Updated: Califf Headed for Confirmation as Next FDA Commissioner

Regulatory NewsRegulatory News
| 23 February 2016 | By Zachary Brennan 

Only six senators voted against Robert Califf in a procedural vote late Monday setting up a final vote for his appointment as the next commissioner of the US Food and Drug Administration. On Tuesday, a handful of senators continued to criticize FDA over their opioid approvals, though these criticisms are not expected to halt Califf's confirmation.

The positive vote on Monday for the former Duke University cardiologist and clinical trials expert also came after an hour of three Democratic senators railing against FDA’s work around opioids and abuse. In 2014, nearly 30,000 people died of an opioid overdose.

Sen. Ed Markey (D-MA) kicked off the discussion on the Senate floor late Monday, chiding the agency for failing to use the advice of expert panels on approvals of new prescription opioids. In particular, Markey pointed to the fact that 80% of heroin overdoses in 2014 were people who were started on prescription opioids.

“FDA is not using the proper safeguards to make sure the problem doesn’t get worse,” Markey said, noting FDA’s recent approval of opioids for pediatric and teenage populations. “We consume 80% of all prescription opioid pills in the world. A pandemic has broken out,” he said.

Earlier Monday, state health officials urged FDA in a citizen petition to add new warnings for doctors and patients on the risks of concomitant use of opioids and benzodiazepine drugs.

“FDA has to ensure protections are put in place, that the warnings are there, and that the measures are used to reduce the number of families devastated by this issue,” Markey added.

Sen. Blumenthal, in announcing his opposition to Dr. Califf on Monday added, “This agency needs drastic reform. It needs to be overhauled in how it approves these substances that can be a gateway to addiction.”

He also said the US is lagging in addressing what he called “a public health hurricane." And though others had previously criticized Califf's ties to industry, Blumenthal and Markey made clear that their attack was directed more at the agency's policies than Califf personally. 

“FDA has utterly and abjectly failed to protect the public from opioid overuse and abuse,” Blumenthal said, noting a troubling precedent for “speed over safety.”

Both senators and Sen. Joe Manchin (D-WV) employed the use of Zohydro’s approval as an example of FDA approving a drug despite strong exceptions made by an advisory committee, which voted 11-2 against approval.

Manchin also took the floor on Tuesday to read the letters of those suffering from opioid abuse and addiction. 

Sen. Patty Murray (D-WA) and Sen. Lamar Alexander (R-TN) also took to the Senate floor Monday to support Califf’s nomination. The final vote was 80 in favor of Califf and six against. Sens. Manchin, Markey, Blumenthal, Bill Nelson (D-FL), Rob Portman (R-OH) and Kelly Ayotte (R-NH) voted against. Ayotte also took issue with FDA's policies on opioids on Tuesday.


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