WASHINGTON – The U.S. Food and Drug Administration is supposed to regulate pharmaceuticals and keep addictive drugs from being easily abused.
But when a U.S. senator say the FDA stands for “Fostering Drug Addiction,” you know there’s a problem.
Complaints have grown in Congress that the FDA abetted the spread of opioids and heroin, put children at risk and ignored recommendations from its advisory committees. The complaints boiled over into the Senate’s confirmation vote Wednesday of a new agency commissioner, cardiologist Dr. Robert Califf.
Nominated by President Barack Obama in September, Califf finally won approval. But first, Ohio U.S. Sen. Rob Portman, a Republican, signaled his displeasure by voting Monday against ending debate on the nomination. Fellow Ohioan, Democratic Sen. Sherrod Brown, said he too was tempted to vote “no.”
The heroin epidemic that hit Ohio and parts of Appalachia in recent years had roots in the spread of OxyContin and other opioid drugs. Prescribed as powerful, effective painkillers, they are highly addictive and sometimes deadly.
Debate raged for years on whether the FDA should do more to regulate the drugs. But approving medicines for people in pain while preventing addiction was a bit of a high-wire act. So was the approval of medicines to combat heroin addiction; opioids approved for that purpose in 2002 turned out to be addictive themselves.
Then came the agency’s decision in 2013 on Zohydro ER, a prescription painkiller made with hydrocodone. The drug differed from other opiates, the Wall Street Journal reported, because it does not contain acetaminophen, which can cause liver damage.
But Zohydro could be easily abused when crushed or chewed. An FDA advisory panel voted 11-2 to recommend that the agency not approve Zohydro, citing the potential for abuse. Brown says he agreed with that recommendation.
The FDA approved it anyway, saying the drug was effective for its prescribed use – and adding later that efforts to stamp out abuse and addiction should focus on the “complex, multidrug epidemic,” rather than singling out this drug.
Then came the FDA’s decision last August to approve the use of OxyContin for children as young as 11.
“This is for kids,” Portman, outraged at decision, told reporters this week. “This is for, as you know, 11- to 16-year-olds. And I am really concerned about both the immediate and long-term effect of prescribing opiates to children.”
Some said the FDA’s decision was misunderstood. As the Washington Post reported, the approval wasn’t intended to expand the use opioids in children. Doctors could already prescribe medications any way they saw fit. The decision gave doctors better evidence-based guidelines about how to use OxyContin safely in pediatric patients.
Critics didn’t buy it. This was just one of the reasons Sen. Ed Markey, a Massachusetts Democrat, said the FDA stands for “Fostering Drug Addiction.”
All those drugs and illnesses
Brown said the FDA’s treatment of opioids represents a broader pattern.
“I’ve been unhappy with the FDA for much of the last 20 years,” he said Wednesday. He cited the extensive use of television marketing of drugs “for illnesses that you didn’t even know existed.”
He mentioned the agency’s refusal to allow drug re-importation from other countries, even though the drugs were made here in the first place and can sometimes be bought more cheaply when ordered from abroad. He criticized the FDA’s slowness to regulate tobacco, and what he says has been a sluggish approach to dealing with e-cigarettes.
Yet the Senate voted yes
Despite this, only four senators voted “no” on Califf in the end, and Portman and Brown were not among them. Portman said his earlier vote to continue debate was meant as a message — on OxyContin, and on what he says is the agency’s inadequate response to the heroin epidemic.
Brown said he almost voted no because of the opioid issue. “But more than that, I want a director there. I want an FDA commissioner who’s going to begin to answer these questions.”
Califf has promised changes, some of which the FDA was planning already. E-cigarettes are likely to come in for regulation this year. The agency is considering ways to deal with “biosimilars,” or generic drugs that may have similar properties to more expensive biologic drugs.
Califf told the Associated Press in an interview, “If addiction to opioids and misuse of opioids is the enemy, then we underestimated the tenacity of the enemy. We’ve got to adjust.”