A coalition of anti-addiction activist groups on Wednesday called for the replacement of Food and Drug Administration Commissioner Margaret Hamburg, saying the FDA’s approval in the past year of “dangerous, high-dose” opioid painkillers “are fueling high rates of addiction and overdose deaths.”
In a letter addressed to Health and Human Services (HHS) Secretary Sylvia Mathews Burwell, who oversees the FDA and sub-agencies under HHS, the Fed Up Coalition this week delivered a strong rebuke of Hamburg’s tenure that began in 2009, saying that “without new leadership at the FDA the opioid crisis will continue unabated.”
“Many, many of us have been to the FDA, to hearings,” said Judy Rummler, president of the Steve Rummler Hope Foundation, a coalition member group. “We’ve met with Commissioner Hamburg and she seems like she is going to do something, but then nothing changes.”
But the FDA responded to the letter Wednesday, telling Al Jazeera in an emailed statement that “Dr. Hamburg has been a tireless public health advocate for more than 20 years and is committed to continuing to champion the rights of patients as Commissioner of the FDA.”
HHS responded by calling painkiller abuse a serious issue "that Secretary Burwell was focused on." It said she was "pursuing a comprehensive strategy with FDA, CDC, and other agencies to combat opioid abuse that protects the legitimate use of prescription opioids while targeting the small percentage of prescribers and patients who drive the abuse epidemic.”
The Fed Up! Coalition also said that Hamburg’s support of using opioids to treat chronic non-cancer pain “is squarely at odds” with the Centers for Disease Control and Prevention (CDC), which it said has been working to discourage this “widespread practice.”
According to the CDC, 46 people die in the United States every day from an overdose of prescription painkillers, and physicians are a leading source of prescription opioids for the highest-risk users.
Calling out what it said was a “slow and tragically ineffective response” to a “public health crisis,” the Fed Up Coalition took issue with the approval of two particular drugs: Zohydro, an opioid painkiller that was approved last October despite an 11-2 vote against it by the FDA’s own advisory committee, and Targiniq, another pain medication that contains oxycodone and naloxone.
The FDA approval of Zohydro — which The Associated Press reported is the first extended-release, pure form of hydrocodone ever cleared for the U.S. market — drew fire from public health advocates. And the agency approved Targiniq in July without holding a scientific advisory committee meeting, a move the coalition said it believes was an attempt to avoid controversy. The coalition said such meetings are convened if the matter involved is controversial or of significant public interest.
“We believe that FDA bypassed its advisory committee because it wanted to avoid the same controversy it faced after approval of Zohydro,” the letter from Fed Up! read. “Yet it is precisely when approval of a drug is controversial that scientific advisory committee meetings are called for.”
FDA on drug approval
But FDA spokesman Jeff Ventura told Al Jazeera that “the FDA makes its approval decisions based on science and by carefully evaluating the safety and effectiveness of every pain medication.”
“In the case of Zohydro ER, we determined that the benefits of the product outweigh its risks,” he said, referring to the drug by its official name.
As for the approval decision on Targiniq — which has abuse-deterring properties that purportedly make it difficult to crush and then snort or inject — Ventura said that “the agency determined that the assistance of an advisory committee was not necessary in interpreting the data of Targiniq ER.”
“The data submitted with the Targiniq ER application was clear with regard to the effects in the human abuse liability studies evaluating the intranasal and intravenous routes of abuse. The efficacy and safety data were also straightforward,” he said.
The CDC, meanwhile, said health care providers in 2012 wrote 259 million prescriptions for painkillers — or enough for every American adult to have a bottle of pills.
“The root of this is the over-prescribing of opioids. We’ve become a society that thinks a pill is the answer to everything, and pharmaceutical industry has a huge influence on the FDA,” Rummler said.
The Fed Up! coalition plans to hold a rally Sunday in Washington, D.C., calling for a “coordinated and comprehensive federal response” to the problems of opioid addiction and overdose deaths.