On Tuesday, January 30, 2018, the Food and Drug Administration held a public meeting of the agency’s Opioid Policy Steering Committee in Silver Spring, Maryland, to explore strategies for responding to the nation’s opioid crisis.
The Perret Group’s Hunter Perret, along with upwards of 500 others—in person and via live stream—were in attendance. The agenda was filled with more than 40 academics, physicians, patients, advocates, and industry officials who presented feedback on how the FDA can best handle the opioid problem.
The American Opioid Epidemic
Approximately 11.5 million Americans misused prescription opioids in the past year with more than 40 people dying each day from overdoses involving prescription opioids.
In September 2017, the FDA issued a request for comment in which they asked for public input on responding to the crisis — an unprecedented appeal. One month later, President Trump declared the opioid epidemic a public health emergency.
Democratic lawmakers wore purple ribbons at the State of the Union address on Tuesday, January 30, 2018, in an effort to raise awareness about the American opioid epidemic.
“My administration is committed to fighting the drug epidemic and helping get treatment for those in need, for those who have been so terribly hurt,” said President Trump. “The struggle will be long, and it will be difficult. But as Americans always do, in the end, we will succeed. We will prevail.”
Too Much Regulation or Not Enough?
Private and public stakeholders were asked to provide feedback and recommendations on how the agency can leverage their role to influence opioid-related regulatory decisions. Presenters delivered arguments for and against FDA intervention.
Those in favor of agency involvement recommended exploring ways to address the growing problem of abuse and misuse through the FDA’s influence on providers through Risk Evaluation Mitigation Strategy (REMS) and prescription drug monitoring programs (PDMP) to prevent “doctor shopping,” mandatory education for prescribing clinicians and changes to opioid packaging to give providers better options for clinical prescriptions.
Those against the agency’s involvement stressed mindful intervention as they fear opioids are already being over-regulated and are harder to access for people who need them. Rather, the FDA should focus efforts on maintaining safe, effective and appropriate prescribing of opioids for patients who need them.
A Community Health Priority
With healthcare investments and involvement in inpatient and outpatient settings ranging from surgical hospitals and outpatient surgical centers to medical and therapy clinics and even a non-profit cancer center, The Perret Group recognizes how post-surgical patients and those suffering from chronic, intractable and cancer-related pain may be affected by the change in regulatory measures.
“First and foremost, patient safety and comfort is our greatest concern,” said Hunter Perret, “which is why the Perret Group has made preventing prescription opioid misuse a top community health priority.”