Markey on New FDA Opioids Action Plan: Not Enough to Protect Americans from Prescription Opioid Epidemic
Will continue to hold nomination of Dr. Robert Califf to head FDA
Washington (February 4, 2016) – Senator Edward J. Markey (D-Mass.) released the following statement after the Department of Health and Human Services (HHS) announced new actions on opioids.
“The Food and Drug Administration today announced some important steps to address the opioid crisis, but they fall short of what is needed. To its credit, the FDA has agreed to my request to reassess the way it considers the risks of addiction and misuse when it evaluates the safety of new opioids. While this is a good start, even more is required to ensure the FDA’s approval process protects Americans from the dangers of opioid painkillers.
"Whether an opioid is abuse deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers. That is why the FDA must change its decision not to seek expert advice about the risks of addiction before it approves abuse-deterrent opioids.
"By refusing to convene advisory committees to inform all of its opioid approval decisions, the FDA continues to ignore outside experts who could help stem the tide of tragic deaths and overdoses plaguing the country.
"This is not a hypothetical concern. The policy announced by the FDA would not have guaranteed an advisory panel for the OxyContin on the market today, or the two other recently-approved opioids – Hysingla and Targiniq – that have raised serious concerns from public health and medical experts. The FDA needs to welcome outside expert advice and must convene expert advisory committees for all opioid approval decisions, period.
Until the FDA commits to convene advisory committees of outside experts for all its opioid approval decisions, I will continue my hold on Dr. Califf’s nomination.”
Last week, Senator Markey placed a hold on the nomination of Dr. Robert Califf to head the Food and Drug Administration. In his hold announcement, Senator Markey called for the FDA’s commitment to convene advisory committees for any future opioid-approval questions; to consider addiction, abuse and dependence as part of its determinations of which opioids are ‘safe’; and to rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision.