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