A senator from a state hit by soaring painkiller abuse is worried that the next leader of the Food and Drug Administration could “go rogue” and approve unnecessary opioids and further contribute to a growing epidemic.
The White House has nominated well-respected clinical researcher Robert Califf to be the next FDA commissioner. While Califf can expect questions on food safety and the speed of drug approvals during his confirmation process in the Senate, one senator wants to hear his thoughts on opioids.
Sen. Joe Manchin, D-W.Va., said Tuesday that he wants a commitment that the agency will be held responsible on opioid approvals after several controversial decisions.
The agency “cannot go rogue as they have been going, bringing things to the market because they think they know best,” Manchin told the Washington Examiner after speaking at a symposium on prescription drug abuse sponsored by the Hazelden Betty Ford Foundation.
Manchin has been a frequent critic of the FDA’s handling of the opioid epidemic. He specifically singled out the agency’s highly controversial approval of Zohydro from the small biotech firm Zogenix.
Zohydro is a long-acting opioid that was approved without abuse-deterrent technology that prevents a drug from being crushed and snorted or injected, common ways abusers employ to get a quicker high.
The FDA approved the drug despite an 11-3 vote from agency advisers recommending denial. The approval decision was uncommon as the agency usually follows the advice of its advisers.
An advisory committee usually includes experts in the disease area, plus industry and patient representatives. It typically reviews information and clinical data on a new drug and then offers its recommendation on whether it should be approved.
Zohydro and the FDA quickly became high-profile targets from lawmakers upset over the opioid epidemic, which has spiraled into their districts.
Each day 44 people die from a prescription drug overdose, according to the Centers for Disease Control and Prevention.
Previous FDA Commissioner Margaret Hamburg has said that the FDA approved Zohydro because it does not contain acetaminophen, which can cause liver problems.
An abuse-deterrent version of the drug has since been approved.
Manchin also chided the agency for approving a child-sized version of popular painkiller Oxycontin. The agency has said that the approval is only for children in severe pain from illnesses such as cancer.
Manchin has filed a bill that would require the FDA in the future to justify to Congress why it wants to go against its advisers’ recommendations.
“You need to answer to the people,” Manchin told the Examiner.
The bill is expected to go before the Senate Health, Education, Labor and Pensions Committee by Thanksgiving.
Other senators said that they wanted to see how Califf and the agency would combat prescription drug abuse.
“I’d like to understand what their viewpoint is on this public health crisis and what they plan to do about it,” Sen. Kelly Ayotte, R-N.H., told the Examiner after her remarks at the same event Tuesday.
Manchin doesn’t serve on the HELP Committee, which will hold confirmation hearings on Califf’s nomination.
Califf is a well-respected medical researcher and cardiologist who has served as the deputy commissioner of medical products since January. He came to the agency from Duke University.
While Califf is respected in the medical community, public health advocates have questioned his deep ties to industry. Califf has previously conducted clinical trials for pharmaceutical giants such as Merck.
Committee Chairman Sen. Lamar Alexander, R-Tenn., said when Califf was nominated last month that the committee will move swiftly on his confirmation.
“The FDA affects nearly every American and needs the certainty of a strong leader,” he said.
