The Opioid Crisis - Webinar Recording/Transcript

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The Opioid Crisis: What Every FDA-Regulated Professional Absolutely Needs to Know

The opioid crisis is out of control and drugmakers are in the crosshairs. The President is tweeting, the FDA has launched an Opioid Task Force, lawsuits are sprouting in courthouses across the land, and even local governments (Chicago is one) are investigating.

Could negative publicity bring down Big Pharma the way it did Big Tobacco? Why wait to find out?

A a lawyer with deep experience advising FDA-regulated companies on opioids offers down-to-earth advice on what to do now.

Prof. Rosalind B. Termini Esq., an expert on the opioid crisis, direct-to-consumer advertising and corporate prosecution and accountability, surveys threats present and prospective. In just 90 fast-paced minutes you’ll get up to speed on:

  • False Claims Act crackdowns on GMP violations and opioid overprescribing
  • DEA enforcement threats, possibly including disclosure of proprietary data
  • Impact of the McCaskill Senate probe of donations by U.S. opioid manufacturers
  • Local investigations, such as in Chicago, of opioid manufacturers
  • Lawsuits at state, local and tribal levels
  • Opioid deterrents: A path to possible profits
  • Off-label liability and how to avoid it
  • The Gottlieb opioid task force: New regulations, warnings, dosage limits?
  • Developing a proactive plan for marketing and legal teams
  • And much more!

FDA Commissioner Gottlieb’s Opioid Task Force is sure to have broad impact — on regulation and more — and it’s just getting started. Drugmakers ought to heed the example of Big Tobacco, brought low by years of negative publicity. This learning session is the first so far to address the opioid crisis in terms FDA-regulated companies will relate to.

The opioid crisis affects nearly every sector of the economy. Drugmakers will not be alone in benefiting from this presentation. So will quality and regulatory firms, hospitals, insurers, physicians and other medical personnel, shippers (i.e. FedEx, UPS) … the list goes on. Pay special heed if your job title touches on:

  • Regulatory affairs/compliance
  • Quality control
  • Risk management
  • Product development/product assurance
  • Sales/marketing
  • Strategic planning
  • Scientists

Roseann B. Termini Esq. is a noted member of the FDA bar and author of Food and Drug Law Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Personal Care Products, Dietary Supplements, Veterinary and Tobacco Products ( In her practice she has focused on the opioid crisis, direct-to-consumer advertising and corporate prosecution and accountability. She teaches Food and Drug Law at Delaware Law School, Widener University and has developed online food and drug law courses for executive regulatory graduate programs. A founding member of the Center for Pharmaceutical Health Services Research, she serves as its Health Law Committee vice chair. She is a frequent speaker on food and drug law topics nationally and internationally.