Senator continues opposition to nomination of Dr. Robert Califf until FDA commits to convening advisory panels of outside experts for all opioid approval decisions
Washington (February 19, 2016) – Calling an “abuse deterrent” opioid a contradiction in terms, Senator Edward J. Markey (D-Mass.) today released a new analysis of the Food and Drug Administration’s (FDA) opioid approval decisions that found that the agency has repeatedly bypassed advisory committees when considering opioids with abuse-deterrent claims. After pressure from Senator Markey, in its recent “Opioid Action Plan,” the FDA announced that it would not convene advisory committees before approving a new opioid classified as abuse-deterrent. But Senator Markey’s analysis found that of eleven opioids with abuse-deterrent properties that FDA has approved since 2010, the agency convened advisory committees for only four of them. In many cases, FDA approved so-called abuse-deterrent opioids despite warnings from the medical community about the potential for abuse — concerns borne out by subsequent experience with the drugs. Senator Markey reiterated his call to Health and Human Services Secretary Sylvia Burwell to commit to convening advisory committees of outside experts for all opioid approval decisions.
Senator Markey’s analysis of approvals of abuse-deterrent opioids can be found HERE.
“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,” writes Senator Markey in his letter to Secretary Burwell. “Furthermore, because, as FDA has stated, abuse-deterrent technology is in its infancy and rapidly evolving, advice from external experts would be most helpful as FDA is grappling with the complexities, risks, and benefits of abuse-deterrent technologies.”
The letter to Secretary Burwell can be found HERE.
FDA’s own guidance recognizes the inherent contradiction in the term “abuse deterrent,” explaining: “It should be noted that [abuse-deterrent] technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria. The fact that a product has abuse-deterrent properties does not mean that there is no risk of abuse.”
In January, 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 and to rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision.