FDA and CBP are teaming up to increase inspection and detention efforts at our nation’s International Mail Facilities (IMFs) and Ports of Entry. In its press release announcing the collaboration, FDA stated that “Thousands of illicit and dangerous products come from overseas each day, such as unapproved fentanyl products, counterfeit prescription drugs or fake over-the-counter products that look legitimate.” FDA added, “In recent years, we’ve committed new resources and have been granted new authorities by Congress to target these violative products and stop them before they’re able to enter our country. When bad actors try to circumvent the safety of our supply chains by breaking federal law, we’ll take all appropriate action necessary to ensure these potential risks do not harm the American public.”
While collaborating with CBP is a worthwhile endeavor for FDA, it does once again raise the specter of mission creep that I previously noted. Further, counterfeit drug products that evade FDA/CBP detection at the IMFs will inevitably threaten vulnerable patients who rely on our legitimate pharmaceutical distribution supply chain (as opposed rogue Internet pharmacies). A commensurate surge by FDA targeting corrupt independent pharmacies and secondary wholesale distributors is long overdue. These bad actors are high-risk conduits for diverted and counterfeit drugs. As a result, they must face increased regulatory and law enforcement scrutiny from FDA and its counterparts.
The tsunami of International Mail Facility packages (close to 275 million per year) and the existence of a historically-porous and under-regulated drug supply chain are a very dangerous combination for all patients. Each of us relies on FDA to ensure the safety of medicines we receive from pharmacies, hospitals, doctors, and medical clinics. An increased presence at the IMFs in response to the opioid crisis is understandable but the security of our legitimate drug supply chain and patient safety should not be sacrificed in the process.