Senator has called on FDA to rescind approval of OxyContin for kids

Boston (November 1, 2016) – As a new study released shows, overdoses among all children increased more than 100 percent over a 16-year period, Senator Edward J. Markey (D-Mass.) called for immediate steps to protect America’s youngest people from the devastating opioid epidemic. A new study published in the Journal of the American Medical Association (JAMA) also revealed that heroin poisonings of children aged 1-19 also increased 161 percent. In 2014, more than 30,000 Americans died from an opioid overdose.

“We have become the United States of Oxy, and our youngest children are suffering from a deadly citizenship,” said Senator Markey. “With prescription opioids proliferating in medicine cabinets across the country, we must ensure that we keep these dangerous prescription painkillers out of the hands of children. The opioid crisis does not discriminate on age, and we need to put protections in place for our youngest people so that they are not poisoned or inadvertently put on a path toward addiction. The FDA can begin by rescinding its misguided decision to approve pediatric use of OxyContin and convene an advisory panel as it reconsiders its decision. We must also mandate education for all prescribers of opioid medication so that they can provide guidance to adults on safety and disposal of opioid medication.”

Last year, Senator Markey called on the Food and Drug Administration (FDA) to rescind its decision to approve a new pediatric use for OxyContin without convening an outside expert advisory committee. In 2015, the FDA approved a new pediatric use of the highly addictive opioid painkiller without convening an advisory committee even though its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment.

In January 2016, Senator Markey placed a hold on the nomination of Dr. Robert Califf to head the FDA, calling on the agency to commit to convene advisory committees for any future opioid-approval questions and to rescind the approval of OxyContin for kids.