Markey Places Legislative Hold on FDA's Califf

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By Nathaniel Weixel

Jan. 25 — Sen. Edward Markey (D-Mass.) has placed a hold on the nomination of Robert Califf to lead the Food and Drug Administration, his office said Jan. 25.

Markey in a statement said he objects to the agency's approval of the opioid OxyContin for use in children. The FDA last year approved the use for OxyContin for children as young as 11 without convening an advisory committee. The move was questioned by a group of senators, including Markey (182 HCDR, 9/21/15).

Markey called for “immediate reforms” to the agency's approval process for opioid painkillers.

“The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf's nomination,” Markey said in a statement. No full Senate vote has been scheduled on the nomination.

Markey isn't the only senator to place a hold on Califf. Sen. Lisa Murkowski (R-Alaska) said she will put a hold on Califf until the FDA answers questions over its labeling of genetically modified salmon. Sen. Bernie Sanders (I-Vt.) may also consider placing a hold on Califf because of his ties to the drug industry (08 HCDR, 1/13/16).

On Jan. 12, a Senate committee approved the nomination of Califf to lead the FDA. Approximately a year ago, Califf was named FDA deputy commissioner for medical products and tobacco. Before that, he was vice chancellor of clinical and translational research at Duke University.

No Confidence

Markey wrote a letter to Department of Health and Human Services Secretary Sylvia Mathews Burwell Dec. 21, outlining his intent to place a hold on the nomination. Markey said he had met with Califf in November and raised concerns about the agency's repeated approval of applications for powerful opioid painkillers.

“Unfortunately, Dr. Califf did not give me confidence that under his stewardship the FDA would confront the highly problematic manner in which the agency is approaching these issues,” Markey wrote in the letter.

Markey said he would only support the nomination if the FDA rescinds its pediatric approval of OxyContin and empanels an advisory committee on the question; agrees to empanel an advisory committee on any future opioid approval questions; and ensures that issues of addiction, abuse and dependence are criteria considered by the FDA when it makes opioid approval decisions.

To contact the reporter on this story: Nathaniel Weixel in Washington at nweixel@bna.com

To contact the editor responsible for this story: Janey Cohen at jcohen@bna.com