, examined more than 800 shipments of drugs and medical devices that entered the United States through an International Mail Facility (IMF) between January 28 and January 30. According to the FDA, many of the shipments were transshipped via third-party countries to hide the point of origin and evade detection.
“With standards and regulations varying in each country, U.S. consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international mail system. Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain.” – FDA Commissioner Stephen M. Hahn, M.D.
The agency states that nine IMFs across the United States receive mail from more than 180 countries on a daily basis. “…It is part of the FDA’s mission to inspect, detect and intercept illegal products, including those that are unapproved, counterfeit and/or potentially dangerous, such as illicit opioid products, counterfeit prescription drugs, medical devices, over-the-counter products, and products labeled as dietary supplements that may contain harmful ingredients,” the agency stated in a press release.