February 04, 2016

Manchin Appreciates but Not Impressed by the FDA Decision to Slightly Improve Response to Opioid Epidemic

Washington, D.C. – U.S. Senator Joe Manchin (D-WV) today was encouraged by the Food and Drug Administration’s (FDA) decision to slightly improve the agency’s response to the opioid epidemic; however, he continues to believe that sweeping changes are necessary. The FDA changes include convening an advisory committee for opioids without abuse-deterrent properties and for pediatric indications, considering the public health impact when approving highly addictive and dangerous opioid medications and supporting the Centers for Disease Control and Prevention’s (CDC) opioid prescribing guidelines. These changes are a step in the right direction, but they are not enough given the devastating impact that opioid abuse and overdose death has had on our country.

“It is past time that the FDA gets serious about the dangers of prescription drugs, and I accept the agency’s decision to finally start listening to the advice of its expert advisory committees – something I have called on them to do for several years,” Senator Manchin said. “However, I believe the FDA should use the advisory committee’s expert advice for all opioid medications, including abuse-deterrent formulations, which are just as addictive and can be just as deadly as non-abuse deterrent opioids. The FDA also needs to commit to adhering to the recommendations that the advisory committee puts forward. In the past, I have been so frustrated with the FDA’s reluctance to accept its own advisory panels’ recommendations. When I testified at the advisory committee hearing in 2013, the expert advisory panel voted 19-10 in favor of rescheduling hydrocodone from a Schedule III to a Schedule II drug. After years of phone calls and fighting with the FDA, the agency finally took its own advisory committee’s recommendation to recommend rescheduling hydrocodone to a Schedule II drug. However, just as we could begin to celebrate that victory, the FDA approved, the very next day, another controversial new painkiller, Zohydro, over the objection of its own experts, which voted 11-2 against allowing the painkiller to advance in the approval process.

“I will continue to strongly pressure the FDA to strengthen its oversight of opioid medications and will continue to push for the strongest possible framework for drug approval to ensure that the agency doesn’t simply continue to approve ever stronger and more deadly opioid medications under this new process. Although this announcement reflects a step toward a commonsense approach that takes into account the scourge of opioid addiction and the more than 18,000 lives lost last year, more needs to be done to change the culture at the FDA. In an effort to end the devastating opioid abuse epidemic, I will continue to fight to ensure that the FDA’s number one priority is only the public’s health and wellbeing, nothing else.”

After the FDA approved the powerful and highly addictive opioid drug Zohydro over the objection of its own Anesthetic and Analgesic Drug Products Advisory Committee, Senator Manchin introduced the FDA Accountability for Public Safety Act to hold the FDA accountable for opioid drugs approved by the agency. To read the full text of the FDA Accountability and for Public Safety Act, please click here.

To review a full timeline of Senator Manchin’s efforts to combat prescription drug abuse, please click here.


The FDA advisory committee consists of the best healthcare experts, doctors, and scientists in their respective fields. Under the FDA’s own regulations, the agency must convene an advisory committee when a matter is of significant public interest, highly controversial, or in need of a specific type of expertise. Given the danger of abuse and overdose death, it is clear that the approval of new opioid drugs meets each of these standards, which would compel the FDA to organize an advisory committee.

In recent years, however, the FDA has either ignored its advisory committee’s recommendations or failed to seek its counsel in the first place. In 2013, the FDA approved the very powerful opioid, Zohydro, despite the advisory committee voting 11-2 against approval of the drug due to their concerns about the safety of the drug.

Since that time, the significant negative feedback that the FDA has received on that decision has led the FDA to avoid the advisory committees altogether despite the fact that opioids clearly fall within the FDA’s own guidelines for when to seek an advisory committee opinion. Since Zohydro, two new opioid medications, Targiniq and Hysingla, have been approved without an advisory committee meeting.