News and Press

Boston Globe: Ed Markey blocks vote on FDA chief over opiate approvals

US Senator Edward Markey is using Senate rules to block the nomination of a proposed new leader of the US Food and Drug Administration in an attempt to force the agency to rescind its approval of a prescription opioid for children and change its regulatory practices, Markey said in a Globe interview.

Using parliamentary procedures, the Massachusetts Democrat has put a “hold” on the nomination of Dr. Robert Califf, which prevents the Senate taking a confirmation vote, at least for the time being.

Markey, who has made the growing wave of opioid addiction one of his legislative priorities, 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.

Markey said he is particularly troubled that the FDA last year approved OxyContin for use by children without convening an advisory panel of experts to study the issue and offer advice, as the agency often does before making significant public health decisions.

Markey was among eight senators who signed a letter to the FDA protesting the decision last September, according to a copy provided by Markey’s office.