- Just like every other public health stakeholder, the FDA is struggling to control the immense impact of opioids on the nation’s health and wellbeing.
The opioid addiction epidemic is currently “the biggest public health crisis facing the FDA,” Commissioner Scott Gottlieb, MD, wrote in a recent blog post, and the agency is seeking all the input it can gather on how to best prevent addiction while ensuring access to pain medications for those with true medical necessity.
“Not a day goes by in my role at FDA without hearing stories of the emotional, physical, and financial toll this epidemic is taking on Americans,” Gottlieb wrote. “FDA is committed to making every possible effort to stem the tide of this crisis.”
“We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients.”
In 2017, the FDA established the Opioid Policy Steering Committee (OPTC) to help navigate a number of complex issues, including how to best establish policies that could limit abuse of opioids and how to foster development of alternative therapies for effective pain management.
The Committee has successfully sparked conversations about how to help manage legitimate pain without stigmatizing patients or creating opportunities to become addicted to painkillers.
“These actions generated a wide range of feedback, and they included the important voices of the patients,” Gottlieb said. “The feedback we received affirmed for us that as we address this crisis, we wouldn’t lose sight of the needs of Americans living with chronic pain or coping with pain at the end of life.”
In light of this input, the agency is considering several different actions to encourage changes to the way opioids are viewed, prescribed, and used.
The FDA is weighing the benefit of asking medical professional societies to develop evidence-based guidelines for appropriate opioid prescribing for different conditions, Gottlieb explained.
Stakeholders would need a shared strategy for how to best support these guidelines with validated research, he noted.
“We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs,” he wrote.
“We will take the first steps toward developing this framework in the coming months, with the goal of providing standards that could inform the development of evidence based guidelines.”
The FDA is also planning to create new guidance documents that will share “an efficient, modern pathway for development of drugs targeted to the treatment of various types of pain,” said Gottlieb.
These documents will modernize the FDA’s existing policies on painkillers and hopefully promote the development of equivalent alternatives that include a lower chance of negative downstream impacts.
Gottlieb also announced a public meeting, to be held on July 9, 2018, at the FDA’s White Oak Campus in Maryland.
“This public meeting is an opportunity for FDA to hear directly from patients, including adult and pediatric patients,” he said. “We want to hear their perspectives on the impacts of chronic pain, their views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments.”
Patients will be given the opportunity to share their stories and perspectives on the challenges of living with chronic pain, as well as the impact of different treatment approaches on their quality of life.
Facilitated discussions and panel sessions will allow patients and caregivers to interact with policy experts around a number of important topics, such as barriers to accessing effective treatments and factors involved in personal decision-making about care.
Interested parties may also submit electronic comments or send in commentary regardless of whether they can attend the in-person summit.
“As we address the opioid crisis with new approaches, and take more vigorous steps to confront addiction, we can’t lose sight of patients who have appropriate needs for these medicines,” Gottlieb concluded.
“This meeting is one of many steps we’re taking to make sure we protect the needs of patients with chronic and acute pain even as we take new actions to reduce overall prescribing and dispensing of opioid medicines.”