FDA-OCI Increasing Efforts To Keep Counterfeit Drugs From Getting Into The Country

The U.S. Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI) held a meeting in Kansas City, Missouri on November 14, 2017. Commissioner Scott Gottlieb, M.D. focused most of his comments on the opioid crisis, describing what the FDA-OCI has done to date, and how they will continue to work to keep dangerous counterfeit and illicit opioids from getting into the country.

Gottlieb stated that 340 million packages reach the U.S. every year, making the efficient and effective searching of packages a high priority. An Enforcement Operations Work Plan was created to focus on preventing the import of unapproved drugs through the International Mail Facilities (IMFs). FDA-OCI almost tripled the staff working at IMFs for eight to 22 and will double the number of ports of entry special agents from six to 12. FDA-OCI’s Cybercrime Investigations Unit, Strategic Intelligence Unit, and Intelligence Analysis Branch will almost double in staff from 11 to 21 employees. Additional laboratory analysts, as well as new equipment both in the FDA’s Forensic Chemistry Center and at IMFs will help investigators more quickly identify what is in seized packages.

Gottlieb touched on several recent cases including the indictment of six people who allegedly produced fake prescription drugs using fentanyl. The group stands accused of selling their counterfeit drugs illegally online to people around the country. He told the agents that disrupting these sorts of organizations and bringing the individuals behind them to justice is one of the FDA-OCI’s highest priorities.