Approval of powerful opioid likely to put scrutiny on FDA

By | November 3, 2018

Activists and Democrats are livid with the Food and Drug Administration’s decision to approve the most powerful opioid ever, hinting at a possible probe into the way the agency oversees drug approvals.

The FDA on Friday made the controversial decision to approve the powerful opioid Dsuvia, which would be administered only in a medical setting. The approval drew a sharp rebuke from Senate Democrats and activists worried about another powerful version of the opioid fentanyl hitting the streets, and concerned that the agency did not involve a key safety committee in the approval process.

“There was no public health need to approve this formulation of supercharged fentanyl in the face of these questions, opposition from one FDA advisory committee chair, and without the full participation of another advisory committee devoted to drug safety,” said Sen. Ed Markey, D-Mass., in a statement Friday.

Markey and three other Democratic senators had asked Gottlieb Wednesday to delay approval until after convening a new advisory committee hearing.

The senators are worried that the opioid could be diverted or copied and sold to addicts. Illicitly-made fentanyl has become a major contributor to opioid deaths in recent years.

In 2016, of the more than 42,000 opioid overdoses, more than half were linked to fentanyl, according to data from the Centers for Disease Control and Prevention.

Gottlieb said in a statement that there are severe restrictions on the application of the powerful opioid. It will be delivered through a single-dose applicator, and used in only hospitals, surgical centers, or emergency rooms.

He added that the drug was a priority for the Department of Defense as it could be used on the battlefield.

“The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee,” he said.

But the consumer advocacy group Public Citizen raised questions about the advisory committee that recommended approval for Dsuvia, which is made by the drugmaker AcelRx. Public Citizen said that the Oct. 12 meeting at which the application was reviewed should have included the FDA’s panel of experts on drug safety issues, which can review the potential for a new opioid to be abused.

Dr. Raeford Brown, who is the chairman of the FDA’s anesthetic and analgesic committee, made the unusual move of calling for the FDA to not approve Dsuvia because of the possibility of abuse. Brown could not make it to the meeting on Oct. 12.

“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said in a statement.

“The FDA should never have any discussion about an individual opioid or a problem affecting a group of opioids without having the drug safety committee,” Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, told the Washington Examiner. “The committee is made up of people who know more about safety and epidemiology.”

From 2016 to 2017, the FDA reviewed 11 drug applications for new opioids. The agency held a joint meeting of both the analgesic committee and the drug safety committee for each of those applications, but did not do the same for Dsuvia.

The letter from Markey and the other Senate Democrats said that it appears the FDA changed its process “to the detriment of public health.”

Wolfe said that the agency doesn’t appear to have learned its lessons from the last time it got into hot water with Congress over opioid approvals.

The FDA approved Zohydro in late 2013. Then-FDA Commissioner Margaret Hamburg argued after its approval that the drug is helpful because it does not contain acetaminophen, which can cause liver damage, like other painkillers.

The agency decided to approve the treatment despite the analgesic and anesthetic advisory committee voting 11-1 to recommend against approval because of concerns the drug could be abused.

The decision sparked condemnation from both Republicans and Democrats.

But the drug safety committee also did not review that drug, just like Dsuvia, said Wolfe, a former member of the drug safety committee.

Markey’s office did not return a request for comment on whether the senator will take up an investigation of the approval of Dsuvia. Wolfe said that he expects a probe, though, given Democratic anger on the subject.

“We will make sure that someone with more power investigates this,” he said.

Healthcare