Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to further secure the U.S. drug supply chain and forcefully confront opioid epidemic

The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. As we continue to take a range of steps to forcefully confront the opioid crisis plaguing our country, most people think first and foremost about the agency’s work to encourage more appropriate prescribing to decrease exposure to opioids and prevent new addiction, as well as our initiatives to advance innovations in both novel pain therapies and better treatments to help those with opioid use disorder. Our efforts to combat this public health emergency, however, extend also to stopping the spread of illicit opioids and further securing all aspects of the supply chain for legitimate medications, including opioids.

On the illicit drugs front, we’ve worked to increase our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international mail facilities (IMFs). Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing FDA-regulated products and were pulled for FDA review indeed contained illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs. In 2017, the U.S. Postal Service processed nearly one half billion international parcels, a volume that has been growing at roughly 50 percent annually. In fact, the USPS Office of Inspector General reported that 80 percent of the websites providing guidance on how to mail illicit drugs instructed traffickers to use the Postal Service for shipments.

CONTINUE READING ON www.fda.gov