Risk Evaluation and Mitigation Strategies (REMS) - Webinar Recording/Transcript

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Risk Evaluation and Mitigation Strategies (REMS): Staying Ahead of the Regulatory and Enforcement Landscape

Drugmakers’ latest Washington headache involves REMS. Changes are afoot inside the FDA and the halls of Congress, reaching all the way into the office of FDA Commissioner Gottlieb:

  • The CREATES Act legislation has momentum on Capitol Hill
  • FDA guidances on SSS REMS are on CDER’s 2018 guidance agenda but not yet issued
  • Forthcoming approval of Opioid Analgesic REMS to include immediate-release products

FDAnews has called on a Washington lawyer with a deep FDA regulatory background to show how these fast-moving changes could affect you. Katlin Backfield Esq., former Associate Chief Counsel for Drugs with the Office of Chief Counsel, walks you through:

  • A recap of the basic legal and regulatory framework, plus recent developments in the REMS space
  • Commissioner Gottlieb’s emphasis on drug pricing and how it will affect the development of single shared system REMS
  • Congress: Bills in the pipeline, odds on passage
  • What the FDA has done: A checklist from recent REMS-related enforcement
  • What the FDA could do: Enforcement trends, requiring new REMS, possible changes to the Opioid REMS
  • And much more!

Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.

  • Executive suite
  • Regulatory affairs/compliance
  • Medical affairs/pharmacovigilance
  • Product lifecycle managers
  • Labeling specialists
  • Risk managers
  • General/corporate counsel
  • Outside attorneys

Katlin Backfield Esq., Attorney and Consultant, Backfield PLLC. In a 11-year FDA career, Ms. Backfield served as Associate Chief Counsel for Drugs with the Office of Chief Counsel and as regulatory counsel in the Office of Prescription Drug Promotion, CDER. Active in FDLI, she helped plan FDLI’s 2017 Advertising and Promotion Conference and serves on FDLI's Academic Programs Committee. She is based in Washington, D.C.