CASE STUDY

OTC Drug Recalls: Prudent Steps to Prepare your Company for When it all Goes Sideways

February 26, 2021 3:00pm

Todd H. Halpern
Assistant General Counsel
GlaxoSmithKline

Ryan Gooley
Recall Consultant
Sedgwick Brand Protection Solutions

Ann Begley
Partner
Wiley Rein LLP

  • Analyzing practical, real-life examples of OTC drug recalls, e.g. ,hand sanitizer contamination, packaging and labeling concerns
    • What were the nature of these recalls?
    • What corrective actions were taken?
    • What are the lessons learned?
  • Deciphering Implications of emergency use authorizations during COVID
  • Developing an action plan for small to large scale recalls
  • Tracking products when there is a middle market of distribution e.g. hotels and airlines
  • How to handle adverse events
  • Evaluating the risks and benefits of cooperating with FDA in the course of a recall
  • Voluntary recalls versus mandatory recalls
  • What are the consequences of not instituting a recall?
    • FDA seizure and injunction power
  • Devising best practices for formulating effective recall execution strategies
  • Assessing the impact of divergent post-marketing reporting requirements for OTC drugs
  • Exploring the interaction between recalls and corrective and preventive action
  • Developing Strategies for introducing a product back to market