Senator Edward Markey (D, MA) is using Senate rules to block the nomination of Rob Califf in an attempt to force the agency to rescind its approval of a prescription opioid for children and change its regulatory practices.
Markey, in Boston Globe interview said he is demanding that the FDA agree to reverse its 2015 decision allowing the pediatric use of the prescription painkiller OxyContin. He also wants the agency to commit to convening expert advisory panels to provide advice whenever considering the approval of an opioid drug, and to ensure that the risks of drug addiction and abuse are taken into account whenever the agency considers approving a prescription opioid.
We call Senator Markey’s attention to the FDA’s new “Guidance Agenda” for 2016.
Prominent on the list are plans to release a new draft guidance on: “General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products.” That’s important.
Senator Markey is rightly concerned about opioids remaining atop the FDA’s list of “must address” items. But his “hold” on the Califf nomination will, if anything, hold back the agency from making progress on this urgent issue.