The Opioid Policy Steering Committee of the Food and Drug
Administration (FDA) has announced
that the agency will hold a
public hearing on Jan. 30 to acquire stakeholder input on ways the FDA can use
its Risk Evaluation and Mitigation Strategy (REMS) authorities to promote the
safe use of opioid analgesics. The public is invited to attend the hearing and
submit written comments until Mar. 16. ADEA will be participating in the
At a Dec. 11 workshop on ways to
enhance opioid safety, the Commissioner of the FDA, Scott Gottlieb, M.D., laid out three broad areas of prescribing activity that the FDA intends to address:
1) over-prescribing of opioids for routine medical problems that may be amenable
to alternative treatments, 2) long-term prescribing of opioids, and 3) the
egregious and sometimes criminal prescribing practices of "pill mills".
Opioid Policy Steering Committee is considering a range of options for curbing these practices. Among them:
- Instituting labeling changes.
- Creating appropriate prescribing and dispensing
- Mandating prescriber education.
- Regulating opioid packaging, storage and
- Creating a nationwide prescription drug
The public hearing is intended to give
stakeholders an opportunity to discuss these and other approaches, to have
input on their implementation and to inform the FDA about how their impact
might be measured.
“While we recognize that some of the ideas we’re
exploring are unprecedented, the tragic truth is that this crisis is so immense
that we need to consider a range of more impactful options that we may not have
considered before,” Gottlieb said.