DC Bar: FDA and DEA Regulation of Opioid Drugs and the Opioid Crisis

  • Date & Time
    June 14, 2018
  • Location

    Washington, DC

  • Event Type
  • Add to Calendar Disabled
Arent Fox FDA Counsel Brian Malkin will speak and moderate a discussion at the DC Bar entitled “FDA and DEA Regulation of Opioid Drugs and the Opioid Crisis.”

The event will be held on June 14 from 6:30PM – 8:30PM ET and follows another DC Bar program, “Legal Ethics, Substance Abuse, and the Opioid Crisis,” which targets the connection between substance abuse and ethical violations by attorneys. In addition to moderating the program, Brian will present on FDA regulatory approval of opioid drugs and drug products to treat opioid addiction, as well as a related group discussion on how we ended up in an opioid crisis and prospective measures to help.  Brian organized the panel, which includes Elaine Lippman from the US Food and Drug Administration speaking about Risk Evaluation and Mitigation Strategies for opioid drugs; Ruth Carter from the US Drug Enforcement Administration speaking about diversion; and Debra Cohn from the American Medical Association speaking about how physicians can help curb the crisis. The DC Bar asked Brian to develop the course and hopes to offer more FDA and other agency-related programming in the future.

“I was thrilled when the DC Bar asked me to organize and speak at a companion CLE program focusing on the FDA and DEA regulation of opioid drugs and what regulatory solutions are being proposed to help curb the opioid drug crisis,” said Brian. “As I understand it, this program was motivated by a well-attended ethics program addressing the connection between the use of opioids and ethical violations by attorneys, related disciplinary proceedings, and the role in assisting attorneys who are substance abusers. Many of the attendees of the ethics program asked for this follow-on course to better understand how these products are regulated and what changes may be in the pipeline. The DC Bar will give attorneys the option to attend one or both programs, hoping many will attend both...What I think is unique about this combined program is that there is a focus on a particular professional audience, who can not only be affected by their own use or a colleague’s, friend’s, or family member’s use of opioid products, but the same audience has the potential to work on potential legislative or regulatory solutions to help curb the epidemic. Our program is unique in this space, because it not only involves the FDA and DEA but also the AMA/physicians into the dialog, which we hope will provide valuable insights for the panel and audience to take home, as our members/profession works with legislators and regulators to help find solutions to curb the opioid drug crisis.”  


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