ASHINGTON — The Food and Drug Administration is failing to properly consult with its advisory committees to vet the approval of certain opioid drugs, Massachusetts Senator Ed Markey alleges in a new report and letter obtained by STAT.
Markey, in a Feb. 19 letter to Health and Human Services Secretary Sylvia Mathews Burwell, said that until the FDA changed its procedures, he would continue to oppose the nomination of Dr. Robert Califf, President Obama’s choice to be the agency’s next commissioner. The first Senate floor vote, a procedural vote, on Califf’s nomination will be held Monday evening.
The report produced by Markey’s office laid out three problems from his point of view: First was that so-called “abuse-deterrent” opioids can still be abused. Second, since 2010, the FDA has not always consulted advisory committees when approving abuse-deterrent opioids.
Third, and the point that Markey focused on in his letter, the opioid action plan that the agency released earlier this month in response to the addiction crisis still allows some abuse-deterrent opioids to be approved without an advisory committee being consulted.
“[The] FDA needs outside expert advice on all opioid approval decisions,” Markey wrote. “Whether an opioid is abuse deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers.”
Markey and other lawmakers, including Senator Joe Manchin of West Virginia, have used Califf’s nomination to urge changes at the FDA that would address the opioid crisis, which is killing nearly 30,000 Americans a year.
The report underlines problems with the FDA’s approval process, said Andrew Kolodny, chief medical officer at Phoenix House, which runs dozens of addiction centers in the United States.
Kolodny emphasized that the abuse-deterrent drugs the FDA is approving can still be abused. Abuse-deterrent drugs are usually intended to only stop the pill from being crushed or injected, Kolodny said. Many people end up addicted to opioids by simply swallowing the pills.
“I have had very serious concerns about the FDA’s opioid decision-making for a long time,” he said. “I’m actually pleased that [Markey is] taking a stand on this.”
The agency has recently endured significant controversy for not consulting with advisory committees. The approval of Oxycontin for children saw backlash, including from Democratic presidential candidate Hillary Clinton. An advisory committee was not consulted on the approval, and those critical of the decision, including Kolodny, said they didn’t believe a committee would have favored it.
The episode was one of those highlighted by Markey’s report, which charged that the FDA “ignored its own guidance calling for an advisory committee when a question of ‘pediatric dosing’ is involved.”
An FDA spokesperson declined to comment. However, when the FDA released its opioid action plan earlier this month, Califf was asked by reporters about one of the big issues that Markey raised — that the plan would still allow some opioids to be approved without consulting an advisory committee.
“We want to shift the market to abuse deterrence because much of the harm being done, as you know, is to people for whom the drugs are not prescribed who are attracted because of the absence of abuse deterrence,” Califf said. “There are requirements that you have to meet to be designated as abuse deterrent, so it’s really a matter of where we’d like it to go. We want to prevent diversion as much as we possibly can and we think this is the most effective way to do it.”
Some suggested that the focus on advisory committees is misplaced. David Gortler, who was a senior medical analyst at the FDA from 2007 to 2012 and is now a drug safety expert with FormerFDA.com, said the committees don’t always attract the best experts because of their conflict-of-interest rules. The FDA also tends to disregard their input, he said.
“To me, it’s just a horrible waste of time,” he said, noting that presenting in front of the committees was part of his job while at the agency. “The FDA doesn’t respect them. The public doesn’t respect them. It’s a boondoggle.”
On the FDA’s track record of not always consulting the committees that Markey criticized, Gortler said: “There really aren’t black-and-white, hard-and-fast rules about what drugs should go in front of an advisory committee.”
Kolodny dismissed those concerns. The FDA has three criteria for convening an advisory panel: if there is significant public interest, if approval is potentially controversial, and if the FDA would make a better decision if it consulted with experts. Opioid approvals meet all three, he said.
“FDA doesn’t have addiction expertise. They should be consulting experts on these decisions,” Kolodny said. “The FDA has good criteria for when to convene advisory committee meetings. They should be following those criteria. If they follow those criteria, decisions involving opioids would have advisory committees.”