Sen. Joe Manchin (D-West Virginia)
Sen. Joe Manchin (D-West Virginia) |

FDA nominee overcomes tough confirmation over pharma connections

The Senate voted 80-6 on Monday to break a Democrat-led "hold" against a new commissioner for the Food and Drug Administration, despite criticism of the nominee's close ties to a pharmaceutical industry blamed for rising painkiller addiction in the United States.

At the core of the opposition to Dr. Robert McKinnon Califf's nomination is the role pharmaceutical companies play in opioid addiction, which include heroin. Speaking on the Senate floor before the vote, Sen. Joe Manchin D-W.Va., told members that Califf received money in the past years from 26 different pharmaceutical companies, including the makers of opioids.

Critics of Califf's nomination say he would continue a "culture" at the FDA of rapid approval and expansion of opioid use. They point to the recent FDA decisions allowing prescriptions of the addictive painkillers to children as young as 11 last year, as well as the approval of new opioid, Zohydro, despite an 11-2 vote against the approval by an FDA advisory panel the year before.

"In the past, Dr. Califf has actually described FDA regulation as a barrier, not a safeguard, to public health," Manchin said during Monday's floor session.

Califf, a cardiologist who currently serves as a deputy commissioner of the FDA, founded the Duke Clinical Research Institute, which conducted a number of studies funded by various pharmaceutical manufacturers. Until his appointment as deputy commissioner in January, 2015, he also served on the board of Portola Pharmaceuticals Inc.

Dr. Carl Sullivan, director of the addiction program at the University of West Virginia, told AMI Newswire that he knows "little" about Califf, but that the growing problem of opioid abuse made the nomination less savory.

“The FDA would do well … to have somebody at the head with no ties to the pharmaceutical industry,” Sullivan said in an interview.

“We need to change the culture of the FDA,” Manchin said in a statement released on Jan. 27. “That will not happen if the person at the helm is not a champion who is committed to pushing back against the pressure to continually approve new opioid medications.”

Manchin promised last month to filibuster Califf’s confirmation.

Efforts to curb opioid addictions — which according to Sullivan often lead to heroin addiction — have also received bipartisan support from a number of state and local politicians as well as Manchin. Vermont Gov. Peter Shumlin, a Democrat, joined Republican senators Kelly Ayotte and Rob Portman in testifying Jan. 27 before the Senate judiciary committee on the need for the federal government to revise its policies.  

“Why is it that physician assistants and nurse practitioners are able to prescribe Oxycontin and other drugs that lead to heroin addiction, but they can't prescribe the treatment drugs that would allow someone to get off this stuff and back to normal life?” Shumlin asked during the hearing.

According to the Centers for Disease Control, nearly two million people abused prescription pain killers in 2013, and roughly 7,000 people were treated “for using [painkillers] in a manner other than as directed.”

Sullivan told AMI he sees progress in the FDA, including some changes he said should have been made “two or three years ago,” such as prescription monitoring boards and new policies for addiction risk assessment. He said the FDA has been slow to respond to the issue of opioid abuse. He said as states began identifying opioid addiction as a public health problem as far back as 15 years ago, the FDA began approving more and more variations of opioids.

“That left a lot of us who do addiction medicine kind of befuddled,” Sullivan told AMI.

In spite of this, Mark Harkins, senior fellow at the Georgetown University Government Affairs Institute, told AMI Newswire he predicted Califf would get the votes necessary for confirmation. However, the process has exposed deep changes in the Senate’s confirmation process, which he said began changing under Sen. Harry Reid and a Democrat-controlled Senate in 2013. Senate rules allow for unlimited debate for the confirmation of the FDA commissioner, including the ability for an individual senator to delay the nomination through a procedure known as a hold. In the case of Califf, a hold was made originally by Bernie Sanders, I-Vt., Sen. Edward Markey, D-Mass., and Sen. Lisa Murkowski, R-Alaska.

The Senate has a long tradition of honoring holds. Harkins called Monday's vote to break that hold "unprecedented."

Harkins told AMI that Califf’s nomination was expected to be an easy one. Recommended by Obama, the current deputy commissioner of the FDA previously served as an adviser to Sen. Richard Burr, R-N.C., who is a former chairman of the Senate’s public health subcommittee.

“We’re breaking a lot of new ground in a lot of new areas,” Harkins said. “Overriding holds to allow for nominations, possibly filibustering a Supreme Court nomination — these are all pretty unusual places for the Senate to be … it almost is acting like the House.”