ADEA Washington Update

Regulatory Focus: FDA Seeks Comment on Curbing Opioid Over-prescribing

(HHS, Opioid Abuse, Prescription Drug Abuse) Permanent link   All Posts

REMSLogoThe 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 public hearing.

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".

The Opioid Policy Steering Committee is considering a range of options for curbing these practices. Among them:

  • Instituting labeling changes.
  • Creating appropriate prescribing and dispensing guidelines.
  • Mandating prescriber education.
  • Regulating opioid packaging, storage and disposal.
  • Creating a nationwide prescription drug monitoring database.

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.

Duggan ad 2013