A coalition of more than 15 consumer advocacy groups and medical experts wants new leadership at the US Food and Drug Administration (FDA), charging that the agency’s opioid policies are exacerbating the nation’s epidemic of opioid addiction and overdose deaths.
In a letter sent to Department of Health and Human Services (HHS) Secretary Sylvia Burwell this week, the coalition, which calls itself “FED UP!: A Coalition to End the Opioid Epidemic,” says they are “especially frustrated” by FDA’s continued approval of “new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths.”
“After careful consideration we have come to believe that without new leadership at FDA the opioid crisis will continue unabated,” the letter reads.
The groups are particularly upset with the FDA’s decision to approve the powerful opioid painkiller Zohydro ER (Zogenix Inc), a single-entity hydrocodone product, against the advice of its own scientific advisory committee, which voted 11-2 against approval.
The move sparked a national outcry from consumer groups, health officials, governors, and state attorneys general and promptedstate and federal efforts to ban the drug.
FDA commissioner Margaret Hamburg, they write, defended the approval, saying that new opioids are needed to meet the needs of “100 million Americans living with severe chronic pain.” Conversely, they point out that Thomas Frieden at the Centers for Disease Control and Prevention (CDC) has called for opioids not to be used for chronic noncancer pain because the risks outweigh the benefits. “In the midst of public health crisis,” they write, HHS agency heads “should not be delivering contradictory messages to the public.”
This past July, the FDA approved another high-dose opioid painkiller, Targiniq ER (Purdue Pharma LP), a combination of oxycodone and naloxone, without seeking input from its scientific advisory committee, the coalition notes.
“The FDA’s decisions are making a severe public health crisis even worse. Commissioner (Margaret) Hamburg should be asked to step down,” Gene DiGirolamo, a state legislator from Pennsylvania who signed the letter to Secretary Burwell, said in a press statement.
Pete Jackson, president of Advocates for the Reform of Prescription Opioids, said, “Until FDA changes course on opioids, it will be impossible to control this crisis.” Jackson lost his 18-year-old daughter to a single dose of oxycodone (OxyContin, Purdue Pharma). “The FDA should be putting the public’s health ahead of drug company profits,” he added.
An HHS spokesperson told Medscape Medical News by email that “Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter. Prescription opioid abuse is a serious issue and one that the Secretary is focused on.”
HHS is 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 comment notes.
“HHS recently hosted a working meeting with state officials from across the country to share best practices and discuss how federal and state governments can work together to put a stop to the epidemic,” the statement adds. “This meeting for the first time assembled governmental partners from across the country to share state successes and comprehensively focus on prescriber-targeted interventions.”
FDA press officer Jeff Ventura said “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.”
“Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA,” he added. “We must continue to have a constructive dialogue with the medical community, law enforcement and patients about these two important public health issues, while the agency continues to apply the best science available during our decision-making.”
Next month, the FDA will host a public meeting to collect public input on the development, assessment, and regulation of opioids with abuse-deterrent properties. “This meeting will be critically important as the FDA continues to support advances in this area,” Ventura said.
The FED UP! Coalition will convene the second FED UP! Rally on the National Mall followed by a march to the White House, the letter adds.
“Thousands of people from across the country will join us in calling for an urgent and coordinated federal response to the worst drug addiction epidemic in our nation’s history,” they write. “At the rally we will express our concern about the slow and tragically ineffective response to this public health crisis by some federal agencies.”