The Opioid Crisis - Webinar Recording/Transcript
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.