A 2017 raid by U.S. Food and Drug Administration investigators in Hermitage, Pennsylvania has resulted in charges against Emil Koledin. The April 30th charges allege that he ran a fake online pharmacy that sold unapproved prescription drugs imported from Russia and China to U.S. residents, the Sharon Herald reports.
According to the bill of information that was filed by the U.S. Attorney for the Western District of Pennsylvania, Koledin ran a website called awakebrain dot com that marketed and sold misbranded and unapproved medication imported from Russia and China. It describes several instances when either the website or emails from Koledin described medications as FDA-approved, when in fact they were not. It also quotes emails that Koledin sent to customers that offered explicit prescriptive benefits that his misbranded medication offered for ailments such as ADHD, compulsive behavior, depression, and anxiety, among others. Other emails quoted in the bill of information illuminated Koledin’s efforts to dodge inspection, bypass FDA discovery, and expedite delivery of bulk medication from Russia and China, in some cases routing the drugs through Canada.
According to New Castle News, on March 7, 2017 a raid at the home of Emil and Maria Koledin precipitated these charges. Maria Koledin, a former Hermitage commissioner, was not named in the bill of information. New Castle news also reports that the National Association of Boards of Pharmacy (“NABP”) labeled awakebrain as “Not Recommend.” NABP states, “Ordering drugs from these websites puts you and your family at risk. Not Recommended Sites are those internet drug outlets that appear to be out of compliance with state and federal laws or NABP patient safety and pharmacy practice standards.”
According to WFMJ, Koledin is scheduled for a plea hearing on May 23rd.
The U.S. Food and Drug Administration Office of Criminal Investigations investigated this case, with assistance from the Hermitage Police Department. The case is being prosecuted by the office of U.S. Attorney for the Western District of Pennsylvania Scott Brady.