One of the most significant obstacles in the way of Robert Califf’s nomination to be Food and Drug Administration commissioner is the agency’s history of prescription painkiller approvals.
Four of five senators currently blocking Califf’s nomination have criticized the agency’s actions in approving opioid painkillers. Some physicians and policy analysts say that for too long the FDA has ignored the drugs’ addictive qualities when evaluating the products, leading doctors to prescribe them liberally to patients who develop crippling dependencies.
“They’re listening to these patients, and the people who stand to gain a lot financially from opiates, instead of taking notice of the evidence,” said Jane Ballantyne, a University of Washington physician and expert in pain medicine who’s president of the advocacy group Physicians for Responsible Opioid Prescribing.
Ever since the FDA first approved the powerful and addictive painkiller OxyContin in 1995, the drug has been controversial because of its potential for abuse. Last year, the agency generated concern and comment again when it approved the drug for use in patients as young as 11 years old. That decision was the driving force behind the holds on Califf’s nomination by Republican Sen. Kelly Ayotte of New Hampshire and Democratic Sen. Edward J. Markey of Massachusetts and Joe Manchin III of West Virginia. The issue also factored into a hold by Democratic presidential contender Sen. Bernard Sanders, I-Vt.
The FDA last week announced changes to its system for evaluating opioids, including convening independent advisory committees for new opioid drugs that do not have abuse-deterrent properties, strengthening its post-market reporting requirements for manufacturers and adding warnings and safety information to labeling requirements.
“We’re going to fundamentally re-examine the risk-benefit paradigm for opioids and be sure that we consider their broader public health effects,” Califf said in a phone call with reporters.
He also acknowledged the scope of the problem: “The more than 250 million prescriptions as far back as 2012 for these types of painkillers give us enough opioids for every adult in the US to have a bottle of pills. That’s clear evidence of the work ahead of us.”
On Jan. 27, Manchin took to the Senate floor to describe how he would filibuster Califf’s nomination. “I will read letters from children who have seen their parents die from an overdose,” he said. “I will read letters from grandparents who have been forced to raise their grandchildren when their kids went to jail, rehab and the grave.”
While Majority Leader Mitch McConnell, R-Ky., could still forge ahead with a confirmation vote, he also is concerned about opioids and is likely to respect the hold of a Republican like Ayotte, who faces a competitive re-election in a state particularly hard hit by prescription drug abuse.
McConnell met with Califf on Feb. 4 and urged the agency take concrete steps to address the severity of the problem. The same day, Ayotte met with Sylvia Mathews Burwell, the secretary of Health and Human Services to discuss the FDA’s planned changes.
“While this is a step in the right direction, I remain concerned that the plan does not immediately require the input of advisory committees for all opioids, including those that are more difficult to abuse,” Ayotte said in a statement.
Markey similarly wants the FDA to convene independent advisory committees whenever it considers a new opioid drug — not just when it lacks an abuse-deterrent formulation — and consider addiction as part of its definition of safety. Both lawmakers also want the agency to rescind its previous decision and restrict the use of OxyContin to ages 16 and older.
Officials tried to explain the recent OxyContin approval by noting that doctors were already prescribing the drug to children, and the FDA wanted to publicize information about safety and proper dosage.
HHS Assistant Secretary for Public Affairs Kevin Griffis referred CQ Roll Call to a statement issued last fall when the FDA first lowered the approved age.
“This approval was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients,” the statement said.
And the FDA is not alone in defending its actions; some patient groups and physicians also support the recent OxyContin decision. In a letter to McConnell last week, the American Academy of Pediatrics urged the Senate to confirm Califf and called the criticism over opioids “misguided.”
“FDA’s approval decision made sure that important information on how to appropriately dose the medication for children was included in the labeling,” the letter said.
But critics who do not buy this explanation seem to outnumber the supporters.
“How can one agency approve something without paying attention to the fact that tens of thousands of Americans are dying a year from it?” former Rep. Mary Bono, R-Calif., told CQ Roll Call.
Bono raised concern about prescription drug abuse when she was in Congress, and co-founded with Rep. Harold Rogers, R-Ky., the Congressional Caucus on Prescription Drug Abuse. Since leaving Congress, she has advised the Hazelden Betty Ford Foundation addiction treatment center as a consultant and serves on the Community Anti-Drug Coalitions of America board.
Bono thinks other parts of the government also must do more. One major problem, she said, is a lack of higher-level coordination among the agencies involved, including the Drug Enforcement Agency, Centers for Disease Control and Prevention and other parts of the Department of Health and Human Services.
“Who is convening all of these agencies together to talk about problems?” she asked.
In remarks recently posted to the FDA website, Woodcock listed the prescription opioid epidemic among her important priorities for 2016. But she also noted, “There are many other parties that have a more leading role there.”
The Obama administration has taken actions outside of the FDA to combat opioid abuse through increased spending, including a plan announced Tuesday to more than double funding to combat misuse through grants to states and other initiatives.
Andrew Kolodny, the executive director of Physicians for Responsible Opioid Prescribing, in an interview that the FDA should take much of the blame for its long history of approving drugs with addictive properties. Some physicians and patients had pushed the agency for more options to control debilitating pain. But Kolodny said the FDA stamp of approval led many doctors to mistakenly believe potent painkillers are appropriate to prescribe to young patients or those with moderate pain.
Ballantyne predicted that the FDA’s solutions wouldn’t do enough to make a difference. “If you’re really an addict, you know how to get around those abuse- deterrent formulations,” she said. Drugs to treat addiction, she noted, don’t do anything to prevent new cases.
No matter what changes the FDA makes, it’s unlikely that lawmakers will be able to turn their attention away from prescription drug abuse any time soon.
“It’s touching every single congressional district in America,” Bono said. “They are hearing the pain and suffering that people are going through with this epidemic.”